Safety of control led-onset extended-release verapamil in middle-aged and older patients with hypertension and coronary artery disease

Background Our purpose was to study the safety of controlled-onset, extende d-release (COER) verapamil in patients with hypertension or coronary artery disease, with a focus on elderly patients. Methods Adverse event data were pooled from 7 double-blind, multicenter, ra ndomized trials including 1999 patients with hypertension or chronic stable angina pectoris. There were 1042 patients who received COER verapamil 180 to 540 mg once daily in the evening for up to 10 weeks, 373 patients who re ceived placebo, and 584 who received an active comparator agent. Data were analyzed according to the following groups: all patients, patients with hyp ertension, patients with angina, older patients (greater than or equal to 6 5 years old), and younger patients (<65 years old). Adverse event rates wer e compared across the treatment groups by the Fisher exact test. Results In all patients combined, the incidence of constipation (13% vs 2%) , dizziness (6% vs 2%), and back pain (3% vs 1%) was higher in patients tre ated with COER verapamil than with placebo. Patients with hypertension had more back pain (4% vs 1%) and constipation (12% vs 1%) with COER verapamil than with placebo, whereas patients with angina had more bradycardia (2.6% vs 0%), dizziness (8% vs 2%), and constipation (15% vs 3%). Older patients treated with COER verapamil had more bradycardia, constipation, dizziness, and fatigue and had fewer headaches compared with younger patients treated with COER verapamil. Second- or third-degree atrioventricular block was not observed after administration.. of COER verapamil in any subgroup. Conclusion These data demonstrate that COER verapamil has an acceptable saf ety profile that is largely unrelated to age in patients with hypertension or coronary artery disease.