Antihypertensive efficacy of optimally titrated doses of once-daily sustained-release diltiazem: a placebo-controlled trial. DILPLACOMP Study Group.
This study assessed once-daily sustained-release (o.d. SR) diltiazem in essential hypertension; 158 patients with supine diastolic blood pressures (BP) of 95-115 mm Hg were randomized to 200 mg diltiazem or placebo, then optimally titrated, at 2-week intervals, to 200, 300 or 400 mg to achieve supine diastolic BP < 90 mm Hg or a > or = 10 mm Hg fall from baseline. BP was measured at trough level, 24 h after dosing. After 2 weeks at the dose of 200 mg, supine diastolic BP was significantly reduced (from 101 to 92 mm Hg) compared with placebo (from 101 to 98 mm Hg; p < 0.001), and yielded 57% of responders with diltiazem against 22% with placebo (p < 0.001). Titration allowed supine diastolic BP normalization with diltiazem (88 mm Hg) compared with placebo (93 mm Hg; p < 0.001) and yielded 78% of responders with diltiazem against 37% with placebo (p < 0.01). The safety profile was similar to placebo. 200 and 300 mg o.d. SR diltiazem formulations enable safe and close regimen adjustments in mild-to-moderate essential hypertension.
Ollivier
J P
JP
Hôpital du Val-de-Grâce, Paris, France.
Wajman
A
A
Stalla-Bourdillon
A
A
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D003692:Delayed-Action Preparations; D004110:Diltiazem / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004110:Diltiazem