A RANDOMIZED COMPARISON OF THE EFFECT OF 4 ANTIHYPERTENSIVE MONOTHERAPIES ON THE SUBJECTIVE QUALITY-OF-LIFE IN PREVIOUSLY UNTREATED ASYMPTOMATIC PATIENTS - FIELD TRIAL IN GENERAL-PRACTICE

Objective: To assess the equivalence of four antihypertensive treatmen ts in patients with mild-to-moderate hypertension, and to compare the effects of those drugs on the subjective quality of life and clinical safety. Design, setting and patients: 653 patients aged greater than o r equal to 18 years with untreated hypertension were randomly allocate d to receive a combination of two diuretics (altizide and spironolacto ne), a beta-blocker (bisoprolol), a calcium antagonist (verapamil), or an angiotensin converting enzyme (ACE) inhibitor (enalapril). Follow- up lasted for 1 year. Main outcome measures: A composite outcome of th e following measures was used to define success: attendance at the 12- month visit; at least nine supine DBP measurements during the study; a nd median supine DBP <90 mmHg and a reduction of at least 10 mmHg comp ared with the baseline value. Failure was defined as one or more of th ose criteria not being fulfilled. Equivalence was concluded if the 95% confidence interval for the success rates differed between two groups by less than +/- 10%. Clinical safety and subjective quality of life were also assessed. Results: No statistically significant differences in the change in DBP or systolic blood pressure were observed between the groups. The success rates were 43.9, 42.0, 32.5 and 43.9% in diure tic, beta-blocker, calcium antagonist and ACE inhibitor groups, respec tively. Equivalence between the treatments could not be concluded, alt hough analysis with a larger equivalence interval showed that some com parisons indicated equivalence. Significant improvement in satisfactio n was observed for certain items for subjective quality of life at 1 m onth in the calcium antagonist treatment group, and significant differ ences in the responses to the clinical safety questionnaire were obser ved after 1-month follow-up in calcium antagonist and beta-blocker gro ups. Differences were no longer significant after 9 months. Conclusion s: These results do not provide evidence on the basis of efficacy of b lood pressure lowering or ability to increase short-term (1-year) safe ty and quality of life favouring any particular treatment among the st udied drugs for newly diagnosed patients with mild-to-moderate hyperte nsion.