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- Title
Effects of Concomitant Therapy with Diltiazem on the Lipid Responses to Simvastatin in Chinese Subjects.
- Authors
You, Joyce H. S.; Chan, Winnie K. Y.; Chung, Polly F. P.; Miao Hu; Tomlinson, Brian
- Abstract
Diltiazem increases systemic exposure to simvastatin via inhibition of CYP3A. This study assessed the impact of this interaction on the lipid-lowering effects of simvastatin. Chinese patients with hypercholesterolemia were randomized to receive simvastatin 20 mg daily alone or together with diltiazem 60 mg 3 times daily for 4 weeks with a washout period of 4 weeks in an open-label, crossover study. Blood pressure, fasting serum lipid profile, and safety tests were determined at baseline and after each treatment period. Trough serum diltiazem was measured at the end of the 4-week combination treatment. In the 30 patients who completed the study, simvastatin treatment significantly reduced low-density lipoprotein cholesterol by mean (± standard error) 41.0% ± 2.2% (P < .001), and the combination with diltiazem showed an additional reduction of 1.66% (95% confidence interval: -4.63 to 7.96, P > .05). The additional change in low-density lipoprotein cholesterol with diltiazem showed a nonsignificant positive correlation with the trough serum diltiazem concentration (R 2 = 0.142, P = .058). Co-administration of diltiazem 60 mg 3 times daily with simvastatin 20 mg daily tended to increase the changes in lipid parameters in these Chinese subjects, but the effects did not reach significance.
- Subjects
HONG Kong (China); ANALYSIS of variance; CALCIUM antagonists; ANTILIPEMIC agents; BLOOD pressure; COMBINATION drug therapy; CLINICAL trials; COMPUTER software; CONFIDENCE intervals; CROSSOVER trials; DRUG interactions; ENZYME inhibitors; HYPERCHOLESTEREMIA; LIQUID chromatography; LONGITUDINAL method; LOW density lipoproteins; RESEARCH funding; VASODILATORS; DATA analysis; BLOOD; ANALYTICAL chemistry; DRUG administration; DRUG dosage; PHARMACODYNAMICS; DRUG therapy; THERAPEUTICS
- Publication
Journal of Clinical Pharmacology, 2010, Vol 50, Issue 10, p1151
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1177/0091270009358082