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 x 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.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Alanine Transaminase / blood
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Alkaline Phosphatase / blood
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Amlodipine / adverse effects
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Amlodipine / pharmacokinetics
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Amlodipine / therapeutic use*
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Anticholesteremic Agents / adverse effects
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Anticholesteremic Agents / pharmacokinetics
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Anticholesteremic Agents / therapeutic use
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Antihypertensive Agents / adverse effects
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Antihypertensive Agents / pharmacokinetics
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Antihypertensive Agents / therapeutic use
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Aspartate Aminotransferases / blood
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Atorvastatin
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Blood Pressure / drug effects
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Cholesterol, LDL / blood
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Dose-Response Relationship, Drug
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Double-Blind Method
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Drug Interactions
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Drug Therapy, Combination
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Dyslipidemias / blood
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Dyslipidemias / complications
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Dyslipidemias / drug therapy*
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Female
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Heptanoic Acids / adverse effects
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Heptanoic Acids / pharmacokinetics
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Heptanoic Acids / therapeutic use*
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Humans
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Hypertension / complications
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Hypertension / drug therapy*
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Hypertension / physiopathology
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Male
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Pyrroles / adverse effects
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Pyrroles / pharmacokinetics
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Pyrroles / therapeutic use*
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Treatment Outcome
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gamma-Glutamyltransferase / blood
Substances
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Anticholesteremic Agents
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Antihypertensive Agents
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Cholesterol, LDL
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Heptanoic Acids
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Pyrroles
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Amlodipine
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Atorvastatin
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gamma-Glutamyltransferase
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Aspartate Aminotransferases
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Alanine Transaminase
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Alkaline Phosphatase