The Experts below are selected from a list of 669 Experts worldwide ranked by ideXlab platform

Rosa Más - One of the best experts on this subject based on the ideXlab platform.

  • Research Article Effects of Policosanol (Sugar Cane Wax Alcohols) and D-003 (Sugarcane Wax Acids) on Cyclooxygenase (Cox) Enzyme Activity In Vitro
    2014
    Co-Authors: Yohani Pérez, Rosa Más, Ámbar Oyarzábal, Sonia Jiménez, Vivian Molina
    Abstract:

    Both Policosanol and D-003 are mixtures of higher aliphatic alcohols and acids, respectively, purified from sugarcane wax, whose main components are octacosanol and octacosanoic acid (an active metabolite of octacosanol), respectively. Both substances share some, not all, pharmacological effects, like cholesterol-lowering, antiplatelet and antioxidant effects. The mechanisms whereby they exhibit cholesterol-lowering have been investigated, but those supporting their antiplatelet effects remain unknown. We hypothesized that these substances could inhibit cyclooxygenase (COX) activity. The aim of this study was to investigate whether Policosanol and D-003 may inhibit COX-1 and COX-2 enzyme activities, effects assessed in cytosolic microsomes from rat platelets and seminal vesicles, respectively. Vehicle, Policosanol or D-003 suspensions (0.6 to 6000 �g/mL) were added to tubes containing a mixture of reactions and absorbance changes at 480 nm were measured. Both Policosanol and D-003 inhibited significantly (maximal inhibition � 80%) and dose-dependently COX-1 enzyme activity (IC50 = 312.5 �g/ml and 14.84 �g/ml, respectively) by modifying both kinetic parameters, so that the inhibition was uncompetitive. D-003, not Policosanol, also inhibited significantly and dosedependently, but moderately (maximal inhibition � 54%), COX-2 activity. Concluding, Policosanol and D-003 produce marked and comparable in vitro inhibitions of COX-1 activity in rat platelet microsomes, D-003 being the most potent. D-003, not Policosanol, also inhibits moderately COX-2 activity in rat seminal vesicles

  • effect of Policosanol on lipofundin induced atherosclerotic lesions in rats
    Journal of Pharmacy and Pharmacology, 2011
    Co-Authors: Miriam Noa, Rosa Más, M C De La Rosa, J Magraner
    Abstract:

    Policosanol is a mixture of higher aliphatic alcohols isolated from sugar cane wax, showing cholesterol-lowering effects and preventing the development of lipofundin-induced lesions in New Zealand rabbits. This study was conducted to determine whether Policosanol orally administered to rats also protects against the development of lipofundin-induced atherosclerotic lesions. Fifty four male Wistar rats were randomly distributed amongst a negative control group, a positive control group intravenously injected with lipofundin for eight days, and four experimental groups also injected with lipofundin, but orally receiving Policosanol at 0·5, 2·5, 5 and 25 mg kg−1, respectively. Policosanol treatment was orally administered once-a-day for eight days, while control groups similarly received equivalent amounts of vehicle. A significant reduction of the atherosclerotic lesions in the treated animals was observed. It is concluded that Policosanol has a protective effect on lipofundin-induced aortic lesions in Wistar rats.

  • effects of combination treatment with Policosanol and omega 3 fatty acids on platelet aggregation a randomized double blind clinical study
    Current Therapeutic Research-clinical and Experimental, 2006
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Lilia Fernandez, M L Arruzazabala, Vivian Molina, Daisy Carbajal, Melbis Mesa
    Abstract:

    Background: Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with Policosanol and omega-3 FA (Ω23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone.

  • comparison of the efficacy and tolerability of Policosanol with atorvastatin in elderly patients with type ii hypercholesterolaemia
    Drugs & Aging, 2003
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, M Mesa, Lilia Fernandez, Estrella Alvarez, Magnolia Lezcay
    Abstract:

    Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5–20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10–80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins. This study was undertaken to compare the efficacy and tolerability of Policosanol with atorvastatin in older patients with type II hypercholesterolaemia. This randomised, single-blind, parallel-group study was conducted in older patients (60–80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to Policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated. At 4 (p < 0.0001) and 8 (p < 0.00001) weeks, Policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, Policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than Policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creati-nine, whereas Policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no Policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no Policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01). This study shows that Policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.

