Evaluation of isradipine (PN 200-110) in mild to moderate hypertension

Nathaniel Winer, Susan Thys-Jacobs, Raminder Kumar, Warren D. Davidson, Martha Grayson, Calvin Harris, Deborah Walker, Harold Itskovitz, Leonard Gonasun

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Abstract

The efficacy and safety of isradipine (PN 200-110), a new dihydropyridine calcium antagonist, was evaluated in 87 hypertensive patients in a placebo-controlled, double-blind, randomized multicenter trial. After a 3-week single-blind washout phase, isradipine (or matching placebo) was administered for 4 weeks, beginning at 2.5 mg b.i.d. with increments of 2.5 mg b.i.d. at weekly intervals if supine diastolic blood pressure remained ≥90 mm Hg. At the end of 1 week average supine blood pressure in the isradipine group (n = 45) fell from a baseline of 156 ± 13 104 ± 4 mm Hg to 146 ± 14 97 ± 7 mm Hg. By week 4 blood pressure was reduced by 19 14mm Hg compared with 4 5mm Hg in the placebo group (P < 0.001 between groups). Supine and standing pulse rates were slightly increased initially with isradipine therapy but returned to baseline with increasing isradipine doses. Blood pressure responses at week 4 were good or excellent (supine diastolic ≤90 mm Hg or ≥10 mm Hg decrease from baseline) in 87% of isradipine-treated patients and in 26% of placebo-treated patients. Headache, edema, abdominal discomfort, and constipation occurred slightly more frequently in isradipine-treated patients than in placebo-treated control subjects. The results indicate that isradipine, administered as monotherapy in doses of 2.5 to 10 mg b.i.d., is safe and effective in patients with mild to moderate essential hypertension.

Original languageEnglish (US)
Pages (from-to)442-448
Number of pages7
JournalClinical Pharmacology and Therapeutics
Volume42
Issue number4
DOIs
Publication statusPublished - Oct 1987

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ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Winer, N., Thys-Jacobs, S., Kumar, R., Davidson, W. D., Grayson, M., Harris, C., ... Gonasun, L. (1987). Evaluation of isradipine (PN 200-110) in mild to moderate hypertension. Clinical Pharmacology and Therapeutics, 42(4), 442-448. https://doi.org/10.1038/clpt.1987.175