COMPARISON OF 2 EXTENDED-RELEASE VERAPAMIL FORMULATIONS IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

The efficacy and safety of two extended-release formulations of verapa mil were compared in patients with mild to moderate hypertension using a three-phase, double-blind, randomized, crossover design. A total of 59 evaluable patients were enrolled in a 4-week, single-blind placebo lead-in period, followed by randomization to either Verelan(R) 240 mg or Calan(R) SR 240 mg for 6 weeks, after which they were crossed over to the alternate therapy for 6 weeks. Efficacy was assessed by blood pressure measurements taken in the physician's office 24 hours postdos e and by 24-hour ambulatory blood pressure monitoring (ABPM). Both ver apamil formulations significantly reduced office diastolic (DBP) and s ystolic (SBP) blood pressure. ABPM confirmed the drugs' antihypertensi ve efficacy. Both medications reduced ambulatory DBP and SBP during th e initial 8 hours after dosage and over the entire 24-hour interval. A significantly greater decrease (P less-than-or-equal-to .03) in ambul atory SBP occurred during the last 4 hours of the 24-hour interval (tr ough effect) with Verelan than with Calan SR. Office SBP results, also a trough effect, showed a trend toward greater reduction in SBP durin g Verelan treatment. Both verapamil formulations were well tolerated: 6 (20%) patients treated with Calan SR and 3 (9%) patients treated wit h Verelan experienced drug-related adverse events, most frequently hea dache and constipation.