  • effects of Policosanol and lovastatin in patients with intermittent claudication a double blind comparative pilot study
    Angiology, 2003
    Co-Authors: Gladys Castano, Rosa Más, Rafael Gamez, Lilia Fernandez, Jose Illnait
    Abstract:

    Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of Policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to Policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, Policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the Policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the Policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, Policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the Policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that Policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

Julio Fernandez - One of the best experts on this subject based on the ideXlab platform.

  • a comparison of the effects of d 003 and Policosanol 5 and 10 mg day in patients with type ii hypercholesterolemia a randomized double blinded study
    Drugs Under Experimental and Clinical Research, 2005
    Co-Authors: G Castano, R Mas, L Fernandez, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Julio Fernandez, M Mesa
    Abstract:

    The main goal of hypercholesterolemia management for coronary prevention is to reduce serum low-density lipoprotein cholesterol (LDL-C) levels. D-003 is a mixture of high molecular weight aliphatic acids purified from sugarcane wax, while Policosanol is a cholesterol-lowering drug purified from the same source, consisting in a mixture of higher aliphatic alcohols. No previous comparative study of both drugs in humans has been reported. This randomized, double-blind study compares the efficacy and tolerability of D-003 and Policosanol (5 and 10 mg/day) in patients with type II hypercholesterolemia. After a baseline period, 100 patients were randomized to D-003 or Policosanol both at 5 mg/day and 10 mg/day, for 8 weeks. D-003 and Policosanol 5 mg/day reduced (p or = 15% (22/25, 88%) was greater (p < 0.01) than with Policosanol (5 mg/day) (19/25, 76%), and the same was true for D-003 10 mg/day (25/25, 100%) and Policosanol (22/25, 88%; p < 0.01). D-003 and Policosanol (5 mg/day) also lowered (p < 0.001) total cholesterol (TC) (16.2% and 13.5%, respectively), and increased high-density lipoprotein cholesterol (HDL-C) by 15.3% (D-003) and 6.7% (Policosanol). At 10 mg/day, D-003 and Policosanol reduced (p < 0.001) TC (21.3% and 16.0%, respectively), while HDL-C was increased by 17.3% and 9.8%, respectively, D-003 being more effective than Policosanol. Treatments did not affect triglycerides. Both drugs were well tolerated, with D-003 tolerated as well as Policosanol. Three patients discontinued the study, none due to adverse events (AEs). Seven patients (three from the D-003 group and four from the Policosanol group) experienced mild AEs. In conclusion, D-003 (5 and 10 mg/day) administered to patients with type II hypercholesterolemia was more effective than Policosanol in lowering LDL-C and TC, and in increasing HDL-C. D-003 could be useful for treating type II hypercholesterolemia, but this subject deserves further clinical research.

  • comparison of two regimens of Policosanol administered at 20 mg d in patients with type ii hypercholesterolemia a randomized double blind placebo controlled study
    Current Therapeutic Research-clinical and Experimental, 2001
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Rafael Gamez, Lilia Fernandez, Julio Fernandez
    Abstract:

    Background: Policosanol is a mixture of higher primary aliphatic alcohols purified from sugar cane wax that has demonstrated dose-dependent cholesterol-lowering effects in patients with type II hypercholesterolemia and dyslipidemia associated with non-insulin-dependent diabetes mellitus. The 20 mg/d dosage is particularly useful for patients at high coronary risk and to date this dosage has been administered as two 10-mg tablets once daily. Objective: This 8-week study was undertaken to compare the cholesterol-lowering effects and tolerability of 2 dosing regimens of Policosanol 20 mg/d: two 10-mg tablets versus one 20-mg tablet taken once daily with the evening meal. Methods: In this randomized, double-blind, placebo-controlled study, after 4 weeks of dietary stabilization, 62 patients with type II hypercholesterolemia were randomly assigned in a 1:1:1 ratio to receive 2 placebo tablets, 2 Policosanol 10-mg tablets, or 1 Policosanol 20-mg tablet plus 1 matched placebo tablet. Physical examinations were performed and lipid profiles and blood samples were obtained at baseline and after 4 and 8 weeks of therapy. The incidence of adverse events (AEs) and compliance with study medications were also evaluated at week 4 and week 8 of treatment. Results: The 2 Policosanol 20 mg/d regimens were similarly effective. Policosanol administered as two 10-mg tablets significantly reduced total cholesterol (TC) (16.0%, P < 0.001 vs baseline), low-density lipoprotein cholesterol (LDL-C) (35.9%, P < 0.001), as well as the TC:high-density lipoprotein cholesterol (HDL-C) ratio (37.3%, P < 0.001) and LDL-C:HDL-C ratio (52.4%, P < 0.001). The regimen significantly increased HDL-C levels (38.0%, P < 0.001 vs baseline). The 20-mg Policosanol tablet also significantly decreased TC (20.0%), LDL-C (37.8%), TC:HDL-C ratio (39.9%), and LDL-C:HDL-C ratio (52.4%) (all P < 0.001), whereas it significantly raised HDL-C levels (39.4%, P < 0.001). Triglyceride levels did not change significantly in either group. The differences between treatment groups were not significant. No significant changes in lipid profile variables were observed in the placebo group. Both Policosanol 20 mg/d regimens were well tolerated. No drug-related clinical or blood biochemistry abnormalities were observed after 8 weeks of treatment. Five patients (8.1%) withdrew from the study, 2 from the placebo group, 2 from the 10-mg tablet group, and 1 from the 20-mg tablet group. One of these patients (in the placebo group) withdrew from the study because of an AE (duodenal ulcer). The other AEs reported during the study were mild, and the frequency of AE reports was similar in all the groups. Conclusions: These results demonstrate that Policosanol 20 mg/d is an effective and well-tolerated cholesterol-lowering regimen whether administered as a 20-mg tablet once daily or two 10-mg tablets once daily with the evening meal.

