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Roberto Fogari - One of the best experts on this subject based on the ideXlab platform.
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Combination Delapril/Manidipine as Antihypertensive Therapy in High-Risk Patients
Clinical Drug Investigation, 2011Co-Authors: Roberto Fogari, Amedeo Mugellini, Maria Circelli, Giovanni CremonesiAbstract:The majority of patients with hypertension, and in particular high-risk patients or those with diabetes mellitus or renal dysfunction, are likely to require combination therapy with at least two antihypertensive agents (from different classes) to achieve their blood pressure (BP) target. The delapril/Manidipine fixed-dose combination consists of two antihypertensive agents with different, yet complementary, mechanisms of action. Delapril/Manidipine has demonstrated short- and long-term antihypertensive efficacy in a number of clinical studies in patients with hypertension with an inadequate response to monotherapy. Comparative studies have demonstrated that delapril/Manidipine is as effective as enalapril/hydrochlorothiazide (HCTZ) in patients with hypertension with an inadequate response to monotherapy, and as effective as irbesartan/HCTZ, losartan/HCTZ, olmesartan medoxomil/HCTZ, ramipril/HCTZ and valsartan/HCTZ in reducing BP in patients with hypertension and diabetes, or in obese patients with hypertension. Therapy with delapril/Manidipine also appears to exert beneficial effects that extend beyond a reduction in BP, including nephroprotective activity and an improvement in fibrinolytic balance, supporting its value as a treatment option in these patient populations at high or very high cardiovascular risk because of the presence of organ damage, diabetes or renal disease.
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efficacy of Manidipine delapril versus losartan hydrochlorothiazide fixed combinations in patients with hypertension and diabetes
Journal of Hypertension, 2008Co-Authors: Alejandro Rocacusachs, Roland E. Schmieder, Filippos Triposkiadis, René R. Wenzel, Stéphane Laurent, Osvaldo Kohlmann, Roberto FogariAbstract:BACKGROUND Hypertension markedly increases the already high risk for cardiovascular complications in patients with diabetes mellitus. Less than one in eight patients with hypertension and type 2 diabetes have adequately controlled blood pressure. As a result, antihypertensive combinations are now widely used in management of hypertension associated with diabetes. METHODS This double-blind study investigated efficacy of a new fixed dose combination of a calcium antagonist, Manidipine 10 mg, and an angiotensin-converting enzyme inhibitor, delapril 30 mg, compared with a combination of an angiotensin receptor blocker, losartan 50 mg, and a diuretic, hydrochlorothiazide 12.5 mg. Patients with hypertension (blood pressure > or = 130/80 mmHg) with controlled type 2 diabetes (HbA1c < or = 7.5%) were randomized to Manidipine/delapril (n = 153) or losartan/hydrochlorothiazide (n = 161), administered once daily for 12 weeks. Patients underwent ambulatory blood pressure monitor evaluation at baseline and end of treatment. RESULTS Mean decreases in 24-h systolic blood pressure were seen with both Manidipine/delapril (-9.3 mmHg) and losartan/hydrochlorothiazide (-10.7 mmHg) combinations. The mean (95% confidence interval) treatment difference was -1.4 (-4.5/1.8) mmHg, demonstrating noninferiority of the Manidipine/delapril combination. Reduction in 24-h diastolic blood pressure (-4.6 versus -4.5 mmHg) and daytime (systolic blood pressure -10.5 versus -11.1 mmHg) and night-time (systolic blood pressure -7.1 versus -9.3 mmHg) blood pressure were also not significantly different between treatments. Compliance and adverse events were comparable for both groups. CONCLUSION The study demonstrated that the combination of Manidipine and delapril is as effective as losartan and hydrochlorothiazide in treatment of hypertension in type 2 diabetes.
