Large-Scale Postmarketing Surveillance of Hypertensive Patients Treated with Verapamil.
BACKGROUND: In general clinical practice, physicians prescribe calcium channel blockers to a wide range of patients with differing demographic characteristics and hypertension history. This study was undertaken to investigate the effectiveness and safety of sustained-release verapamil (Verelan((R)), verapamil HCl) in patients with essential hypertension, studied under "usual use" conditions. METHODS: In this prospective, open-label, postmarketing surveillance study, 25 089 patients with hypertension received once-daily verapamil therapy for 4 weeks, during which they were evaluated by 8106 physicians at baseline and at two follow-up visits (weeks 2 and 4). In this study, hypertension was defined as an average sitting diastolic blood pressure (DBP) of greater-than-or-equal 90 mm Hg at baseline. Previously diagnosed hypertensive patients with a sitting DBP <90 mm Hg but experiencing untoward effects requiring discontinuation of current antihypertensive therapy were also included. RESULTS: Eighty-five percent (n = 21 446) of the total patients enrolled at baseline completed this office-based trial. Nearly 24% of patients were newly diagnosed hypertensives. At baseline, the mean systolic blood pressure (SBP) and diastolic blood pressure were 161 and 96 mm Hg, respectively. In evaluable patients with mild, moderate, and severe hypertension, as stratified by baseline measurements, treatment with verapamil produced DBP reductions of 12, 19, and 29 mm Hg, respectively. Verapamil treatment produced clinically similar SBP, DBP, and HR (heart rate) reductions across gender and racial groups studied (white, black, Hispanic, and Asian). Only 6.1% of patients failed to complete the study because of any reported adverse experiences (4.5% of patients discontinued because of adverse experiences considered drug related). Constipation (5.0%) and headache (1.1%) were the most commonly reported adverse events. CONCLUSION: In general clinical practice, verapamil is well tolerated and effective in a broad range of hypertensive patients.
Cobb
Margaret M.
MM
Lederle Laboratories, Pearl River, USA.
Johnson
Deborah
D
Gallo
Jose
J
Crawley
Joseph A.
JA
Cargo
Paul H.
PH
Lefkowitz
Martin P.
MP