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Azza A Gazy - One of the best experts on this subject based on the ideXlab platform.
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determination of Amlodipine Besylate by adsorptive square wave anodic stripping voltammetry on glassy carbon electrode in tablets and biological fluids
Talanta, 2004Co-Authors: Azza A GazyAbstract:Abstract The adsorptive and electrochemical behavior of Amlodipine Besylate on a glassy carbon electrode were explored in Britton–Robinson buffer solution by using cyclic and square-wave voltammetry. Cyclic voltammetric studies indicated the oxidation of Amlodipine Besylate at the electrode surface through a single two-electron irreversible step and fundamentally controlled by adsorption. The solution conditions and instrumental parameters were optimized for the determination of the authentic drug by adsorptive square-wave stripping voltammetry. Amlodipine Besylate gave a sensitive adsorptive oxidation peak at 0.510 V (versus Ag/AgCl). The oxidation peak was used to determine Amlodipine Besylate in range 4.0×10 −8 to 2.0×10 −6 with a detection limit of 1.4×10 −8 M. The procedure was successfully applied for the assay of Amlodipine Besylate in tablets (Norvasc) ® . The percentage recoveries were in agreement with those obtained by the reference method. Applicability to assay the drug in urine and serum samples was illustrated. The mean percentage recoveries were 96.31±1.18 and 96.98±1.17, respectively. The proposd method used for monotoring clinically relevant concntrations of drug in human urine and serum.
Byunghee Oh - One of the best experts on this subject based on the ideXlab platform.
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quantification of pedal edema during treatment with s Amlodipine nicotinate versus Amlodipine Besylate in female korean patients with mild to moderate hypertension a 12 week multicenter randomized double blind active controlled phase iv clinical tria
Clinical Therapeutics, 2012Co-Authors: Gyuchul Oh, Hyunjae Kang, Joohee Zo, Dongju Choi, Byunghee OhAbstract:Abstract Background Amlodipine is a racemic mixture of (R)- and (S)-enantiomers. It has been suggested that removing the therapeutically inactive (R)-enantiomer will reduce adverse events while preserving the agent's efficacy. Women experience more adverse effects from Amlodipine. Objective This exploratory study compared the amount of pedal edema experienced by female Korean patients with mild to moderate hypertension when receiving S(-)-Amlodipine nicotinate compared with Amlodipine Besylate. Methods This study was a 12-week, multicenter, randomized, double-blind, active-controlled, Phase IV clinical trial. Female patients with mild to moderate hypertension were randomly assigned to receive either S(-)-Amlodipine nicotinate 2.5 to 5 mg once daily or Amlodipine Besylate 5 to 10 mg once daily for 12 weeks. The primary objective was to compare the change in ankle–foot volume quantified by using a water displacement method after 12 weeks of therapy. The secondary objectives were to compare the changes in mean sitting systolic and diastolic blood pressures. Safety assessment included monitoring all laboratory tests, adverse events (AEs), serious AEs, and possible relation to the study medication. Results Of the 38 patients enrolled, 17 patients in each group were eligible for final analysis. In the S(-)-Amlodipine nicotinate group, the mean ankle–foot volume at baseline was 1056.91 (98.15) mL, and volume after 12 weeks of treatment was 1016.68 (158.37) mL, a decrease of 40.24 (110.05) mL. In the Amlodipine Besylate group, mean ankle–foot volume at baseline was 1037.56 (158.30) mL, and volume after treatment was 1067.59 (152.54) mL, an increase of 30.03 (69.59) mL. There was a significant difference in the change of ankle–foot volume between the 2 groups (–70.26 mL [95% CI, –134.60 to –5.94], P = 0.028). After 12 weeks, the mean changes in sitting systolic blood pressure from baseline were not significantly different between the 2 groups (–21.82 [8.76] vs –26.82 [11.89] mm Hg; P = 0.172). Changes in mean sitting diastolic blood pressure also were not significant (–14.71 [6.94] vs –10.88 [5.81] mm Hg; P = 0.091). One patient in each group had facial edema, and another patient in the Amlodipine Besylate group had facial flushing. Overall, there was no significant difference in drug-related AEs between the 2 groups ( P = 0.999). Conclusions These female Korean patients with hypertension taking S(-)-Amlodipine nicotinate had less ankle edema, with no significant difference in BP-lowering efficacy, compared with those taking Amlodipine Besylate. S(-)-Amlodipine nicotinate may be a suitable alternative for patients intolerant to Amlodipine Besylate. (Clinical Research Information Service: CRiS, KCT0000450).
