A placebo-controlled crossover study of ketanserin in elderly hypertensive patients

Abstract

The results of the European Working Party for Hypertension in the Elderly Study showed that treatment of high blood pressure reduced the morbidity and mortality from strokes and myocardial infarction and reduced the incidence of heart failure in elderly patients. The largest number of hypertensive patients are elderly, and it is in this group of patients that the maximum benefit of treatment might be expected. The present study was designed to study in detail the efficacy and tolerability of ketanserin in an elderly population. Seventeen elderly (greater than 70 years) patients with a lying systolic blood pressure of 160 mmHg and/or a diastolic blood pressure of greater than or equal to 90 mmHg were included in the study. For the 12 patients who completed the study, the mean blood pressure was significantly reduced on ketanserin compared with placebo (p less than 0.001) in the supine and erect positions. The mean net changes in blood pressure after 8 weeks were 21/17 mmHg and 23/16 mmHg erect. Heart rate was also significantly reduced (p less than 0.001) by a mean of 8 beats/min lying and 9 beats/min erect. Analysis of ambulatory 24-hour ECG tapes showed no significant effect of ketanserin on heart rhythms. Ketanserin therapy had no significant effect on routine hematology, plasma electrolytes, biochemistry, or urinalysis. Total exchangeable sodium and potassium and body weight were also unchanged. On ketanserin treatment, the overall quality of life score was significantly improved (p = 0.002; analysis of variance on log transformed data) compared with the placebo phase.

Impact of antihypertensive treatment on quality of life: comparison between bisoprolol and bendrofluazide

“…28 In a previous crossover study, differences in quality of life scores between ketanserin and placebo have been obtained with only 17 patients. 32 In the present study, efficacy analysis was performed on 61 patients. Quality of life trials should last sufficiently long, 4,28 in order to allow for adaptation to side effects.…”

Quality of Life as a Therapeutic End-Point An Analysis of Therapeutic Trials in Hypertension

“…Two studies have been reported on the influence of ketanserin on quality of life in older hypertensives (McCarthy et al 1990;Meyer & Safar 1988). The first was a comparative study involving a novel placebo-controlled crossover design: despite the fact that only 17 patients were enrolled, a striking difference appeared in the overall quality of life score between the patients receiving ketanserin and those in the placebo phase, and the results were independent of treatment sequence.…”