The safety of amlodipine.

The safety profile of amlodipine was assessed from the pooled data base of clinical research studies. This data base included 4227 subjects, 2495 of whom received amlodipine (including 2189 who received multiple-dose amlodipine); the remainder received comparative agents (placebo 1213; active comparatives 519). Amlodipine treatment was associated with a slightly higher incidence of side effects compared with placebo, but most of this difference was the result of edema, which was usually well tolerated. When compared with the beta-blockers atenolol and nadolol, amlodipine had a favorable safety profile. In particular, the incidence of severe side effects in patients receiving amlodipine was approximately half that reported for patients receiving beta-blockers. The data base comparing different calcium antagonists was small; in a study versus verapamil, edema was more common in patients receiving amlodipine, but constipation was more common in patients receiving verapamil. In a study versus diltiazem, both amlodipine and diltiazem were similarly well tolerated. Amlodipine was not associated with the deleterious effects of serum creatinine, urate, and fasting glucose, which was caused by hydrochlorothiazide, and in contrast to hydrochlorothiazide and nadolol, amlodipine was not associated with unfavorable changes in serum cholesterol and serum triglyceride levels. Amlodipine was well tolerated by elderly patients and is not contraindicated in patients with conduction abnormalities. Dosage modifications are unnecessary in renal impairment, but the dosage regimen for patients with hepatic impairment is not yet established. Amlodipine is an antihypertensive and antiischemic agent that has the combined advantages of a good safety profile with once-daily dosage and a smooth onset and long duration of action.