  • comparison of the efficacy safety and tolerability of Policosanol versus fluvastatin in elderly hypercholesterolaemic women
    Clinical Drug Investigation, 2001
    Co-Authors: Julio Fernandez, Rosa Más, Roberto Menéndez, R.m. González, A.m. Amor, Gladys Castano, E Alvarez
    Abstract:

    To compare the efficacy and tolerability of Policosanol with that of fluvastatin in older hypercholesterolaemic women. Randomised, single-blind, parallel-group study performed at a single centre in Cuba. 70 women aged 60 to 80 years with type II hypercholesterolaemia. Patients were randomised after 4 weeks’ dietary stabilisation on a step-one cholesterol-lowering diet to treatment with Policosanol (10mg) or fluvastatin (20mg) tablets once daily for 8 weeks. Policosanol significantly lowered low density lipoprotein cholesterol (LDL-C) [29.2%, p < 0.001], total cholesterol (TC) [19.3%, p <0.001], triglycerides (7%, p < 0.05) and the ratios of LDL-C (39.8%, p < 0.001) and TC (31.6%, p < 0.001) to high density lipoprotein cholesterol (HDL-C), and significantly increased HDL-C (19.8%, p < 0.001). Fluvastatin significantly lowered LDL-C (22.9%, p < 0.001), TC (16.7%, p < 0.001), triglycerides (8.2%, p < 0.05), LDL-C/HDL-C (28.4%, p < 0.001) and TC/HDL-C (22.8%, p < 0.001), and significantly increased HDL-C (9.2%, p < 0.001). Policosanol was more effective than fluvastatin in reducing LDL-C (p < 0.01), TC/HDL-C (p < 0.01) and LDL-C/HDL-C (p < 0.001) as well as in increasing HDL-C (p < 0.01). Policosanol, but not fluvastatin, significantly increased lag time for LDL lipid peroxidation (36.5%, p < 0.001) and significantly decreased the diene peroxidation rate (15.5%, p < 0.05). Both treatments were well tolerated. Five fluvastatin, but no Policosanol, recipients discontinued the study, three because of adverse events (chest pain and gastric discomfort, skin rash, and dizziness). Overall, three Policosanol and five fluvastatin recipients reported adverse events during the study. The cholesterol-lowering effects of Policosanol 10 mg/day administered for 8 weeks to older women with type II hypercholesterolaemia were slightly better than those of fluvastatin 20 mg/day with respect to the extent of the changes in LDL-C, atherogenic indices and HDL-C levels. In addition, Policosanol, but not fluvastatin, significantly inhibited the susceptibility of LDL to undergo lipid peroxidation in this particular study population. Nevertheless, further studies in larger populations and with higher dosages must be conducted to corroborate the present results.

