The addition of doxazosin to the therapeutic regimen of hypertensive patients inadequately controlled with other antihypertensive medications: a randomized, placebo-controlled study.

This randomized, double-blind, placebo-controlled study evaluated the use of doxazosin as an add-on therapy for inadequately controlled hypertension. Patients with a sitting diastolic blood pressure (BP) of 95 to 115 mm Hg received either doxazosin (n = 38) or placebo (n = 32) in addition to one or two baseline antihypertensive medications. After an upward titration period, patients were maintained on a fixed dosage of doxazosin (1 to 16 mg/day) or matching placebo for 4 weeks. Doxazosin add-on therapy led to improvements, compared with placebo, in sitting systolic BP (adjusted mean change = -20.9 v -8.5 mm Hg, P = .001), sitting diastolic BP (-13.0 v -8.1 mm Hg, P = .026), and standing systolic BP (-22.0 v -11.5 mm Hg, P = .011). Baseline antihypertensive therapy was gradually tapered or discontinued in patients who achieved a target reduction in BP (sitting diastolic BP of < 90 mm Hg in addition to a minimum improvement of 10 mm Hg in sitting diastolic BP over baseline) with add-on therapy (55% [n = 21] with doxazosin, 31% [n = 10] with placebo). Twelve patients in the doxazosin group maintained the target reduction in BP after complete withdrawal of their baseline antihypertensive therapy, compared with none in the placebo group. A small but statistically significant positive effect on the lipid profile was seen in the doxazosin group during add-on therapy. Doxazosin treatment was well tolerated, with an adverse event profile similar to that of placebo. These findings demonstrate that doxazosin add-on therapy is an effective, well-tolerated treatment strategy for patients with inadequately controlled hypertension.

The nifedipine gastrointestinal therapeutic system in the treatment of hypertension.

As the number of antihypertensive agents increases, the choice of optimal therapy becomes more difficult. Certainly, hemodynamic derangements caused by the disease state as well as therapy must be considered. Patient convenience and quality of life are also issues that must be addressed. Preliminary experience suggests that the gastrointestinal therapeutic system (GITS) push-pull osmotic pump formulation of nifedipine is safe and efficacious in the treatment of hypertension. In 1 study, nifedipine GITS was compared with sustained-release propranolol in patients with mild to moderate hypertension already receiving diuretics. Using a 2-week placebo run-in, double-blind study design, patients were randomly assigned to receive nifedipine GITS (n = 31) in doses of 30, 60 or 90 mg once daily, or sustained-release propranolol (n = 32) in doses of 80, 160 or 240 mg once daily. Previous diuretic therapy was continued. Sitting and 5-minute standing blood pressure and heart rate measurements were obtained 24 hours after dosing. At the end point of treatment, both nifedipine GITS and sustained-release propranolol reduced blood pressure compared with placebo (p less than 0.001) in the sitting and standing positions. Nifedipine GITS was more effective than sustained-release propranolol in reducing standing (p less than 0.005) and sitting (p less than 0.001) systolic blood pressure and sitting diastolic blood pressure (p less than 0.02). Sustained-release propranolol caused a greater reduction in standing (p less than 0.001) and sitting (p less than 0.0006) resting heart rate than nifedipine GITS. Both drugs were well tolerated.(ABSTRACT TRUNCATED AT 250 WORDS)

Multicenter comparison of the nifedipine gastrointestinal therapeutic system and long-acting propranolol in patients with mild to moderate systemic hypertension receiving diuretics. A preliminary experience.

The efficacy and safety of nifedipine in a gastrointestinal therapeutic system (GITS) push-pull osmotic pump formulation was compared with long-acting propranolol in 49 patients with mild to moderate hypertension already receiving diuretics. Using a two-week placebo run-in, double-blind study design, patients were randomly assigned to receive nifedipine GITS (n = 24) in doses of 30 mg, 60 mg, or 90 mg once daily; or long-acting propranolol (n = 25) in doses of 80, 160, or 240 mg once daily. Previous diuretic therapy was continued. Sitting and five-minute standing blood pressure and heart rate measurements were made 24 hours after dosing. At the endpoint of treatment, both nifedipine GITS and sustained-release propranolol reduced blood pressure compared with placebo (p less than 0.001) in the sitting and standing positions. Nifedipine GITS was more effective in lowering standing systolic blood pressure than was propranolol (p less than 0.02). Propranolol caused a greater reduction in resting heart rate than did nifedipine GITS (p less than 0.003). Both drugs were well tolerated. Nifedipine GITS is an effective and safe once-daily drug for use in patients with hypertension who are already receiving diuretics, may be more effective than sustained-release propranolol, and may be better tolerated than conventional nifedipine capsules.