EFFICACY, TOLERABILITY, AND EFFECTS ON QUALITY-OF-LIFE OF LOSARTAN, ALONE OR WITH HYDROCHLOROTHIAZIDE, VERSUS AMLODIPINE, ALONE OR WITH HYDROCHLOROTHIAZIDE, IN PATIENTS WITH ESSENTIAL-HYPERTENSION

A randomized, double-masked, parallel-group, multicenter clinical tria l was conducted to compare the efficacy, tolerability, and effects on quality of life associated with treatment regimens including the angio tensin II receptor antagonist losartan, with hydrochlorothiazide (HCTZ ) added as needed, with regimens including the dihydropyridine calcium channel blocker amlodipine with HCTZ added as needed. The trial inclu ded patients whose sitting diastolic blood pressure (SiDBP) measuremen ts were between 95 and 114 mm Hg, inclusive, at placebo baseline. Pati ents were randomized to receive either losartan or amlodipine in a dou ble-masked, double-dummy fashion. A 4-week placebo washout period was followed by a 12-week active treatment period. Patients in the losarta n arm (n = 97) were initially given 50 mg of oral (PO) losartan once a day (QD); the medication could be titrated to 50-mg losartan/12.5-mg HCTZ PO QD after 4 weeks, followed by 50-mg losartan plus 25-mg HCTZ P O QD after 8 weeks as necessary. Patients in the amlodipine group (n = 93) received 5-mg amlodipine PO QD, which could be titrated to 10 mg PO QD after 4 weeks, followed by 10 mg plus 25-mg HCTZ PO QD after 8 w eeks. Medication was titrated upward as necessary to achieve trough Si DBP <90 mm Hg. Efficacy, tolerability, and quality-of-life scores were assessed after 12 weeks of therapy with each regimen. Trough SiDBP re ductions after 4, 8, and 12 weeks of therapy were clinically comparabl e (losartan group: 7.3, 10.4, and 11.1 mm Hg, respectively; amlodipine group: 7.9, 11.2, and 11.8 mm Hg, respectively). Similar reductions i n systolic blood pressure were also seen for both treatment groups. Th e percentage of patients reaching goal SiDBP (defined as trough SiDBP <90 mm Hg or SiDBP greater than or equal to 90 mm Hg with a greater th an or equal to 10 mm Hg drop from placebo baseline) was camparable for the two groups, with 68% of patients in the losartan group and 71% of patients in the amlodipine group reaching goal. Significantly more pa tients in the amlodipine group had drug-related adverse experiences (2 7% vs 13%). In particular, drug-related edema was more common in patie nts receiving the amlodipine regimen than in those receiving the losar tan regimen (11% vs 1%). Patients in the amlodipine arm reported signi ficantly more bother due to edema, regardless of whether edema was pre sent at baseline, than did patients in the losartan arm (12% vs 2%), a lthough overall quality of life was not different in the two treatment groups. This study demonstrates that a regimen of losartan with HCTZ added as needed, when compared with a regimen of amlodipine with HCTZ added as needed, provides comparable efficacy and superior tolerabilit y and less bather to patients with respect to edema.