Dose-response evaluation of oral labetalol in patients presenting to the emergency department with accelerated hypertension

Abstract

Study objective: Dose-response evaluation of oral labetalol (100, 200, or 300 mg) on heart rate and systemic blood pressure in emergency department patients with hypertensive urgency (diastolic blood pressure, 110 to 140 mm Hg, and no end-organ evidence of hypertensive emergency).

Methods: This acute-treatment, dose-ranging study used a randomized, double-blind, parallel design. Patients with supine diastolic blood pressure of 110 to 140 mm Hg after 30 minutes of bedrest received an oral dose of labetalol. Supine blood pressure and heart rate were measured manually and recorded hourly for four hours after dose. Diastolic blood pressure of 100 mm Hg or less or a 30-mm Hg reduction in diastolic blood pressure was considered a treatment success.

Results: Two hundred fifty-five patients were evaluated for inclusion, and 36 patients (19 women and 17 men; mean age, 44 years; age range, 23 to 67 years) were studied. The most frequent reason for exclusion was a spontaneous decrease in diastolic blood pressure to less than 110 mm Hg (31%) with bedrest. There were 12 patients in each treatment group. Compared with baseline, the 100-mg dose significantly (P less than .05) reduced heart rate at three and four hours after dose, and the 300-mg dose significantly (P less than .05) reduced heart rate at one, two, and three hours after dose; the 200-mg dose did not significantly affect heart rate. All doses produced a significant decrease in systolic and diastolic blood pressures at one, two, three, and four hours after dose compared with baseline. There were no statistically significant differences between treatment groups with regard to systolic or diastolic blood pressure or heart rate at baseline or one, two, three, or four hours after dose. At two hours after dose, diastolic blood pressure control was observed in 75%, 58%, and 67% of patients receiving 100, 200, and 300 mg, respectively (P = .903). At four hours after dose, diastolic blood pressure control was observed in 50%, 64%, and 67% of patients receiving 100, 200, and 300 mg, respectively (P = .755). A comparison of treatment success rates between the two time periods showed a waning of response with the 100-mg dose of labetalol at hour 4 compared with hour 2 (P less than .05). No adverse effects were observed.

Conclusion: Labetalol provides safe and effective treatment for hypertensive urgencies when administered orally in doses of 100 to 300 mg.