The efficacy and safety of mibefradil in subgroups of patients with chronic stable angina pectoris.
The pool of controlled clinical studies on mibefradil, a new selective T-type calcium channel blocker, for the treatment of chronic stable angina pectoris was analysed to determine the effects in subgroups of patients defined by age, gender, body weight and common co-existing conditions. Total exercise tolerance test duration increased similarity in all subgroups, both at 50 mg (range 8.9-17.3%; n = 383) and 100 mg mibefradil (range 23.6-30.8%; n = 235). The increases in time to onset of angina and 1 mm ST-segment depression were similarly comparable. Safety and tolerability was similar to placebo for subgroups at 50 mg, but the incidence of adverse events was slightly higher in females, older, and lower weight patients at the 100 mg dose, particularly in reported leg oedema (7.9% in females vs 1.0% in males and 5.1% in older vs 0% in younger patients). Mibefradil proved a safe, well tolerated, and effective antianginal agent that can be used regardless of demographic factors or of frequently coexisting clinical conditions.
Charlon
V
V
Hoffmann-LaRoche, Clinical Research Department, Nutley, NJ, USA.
Kobrin
I
I
D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002908:Chronic Disease; D005080:Exercise Test; D005260:Female; D006801:Humans; D008297:Male; D020748:Mibefradil; D008875:Middle Aged; D012737:Sex Factors; D013764:Tetrahydronaphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D001562:Benzimidazoles; D002121:Calcium Channel Blockers; D013764:Tetrahydronaphthalenes; D020748:Mibefradil