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effect of delapril Manidipine vs olmesartan hydrochlorothiazide combination on insulin sensitivity and fibrinogen in obese hypertensive patients
Internal Medicine, 2008Co-Authors: Roberto Fogari, A Zoppi, L Corradi, G Derosa, P Lazzari, Paola Preti, Amedeo MugelliniAbstract:Objective To compare the effect of delapril/Manidipine vs olmesartan/hydrochlorothiazide (HCTZ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients. Patients and Methods After a 4-week placebo period, 88 obese, hypertensive (DBP >95 and <110 mmHg) outpatients were randomized to delapril 30 mg/Manidipine 10 mg combination or to olmesartan 20 mg/HCTZ 12.5 mg combination for 24 weeks according to a prospective, randomized, open-label, blinded endpoint, parallel group design. At the end of the placebo period and treatment period, clinical BP, fasting plasma glucose (FPG), plasma insulin, insulin sensitivity (by euglycemic hyperinsulinemic clamp) and plasma fibrinogen were evaluated. Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes (glucose infusion rate, GIR) in mg/Kg/min. The total glucose requirement (TGR) to maintain a steady-state blood glucose level in response to a defined increase in plasma insulin concentration was also evaluated. Results Both combinations significantly reduced SBP/DBP values (-22.3/16.4 mmHg and -22.6/17.2 mmHg, respectively, all p <0.001 vs placebo). GIR was significantly increased only by delapril/Manidipine (+3.01 mg/min/Kg, p=0.038 vs placebo), the difference between treatments being significant (p <0.05). TGR was significantly increased by delapril/Manidipine (+9.7 g, p=0.034), while it was unaffected by olmesartan/HCTZ. Plasma insulin as well as fibrinogen were significantly reduced by delapril/Manidipine (-17.8 pmol/l, p=0.047 and -67.5 mg/dl, p=0.021, respectively), but not by olmesartan/HCTZ, the difference between the two treatments being statistically significant (p <0.05). Conclusion In obese hypertensive patients the delapril/Manidipine combination but not the olmesartan/HCTZ combination significantly decreased insulin resistance and plasma fibrinogen levels, despite the similar BP lowering efficacy.
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Efficacy of Manidipine/delapril versus losartan/hydrochlorothiazide fixed combinations in patients with hypertension and diabetes.
Journal of hypertension, 2008Co-Authors: Alejandro Roca-cusachs, Roland E. Schmieder, Filippos Triposkiadis, René R. Wenzel, Stéphane Laurent, Osvaldo Kohlmann, Roberto FogariAbstract:BACKGROUND Hypertension markedly increases the already high risk for cardiovascular complications in patients with diabetes mellitus. Less than one in eight patients with hypertension and type 2 diabetes have adequately controlled blood pressure. As a result, antihypertensive combinations are now widely used in management of hypertension associated with diabetes. METHODS This double-blind study investigated efficacy of a new fixed dose combination of a calcium antagonist, Manidipine 10 mg, and an angiotensin-converting enzyme inhibitor, delapril 30 mg, compared with a combination of an angiotensin receptor blocker, losartan 50 mg, and a diuretic, hydrochlorothiazide 12.5 mg. Patients with hypertension (blood pressure > or = 130/80 mmHg) with controlled type 2 diabetes (HbA1c < or = 7.5%) were randomized to Manidipine/delapril (n = 153) or losartan/hydrochlorothiazide (n = 161), administered once daily for 12 weeks. Patients underwent ambulatory blood pressure monitor evaluation at baseline and end of treatment. RESULTS Mean decreases in 24-h systolic blood pressure were seen with both Manidipine/delapril (-9.3 mmHg) and losartan/hydrochlorothiazide (-10.7 mmHg) combinations. The mean (95% confidence interval) treatment difference was -1.4 (-4.5/1.8) mmHg, demonstrating noninferiority of the Manidipine/delapril combination. Reduction in 24-h diastolic blood pressure (-4.6 versus -4.5 mmHg) and daytime (systolic blood pressure -10.5 versus -11.1 mmHg) and night-time (systolic blood pressure -7.1 versus -9.3 mmHg) blood pressure were also not significantly different between treatments. Compliance and adverse events were comparable for both groups. CONCLUSION The study demonstrated that the combination of Manidipine and delapril is as effective as losartan and hydrochlorothiazide in treatment of hypertension in type 2 diabetes.
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effects of Manidipine delapril versus olmesartan hydrochlorothiazide combination therapy in elderly hypertensive patients with type 2 diabetes mellitus
Hypertension Research, 2008Co-Authors: Roberto Fogari, A Zoppi, G Derosa, P Lazzari, Paola Preti, Andrea Rinaldi, Amedeo MugelliniAbstract:The purpose of this study was to compare the combination treatments of Manidipine/delapril and olmesartan/hydrochlorothiazide (HCTZ) in elderly diabetic hypertensives. After a 4-week placebo period, 158 hypertensive patients with type 2 diabetes (age range: 66 to 74 years) were randomized to receive combination treatment of 10 mg Manidipine plus 30 mg delapril or 20 mg olmesartan plus 12.5 mg HCTZ for 48 weeks in a prospective, parallel arm trial. After 12 weeks, Manidipine or HCTZ was doubled in nonresponders (systolic blood pressure [SBP] ≥130 mmHg and/or diastolic blood pressure [DBP] ≥80 mmHg). Patients were checked at the end of the placebo period and every 12 weeks thereafter. At each visit, lying, sitting and standing BP as well as fasting glycemia, glycosylated hemoglobin (HbA1c), electrolytes, uric acid, total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG) were evaluated. Both combinations reduced sitting SBP (−27.7 and −28.3 mmHg, respectively; both p<0.001) and DBP (−15.1 and −14.8 mmHg, respectively; both p<0.01) with no difference between the two treatments. Standing DBP was more markedly reduced by olmesartan/HCTZ (−19.5 mmHg; p<0.001) than by Manidipine/delapril (−14.7 mmHg; p<0.05 vs. olmesartan/HCTZ). No changes in metabolic parameters were observed with Manidipine/delapril, whereas an increase in HbA1c (+0.7%; p<0.05), uric acid (+0.4 mg/dL; p<0.05) and TG (+41.3 mg/dL; p<0.05), and a decrease in serum potassium (−0.3 mmol/L; p<0.05) and HDL-C (−3.4 mg/dL; p<0.05) were found in the olmesartan/HCTZ group. In conclusion, both combinations were similarly effective in reducing BP in elderly hypertensive diabetic patients. However, Manidipine/delapril offered some advantages in terms of the less-pronounced BP orthostatic changes and absence of metabolic adverse effects. (Hypertens Res 2008; 31: 43−50)
Amedeo Mugellini - One of the best experts on this subject based on the ideXlab platform.
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Combination Delapril/Manidipine as Antihypertensive Therapy in High-Risk Patients
Clinical Drug Investigation, 2011Co-Authors: Roberto Fogari, Amedeo Mugellini, Maria Circelli, Giovanni CremonesiAbstract:The majority of patients with hypertension, and in particular high-risk patients or those with diabetes mellitus or renal dysfunction, are likely to require combination therapy with at least two antihypertensive agents (from different classes) to achieve their blood pressure (BP) target. The delapril/Manidipine fixed-dose combination consists of two antihypertensive agents with different, yet complementary, mechanisms of action. Delapril/Manidipine has demonstrated short- and long-term antihypertensive efficacy in a number of clinical studies in patients with hypertension with an inadequate response to monotherapy. Comparative studies have demonstrated that delapril/Manidipine is as effective as enalapril/hydrochlorothiazide (HCTZ) in patients with hypertension with an inadequate response to monotherapy, and as effective as irbesartan/HCTZ, losartan/HCTZ, olmesartan medoxomil/HCTZ, ramipril/HCTZ and valsartan/HCTZ in reducing BP in patients with hypertension and diabetes, or in obese patients with hypertension. Therapy with delapril/Manidipine also appears to exert beneficial effects that extend beyond a reduction in BP, including nephroprotective activity and an improvement in fibrinolytic balance, supporting its value as a treatment option in these patient populations at high or very high cardiovascular risk because of the presence of organ damage, diabetes or renal disease.
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effect of delapril Manidipine vs olmesartan hydrochlorothiazide combination on insulin sensitivity and fibrinogen in obese hypertensive patients
Internal Medicine, 2008Co-Authors: Roberto Fogari, A Zoppi, L Corradi, G Derosa, P Lazzari, Paola Preti, Amedeo MugelliniAbstract:Objective To compare the effect of delapril/Manidipine vs olmesartan/hydrochlorothiazide (HCTZ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients. Patients and Methods After a 4-week placebo period, 88 obese, hypertensive (DBP >95 and <110 mmHg) outpatients were randomized to delapril 30 mg/Manidipine 10 mg combination or to olmesartan 20 mg/HCTZ 12.5 mg combination for 24 weeks according to a prospective, randomized, open-label, blinded endpoint, parallel group design. At the end of the placebo period and treatment period, clinical BP, fasting plasma glucose (FPG), plasma insulin, insulin sensitivity (by euglycemic hyperinsulinemic clamp) and plasma fibrinogen were evaluated. Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes (glucose infusion rate, GIR) in mg/Kg/min. The total glucose requirement (TGR) to maintain a steady-state blood glucose level in response to a defined increase in plasma insulin concentration was also evaluated. Results Both combinations significantly reduced SBP/DBP values (-22.3/16.4 mmHg and -22.6/17.2 mmHg, respectively, all p <0.001 vs placebo). GIR was significantly increased only by delapril/Manidipine (+3.01 mg/min/Kg, p=0.038 vs placebo), the difference between treatments being significant (p <0.05). TGR was significantly increased by delapril/Manidipine (+9.7 g, p=0.034), while it was unaffected by olmesartan/HCTZ. Plasma insulin as well as fibrinogen were significantly reduced by delapril/Manidipine (-17.8 pmol/l, p=0.047 and -67.5 mg/dl, p=0.021, respectively), but not by olmesartan/HCTZ, the difference between the two treatments being statistically significant (p <0.05). Conclusion In obese hypertensive patients the delapril/Manidipine combination but not the olmesartan/HCTZ combination significantly decreased insulin resistance and plasma fibrinogen levels, despite the similar BP lowering efficacy.
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effects of Manidipine delapril versus olmesartan hydrochlorothiazide combination therapy in elderly hypertensive patients with type 2 diabetes mellitus
Hypertension Research, 2008Co-Authors: Roberto Fogari, A Zoppi, G Derosa, P Lazzari, Paola Preti, Andrea Rinaldi, Amedeo MugelliniAbstract:The purpose of this study was to compare the combination treatments of Manidipine/delapril and olmesartan/hydrochlorothiazide (HCTZ) in elderly diabetic hypertensives. After a 4-week placebo period, 158 hypertensive patients with type 2 diabetes (age range: 66 to 74 years) were randomized to receive combination treatment of 10 mg Manidipine plus 30 mg delapril or 20 mg olmesartan plus 12.5 mg HCTZ for 48 weeks in a prospective, parallel arm trial. After 12 weeks, Manidipine or HCTZ was doubled in nonresponders (systolic blood pressure [SBP] ≥130 mmHg and/or diastolic blood pressure [DBP] ≥80 mmHg). Patients were checked at the end of the placebo period and every 12 weeks thereafter. At each visit, lying, sitting and standing BP as well as fasting glycemia, glycosylated hemoglobin (HbA1c), electrolytes, uric acid, total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG) were evaluated. Both combinations reduced sitting SBP (−27.7 and −28.3 mmHg, respectively; both p<0.001) and DBP (−15.1 and −14.8 mmHg, respectively; both p<0.01) with no difference between the two treatments. Standing DBP was more markedly reduced by olmesartan/HCTZ (−19.5 mmHg; p<0.001) than by Manidipine/delapril (−14.7 mmHg; p<0.05 vs. olmesartan/HCTZ). No changes in metabolic parameters were observed with Manidipine/delapril, whereas an increase in HbA1c (+0.7%; p<0.05), uric acid (+0.4 mg/dL; p<0.05) and TG (+41.3 mg/dL; p<0.05), and a decrease in serum potassium (−0.3 mmol/L; p<0.05) and HDL-C (−3.4 mg/dL; p<0.05) were found in the olmesartan/HCTZ group. In conclusion, both combinations were similarly effective in reducing BP in elderly hypertensive diabetic patients. However, Manidipine/delapril offered some advantages in terms of the less-pronounced BP orthostatic changes and absence of metabolic adverse effects. (Hypertens Res 2008; 31: 43−50)
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Addition of Manidipine improves the antiproteinuric effect of candesartan in hypertensive patients with type II diabetes and microalbuminuria.
American journal of hypertension, 2007Co-Authors: Roberto Fogari, A Zoppi, Amedeo Mugellini, Paola Preti, Pierangelo Lazzari, Luca Corradi, Andrea RinaldiAbstract:Background We sought to compare the effect of Manidipine versus hydrochlorothiazide (HCTZ) in addition to candesartan on the urinary albumin excretion rate (UAER) in hypertensive patients with type II diabetes and microalbuminuria. Methods After a 2-week washout and run-in period, and 8-week monotherapy with candesartan 16 mg every day, 174 microalbuminuric diabetic hypertensive patients with uncontrolled blood pressure (BP) (>130/80 mm Hg) were randomized to addition of Manidipine 10 mg every day (n = 87) or HCTZ 12.5 mg every day (n = 87) for 24 weeks, with a titration after 4 weeks (Manidipine or HCTZ dose-doubling) in nonresponder patients. Blood pressure, UAER, creatinine clearance, serum electrolytes, fasting plasma glycemia, and glycosylated hemoglobin were evaluated at baseline (end of run-in period), after candesartan monotherapy, and at the end of the combination treatment period. Results Both combinations produced greater systolic BP/diastolic BP reduction than candesartan monotherapy (−28/21 mm Hg versus −16/11 mm Hg and −28/20 mm Hg versus −15/11 mm Hg, respectively; all P Conclusions These findings show that, despite equivalent reduction in BP, the addition of Manidipine to candesartan further reduced the UAER, whereas the addition of HCTZ did not modify the UAER. This suggests that the antiproteinuric effect of Manidipine is partially independent of BP reduction, and is attributable to mechanisms different from those mediated by angiotensin receptor blockade.
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Fixed combination of Manidipine and delapril in the treatment of mild to moderate essential hypertension: evaluation by 24-hour ambulatory blood pressure monitoring.
Blood Pressure, 2005Co-Authors: Amedeo Mugellini, A Zoppi, Alvaro Vaccarella, Aldo Celentano, Flavio Scanferla, Roberto FogariAbstract:This present study assessed the antihypertensive efficacy of the fixed combination of Manidipine and delapril by ambulatory blood pressure monitoring in patients with hypertension inadequately controlled by monotherapy with either component. After a 2‐week placebo period, 55 mild to moderate hypertensive patients were randomized to Manidipine 20 mg o.d. or delapril 30 mg b.i.d. for 4 weeks. After this period, 30 patients, aged 30–76 years (18 males and 12 females) whose diastolic blood pressure was not adequately controlled (≥90 mmHg) by monotherapy were treated with the fixed combination of Manidipine 10 mg plus delapril 30 mg o.d. for 8 weeks. A 24‐h ambulatory blood pressure monitoring recording was performed at the end of the placebo washout, of the monotherapy and of the combination therapy. Blood pressure control over the 24 h was quantified by the trough‐to‐peak ratio and the smoothness index. As compared to placebo, the fixed combination of Manidipine and delapril produced a statistically signific...
Shinichi Kitamura - One of the best experts on this subject based on the ideXlab platform.
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delapril versus Manidipine in hypertensive therapy to halt the type 2 diabetes mellitus associated nephropathy
Diabetes Research and Clinical Practice, 2000Co-Authors: Teruo Shiba, Masahiro Inoue, Hisaya Tada, Yoichi Hayashi, Yukichi Okuda, Rie Fujita, Fuminori Makino, Chieko Takahasi, Shigeru Kageyama, Shinichi KitamuraAbstract:Thirty-nine hypertensive patients with type 2 diabetes mellitus were followed under long-term treatment (mean, 20.7 months) with Manidipine hydrochloride, a Ca antagonist, or delapril hydrochloride, an ACE inhibitor, at nine institutions. Both the treatments showed similar antihypertensive effects, although slight but significantly larger decreases were observed in systolic and mean blood pressures at months 12 and 24 in the patients treated with Manidipine (P<0.02). The urinary albumin excretion index (AEI) tended to increase throughout the study in both treatment groups, but no significant difference in AEI was observed between the two treatment groups at any time point. Overt albuminuria developed in four patients on Manidipine but did not appear in any of the patients on delapril. The risk of progression to overt albuminuria was significantly different between Manidipine and delapril groups (P=0.011). No increase in serum creatinine (Cr) was observed with delapril. The average excretion indexes of tubular markers such as β2-microglobulin, α1-microglobulin, and NAG tended to be higher in the patients on Manidipine than in those on delapril. Taken in sum, these findings suggest that the ACE inhibitor delapril is more beneficial than the Ca antagonist Manidipine in the treatment of diabetic renal diseases via mechanisms other than the blood pressure regulation, partly through their different effects on tubular function. In conclusion, delapril was significantly more effective than Manidipine in inhibiting progression to overt albuminuria in hypertensive type 2 diabetes mellitus patients.
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Delapril versus Manidipine in hypertensive therapy to halt the type-2-diabetes-mellitus-associated nephropathy.
Diabetes research and clinical practice, 2000Co-Authors: Teruo Shiba, Masahiro Inoue, Hisaya Tada, Yoichi Hayashi, Yukichi Okuda, Rie Fujita, Fuminori Makino, Chieko Takahasi, Shigeru Kageyama, Shinichi KitamuraAbstract:Thirty-nine hypertensive patients with type 2 diabetes mellitus were followed under long-term treatment (mean, 20.7 months) with Manidipine hydrochloride, a Ca antagonist, or delapril hydrochloride, an ACE inhibitor, at nine institutions. Both the treatments showed similar antihypertensive effects, although slight but significantly larger decreases were observed in systolic and mean blood pressures at months 12 and 24 in the patients treated with Manidipine (P
Yoshio Ohta - One of the best experts on this subject based on the ideXlab platform.
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Manidipine Improves Spermatogenesis in the Stroke-Prone Spontaneously Hypertensive Rat
Journal of andrology, 1997Co-Authors: Keigo Akagashi, Naoki Itoh, Yoshiaki Kumamoto, Taiji Tsukamoto, Tsuneyuki Suzuki, Yoshio OhtaAbstract:We evaluated the protective effects of Manidipine, which is a long-lasting calcium-channel blocker, against damage to spermatogenesis arising from hypertensive vascular changes in stroke-prone spontaneously hypertensive rats (SHRSP). SHRSP showed severe hypertension at 11 weeks of age, followed by hypertensive changes in intratesticular arterioles from 15 weeks of age. Manidipine lowered the blood pressure and the hypertensive vascular changes of intratesticular arterioles in SHRSP. The percentages of atrophic seminiferous tubules and tubules with less-differentiated germ cells were increased in SHRSP at 23 weeks of age, although the administration of Manidipine preserved spermatogenesis at a normal level. The transferrin concentration in testicular cytosol was comparable, whereas insulin-like growth factor-I (IGF-I) was reduced from 19 weeks of age in SHRSP. Manidipine preserved the normal IGF-I concentration. Therefore, Manidipine prevented the development of hypertensive vascular changes in the testis and maintained normal Sertoli cell function. As a result, Manidipine protected spermatogenesis in SHRSP. These findings also suggested that hypertensive vascular changes in the testes play the most important role in spermatogenic damage in SHRSP.
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PROTECTIVE EFFECTS OF Manidipine ON SPERMATOGENESIS IN STROKE-PRONE SPONTANEOUSLY HYPERTENSIVE RATS
Clinical and experimental pharmacology & physiology. Supplement, 1995Co-Authors: Keigo Akagashi, Naoki Itoh, Yoshiaki Kumamoto, Taiji Tsukamoto, Tsuneyuki Suzuki, Yoshio OhtaAbstract:Summary 1. We evaluated the protective effects of Manidipine on spermatogenic damage induced by the hypertensive vascular changes in stroke-prone spontaneously hypertensive rats (SHRSP). 2. Blood pressure reached more than 250 mmHg in SHRSP at 15 weeks of age, and thereafter the hypertensive changes in testicular arterioles developed. Manidipine reduced both the blood pressure and the hypertensive vascular changes. 3. Although immature and mature spermatids greatly diminished in SHRSP at 23 weeks of age, Manidipine could preserve almost normal spermatogenesis even at 23 weeks of age. Transferrin concentration in testicular cytosol, which was considered to be indicative of the Sertoli cell function, in SHRSP with Manidipine administration was significantly higher than that in SHRSP with no treatment at 23 weeks of age. 4. In conclusion, Manidipine could prevent the development of the hypertensive changes in intratesticular arterioles and maintain normal Sertoli cell function. As a result, Manidipine protected spermatogenic damage in SHRSP.
Andrea Rinaldi - One of the best experts on this subject based on the ideXlab platform.
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effects of Manidipine delapril versus olmesartan hydrochlorothiazide combination therapy in elderly hypertensive patients with type 2 diabetes mellitus
Hypertension Research, 2008Co-Authors: Roberto Fogari, A Zoppi, G Derosa, P Lazzari, Paola Preti, Andrea Rinaldi, Amedeo MugelliniAbstract:The purpose of this study was to compare the combination treatments of Manidipine/delapril and olmesartan/hydrochlorothiazide (HCTZ) in elderly diabetic hypertensives. After a 4-week placebo period, 158 hypertensive patients with type 2 diabetes (age range: 66 to 74 years) were randomized to receive combination treatment of 10 mg Manidipine plus 30 mg delapril or 20 mg olmesartan plus 12.5 mg HCTZ for 48 weeks in a prospective, parallel arm trial. After 12 weeks, Manidipine or HCTZ was doubled in nonresponders (systolic blood pressure [SBP] ≥130 mmHg and/or diastolic blood pressure [DBP] ≥80 mmHg). Patients were checked at the end of the placebo period and every 12 weeks thereafter. At each visit, lying, sitting and standing BP as well as fasting glycemia, glycosylated hemoglobin (HbA1c), electrolytes, uric acid, total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TG) were evaluated. Both combinations reduced sitting SBP (−27.7 and −28.3 mmHg, respectively; both p<0.001) and DBP (−15.1 and −14.8 mmHg, respectively; both p<0.01) with no difference between the two treatments. Standing DBP was more markedly reduced by olmesartan/HCTZ (−19.5 mmHg; p<0.001) than by Manidipine/delapril (−14.7 mmHg; p<0.05 vs. olmesartan/HCTZ). No changes in metabolic parameters were observed with Manidipine/delapril, whereas an increase in HbA1c (+0.7%; p<0.05), uric acid (+0.4 mg/dL; p<0.05) and TG (+41.3 mg/dL; p<0.05), and a decrease in serum potassium (−0.3 mmol/L; p<0.05) and HDL-C (−3.4 mg/dL; p<0.05) were found in the olmesartan/HCTZ group. In conclusion, both combinations were similarly effective in reducing BP in elderly hypertensive diabetic patients. However, Manidipine/delapril offered some advantages in terms of the less-pronounced BP orthostatic changes and absence of metabolic adverse effects. (Hypertens Res 2008; 31: 43−50)
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Addition of Manidipine improves the antiproteinuric effect of candesartan in hypertensive patients with type II diabetes and microalbuminuria.
