QUALITY-OF-LIFE COMPARISON BETWEEN BISOPROLOL AND NIFEDIPINE-RETARD IN HYPERTENSION

Quality of life with the selective beta(1)-blocker bisoprolol and the calcium channel blocker nifedipine as a retard formulation was compare d in patients with essential hypertension. A multicenter randomized, d ouble-blind, two-way, crossover study design was used. After a placebo run-in period (4-6 weeks), during which all antihypertensive therapy was withdrawn, 82 patients were randomized. During the active treatmen t periods (8 weeks each), patients received either bisoprolol once dai ly or nifedipine retard twice daily, using the double-dummy technique. A washout period (4-6 weeks) separated the treatment periods. Data at baseline (at randomization) and at the end of each treatment period w ere compared. Seventy-five patients completed the study. Blood pressur e (168 +/- 2/103 +/- 1 mmHg) decreased (p < 0.001) similarly with biso prolol (153 +/- 2/90 +/- 1 mmHg) and nifedipine (154 +/- 2/90 +/- 1 mm Hg). Compared with baseline values, none of the quality of life variab les investigated changed during bisoprolol or nifedipine retard use. N either in the intention-to-treat nor the efficacy analysis were differ ences between bisoprolol and nifedipine found in quality of life varia bles, such as the Health Status Index, somatic symptoms, anxiety, depr ession, total psychiatric morbidity, cognitive symptoms, and hostility score. Only in the efficacy analysis did Health Status Index tend to be better (p = 0.055) during nifedipine intake when compared with biso prolol. This trend was not present in the intention-to-treat analysis. The number of dropouts during bisoprolol (n = 2) and nifedipine (n = 3) treatment, and the number of patients reporting side effects (21% a nd 16%,respectively) did not differ (p = 0.64) between both treatments . It can be concluded that at equipotent antihypertensive dosages, an 8-week treatment period with the selective beta(1)-blocker bisoprolol or the calcium antagonist nifedipine as a retard formulation does not result in any difference in quality of life variables. It is not clear whether the trend of Health Status Index to become better during nife dipine intake, which was only found in the efficacy analysis and not i n the intention-to-treat analysis, is of clinical relevance.