A DOUBLE-BLIND COMPARISON OF THE EFFICACY AND SAFETY OF LACIDIPINE WITH ATENOLOL IN THE TREATMENT OF ESSENTIAL-HYPERTENSION

Thirty-one centers in the U.K. recruited 637 patients (aged 21 to 75 years) with mild-to-moderate essential hypertension [diastolic blood pressure (DBP) of 95 to 115 mm Hg, and systolic blood pressure (SBP) less-than-or-equal-to 200 mm Hg on three occasions]. After a 4-week placebo run-in period, 533 patients were randomized to receive double-blind 4 mg of lacidipine once daily (n = 268) or 50 mg of atenolol once daily (n = 265). If blood pressure was not controlled after 1 month (control = DBP less-than-or-equal-to 90 mm Hg, or less-than-or-equal-to 95 mm Hg if reduced by greater-than-or-equal-to 15 mm Hg from baseline), dosages were increased to 6 mg of lacidipine once daily or 100 mg of atenolol once daily. Hydrochlorothiazide (HCTZ, 25 mg once daily) was added after 2 months of active treatment if required for blood pressure control. Both lacidipine and atenolol reduced blood pressure to a similar degree over the 5 months of double-blind active treatment. The reduction achieved was maintained for the duration of the open phase of the study (to month 14). The incidence of adverse events was also similar for both drugs, and serious adverse events were rare and thought to be unrelated to the study drug therapy. The results indicate that lacidipine once daily for mild-to-moderate hypertension has an efficacy and safety similar to that of atenolol.