American journal of hypertension, 2007Co-Authors: Roberto Fogari, A Zoppi, Amedeo Mugellini, Paola Preti, Pierangelo Lazzari, Luca Corradi, Andrea RinaldiAbstract:Background We sought to compare the effect of Manidipine versus hydrochlorothiazide (HCTZ) in addition to candesartan on the urinary albumin excretion rate (UAER) in hypertensive patients with type II diabetes and microalbuminuria. Methods After a 2-week washout and run-in period, and 8-week monotherapy with candesartan 16 mg every day, 174 microalbuminuric diabetic hypertensive patients with uncontrolled blood pressure (BP) (>130/80 mm Hg) were randomized to addition of Manidipine 10 mg every day (n = 87) or HCTZ 12.5 mg every day (n = 87) for 24 weeks, with a titration after 4 weeks (Manidipine or HCTZ dose-doubling) in nonresponder patients. Blood pressure, UAER, creatinine clearance, serum electrolytes, fasting plasma glycemia, and glycosylated hemoglobin were evaluated at baseline (end of run-in period), after candesartan monotherapy, and at the end of the combination treatment period. Results Both combinations produced greater systolic BP/diastolic BP reduction than candesartan monotherapy (−28/21 mm Hg versus −16/11 mm Hg and −28/20 mm Hg versus −15/11 mm Hg, respectively; all P Conclusions These findings show that, despite equivalent reduction in BP, the addition of Manidipine to candesartan further reduced the UAER, whereas the addition of HCTZ did not modify the UAER. This suggests that the antiproteinuric effect of Manidipine is partially independent of BP reduction, and is attributable to mechanisms different from those mediated by angiotensin receptor blockade.
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Effect of Manidipine as compared to atenolol on platelet aggregation in elderly patients with isolated systolic hypertension and type II diabetes mellitus.
Journal of cardiovascular pharmacology, 2005Co-Authors: Amedeo Mugellini, A Zoppi, Andrea Rinaldi, Pierangelo Lazzari, Elena Fogari, Luca Corradi, Roberto FogariAbstract:This study was done to evaluate the effect of treatment with Manidipine as compared with atenolol on thrombin-mediated platelet aggregation in elderly patients with isolated systolic hypertension and type II diabetes mellitus. After a 2-week washout placebo period, 60 elderly patients (aged 65-80 years) with isolated systolic hypertension (SBP > 140 mm Hg and DBP < 90 mm Hg) were randomly assigned to Manidipine 10 mg or atenolol 50 mg 6-week treatment according to a double-blind, crossover design. Thirty patients had a concomitant well-controlled type 2 diabetes mellitus (HbA1c < or = 6.5%). At the end of the washout and of each treatment period, blood pressure (BP) (by mercury sphygmomanometer) and platelet aggregation (by Born-type aggregometer) were evaluated. Blood samples were collected using sodium citrate as anticoagulant, and platelet aggregation was induced by 2 different concentrations of ADP and collagen. Manidipine and atenolol produced a significant BP reduction in both diabetic and nondiabetic patients, with no difference between treatments. Despite the similar BP effect, in diabetic patients Manidipine produced a significant reduction in platelet aggregation induced by both doses of either ADP or collagen. In nondiabetic hypertensives, Manidipine inhibited platelet aggregation only at the highest doses of both inducers. The difference in the platelet inhibitory effect of Manidipine between diabetic and nondiabetic subjects was statistically significant (P < 0.05) at both inducer concentrations. No changes in platelet aggregation were observed in the atenolol group. These data indicate that, unlike atenolol, Manidipine inhibits platelet aggregation in elderly hypertensive patients, expecially in those with associated type II diabetes mellitus. The clinical impact of this positive effect in terms of prevention of cardiovascular complications in these high-risk patients remains to be clarified.