Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison

Lee, Hae Young; Kang, Hyun–Jae; Koo, Bon‐Kwon; Oh, Byung‐Hee; Hj, Kang; Kim, Kee‐Sik; Seo, Hong Seog; Ro, Young Moo; Kang, Jeonggyu; Woong, Choi Jae; Joo, Seung-Jae; Kim, Moo Hyun; Shin, Joon-Han; Yoon, Junghan; Park, Seong Hoon; Jin-Ok, Jeong; Ju, Ahn Kyoung; Chong-Yun, Rhim; Yeon, Kyu Jeong; Park, Kyung Mi; Lim, Dong Kwon; Park, So Youn

doi:10.1016/j.clinthera.2005.06.011

Cited by 18 publications

(10 citation statements)

References 25 publications

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“…In this study of healthy subjects, however, the incidences of adverse drug reactions were not significantly different between the test and reference treatments. These safety profiles between amlodipine adipate and amlodipine besylate are comparable to those in mild to moderate hypertensive patients [25]. Our safety results are consistent with these findings.…”

Section: Discussionsupporting

confidence: 90%

Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers

Nam¹,

Kim

et al. 2015

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The aim of this study was to compare pharmacokinetic characteristics of fixed-dose combination (FDC) of two different salt form of amlodipine, amlodipine adipate/valsartan and amlodipine besylate/ valsartan, in healthy Korean volunteers under fasting conditions. A randomized, open-label, single-dose, two-treatment, two-way crossover study with a 14-day wash-out period was conducted. Plasma samples were collected for up to 144 hours for amlodipine and 24 hours for valsartan. Plasma concentrations of amlodipine and valsartan were analyzed using a validated ultra-performance liquid chromatography tandem mass-spectrometry. A non-compartmental method was used to calculate pharmacokinetic parameters. Vital signs and adverse events were monitored and physical examinations, laboratory tests, and electrocardiograms were conducted to evaluate safety. 44 subjects completed the study. The 90% CIs for the geometric mean ratio of Cmax and the AUC0-t were 93.5 - 100.4% and 93.2 - 98.3% for amlodipine, and 92.1 - 121.3% and 94.1 - 115.2% for valsartan, respectively. 17 adverse events occurred in 15 subjects during the study; 5 and 7 adverse drug reactions from the 5 and 6 subjects were considered to probably be related to the test and reference treatments respectively. All adverse drug reactions were in line with those known for the reference drug. All subjects recovered fully with no sequelae. A FDC of amlodipine adipate/valsartan and amlodipine besylate/valsartan combination tablets met the regulatory criteria for bioequivalence. In addition, no significant difference was observed in the safety assessments between two treatments. Thus, the newly developed FDC of amlodipine adipate/valsartan seems to be interchangeable with amlodipine besylate valsartan combination.

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Section: Discussionsupporting

confidence: 90%

Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers

Nam¹,

Kim

et al. 2015

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“…The observed difference in blood pressure reduction with the same antihypertensive medication could be attributed to the different racial backgrounds, with differences in body weight and BMI. 24 The mean compliance rate in the amlodipine orotate group was 97.6%, which was comparable to 96.5% in the amlodipine besylate group in the present study. The compliance rate in the study of whites using amlodipine was 95.9%, 32 which was similar to that of the present study.…”

Section: Discussionsupporting

confidence: 74%

Comparison of efficacy and tolerability of amlodipine orotate versus amlodipine besylate in adult patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 8-week follow-up noninferiority trial

