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High-risk patients treated with enalapril maleate: safety considerations
E J Rucinska1, R Small, J Irvin
1Merck Sharp & Dohme Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486.
Insights
Enalapril is safe and effective for high-risk patients, including those with kidney disease or heart failure. Treatment discontinuation rates were similar to other therapies, with no specific adverse events reported.
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- High-risk patients often have complex conditions like collagen vascular disease, renal disease, or severe hypertension.
- Standard antihypertensive therapies may have limitations in this population.
Purpose of the Study:
- To evaluate the safety and tolerability of enalapril in a cohort of 738 high-risk patients.
- To compare enalapril's adverse reaction profile against standard antihypertensive treatments.
Main Methods:
- Prospective evaluation of 738 high-risk patients receiving enalapril across multiple clinical programs.
- High-risk criteria included specific comorbidities and baseline serum creatinine levels.
- Adverse events leading to treatment discontinuation were systematically recorded.
Main Results:
- Enalapril treatment discontinuation rates were comparable to standard therapies in less severe patient groups.
- No cases of enalapril-associated neutropenia, proteinuria, dysgeusia, or ageusia were observed.
- Rash led to discontinuation in less than 0.5% of patients.
- Patients with collagen vascular diseases or severe renal impairment showed similar safety profiles.
Conclusions:
- Enalapril demonstrates efficacy and a favorable safety profile in high-risk patient populations.
- The drug is well-tolerated, even in patients with significant comorbidities and impaired renal function.
- Enalapril may offer a viable treatment option for managing hypertension and heart failure in complex cases.
Abstract:
The safety of 738 high-risk patients treated with enalapril under various clinical programs was evaluated. High risk was defined as the presence of a collagen vascular disease; a renal disease, including renovascular hypertension; or either hypertension or refractory cardiac failure with serum creatinine greater than or equal to 1.7 mg/dl at baseline. Essential hypertension was the primary diagnosis in most of these patients. Treatment with enalapril in these patients usually continued without interruption for the length of the particular protocol. The incidence of adverse reactions resulting in discontinuation of treatment was comparable to that observed with other standard antihypertensive therapies in patients with milder forms of disease. No enalapril-related neutropenia, proteinuria, dysgeusia or ageusia were reported in these high-risk patients. The incidence of discontinuation due to rash was less than 0.5%. Resolution and/or improvement of captopril-related adverse effects was observed in many patients crossed over to treatment with enalapril. In patients with collagen vascular diseases and those with severe impairment of renal function (serum creatinine greater than or equal to 3.0 mg/dl), the incidence of discontinuation due to adverse experiences or death as well as the profile of reported adverse experiences was similar to those for the total group of high-risk patients. The data suggest that enalapril is efficacious and well tolerated by the high-risk patients.