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Lisinopril

A Review of its Use in Congestive Heart Failure

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Abstract

The ACE inhibitor lisinopril is a lysine derivative of enalaprilat, the active metabolite of enalapril. In patients with heart failure, maximum pharmacodynamic effects are produced 6 to 8 hours after administration of the drug and persist for 12 to 24 hours.

High doses (32.5 to 35mg, administered once daily) of lisinopril in the Assessment of Treatment with Lisinopril and Survival (ATLAS) study demonstrated clinically important advantages over low doses (2.5 to 5mg, administered once daily) of the drug in the treatment of congestive heart failure. High doses of lisinopril were more effective than low doses in reducing the risk of major clinical events in patients with heart failure treated for 39 to 58 months. Compared with recipients of low doses, those receiving high doses of lisinopril had an 8% lower risk of all-cause mortality (p = 0.128), a 12% lower risk of death or hospitalisation for any reason (p = 0.002) and 24% fewer hospitalisations for heart failure (p = 0.002). These benefits were associated with significant cost savings.

In short term (generally 12 weeks’ duration) randomised, double-blind, parallel-group, multicentre clinical trials, lisinopril was significantly more effective than placebo and was at least as effective as captopril, enalapril, digoxin and irbesartan at improving symptomatic end-points and clinical status in patients with heart failure.

Lisinopril is generally well tolerated by patients with heart failure. In controlled clinical trials, the most common adverse events occurring in recipients of the drug were dizziness, headache, hypotension and diarrhoea. Overall adverse event profiles for patients treated with high or low doses of lisinopril in the ATLAS study were similar. However, high doses of lisinopril used in the ATLAS study were associated with a higher incidence of adverse events, importantly hypotension and worsening renal function; nevertheless, these events were generally well managed by altering the dose of lisinopril or concomitant medications. Furthermore, despite the higher incidence of some adverse events with high doses of lisinopril, the frequency of treatment discontinuations because of adverse events was the same in the high and low dose groups.

Conclusions: Lisinopril (when added to diuretics and/or digoxin) provides symptomatic benefits in patients with congestive heart failure. The ATLAS study demonstrated that high doses of lisinopril significantly reduced the risk of the combined end-point of morbidity and mortality compared with low doses of the drug. Importantly, there was no clinically significant decrease in the tolerability of the drug with use of a high dose. Lisinopril is at least as effective and as well tolerated as other members of the ACE inhibitor class for the treatment of congestive heart failure.

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    Kerryn Simpson & Blair Jarvis

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  1. Kerryn Simpson
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Correspondence to Kerryn Simpson.

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Various sections of the manuscript reviewed by: P.W. Armstrong, Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada; N. Doba, The 3rd Department of Internal Medicine, Teikyo University School of Medicine, Ichihara, Japan; J. Herlitz, Division of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden; F.D.R. Hobbs, Division of Primary Care Public and Occupational Health, Department of Primary Care and General Practice, The University of Birmingham, Birmingham, England; A. Struthers, Ninewells Hospital and Medical School, Dundee, Scotland; B. Trimarco, Department of Internal Medicine, Federico II University, Napoli, Italy.

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Sources: Medical literature published in any language since 1966 on Lisinopril, identified using AdisBase (a proprietary database of Adis International, Auckland, New Zealand), Medline and EMBASE. Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: AdisBase search terms were ‘Lisinopril’ or ‘MK-521’ and ‘Congestive-Heart-Failure’ or ‘Lisinopril adj PK/PD’. Medline search terms were ‘Lisinopril’ or ‘MK 521’ and ‘Heart-Failure-Congestive’ or ‘Lisinopril adj PK/PD’. EMBASE search terms were ‘Lisinopril’ or ‘MK 521’ and ‘Congestive-Heart-Failure’ or ‘Lisinopril adj PK/PD’. Searches were last updated 14 March, 2000.

Selection: Studies in patients with congestive heart failure who received lisinopril. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Lisinopril, congestive heart failure, ACE inhibitors, ATLAS, pharmacodynamics, pharmacokinetics, therapeutic use.

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Simpson, K., Jarvis, B. Lisinopril. Drugs 59, 1149–1167 (2000). https://doi.org/10.2165/00003495-200059050-00012

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