Placebo‐Controlled Trial of Once‐A‐Day Isradipine Monotherapy in Mild to Moderately Severe Hypertension

Abstract

The efficacy and safety of once-daily dosing of isradipine, a new calcium antagonist vasodilator, was evaluated in a multicenter, placebo-controlled trial in hypertensive patients who had supine diastolic blood pressure (SDBP) 100-119 mm Hg. After a 3-week single-blind placebo washout patients randomly received either isradipine, 5 mg once daily, or a matching placebo; if SDBP remained greater than or equal to 95 mm Hg or less than or equal to 10 mm Hg below baseline at four weekly clinic visits, isradipine was increased at weekly intervals by 5 mg once daily up to 20 mg and maintained during weeks 5 and 6. At week 6 mean supine blood pressure 24 hours after dosing had declined from 163 +/- 20/105 +/- 5 (N = 78) to 146 +/- 17/92 +/- 7 mm Hg (N = 60) on isradipine, 14.5 mg once daily, and from 163 +/- 20/105 +/- 6 (N = 85) to 157 +/- 18/99 +/- 10 mm Hg (N = 64) on placebo (P less than .001 between groups). Standing blood pressure decreased from 159 +/- 20/104 +/- 8 to 144 +/- 18/93 +/- 11 mm Hg with isradipine and from 160 +/- 22/105 +/- 9 to 154 +/- 19/101 +/- 11 mm Hg with placebo (P less than .001 between groups) without signs or symptoms of postural hypotension. A SDBP less than or equal to 90 mm Hg or a greater than or equal to 10 mm Hg fall below baseline was achieved in 41 of 78 isradipine-treated (53%) and 18 of 85 placebo-treated subjects (21%).(ABSTRACT TRUNCATED AT 250 WORDS)