Effect of Clinoril (sulindac, MSD), piroxicam and placebo on the hypotensive effect of propranolol in patients with mild to moderate essential hypertension.

One hundred ten patients of both sexes with mild to moderate essential hypertension were studied in this double-blind, multicenter study. In the double-blind portion of this study, which covered weeks 11 to 14, 71 patients were evaluated to determine the effect of Clinoril (sulindac, MSD), piroxicam, and placebo on the hypotensive effect of propranolol. All 110 patients were considered for safety evaluation. Patients treated with propranolol alone were distributed randomly into three groups (Clinoril, piroxicam and placebo) and compared in a 15-week study with four periods (I through IV). Having fulfilled the criteria for hypertension (I) and having been successfully controlled with propranolol alone (II), patients were entered into a double-blind period (III) comparing the three drug treatments during four weeks followed by one week of propranolol alone (IV). During period III, patients treated with piroxicam had significantly greater (p less than 0.05) increases in supine and standing diastolic blood pressure than patients treated with Clinoril. No clinical difference was shown between patients treated with Clinoril and placebo. At the end of period IV patients treated with piroxicam maintained the increase in their diastolic blood pressure, in contrast to Clinoril and placebo where no clinical difference was noted. Significantly more patients treated with piroxicam than Clinoril had a 10 mmHg or greater increase of their supine diastolic blood pressure. These results show that Clinoril does not blunt the antihypertensive effect of propranolol in patients with mild to moderate hypertension in contrast to piroxicam. This is an extension of a report previously published in Advances in Therapy, Vol. 2, No. 4, July/August 1985.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes