A COMPARISON OF FOSINOPRIL AND HYDROCHLOROTHIAZIDE WITH NIFEDIPINE SRIN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

This study compared the antihypertensive effects of a once-daily fosin opril/hydrochlorothiazide (FOS/HCTZ) combination (FOS 10 to 20 mg/HCTZ 12.5mg once daily) with that of twice-daily slow-release nifedipine ( 20mg) [NIF-SR] in patients with mild to moderate essential hypertensio n [seated diastolic blood pressure (SeDBP) of 95 to 110mm Hg]. A total of 164 patients were randomised to double-blind treatment (FOS/HCTZ, 80 patients; NIF-SR, 84 patients). At week 8, the percentage of patien ts meeting the therapeutic response criteria (SeDBP less than or equal to 90mm Hg or reduction of SeDBP by greater than or equal to 10mm Hg from baseline) was 78% in the FOS/HCTZ group with the majority of pati ents on the lower FOS/HCTZ dosage vs 65% in the NIF-SR group (p = NS). No patient who received FOS/HCTZ withdrew because of an adverse event , while 13 patients who received NIF-SR discontinued participation as a result of adverse events; this difference was statistically signific ant (p < 0.001). In the FOS/HCTZ group, 26% of patients reported treat ment-emergent adverse events, compared with 54% in the NIF-SR group (p < 0.001). The incidence of cardiovascular adverse events was signific antly higher with NIF-SR than with FOS/HCTZ (34 vs 1%, respectively; p < 0.001). The study demonstrated that the FOS/HCTZ combination was as effective as NIF-SR in lowering blood pressure; however, the tolerabi lity profile of FOS/HCTZ was significantly better than NIF-SR. This ma y have important clinical considerations in selecting an antihypertens ive agent with regard to compliance and incidence of adverse events du ring long-term treatment for a broad spectrum of hypertensive patients .