The antianginal and anti-ischemic properties of isosorbide-5-mononitrate (ISMN) were evaluated in 40 patients with chronic stable angina pectoris in a randomized double-blind parallel-group placebo-controlled study. After 2 weeks’ placebo run-in period the patients were randomized to either ISMN, orally 20 mg 2–3 times daily (titrated) or placebo. They underwent bicycle exercise stress test at the end of the placebo period and after 4 weeks of treatment. Compared with placebo ISMN increased the exercise performance, reduced ST-segment depression, anginal frequency and sublingual nitroglycerin consumption. All these changes were statistically significant. It may be concluded that ISMN is an effective antianginal and anti-ischemic agent in patients with chronic stable angina pectoris.
SUMMARY This double‐blind, randomised, cross‐over study investigated the antihypertensive efficacy of ramipril and enalapril was completed by 30 patients with mild‐to‐moderate essential hypertension. After a four‐week placebo run‐in phase, the patients received either 2.5mg ramipril or 10mg enalapril once daily for four weeks. The dosages were increased to 5mg ramipril and 20mg enalapril for a further four weeks. After a placebo washout phase of four weeks, the patients were crossed over to the alternative treatment. The decrease in average 24‐hour ambulatory diastolic blood pressure from week 0 to week 8 was 1.6mmHg greater with ramipril than enalapril (90% confidence interval 0.6‐2.7mmHg). The corresponding reduction in for systolic blood pressure was also greater with ramipril than enalapril by 2.4mmHg (90% confidence interval: 0.5‐4.2mmHg). For the difference in the drop of 24‐hour ambulatory diastolic blood pressure between ramipril and enalapril the lower level of the 90% confidence interval (CI) is above the clinically relevant difference of ‐3mmHg. This is an indication that ramipril (2.5 and 5mg dose) is at least as effective as enalapril (10 and 20mg dose) in decreasing blood pressure in patients with mild‐to‐moderate essential hypertension. The duration of adequate antihypertensive effect was relatively long for both ramipril and enalapril; however, ramipril tended to have a more prolonged antihypertensive effect. Ramipril had a higher diastolic and systolic trough/peak ratio than enalapril, resulting in a more uniform antihypertensive effect over the 24‐hour treatment period. Both ramipril and enalapril were well tolerated and the two treatment groups had similar safety profiles.
The antihypertensive efficacy and tolerability of a fixed-dose combination containing 40 mg penbutolol (a beta-blocking agent) and 6 mg piretanide (a diuretic) in comparison to placebo was investigated in a double-blind, crossover study in 20 patients with mild to moderate essential hypertension. After a 1-week period on placebo, patients were allocated at random to receive 1 tablet daily for 4 weeks of either the combination preparation or placebo and were then crossed over to the alternative medication for a further 4 weeks. The reduction in systolic and diastolic blood pressure both at rest, during maximal ergometric exercise and isometric word load, and also in the diurnal blood pressure profile over 24 hours was significantly greater in the group treated with the fixed-dose combination than in the placebo group. Pulse rate was also decreased to a greater extent. Mean diastolic blood pressure before exercise was reduced to normal (85.5 mmHg) after 4-weeks' treatment with the fixed-dose combination. Biochemical, haematological and urinary parameters showed no clinically relevant changes after either treatment. One patient complained of transient dizziness during treatment with the fixed-dose combination. No patient withdrew prematurely from the study because of side-effects.
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