Efficacy and tolerability of once-daily barnidipine in the clinical management of patients with mild to moderate essential hypertension.
Four multicentre trials have investigated the efficacy and tolerability of treatment with once-daily, modified-release capsules of barnidipine, a long-acting dihydropyridine calcium antagonist, in patients with mild to moderate essential hypertension. In two of these trials, the clinical profile of barnidipine was compared with those of amlodipine and nitrendipine, which belong to the same class of drug as barnidipine, in a randomized, double-blind, parallel-group manner. In one study, 37 patients received amlodipine and 79 patients received barnidipine. In a second study, 46 patients received nitrendipine and 96 received barnidipine. In each trial, a 4-week placebo run-in phase was followed by a 12-week comparative phase. Changes in sitting and standing diastolic and systolic blood pressures were assessed, and adverse events were recorded. Both studies demonstrated that the antihypertensive efficacy of barnidipine was equivalent to each comparator agent, but barnidipine tended to produce fewer class I adverse reactions. The long-term efficacy and safety of barnidipine were demonstrated in an open-label study. In total, 106 patients were followed for the first year of the study, during which time they received barnidipine at a dose titrated to achieve a sitting diastolic blood pressure of less than 90 mm Hg; if necessary, another antihypertensive agent was added to achieve normalization of blood pressure. Seventy-nine of these patients, most of whom were maintained on barnidipine monotherapy, were followed for a second year, and 32 patients, all of whom received barnidipine monotherapy throughout the study period, were followed for a third year. Blood pressure normalization after 1 year of follow-up was achieved in 91% of patients, and was maintained for the second and third years in 91% and 81% of patients, respectively. The incidence of adverse events, possibly or probably attributable to barnidipine, was 22%, 14% and 3%, respectively, during each successive year. The suitability of barnidipine for once-daily dosing was confirmed in a randomized, double-blind, placebo-controlled, crossover study of 20 patients. These patients were given 6-week regimens of both barnidipine (20 mg) and placebo, preceding 24-h ambulatory blood pressure monitoring. Barnidipine lowered blood pressure to a significantly greater extent than placebo both at night and during the day. These studies suggest that barnidipine possesses equivalent efficacy to amlodipine and nitrendipine, but produces fewer class-specific side-effects. It provides 24-h efficacy from a once-daily dosing regimen, and this efficacy and its safety profile are maintained for at least 3 years.
Spieker
C
C
Raphaelsklinik, Münster, Germany.
D000959:Antihypertensive Agents / Q000008:administration & dosage; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D015337:Multicenter Studies as Topic; D009543:Nifedipine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; C050699:mepirodipine; D009543:Nifedipine