LOSARTAN POTASSIUM AS INITIAL THERAPY IN PATIENTS WITH SEVERE HYPERTENSION

This 12-week, open-label study was conducted to gain experience with l osartan potassium, an angiotensin II receptor antagonist, in patients with severe hypertension. Patients were either untreated or withdrawn from current therapy for at least 48 h before initiation of losartan 5 0 mg once daily. Patients were titrated to 100 mg as needed to achieve a goal of sitting diastolic blood pressure (SiDBP) 90 or 95 mm Hg. Hy drochlorothiazide (12.5 mg once daily titrated to 25mg) was added and followed by either a dihydropyridine calcium channel blocker (CCB) and /or atenolol, if BP was not controlled. A total of 179 patients with a pretreatment mean baseline BP of 172 +/- 17/112 +/- 18 mm Hg enrolled in the trial and BP was recorded 24 h after dosing at baseline and we eks 2, 4, 8 and the final week (10-12 weeks). The mean reductions in S IDBP from baseline were 7.3, 9.3, 15.9 and 18.9 mmHg, respectively, an d these changes from baseline were statistically significant, P<0.001. At the end of the trial, 22% of patients remained on losartan monothe rapy, 30% required the addition of hydrochlorothiazide (HCTZ) and 31% required both HCTZ and a CCB; 11% required HCTZ and atenolol while 4% required HCTZ, a CCB and atenolol; 2% of patients were on regimens not specified by the protocol. SIDBP < 90 mm Hg was achieved in 68 patien ts by the final visit; 24% of these patients were treated with losarta n monotherapy (50 or 100 mg), 41% achieved control with the addition o f HCTZ (12.5 or 25 mg) and 24% required triple therapy which included losartan, HCTZ and a CCB. As assessed by the investi; gator, 25% of th e patients in the study had drug-related clinical adverse experiences. Headache was the most frequently reported clinical adverse event (26% of patients). Mo clinically significant changes in laboratory paramet ers were observed. it is concluded that losartan potassium can be used as initial therapy for patients with severe hypertension and can be a dministered concurrently with hydrochlorothiazide, calcium channel blo ckers and atenolol.