2006

Clinical Therapeutics

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Objective: The purpose of this study was to compare the efficacy and tolerability of amlodipine orotate with those of amlodipine besylate in Korean patients with mild to moderate hypertension.Methods: This multicenter, randomized, doubleblind, placebo-controlled, parallel-group study was designed as a noninferiority study. To be included in the study, previously untreated patients had to have a sitting diastolic blood pressure (SiDBP) of 90 to 109 mm Hg. Previously treated patients had to discontinue their current antihypertensive medications and have a baseline SiDBP between 90 and 109 mm Hg after a 2-week washout period. Patients who met the inclusion criteria were randomly assigned to receive 5 mg amlodipine orotate or 5 mg amlodipine besylate for 8 weeks. The medication dose was doubled (10 mg QD for either amlodipine orotate or amlodipine besylate) 4 weeks after enrollment if SiDBP was >90 mm Hg. The primary efficacy analysis was noninferiority of the difference in mean trough SiDBP changes from baseline for amlodipine orotate as compared with amlodipine besylate after 8 weeks of treatment. For the secondary efficacy analysis, 2 other measures were analyzed after 8 weeks of treatment. The SiDBP response rate was defined as an SiDBP measurement <90 mm Hg at the last clinical follow-up visit or an absolute reduction of >10 mm Hg in SiDBP from baseline until the last clinical follow-up visit. In addition, noninferiority of the difference in mean trough sitting systolic blood pressure (SiSBP) changes from baseline was analyzed for amlodipine orotate as compared with amlodipine besylate. The drug compliance rate was estimated by pill count.Results: Eligible patients (n = 109; 43 women and 66 men) were randomly assigned to receive amlodipine orotate (n = 53) or amlodipine besylate (n = 56). No significant differences were found in sex, age, weight, or current smoking between the groups (all, P = NS). The proportion of patients with previous antihypertensive medications was not different between the groups (47.2% [25/53] -14.5 (5.5) mm Hg for the amlodipine besylate group (P = NS). The difference in change in mean (SD) SiDBP between the amlodipine orotate and amlodipine besylate groups was 1.1 (5.9) mm Hg (95% CI, -0.87 to oo), and because the lower boundary of the 95% CI was greater than -5 mm Hg, amlodipine orotate was considered noninferior to amlodipine besylate. The response rate was 48 of 51 (94.1%) in the amlodipine orotate group compared with 50 (92.6%) of 54 in the amlodipine besylate group after 8 weeks of treatment (P = NS). The mean (SD) compliance rates were 97.6% (3.6%) in the amlodipine orotate group and 96.5% (4.3%) in the amlodipine besylate group (P = NS). Conclusions: The reduction in SiDBP after 8 weeks of amlodipine orotate treatment was noninferior to that of amlodipine besylate in these Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction in SiSBP after 8 weeks of amlodipine orotate treatment were not significantly different from those of a...

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“…Blood pressure was measured at the same time of the day, before dosing, in the same arm, and by the same investigator, at each center, with mercury sphygmomanometers manufactured by one company (W. A. Baum Co. Inc, New York, U.S.A.) 11). At each visit, patients were asked about adverse events (AEs).…”

Section: Methodsmentioning

confidence: 99%

Losartan/Hydrochlorothiazide Fixed Combination Versus Amlodipine Monotherapy in Korean Patients With Mild to Moderate Hypertension

et al. 2009

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Background and ObjectivesThe antihypertensive efficacy and tolerability of losartan (LST) in fixed combination with hydrochlorothiazide (HCTZ) has not been compared to those of amlodipine monotherapy in Asians. This is an important comparison to draw, because Asians have been suggested to respond more favorably to calcium channel blockers and less favorably to angiotensin-converting enzyme inhibitors in comparison to Westerners. We sought to compare these two regimens in Korean patients with mild to moderate hypertension.Subjects and Methods174 patients were randomized to receive LST 50 mg once daily, which could be titrated to LST/HCTZ 50/12.5 mg at 4 weeks, followed by 100/25 mg at 8 weeks; or to receive amlodipine besylate 2.5 mg once daily, which could be titrated to 5 mg at 4 weeks, followed by 10 mg at 8 weeks to achieve diastolic blood pressure <90 mmHg.ResultsAt 12 weeks, the differences between the LST/HCTZ and amlodipine groups with regard to diastolic and systolic blood pressure were 1.2 mmHg (95% confidence interval: -1.1 to 3.4) and -0.5 mmHg (95% confidence interval: -4.3 to 3.4), respectively. The rates of achieving systolic blood pressure <140 mmHg were 66.7% in the LST/HCTZ group and 75.9% in the amlodipine group (p=0.20). The rates of drug-related adverse events were 15.6% in the LST/HCTZ group and 11.9% in the amlodipine group (p=0.49).ConclusionThe two regimens, with a relatively higher dose of LST/HCTZ compared to that required in Westerners, produced equivalent blood pressure reduction and were comparably well tolerated in Korean patients with mild to moderate hypertension.

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Clinic blood pressure responses to two amlodipine salt formulations, adipate and besylate, in adult Korean patients with mild to moderate hypertension: A multicenter, randomized, double-blind, parallel-group, 8-week comparison

Cited by 18 publications

References 25 publications

Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers

Pharmacokinetic comparison of amlodipine adipate/valsartan fixed-dose combination with amlodipine besylate/valsartan fixed-dose combination in healthy volunteers

Comparison of efficacy and tolerability of amlodipine orotate versus amlodipine besylate in adult patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 8-week follow-up noninferiority trial

Losartan/Hydrochlorothiazide Fixed Combination Versus Amlodipine Monotherapy in Korean Patients With Mild to Moderate Hypertension

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