  • a long term study of Policosanol in the treatment of intermittent claudication
    Angiology, 2001
    Co-Authors: Gladys Castano, Jose Illnait, Rafael Gamez, Rosa Mas Ferreiro, Lilia Fernandez, Julio Fernandez
    Abstract:

    Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. This study was undertaken to investigate the long-term effects of Policosanol administered to patients with moderately severe intermittent claudication. The study consisted of a 6-week single-blind, placebo-controlled run in phase, followed by a 2-year double-blind, randomized treatment step. Fifty-six patients who met study entry criteria were randomized to receive placebo or Policosanol 10 mg twice daily. Walking distances on a treadmill (constant speed 3.2 km/h, slope 10 degrees, temperature 25 degrees C) were assessed before and after 6, 12, 18, and 24 months of treatment. Both groups were similar at randomization. After 6 months of therapy, Policosanol significantly increased (p 50% (p < 0.001). Policosanol, but not placebo, significantly increased the ankle/arm pressure index. In addition, from month 6 up to study completion, the frequency of patients reporting improvement of lower limb symptoms was greater in the Policosanol group than in the placebo group. The treatment was tolerated well. There were 16 withdrawals (12 placebo, 4 Policosanol) from the study. Eight patients in the placebo group experienced a total of 10 serious adverse events, 8 of which were vascular events, compared with none in the Policosanol group (p < 0.01). In addition, 3 patients in the Policosanol group and 3 patients in the placebo group reported mild adverse events during the study. The present results demonstrate the long-term usefulness of Policosanol therapy to treat patients with intermittent claudication.

  • effects of Policosanol treatment on the susceptibility of low density lipoprotein ldl isolated from healthy volunteers to oxidative modification in vitro
    British Journal of Clinical Pharmacology, 2000
    Co-Authors: Roberto Menéndez, Rosa Más, Idania Rodeiro, Rosa Ma. González, Julio Fernandez, Ana Ma Amor, Mirta Zayas, Sonia Jiménez
    Abstract:

    Aims The aim of this study was to investigate the effect of Policosanol on the susceptibility of LDL-C to in vitro lipid peroxidation in human healthy volunteers. Methods The effect of Policosanol (5 and 10 mg day−1) on LDL-C oxidation was studied in a double-blind, randomized, placebo-controlled trial conducted in 69 subjects. LDL-C samples isolated at baseline and after 8 weeks were subjected to in vitro tests of LDL-C oxidation. We tested the susceptibility of LDL-C to lipid peroxidation in a cell-free system by the addition of copper ions as well as in a more physiological system, macrophage-mediated oxidation. Results At baseline all groups were well matched regarding all variables. After 8 weeks of therapy Policosanol administered at 5 and 10 mg, significantly and in a dose-dependent manner increased the lag phase of conjugated diene generation (mean ± s.d.) from 83.79 ± 29.16 min to 94.90 ± 25.50 min (5 mg day−1) and from 82.74 ± 17.16 min to 129.89 ± 35.71 min (10 mg day−1), while in the placebo group LDL-C oxidation did not change significantly. Policosanol (10 mg day−1), but not placebo, significantly decreased the rate of conjugated diene generation. Comparison with placebo after therapy also showed significant differences. Macrophage mediated-oxidation was also inhibited by Policosanol as evident by measuring thiobarbituric acid reactive substances (TBARS). Policosanol (10 mg day−1) significantly lowered malondialdehyde (MDA) generation from 8.50 ± 0.91 to 5.76 ± 1.01 nmol mg−1 protein. Comparison with placebo after 5 and 10 mg day−1 showed significant differences. Policosanol significantly lowered total cholesterol by 10.5% (5 mg day−1) and 12.4% (10 mg day−1) and LDL-C by 16.7% and 20.2%, respectively. Also, Policosanol (10 mg day−1) increased HDL-C by 15.2%. Five subjects withdrew from the study, none because of adverse experiences. No clinical or blood biochemical drug-related disturbances were found. Conclusions The present study demonstrated that Policosanol administered within its therapeutic dosage for lowering cholesterol (5 and 10 mg day−1), decreased the susceptibility of LDL-C to lipid peroxidation in vitro.

Gladys Castano - One of the best experts on this subject based on the ideXlab platform.

  • effects of combination treatment with Policosanol and omega 3 fatty acids on platelet aggregation a randomized double blind clinical study
    Current Therapeutic Research-clinical and Experimental, 2006
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Lilia Fernandez, M L Arruzazabala, Vivian Molina, Daisy Carbajal, Melbis Mesa
    Abstract:

    Background: Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with Policosanol and omega-3 FA (Ω23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone.

