Lisinopril warnings
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Lisinopril Warnings: Safety and Tolerability Insights
Common Adverse Events with Lisinopril
Lisinopril, an ACE inhibitor, is generally well tolerated, but it does come with some common adverse events. In patients with hypertension, the most frequently reported side effects include headache, dizziness, cough, nausea, diarrhea, and fatigue2 3. For those with congestive heart failure (CHF), common adverse events are dizziness, dyspnea, diarrhea, hypotension, and fatigue2 3. These side effects are typically mild to moderate and often do not necessitate discontinuation of the drug3.
Serious Adverse Events and Discontinuation Rates
While most adverse events are manageable, some can lead to discontinuation of lisinopril. In hypertensive patients, about 6.1% discontinued the drug due to adverse events, with cough and nausea being the most common reasons2. In CHF patients, the discontinuation rate was higher at 9.6%, primarily due to hypotension, dizziness, diarrhea, and rash2. Despite these issues, the overall discontinuation rates due to adverse events are relatively low, indicating that lisinopril is generally well tolerated2 3.
Hypotension and Renal Function Concerns
Hypotension is a notable concern, especially following the initial dose of lisinopril. In hypertensive patients, the incidence of first-dose hypotension was 0.6%, but this increased to 6.7% in those with impaired renal function3. For CHF patients, the incidence of first-dose hypotension was 4.8%, with a higher risk in those also taking diuretics2 3. Additionally, high doses of lisinopril have been associated with worsening renal function, although these events are generally well managed by adjusting the dose or concomitant medications1.
Mortality and Serious Outcomes
In clinical trials, mortality rates among hypertensive patients on lisinopril were low and not considered drug-related2 3. However, in CHF patients, there were instances where deaths were potentially linked to lisinopril therapy2. Despite these serious outcomes, the overall mortality rates were comparable to those of other treatments, suggesting that lisinopril's risk profile is similar to other ACE inhibitors3.
Conclusion
Lisinopril is a well-tolerated ACE inhibitor with a safety profile comparable to other drugs in its class. Common adverse events include headache, dizziness, and cough in hypertensive patients, and dizziness, dyspnea, and hypotension in CHF patients. While serious adverse events like hypotension and renal impairment can occur, they are generally manageable. Overall, lisinopril remains a viable option for treating hypertension and CHF, with benefits often outweighing the risks.
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Most relevant research papers on this topic
Lisinopril
High doses of lisinopril significantly reduce the risk of major clinical events and hospitalizations in patients with congestive heart failure, with significant cost savings.
Clinical experience with lisinopril. Observations on safety and tolerability.
Lisinopril is well-tolerated for long-term treatment of hypertension and congestive heart failure, with a similar side-effect profile to other ACE inhibitors, but taste disturbance is rarely observed.
Observational StudyThe Safety and Tolerability of Lisinopril in Clinical Trials
Lisinopril is generally well-tolerated with mild to moderate adverse experiences, rarely requiring discontinuation of therapy.
Observational StudyEffect of the ACE inhibitor lisinopril on mortality in diabetic patients with acute myocardial infarction: data from the GISSI-3 study.
Early treatment with lisinopril in diabetic patients with acute MI is associated with a decreased 6-week mortality.
RCT
Large Human Trial
Highly CitedA double-blind, placebo-controlled, dose-response study of the effectiveness and safety of lisinopril for children with hypertension.
Lisinopril is an effective and well-tolerated antihypertensive in children aged 6 to 16 years, with a dose-dependent reduction in blood pressure within 2 weeks.
RCTHighly CitedComparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group.
High doses of ACE inhibitors are generally recommended for patients with heart failure, as they reduce morbidity and mortality, while very low doses may be tolerated but have limited benefits.
RCTLarge Human TrialHighly CitedThe Clinical Pharmacology of Lisinopril
Lisinopril effectively reduces blood pressure in hypertensive patients without affecting heart rate or cardiovascular reflexes, and is well-tolerated and has a good safety profile.
Highly CitedLisinopril in the Treatment of Congestive Heart Failure in Elderly Patients: Comparison versus Captopril
Lisinopril 5-20 mg once daily is as effective and well-tolerated as captopril 12.5-50 mg daily in treating congestive heart failure in elderly patients.
RCTLisinopril versus hydrochlorothiazide in obese hypertensive patients: a multicenter placebo-controlled trial. Treatment in Obese Patients With Hypertension (TROPHY) Study Group.
Lisinopril is as effective as hydrochlorothiazide in treating obesity-associated hypertension, with angiotensin-converting enzyme inhibitors showing greater efficacy at lower doses and faster response rates.
RCTHighly CitedOral Lisinopril Raises Tissue Levels of ACE2, the SARS-CoV-2 Receptor, in Healthy Male and Female Mice
Oral lisinopril increases ACE2 in tissues relevant to COVID-19 transmission and pathogenesis, but the addition of losartan prevents these increases in ACE2 levels.
RCT
Animal Study