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efficacy and safety profiles of a new s Amlodipine nicotinate formulation versus racemic Amlodipine Besylate in adult korean patients with mild to moderate hypertension an 8 week multicenter randomized double blind double dummy parallel group phase i
Clinical Therapeutics, 2008Co-Authors: Sungha Park, Joo Young Yang, Byunghee Oh, Namsik Chung, Seung-jea TahkAbstract:Abstract Background: "Chiral switching" from an existing racemate to a pure enantiomeric compound is a popular theme in drug development, especially when the enantiomer is found to have better efficacy and safety profiles. Amlodipine is a racemic mixture, composed of the S (-)-enantiomer, which is the pharmacologically active isomer, and the R (+)-enantiomer, which is 1000-fold less active. S (-)-Amlodipine nicotinate, a chirally switched form of Amlodipine nicotinate, has been developed and found to be bioequivalent to Amlodipine Besylate in Phase I clinical trials in Korea. Objective: The aim of this study was to compare the efficacy and safety profiles of S (-)-Amlodipine nicotinate with those of Amlodipine Besylate in adult Korean patients with mild to moderate hypertension (diastolic blood pressure [DBP] ≥90 mm Hg and ≤109 mm Hg). Methods: This was an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase III, noninferiority clinical trial. After an initial 2-week placebo run-in period, patients aged 18 to 75 years with sitting DBP (SiDBP) ≥90 and ≤109 mm Hg at day 0 (baseline) were randomly allocated to receive S (-)-Amlodipine nicotinate 2.5 mg QD or Amlodipine Besylate 5 mg QD for 8 weeks. The dose of study medication was doubled after 4 weeks in patients who had not responded to treatment (SiDBP ≥90 mm Hg). The primary end point was noninferiority of the difference in mean SiDBP from baseline to week 8 for S (-)-Amlodipine nicotinate compared with Amlodipine Besylate. Secondary end points were as follows: (1) noninferiority of the difference in mean sitting systolic blood pressure (SiSBP) from baseline to week 8 between the study groups; and (2) SiDBP response rate (defined as the proportion of patients whose SiDBP was Severe AEs/ADRs were defined as those associated with any of the following: death; an event associated with a high risk of mortality; an event requiring hospitalization; or development of a permanent disability or congenital malformation. Results: One hundred fifty-seven patients were assessed for inclusion in the study. Of these, 124 patients were randomly allocated to receive S (-)-Amlodipine nicotinate (42 men, 21 women; mean [SD] age, 52.4 [10.3] years [range, 23–70 years]; weight, 67.7 [10.8] kg [range, 44–92 kg]) or Amlodipine Besylate (45 men, 16 women; mean [SD] age, 54.5 [10.0] years [range, 30-73]; weight, 68.9 [9.8] kg [range, 49–95 kg]). One hundred sixteen patients completed the study, but 11 patients (8.9%) were dropped from the per-protocol analysis due to violations; therefore, 105 patients were included in the modified intent-to-treat population analysis ( S [-]-Amlodipine nicotinate, 55 patients; Amlodipine Besylate, 50 patients). There were no significant between-group differences in the baseline characteristics. Baseline mean (SD) SiSBP and SiDBP were 142.6 (11.3) and 94.9 (4.8) mm Hg in the S (-)-Amlodipine nicotinate group, and 141.8 (8.3) and 96.1 (4.9) mm Hg in the Amlodipine Besylate group. Mean (SD) changes in SiSBP were 17.6 (11.2) mm Hg in the S (-)-Amlodipine nicotinate group and 18.6 (12.3) mm Hg in the Amlodipine Besylate group. The SiDBP response rates were 92.7% in the S (-)-Amlodipine nicotinate group and 88.0% in the Amlodipine Besylate group. There were no significant between-group differences in the prevalence of AEs and ADRs. In the S(-)-Amlodipine nicotinate group, 15 patients (23.8%) reported a total of 28 AEs, and 19 patients (31.1%) reported a total of 27 AEs in the Amlodipine Besylate group. Six patients (9.5%) in the S (-)-Amlodipine nicotinate group and 7 patients (11.4%) in the Amlodipine Besylate group experienced a total of 19 ADRs (11 and 8, respectively). The most common ADRs were liver enzyme elevation (3/63 [4.8%]) in the S (-)-Amlodipine nicotinate group and facial flushing (3/61 [4.9%]) in the Amlodipine Besylate group. No cases of severe AEs or ADRs were reported in either group. Conclusions: The reduction of SiDBP after 8 weeks of treatment with S (-)-Amlodipine nicotinate was noninferior compared with that of racemic Amlodipine Besylate in these adult Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction of SiSBP after 8 weeks of treatment with S (-)-Amlodipine nicotinate were not significantly different from those with racemic Amlodipine Besylate. Both treatments were generally well tolerated.