  • effects of Policosanol and lovastatin in patients with intermittent claudication a double blind comparative pilot study
    Angiology, 2003
    Co-Authors: Gladys Castano, Rosa Más, Rafael Gamez, Lilia Fernandez, Jose Illnait
    Abstract:

    Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of Policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to Policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, Policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the Policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the Policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, Policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the Policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that Policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

  • comparison of the efficacy and tolerability of Policosanol with atorvastatin in elderly patients with type ii hypercholesterolaemia
    Drugs & Aging, 2003
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, M Mesa, Lilia Fernandez, Estrella Alvarez, Magnolia Lezcay
    Abstract:

    Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5–20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10–80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins. This study was undertaken to compare the efficacy and tolerability of Policosanol with atorvastatin in older patients with type II hypercholesterolaemia. This randomised, single-blind, parallel-group study was conducted in older patients (60–80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to Policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated. At 4 (p < 0.0001) and 8 (p < 0.00001) weeks, Policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, Policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than Policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creati-nine, whereas Policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no Policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no Policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01). This study shows that Policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.

  • antiplatelet effects of Policosanol 20 and 40 mg day in healthy volunteers and dyslipidaemic patients
    Clinical and Experimental Pharmacology and Physiology, 2002
    Co-Authors: M L Arruzazabala, Rosa Más, Lilia Fernandez, Vivian Molina, Daisy Carbajal, S Valdes, Gladys Castano
    Abstract:

    1. The present study was undertaken to compare the effects of a higher dose of Policosanol, a cholesterol-lowering drug, (40 mg/day) with the effects of 20 mg/day Policosanol on platelet aggregation in healthy volunteers and type II hypercholesterolaemic patients. 2. Study subjects were randomized to receive, under double-blind conditions, placebo or Policosanol (20 or 40 mg/day) for 30 days once a day. Blood sampling was performed at baseline and after 30 days on therapy. 3. Platelet aggregation was induced with three aggregating agents: arachidonic acid (AA), collagen and low doses of ADP. 4. Policosanol (20 and 40 mg/day) moderately yet significantly reduced platelet aggregation, but no differences were observed in the effects produced by either dose of Policosanol. In healthy volunteers, Policosanol at 20 and 40 mg/day inhibited aggregation induced by 2 mmol/L AA (28.2 and 24.9%, respectively), 1 micro g/mL collagen (21.1 and 20.2%) and 1 micro mol/L ADP (30.9 and 29.1%). Changes that occurred following the administration of placebo were not significant, although an upward trend for collagen- and ADP-induced aggregation occurred in normal and hypercholesterolaemic subjects, respectively, thus partially masking the effects of Policosanol on these responses. 5. The antiplatelet effects of Policosanol at 20 and 40 mg/day in hypercholesterolaemic patients were also similar, so that both doses inhibited aggregation induced by 1.5 mmol/L AA (20.1 and 33.0%, respectively), 0.5 micro g/mL collagen (22.7 and 21.1%) and 1 micro mol/L ADP (40.5 and 34.7%). 6. In addition, after 30 days of therapy, 20 and 40 mg/day Policosanol significantly (P < 0.01) reduced low-density lipoprotein-cholesterol (15.9 and 17.0%, respectively) and total cholesterol (12.4 and 12.3%, respectively; P < 0.05), yet increased high-density lipoprotein-cholesterol values by 5% in both groups (P < 0.05). 7. Triglycerides were decreased compared with baseline, but not with respect to the placebo. 8. We conclude that the antiplatelet effects induced by 40 mg/day Policosanol administered for 30 days to healthy volunteers and to hypercholesterolaemic patients were similar to the effects induced by 20 mg/day Policosanol. Thus, no enhancement of the response was achieved with the use of a higher dose of Policosanol in study patients.

  • effects of Policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia associated with type 2 diabetes mellitus
    International Journal of Clinical Pharmacology Research, 2002
    Co-Authors: Gladys Castano, Rosa Más, Roberto Menéndez, A.m. Amor, Magnolia Lezcay, J L Fernandez, R L Gonzalez, E Alvarez
    Abstract:

