A S Petrulis1, T F Imperiale, T Speroff. 1. Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Abstract
STUDY OBJECTIVE: To determine the acute effect of phenylpropanolamine, 75 mg, and brompheniramine, 12 mg, in combination (PPA/B) on blood pressure in patients with controlled hypertension, using ambulatory blood pressure monitoring (ABPM). DESIGN: Randomized double-blind crossover trial. SETTING:Outpatient clinic at one medical center. PARTICIPANTS: 13 healthy volunteers aged 36 to 64 years, receiving medication for hypertension. INTERVENTIONS: Following 24-hour baseline ABPM, participants were randomized to receive either placebo or PPA/B every 12 hours for three doses, while ABPM continued. After a 24-hour washout period, all participants received the crossover regimen. MEASUREMENTS AND MAIN RESULTS: No clinically important or statistically significant difference was noted for mean systolic and diastolic blood pressures during the baseline (125/75), PPA/B (127/72), and placebo (126/73) phases of the study. Within the first four hours of treatment, the mean change in systolic blood pressure from baseline between PPA/B and placebo phases was 1.7 mm Hg (95% CI -5.3 to 8.7), and mean change in diastolic blood pressure was 0.9 mm Hg (95% CI -1.6 to 3.5), excluding a first-dose pressor effect. CONCLUSION: When used as recommended, PPA/B, a commonly used over-the-counter cold medication, has no significant acute effect on blood pressure in patients with controlled hypertension.
RCT Entities:
STUDY OBJECTIVE: To determine the acute effect of phenylpropanolamine, 75 mg, and brompheniramine, 12 mg, in combination (PPA/B) on blood pressure in patients with controlled hypertension, using ambulatory blood pressure monitoring (ABPM). DESIGN: Randomized double-blind crossover trial. SETTING:Outpatient clinic at one medical center. PARTICIPANTS: 13 healthy volunteers aged 36 to 64 years, receiving medication for hypertension. INTERVENTIONS: Following 24-hour baseline ABPM, participants were randomized to receive either placebo or PPA/B every 12 hours for three doses, while ABPM continued. After a 24-hour washout period, all participants received the crossover regimen. MEASUREMENTS AND MAIN RESULTS: No clinically important or statistically significant difference was noted for mean systolic and diastolic blood pressures during the baseline (125/75), PPA/B (127/72), and placebo (126/73) phases of the study. Within the first four hours of treatment, the mean change in systolic blood pressure from baseline between PPA/B and placebo phases was 1.7 mm Hg (95% CI -5.3 to 8.7), and mean change in diastolic blood pressure was 0.9 mm Hg (95% CI -1.6 to 3.5), excluding a first-dose pressor effect. CONCLUSION: When used as recommended, PPA/B, a commonly used over-the-counter cold medication, has no significant acute effect on blood pressure in patients with controlled hypertension.