Robert A Vogel - One of the best experts on this subject based on the ideXlab platform.
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a randomized double blind trial comparing the effects of Amlodipine Besylate benazepril hcl vs Amlodipine on endothelial function and blood pressure
Journal of Clinical Hypertension, 2006Co-Authors: Emile R Mohler, David M Herrington, Pamela Ouyang, Charles Mangano, Susan Ritter, Pamela Davis, Das Purkayastha, Marjorie Gatlin, Robert A VogelAbstract:Evidence suggests that renin-angiotensin-aldosterone system inhibition ameliorates endothelial dysfunction. The authors examined the effect of Amlodipine Besylate/benazepril HCl combination treatment compared with Amlodipine Besylate monotherapy in modulating endothelial dysfunction. This multicenter, double-blind, 12-week study randomized 70 hypertensive subjects with at least one other endothelial dysfunction risk factor to Amlodipine Besylate/benazepril HCl (5/20 mg/d force-titrated to 5/40 mg/d) or Amlodipine Besylate monotherapy (5 mg/d force-titrated to 10 mg/d). Both the combination and monotherapy produced significant median increases from baseline in percentage flow-mediated vasodilation (2.0% and 1.2%, respectively) and percentage change in percent flow-mediated vasodilation (25% and 16%, respectively). These improvements were numerically larger with combination treatment, but between-group differences did not achieve statistical significance. Reductions in systolic and diastolic blood pressure were significantly greater (P=.0452/P=.0297) with combination treatment (−18.6/−12.3 mm Hg) than with monotherapy (−14.8/−9.1 mm Hg). A highly positive correlation between change in systolic blood pressure and change in percent of flow-mediated vasodilation was demonstrated only for combination treatment.
Hongbo Chen - One of the best experts on this subject based on the ideXlab platform.
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calcium channel blocker Amlodipine Besylate therapy is associated with reduced case fatality rate of covid 19 patients with hypertension
Cell discovery, 2020Co-Authors: Leike Zhang, Haolong Zeng, Xiaming Jiang, Weijuan Shang, Yulan Zhang, Hongbo Chen, Yuan Sun, Qingxing Wang, Zhaonian Hao, Runming JinAbstract:The coronavirus disease (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread to >200 countries posing a global public health concern. Patients with comorbidity, such as hypertension suffer more severe infection with elevated mortality. The development of effective antiviral drugs is in urgent need to treat COVID-19 patients. Here, we report that calcium channel blockers (CCBs), a type of antihypertensive drug that is widely used in clinics, inhibited the post-entry replication events of SARS-CoV-2 in vitro, while no in vitro anti-SARS-CoV-2 effect was observed for the two other major types of antihypertensive drugs, namely, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers. CCB combined with chloroquine showed a significantly enhanced anti-SARS-CoV-2 efficacy. A retrospective clinical investigation on hospitalized COVID-19 patients with hypertension as the only comorbidity revealed that the CCB Amlodipine Besylate therapy was associated with a decreased case fatality rate. The results from this study suggest that CCB administration to COVID-19 patients with hypertension as the comorbidity might improve the disease outcome.
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calcium channel blocker Amlodipine Besylate is associated with reduced case fatality rate of covid 19 patients with hypertension
medRxiv, 2020Co-Authors: Leike Zhang, Haolong Zeng, Yudong Peng, Xiaming Jiang, Weijuan Shang, Yulan Zhang, Shufen Li, Yan Wu, Liu Yang, Hongbo ChenAbstract:The coronavirus disease (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread to more than 100 countries posing as a serious threat to the public health on a global scale. Patients with comorbidity such as hypertension suffer more severe infection with elevated case fatality rate. Development of effective anti-viral drug is in urgent need to treat COVID-19 patients. Here we report that calcium channel blockers (CCBs), a type of anti-hypertension drugs that are widely used in the clinics, can significantly inhibit the post-entry replication events of SARS-CoV-2 in vitro. Comparison with two other major types of anti-hypertension drugs, the angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB), showed that only CCBs display significant anti-SARS-CoV-2 efficacy. Combined treatment with chloroquine and CCBs significantly enhanced the anti-SARS-CoV-2 efficacy. Retrospective clinical investigation of COVID-19 patients revealed that the CCB Amlodipine Besylate administration distinctly reduced the case fatality rate of patients with hypertension. Results from this study suggest that CCB administration for COVID-19 patients with hypertension as the comorbidity might improve the disease outcome.
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calcium channel blocker Amlodipine Besylate is associated with reduced case fatality rate of covid 19 patients with hypertension
medRxiv, 2020Co-Authors: Leike Zhang, Haolong Zeng, Yudong Peng, Xiaming Jiang, Weijuan Shang, Yulan Zhang, Shufen Li, Yan Wu, Liu Yang, Hongbo ChenAbstract:The coronavirus disease (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread to more than 100 countries posing as a serious threat to the public health on a global scale. Patients with comorbidity such as hypertension suffer more severe infection with elevated case fatality rate. Development of effective anti-viral drug is in urgent need to treat COVID-19 patients. Here we report that calcium channel blockers (CCBs), a type of anti-hypertension drugs that are widely used in the clinics, can significantly inhibit the post-entry replication events of SARS-CoV-2 in vitro. Comparison with two other major types of anti-hypertension drugs, the angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB), showed that only CCBs display significant anti-SARS-CoV-2 efficacy. Combined treatment with chloroquine and CCBs significantly enhanced the anti-SARS-CoV-2 efficacy. Retrospective clinical investigation of COVID-19 patients revealed that the CCB Amlodipine Besylate administration distinctly reduced the case fatality rate of patients with hypertension. Results from this study suggest that CCB administration for COVID-19 patients with hypertension as the comorbidity might improve the disease outcome.
Omar Shoheiber - One of the best experts on this subject based on the ideXlab platform.
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adherence to antihypertensive therapy with fixed dose Amlodipine Besylate benazepril hcl versus comparable component based therapy
Congestive Heart Failure, 2003Co-Authors: Addison A Taylor, Omar ShoheiberAbstract:Adhering to medication regimens has the potential to significantly improve clinical outcomes for persons with high blood pressure. A patient-related factor likely to affect adherence to treatment is the convenience of the prescribed drug regimen. The authors hypothesized that medication adherence would be superior and cost benefits would accrue in subjects who receive a once-daily, single-capsule, fixed-dose combination product for blood pressure control, compared with subjects who receive a similar regimen of separate components. A managed care organization that provides benefits for members enrolled in various health plans provided the data for this retrospective analysis. The database was used to assess medication adherence patterns for two groups of hypertensive subjects. Group 1 included subjects who had been prescribed the single-capsule, fixed-dose combination of Amlodipine Besylate/benazepril HCl. Group 2 comprised subjects who had been prescribed a regimen including an angiotensin-converting enzyme inhibitor and a dihydropyridine calcium channel blocker as separate drugs. Adherence was measured by the medication possession ratio, and medical resource utilization by the two groups was assessed during the study period. Group 1 (n=2754) and Group 2 (n=2978) were balanced with regard to age (mean, 53 years; range, 18–64 years) and sex (men, 50%; women, 50%). The overall medication possession ratio for Group 1 was significantly higher than that for Group 2 (80.8% vs. 73.8%; p<0.001). The average annual cost of cardiovascular-related care per subject was significantly lower in Group 1 compared with Group 2 (p<0.001). Subjects receiving the once-daily, single-capsule, fixed-dose combination of Amlodipine/benazepril HCl demonstrated significantly better medication adherence and required fewer medical resources than did subjects receiving an angiotensin-converting enzyme inhibitor and a dihydropyridine calcium channel blocker as separate components.