title: Fixed-dose combination therapy with trandolapril and verapamil SR is effective in primary hypertension. Trandolapril Study Group.
abstract: We assessed the efficacy of monotherapy with trandolapril, an angiotensin converting enzyme (ACE) inhibitor, and of verapamil slow-release (SR), a calcium antagonist, each in a range of three doses as monotherapy, and in the nine possible combinations of therapy in patients with stage I to III diastolic hypertension. After 4 weeks of single-blind placebo, 746 patients in 39 study centers were randomized to one of the 16 double-blind treatments for 6 weeks (placebo; verapamil SR monotherapy 120, 180, or 240 mg; trandolapril monotherapy 0.5, 2, or 8 mg; and trandolapril/verapamil SR combinations 0.5/120, 0.5/180, 0.5/240, 2/120, 2/180, 2/240, 8/120, 8/180, or 8/240 mg. Both mono- and combination therapies achieved the primary efficacy parameters: lowered supine diastolic blood pressure (at trough) more than placebo, P < .01 (except 0.5 mg trandolapril, 0.5/180 and 2/120 combinations, P < .05, and the 120 mg verapamil SR, P = NS). The therapies yielded a trough to peak ratio of >0.52 and had higher percentages of responders as compared with placebo (P < .01, < .05). Supine systolic blood pressures were lowered more by combination therapy than the respective monotherapies, P < .05, P < .01, except the 8/120 combination. Combination therapy was more effective than monotherapy for sitting diastolic blood pressure, P < .05. The percentage of patients with adverse reactions were similar for mono- and combination therapy. Trandolapril had a greater "apparent" incremental effect on the systolic blood pressure reductions than verapamil SR.
authors.affiliation: Division of Cardiology, USC School of Medicine, Los Angeles, California, USA.
authors.forename: V
authors.initials: V
authors.lastname: DeQuattro
authors.forename: D
authors.initials: D
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014700:Verapamil / Q000627:therapeutic use*
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D007211:Indoles; C052035:trandolapril; D014700:Verapamil