MAIN RESULTS OF THE LOSARTAN VERSUS AMLODIPINE (LOA) STUDY ON DRUG TOLERABILITY AND PSYCHOLOGICAL GENERAL WELL-BEING

Objective To compare two losartan regimens (with and without hydrochlo rothiazide) and amlodipine in treating mild-to-moderate hypertension r egarding their blood-pressure-lowering effect, drug tolerability and q uality of life. Design A 12-week, randomized, double-blind, parallel-g roup, multi-centre study, After 4 weeks of placebo, patients with a di astolic blood pressure (DBP) in the range 95-115 mmHg were allocated r andomly to be administered 50 mg losartan (increased to 100 mg if the DBP was 90 mmHg or more after 6 weeks), 50 mg losartan (plus 12.5 mg h ydrochlorothiazide under the above conditions), or 5 mg amlodipine (in creased to 10 mg under the above condition), The tolerability of the t reatment and the quality of life were evaluated by spontaneous reporti ng, active questioning and the Psychological General Well-Being (PGWB) index, Study population In total 898 hypertensives, mainly referred f rom primary health care (mean age 57.8 years) of whom 52% were men. Re sults Administration of 50 mg losartan (plus 12.5 hydrochlorothiazide if necessary) and of 5 mg amlodipine (or 10 mg if necessary) lowered t he blood pressure as well as or better than did 50 mg losartan (or 100 mg if necessary), The incidence of 'any discomfort' and 'swollen ankl es' increased with amlodipine but not with losartan treatment. The opp osite was found for 'dizziness upon standing', The incidence of drug-r elated adverse events and the number of patients withdrawn from therap y were higher with amlodipine than they were with losartan treatment. The PGWB index at week 12 indicated that improvements from baseline ha d occurred in some domains for the losartan groups whereas it remained unchanged for the amlodipine group, Conclusion Both losartan and amlo dipine were effective in lowering the blood pressure and were tolerate d well, Administration of 50 mg losartan (plus 12.5 mg hydrochlorothia zide if necessary) and of 5 mg amlodipine (or 10 mg if necessary) lowe red the blood pressure equally well or better than did 50 mg losartan (or 100 mg if necessary), Drug-related adverse effects and withdrawal from the study were more common for the amlodipine group, The clinical significance of the improvements in the PGWB index with losartan need s to be studied further.