    In this pilot, randomized, double-blind study, we compared the effects of Policosanol and lovastatin on lipid profile and lipid peroxidation in patients with dyslipidemia and type 2 diabetes mellitus. After 4 weeks on a cholesterol-lowering diet, 36 patients were randomized to Policosanol (10 mg/day) or lovastatin (20 mg/day) tablets o.i.d. for 8 weeks. Policosanol significantly (p < 0.001) lowered serum low-density lipoprotein-cholesterol (LDL-C) (29.9%), total cholesterol (21.1%), triglycerides (13.6%) and the LDL-C/high-density lipoprotein-cholesterol (HDL-C) (36.7%) and total cholesterol/HDL-C (28.9%) ratios and significantly (p < 0.01) increased HDL-C (12.5%). Lovastatin significantly (p < 0.001) lowered LDL-C (25%), total cholesterol (18%), triglycerides (10.9%) and the LDL-C/HDL-C (30.4%) and total cholesterol/HDL-C ratios (23.9%) and significantly (p < 0.01) raised HDL-C (8.3%). Policosanol was more effective (p < 0.05) than lovastatin in reducing both ratios and in increasing (p < 0.05) HDL-C. Policosanol, but not lovastatin, significantly raised the lag time (20.9%) of Cu+2-induced LDL peroxidation and total plasma antioxidant activity (24.2%) (p < 0.05). Both Policosanol and lovastatin significantly decreased the propagation rate (41.9% and 41.6% respectively, p < 0.001), maximal diene production (8.3% and 5.7%) and plasma levels of thiobarbituric acid reactive substances (9.7% and 11.5%, p < 0.001). Both treatments were well tolerated. Only one patient in the lovastatin group withdrew from the trial due to adverse events. In conclusion, Policosanol and lovastatin administered short term to patients with dyslipidemia secondary to type 2 diabetes were effective in lowering cholesterol and in inhibiting the extent of lipid peroxidation. Policosanol (10 mg/day) was slightly more effective than lovastatin (20 mg/day) in reducing the LDL-C/HDL-C and total cholesterol/HDL-C ratios, in increasing HDL-C levels and in preventing LDL oxidation. Nevertheless, since this was a pilot study, further clinical studies performed in larger sample sizes of diabetic patients are needed for definitive conclusions.

Jose Illnait - One of the best experts on this subject based on the ideXlab platform.

  • effects of combination treatment with Policosanol and omega 3 fatty acids on platelet aggregation a randomized double blind clinical study
    Current Therapeutic Research-clinical and Experimental, 2006
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Lilia Fernandez, M L Arruzazabala, Vivian Molina, Daisy Carbajal, Melbis Mesa
    Abstract:

    Background: Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with Policosanol and omega-3 FA (Ω23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone.

  • a comparison of the effects of d 003 and Policosanol 5 and 10 mg day in patients with type ii hypercholesterolemia a randomized double blinded study
    Drugs Under Experimental and Clinical Research, 2005
    Co-Authors: G Castano, R Mas, L Fernandez, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Julio Fernandez, M Mesa
    Abstract:

    The main goal of hypercholesterolemia management for coronary prevention is to reduce serum low-density lipoprotein cholesterol (LDL-C) levels. D-003 is a mixture of high molecular weight aliphatic acids purified from sugarcane wax, while Policosanol is a cholesterol-lowering drug purified from the same source, consisting in a mixture of higher aliphatic alcohols. No previous comparative study of both drugs in humans has been reported. This randomized, double-blind study compares the efficacy and tolerability of D-003 and Policosanol (5 and 10 mg/day) in patients with type II hypercholesterolemia. After a baseline period, 100 patients were randomized to D-003 or Policosanol both at 5 mg/day and 10 mg/day, for 8 weeks. D-003 and Policosanol 5 mg/day reduced (p or = 15% (22/25, 88%) was greater (p < 0.01) than with Policosanol (5 mg/day) (19/25, 76%), and the same was true for D-003 10 mg/day (25/25, 100%) and Policosanol (22/25, 88%; p < 0.01). D-003 and Policosanol (5 mg/day) also lowered (p < 0.001) total cholesterol (TC) (16.2% and 13.5%, respectively), and increased high-density lipoprotein cholesterol (HDL-C) by 15.3% (D-003) and 6.7% (Policosanol). At 10 mg/day, D-003 and Policosanol reduced (p < 0.001) TC (21.3% and 16.0%, respectively), while HDL-C was increased by 17.3% and 9.8%, respectively, D-003 being more effective than Policosanol. Treatments did not affect triglycerides. Both drugs were well tolerated, with D-003 tolerated as well as Policosanol. Three patients discontinued the study, none due to adverse events (AEs). Seven patients (three from the D-003 group and four from the Policosanol group) experienced mild AEs. In conclusion, D-003 (5 and 10 mg/day) administered to patients with type II hypercholesterolemia was more effective than Policosanol in lowering LDL-C and TC, and in increasing HDL-C. D-003 could be useful for treating type II hypercholesterolemia, but this subject deserves further clinical research.

