A multi-centre comparative study between ramipril and enalapril in patients with mild to moderate essential hypertension.

A multi-centre, randomized, double-blind, parallel group study was undertaken in order to assess efficacy and tolerability of ramipril as compared to enalapril in mild to moderate hypertension. A 4-week placebo run-in period was followed by 4 weeks of treatment with active medication (5 mg ramipril or 10 mg enalapril in a single morning dose). In patients not responding to this dosage regimen at the end of a 4-week treatment period, the dose was doubled. After 8 weeks of active medication, 3 mg daily of the diuretic piretanide was added to the treatment of patients not responding to the doubled dose. A total of 202 patients was admitted in the placebo phase from which 174 patients who had evaluable data at the end of the study were included in the efficacy analysis. Based on the definition of a 'responder' as a patient who achieved a supine diastolic blood pressure of 90 mmHg or less, 40% of those on 5 mg ramipril achieved this level within 4 weeks; in the enalapril group, the corresponding figure was 36.6%. By the end of 12 weeks of active treatment, a total of 55% of the ramipril group had responded to a daily dose of 5 to 10 mg ramipril. An additional 18% responded when 3 mg piretanide was added to the regimen. In the enalapril group, 59% responded to 10 to 20 mg enalapril. A further 17% responded to addition of piretanide to 20 mg enalapril. A total of 19 patients developed 29 adverse drug events while receiving ramipril, alone and in combination with piretanide. In the enalapril group, 24 patients developed 36 adverse events during enalapril monotherapy and combination treatment. It is concluded that ramipril and enalapril in a ratio of 1:2 have comparable antihypertensive efficacy in mild to moderate hypertension but the number of adverse reactions was slightly higher with enalapril in this study.

A comparative study of cefotaxime sodium versus a combination of cefapirin and gentamicin in the prophylactic treatment of patients undergoing cholecystectomy.

This was a randomized open evaluation of claforan vs. combination treatment of cefapirin + gentamicin. Patients taking part in the study were randomized in 3 parallel groups: 3 x 1 g claforan given during a period of 24 h (regimen I) was compared to 1 x 1 g claforan given at the time of incision (regimen II) and to a combination of cefapirin + gentamicin given in divided doses for 5 days (regimen III). Sixty-five patients (31 males and 34 females) aged between 23 and 76 years, who underwent cholecystectomy, were included in the study. There were no significant differences between the study groups in terms of sex, age, height, weight, diagnosis, aggravating factors and clinical condition of patients. Sixty of sixty-five patients noted "cholelithiasis" as diagnosis. The majority of patients documented an acute exacerbation of chronic condition. Twenty-three patients documented concomitant diseases/conditions or aggravating factors. The most frequent were: Diabetes mellitus, jaundice and clonorchiasis. During the study no additional administration of antibiotics or other concurrent treatment was recorded. Tolerance of the test substances was noted as "good" by 63 patients and satisfactory in 2 patients. In 3 patients (one patient in each treatment group) a postoperative wound infection was documented. One patient from regimen II with wound infection, therefore, received more than 1 g claforan. Postoperative hemoglobin decreased in all 3 groups (p less than 0.05). BUN decreased in the regimen group I (p less than 0.05) and increased together with creatinine in the group of regimen III (p less than 0.05). No side effects were documented in any treatment groups. The use of a single or three doses of claforan was more convenient and simple than the combination regimen. Less laboratory adverse effects (renal function) were also noted in claforan treated patients than the combination of cefapirin + gentamicin group.

Efficacy of ramipril versus enalapril in patients with mild to moderate essential hypertension.

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.