Ketanserin in the treatment of essential hypertension. A double blind trial against metoprolol followed by one-year open treatment.

The present study was designed to compare the antihypertensive potencies of ketanserin and metoprolol in a double-blind trial and to study ketanserin long-term efficacy in a one-year open trial, plain or combined with metoprolol, according to diastolic blood pressure (DBP) normalization. Thirty-four patients were randomly assigned to two groups, one (n = 17) received ketanserin, 80 mg/day, and the other, (n = 17) metoprolol, 200 mg/day. After 3 mo. double blind treatment, all patients received plain ketanserin, or combined with metoprolol if ketanserin failed to normalize DBP. A significant effect was demonstrated after 3 mo. double blind treatment, for both drugs, in both standing and supine DBP (p less than 0.001). In the one-year follow-up, all patients received ketanserin and were divided in: I (n = 15) previously treated with the same drug; II (n = 2) plus metoprolol, in whom ketanserin had failed to decrease DBP; and III (n = 15) previously treated with metoprolol. In group I the blood pressure lowering effect of ketanserin remained constant during the one-year follow-up. In group II a trend in the decrease of parameters was observed. In group III, supine DBP diminished from 92.5 +/- 2 mmHg during treatment with metoprolol to 86.0 +/- 2 at 12 mo., after treatment with ketanserin (p less than 0.05). In groups I and III, 24/30 of patients normalized their DBP during one-year ketanserin open treatment. Ketanserin appears as a new alternative in the treatment of mild and moderate essential hypertension.

Multicenter study with ketanserin in essential hypertension: an Argentine experiment.

One thousand eleven patients with essential hypertension (H) were evaluated upon compliance with the following inclusion criteria: (a) mild to moderate uncomplicated H, with supine diastolic blood pressure (Su DBP) greater than 90 mm Hg at the end of the placebo period, with or without antihypertensive treatment; (b) greater than 20 years old. The dosage of ketanserin (K) was 20 mg b.i.d. up to the fourth week. Afterwards, if the patients normalized, we continued with the same schedule. If this did not occur, the dosage was increased (40 mg b.i.d.) up to the eighth week. Four hundred fifty-one men and 560 women were included, with a mean age of 56.6 years, mean body weight 74.8 kg, and mean height 166.30 cm. At the end of the eighth week, the percentage of normalization was 75.5% of the patients, and the percentage of partial responders was 5.6%. The decrease of the blood pressure (diastolic and systolic) was significant at the second week (paired t test, two-tailed probability, p less than or equal to 0.001). There were 62 dropouts: 10 due to inefficacy, 14 due to adverse reaction, and 38 due to other reasons. Laboratory examinations were performed before and after treatment and did not show statistical differences. Also, a 12-lead ECG was performed before and after treatment with K. The QTc was analyzed in a sample of 140 patients and did not show statistically significant changes. The incidence of side effects was minimal (24% of the patients, n = 224), mild, and transient; only 1% of the patients dropped out due to adverse reactions. In our experience, ketanserin was an effective and safe drug, to be used primarily for the treatment of mild to moderate H.

Ketanserin versus metoprolol in the treatment of essential hypertension.

This study was designed to compare the antihypertensive effectiveness of ketanserin (K) and metoprolol (M) in a 3-month double-blind treatment, and to assess the long-term efficacy of K in a 1-year open trial. Twenty-four patients with mild to moderate hypertension were randomly placed in two groups: group 1 (n = 11) received K, 40 mg/day, and group 2 (n = 13) received M, 200 mg/day. In the double-blind phase of treatment both K and M significantly lowered blood pressure (BP) (P less than 0.01). The heart rate was significantly decreased by M (P less than 0.01). In the 1-year follow-up, patients were divided into three groups: group I (n = 7) had been previously treated with K and maintained on K; group II (n = 4) was given K plus M (these patients had previously been treated with K, but K had failed to decrease diastolic BP to less than or equal to 90 mmHg); and group III (n = 13) was given K (previously these patients had been treated with M). In group I, the BP lowering effect remained constant throughout the 1-year follow-up. In group III, supine and standing diastolic BP decreased significantly after treatment with K (P less than 0.05). Side effects from K were minimal. Ketanserin appears to be a new alternative approach in the treatment of mild and moderate essential hypertension.

Ketanserin in the treatment of essential hypertension. A double-blind study against metoprolol and a further long-term open treatment.

Monotherapy with Ketanserin, a serotonin receptor antagonist, reduces blood pressure in a sizeable number of patients with essential hypertension. The present study was designed to compare its antihypertensive potency with those of metoprolol in a double-blind treatment and further to study its long-term efficacy and safety in a one-year open trial, alone or combined to metoprolol, according to diastolic blood pressure (DBP) normalization. Twenty-four patients with mild to moderate hypertension were randomly assigned to two parallel treatment groups, one group (n = 11) received Ketanserin (40 mg/day) and the other one (n = 13) metoprolol (200 mg/day). After 3 months double-blind treatment, all patients received Ketanserin, on an open basis for one year alone or combined to metoprolol if Ketanserin failed to normalize DBP. A significant antihypertensive effect was demonstrated after 3 months double-blind treatment, for Ketanserin and metoprolol, in both standing and supine position (p less than 0.01). Heart rate showed a clear decrease by metoprolol (p less than 0.01). In the one-year follow-up, patients were divided in: I (n = 7) patients on Ketanserin (previously treated with the same drug); II (n = 4) patients on Ketanserin plus metoprolol (previously treated with Ketanserin, in whom it failed to normalize DBP); and III (n = 13) patients on Ketanserin (previously treated with metoprolol). In group I the blood pressure lowering effect of Ketanserin remained constant after one-year follow-up. In group II, although the number of patients was insufficient, a trend in the decrease of parameters was observed. In group III, supine and standing DBP diminished from 92.5 +/- 8 and 92.5 +/- 7 during treatment with metoprolol to 83.6 +/- 9 and 79.8 +/- 8 mmHg respectively at 12 months, after treatment with Ketanserin (p less than 0.05); accordingly, the cumulative percentage of normalized DBP increased from 4/13 after metoprolol to 12/13 at the end of the trial. Ketanserin side effects were minimal. Taking into account the wide variety of contraindications or side effects with beta-blockers and diuretics, Ketanserin appears as a new and important alternative in the treatment of mild and moderate essential hypertension.