  • effects of Policosanol and lovastatin in patients with intermittent claudication a double blind comparative pilot study
    Angiology, 2003
    Co-Authors: Gladys Castano, Rosa Más, Rafael Gamez, Lilia Fernandez, Jose Illnait
    Abstract:

    Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of Policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to Policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, Policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the Policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the Policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, Policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the Policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that Policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

  • comparison of the efficacy and tolerability of Policosanol with atorvastatin in elderly patients with type ii hypercholesterolaemia
    Drugs & Aging, 2003
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, M Mesa, Lilia Fernandez, Estrella Alvarez, Magnolia Lezcay
    Abstract:

    Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5–20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10–80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins. This study was undertaken to compare the efficacy and tolerability of Policosanol with atorvastatin in older patients with type II hypercholesterolaemia. This randomised, single-blind, parallel-group study was conducted in older patients (60–80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to Policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated. At 4 (p < 0.0001) and 8 (p < 0.00001) weeks, Policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, Policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than Policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creati-nine, whereas Policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no Policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no Policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01). This study shows that Policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.

  • effects of Policosanol in older patients with type ii hypercholesterolemia and high coronary risk
    Journals of Gerontology Series A-biological Sciences and Medical Sciences, 2001
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Lilia Fernandez, Juan Carlos Palma Fernandez, Estrella Alvarez
    Abstract:

    Background. The present study was undertaken to investigate the effects of Policosanol in older patients with type II hypercholesterolemia and more than one concomitant atherosclerotic risk factor. Methods. After 6 weeks on a lipid-lowering diet, 179 patients randomly received a placebo or Policosanol at doses of 5 followed by 10 mg per day for successive 12-week periods of each dose. Policosanol (5 and 10 mg/d) significantly ( p , .001) reduced low-density lipoprotein cholesterol (LDL-C; 16.9% and 24.4%, respectively) and total cholesterol (TC; 12.8% and 16.2%, respectively), while significantly ( p , .01) increasing ( p , .001) high-density lipoprotein cholesterol (HDL-C) by 14.6% and 29.1%, respectively. Results. Policosanol significantly decreased ( p , .01) the ratios of LDL-C to HDL-C (29.1%) and TC to HDL-C (28%) at study completion, although triglycerides remained unchanged. Policosanol, but not the placebo, significantly improved ( p .01) cardiovascular capacity, which was assessed using the Specific Activity Scale. No serious adverse experiences occurred in Policosanol patients ( p , .01), compared with seven adverse experiences (7.9%) reported by placebo patients. Conclusions. This study shows that Policosanol is effective, safe, and well tolerated in older hypercholesterolemic patients.

Lilia Fernandez - One of the best experts on this subject based on the ideXlab platform.

  • effects of combination treatment with Policosanol and omega 3 fatty acids on platelet aggregation a randomized double blind clinical study
    Current Therapeutic Research-clinical and Experimental, 2006
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Sarahi Mendoza, Rafael Gamez, Lilia Fernandez, M L Arruzazabala, Vivian Molina, Daisy Carbajal, Melbis Mesa
    Abstract:

    Background: Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with Policosanol and omega-3 FA (Ω23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone.

  • comparison of the efficacy and tolerability of Policosanol with atorvastatin in elderly patients with type ii hypercholesterolaemia
    Drugs & Aging, 2003
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, M Mesa, Lilia Fernandez, Estrella Alvarez, Magnolia Lezcay
    Abstract:

    Hypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5–20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10–80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins. This study was undertaken to compare the efficacy and tolerability of Policosanol with atorvastatin in older patients with type II hypercholesterolaemia. This randomised, single-blind, parallel-group study was conducted in older patients (60–80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to Policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated. At 4 (p < 0.0001) and 8 (p < 0.00001) weeks, Policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, Policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than Policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creati-nine, whereas Policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no Policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no Policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01). This study shows that Policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.

