A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia

The respond trial

Richard A Preston, Peter Harvey, Ottmar Herfert, Gary Dykstra, J. Wouter Jukema, Franklin Sun, David Gillen

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Guidelines stress the importance of the simultaneous management of multiple cardiovascular risk factors. This can in part be achieved by coadministration of lipid-lowering and antihypertensive treatments. Potential pharmacodynamic interaction between drugs should be investigated as part of developing single-pill combinations. The Respond trial assessed whether combining amlodipine to treat hypertension and atorvastatin to treat dyslipidemia affected the action of either monotherapy. A total of 1660 hypertensive patients with dyslipidemia received 1 of 15 combinations of amlodipine (placebo, 5, or 10 mg) and atorvastatin (placebo, 10, 20, 40, or 80 mg) in a 3 × 5 factorial randomized, placebo-controlled design. At 8 weeks, combination-treated patients experienced dose-related and statistically significant reductions in systolic blood pressure, low-density lipoprotein cholesterol, and Framingham risk score. Overall, coadministered atorvastatin and amlodipine was well tolerated and without adverse pharmacodynamic interaction; combination treatment did not affect the low-density lipoprotein cholesterol-lowering efficacy and safety of atorvastatin, or the systolic blood pressure-lowering efficacy and safety of amlodipine.

Original languageEnglish
Pages (from-to)1555-1569
Number of pages15
JournalJournal of Clinical Pharmacology
Volume47
Issue number12
DOIs
StatePublished - Dec 1 2007

Fingerprint

Dyslipidemias
Amlodipine
Randomized Controlled Trials
Placebos
Blood Pressure
Hypertension
Safety
LDL Cholesterol
Drug Interactions
Antihypertensive Agents
Guidelines
Lipids
atorvastatin drug combination amlodipine
Therapeutics
Atorvastatin Calcium

Keywords

  • Amlodipine
  • Atorvastatin
  • Drug interaction
  • Framingham coronary heart disease estimated risk

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

A randomized, placebo-controlled trial to evaluate the efficacy, safety, and pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660 patients with concomitant hypertension and dyslipidemia : The respond trial. / Preston, Richard A; Harvey, Peter; Herfert, Ottmar; Dykstra, Gary; Jukema, J. Wouter; Sun, Franklin; Gillen, David.

In: Journal of Clinical Pharmacology, Vol. 47, No. 12, 01.12.2007, p. 1555-1569.

Research output: Contribution to journalArticle

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