Efficacy, tolerability, and quality of life of losartan, alone or with hydrochlorothiazide, versus nifedipine GITS in patients with essential hypertension

摘要: A randomized, double-masked, parallel-group, multicenter clinical trial was conducted to compare the efficacy, tolerability, and effects on quality of life associated with angiotensin II receptor antagonist losartan, alone or hydrochlorothiazide (HCTZ), dihydropyridine calcium channel blocker nifedipine gastrointestinal therapeutic system (GITS) in patients whose sitting diastolic blood pressure measurements were between 95 115 mm Hg, inclusive, while receiving placebo. Patients randomized receive either losartan GITS a double-dummy fashion. 4-week placebo washout period established baseline untreated followed by 12-week active treatment period. (n = 110) initially given 50 mg once day (QD) could be titrated losartan/HCTZ mg/12.5 QD after 4 weeks mg/25 8 weeks, as necessary. group 113) received 30 QD, which 60 90 weeks. Medication upward necessary achieve trough <90 Hg. Efficacy, quality-of-life scores assessed 12 each therapy. Trough reductions 4, 8, therapy clinically comparable: −8.9, −11.6, −12.7 respectively, GITS, −9.3, −11.0, −11.1 mean reduction at 1.6 Hg lower (95% confidence interval, 3.4 0.3 higher) than group. Similarly, systolic two groups comparable all time points. The percentage reaching goal for groups, 74% regimen 68% goal. Of reporting adverse events (75 69 GITS), there significantly more edema (15% vs 4%; P 0.005). Fourteen (12%) withdrawn due an event (eight these edema). Six (5%) (none had There significant differences patient-reported symptom bother inventory respect edema, causing patients, regardless whether that present (27% 9%; 0.0004). No statistically other symptoms noted. note, incidence 27%, physician-reported drug-related 12%. This difference points need improved physician—patient communication regarding their impact patients' life. In conclusion, when compared provides superior less fewer dropouts.