  • effects of Policosanol and lovastatin in patients with intermittent claudication a double blind comparative pilot study
    Angiology, 2003
    Co-Authors: Gladys Castano, Rosa Más, Rafael Gamez, Lilia Fernandez, Jose Illnait
    Abstract:

    Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of Policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to Policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, Policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the Policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the Policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, Policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the Policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that Policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

  • antiplatelet effects of Policosanol 20 and 40 mg day in healthy volunteers and dyslipidaemic patients
    Clinical and Experimental Pharmacology and Physiology, 2002
    Co-Authors: M L Arruzazabala, Rosa Más, Lilia Fernandez, Vivian Molina, Daisy Carbajal, S Valdes, Gladys Castano
    Abstract:

    1. The present study was undertaken to compare the effects of a higher dose of Policosanol, a cholesterol-lowering drug, (40 mg/day) with the effects of 20 mg/day Policosanol on platelet aggregation in healthy volunteers and type II hypercholesterolaemic patients. 2. Study subjects were randomized to receive, under double-blind conditions, placebo or Policosanol (20 or 40 mg/day) for 30 days once a day. Blood sampling was performed at baseline and after 30 days on therapy. 3. Platelet aggregation was induced with three aggregating agents: arachidonic acid (AA), collagen and low doses of ADP. 4. Policosanol (20 and 40 mg/day) moderately yet significantly reduced platelet aggregation, but no differences were observed in the effects produced by either dose of Policosanol. In healthy volunteers, Policosanol at 20 and 40 mg/day inhibited aggregation induced by 2 mmol/L AA (28.2 and 24.9%, respectively), 1 micro g/mL collagen (21.1 and 20.2%) and 1 micro mol/L ADP (30.9 and 29.1%). Changes that occurred following the administration of placebo were not significant, although an upward trend for collagen- and ADP-induced aggregation occurred in normal and hypercholesterolaemic subjects, respectively, thus partially masking the effects of Policosanol on these responses. 5. The antiplatelet effects of Policosanol at 20 and 40 mg/day in hypercholesterolaemic patients were also similar, so that both doses inhibited aggregation induced by 1.5 mmol/L AA (20.1 and 33.0%, respectively), 0.5 micro g/mL collagen (22.7 and 21.1%) and 1 micro mol/L ADP (40.5 and 34.7%). 6. In addition, after 30 days of therapy, 20 and 40 mg/day Policosanol significantly (P < 0.01) reduced low-density lipoprotein-cholesterol (15.9 and 17.0%, respectively) and total cholesterol (12.4 and 12.3%, respectively; P < 0.05), yet increased high-density lipoprotein-cholesterol values by 5% in both groups (P < 0.05). 7. Triglycerides were decreased compared with baseline, but not with respect to the placebo. 8. We conclude that the antiplatelet effects induced by 40 mg/day Policosanol administered for 30 days to healthy volunteers and to hypercholesterolaemic patients were similar to the effects induced by 20 mg/day Policosanol. Thus, no enhancement of the response was achieved with the use of a higher dose of Policosanol in study patients.

  • effects of Policosanol in older patients with type ii hypercholesterolemia and high coronary risk
    Journals of Gerontology Series A-biological Sciences and Medical Sciences, 2001
    Co-Authors: Gladys Castano, Rosa Más, Jose Illnait, Lilia Fernandez, Juan Carlos Palma Fernandez, Estrella Alvarez
    Abstract:

    Background. The present study was undertaken to investigate the effects of Policosanol in older patients with type II hypercholesterolemia and more than one concomitant atherosclerotic risk factor. Methods. After 6 weeks on a lipid-lowering diet, 179 patients randomly received a placebo or Policosanol at doses of 5 followed by 10 mg per day for successive 12-week periods of each dose. Policosanol (5 and 10 mg/d) significantly ( p , .001) reduced low-density lipoprotein cholesterol (LDL-C; 16.9% and 24.4%, respectively) and total cholesterol (TC; 12.8% and 16.2%, respectively), while significantly ( p , .01) increasing ( p , .001) high-density lipoprotein cholesterol (HDL-C) by 14.6% and 29.1%, respectively. Results. Policosanol significantly decreased ( p , .01) the ratios of LDL-C to HDL-C (29.1%) and TC to HDL-C (28%) at study completion, although triglycerides remained unchanged. Policosanol, but not the placebo, significantly improved ( p .01) cardiovascular capacity, which was assessed using the Specific Activity Scale. No serious adverse experiences occurred in Policosanol patients ( p , .01), compared with seven adverse experiences (7.9%) reported by placebo patients. Conclusions. This study shows that Policosanol is effective, safe, and well tolerated in older hypercholesterolemic patients.