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Safety and costs of initiating angiotensin converting enzyme inhibitors for heart failure in primary care: analysis of individual patient data from studies of left ventricular dysfunction

BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7269.1113 (Published 04 November 2000) Cite this as: BMJ 2000;321:1113
  1. James Mason, senior research fellow (jmm7{at}york.ac.uk)a,
  2. Philip Young, lecturer in biostatisticsa,
  3. Nick Freemantle, reader in epidemiology and biostatisticsa,
  4. Richard Hobbs, professor of primary care and general practiceb
  1. a Medicines Evaluation Group, Centre for Health Economics University of York, York YO10 5DD
  2. b Division of Primary Care, Public and Occupational Health, School of Medicine, University of Birmingham, Birmingham B15 2TT
  1. Correspondence to: J Mason
  • Accepted 3 August 2000

Abstract

Objective: To estimate the costs and consequences of diagnosing symptomatic heart failure with left ventricular systolic dysfunction and initiating angiotensin converting enzyme inhibitors in primary care.

Design: Analysis of individual patient data from studies of left ventricular dysfunction (SOLVD) to identify complications during test dose and titration phases.

Setting: Two randomised controlled trials in secondary care.

Participants: 7487 patients taking a test dose of enalapril at enrolment to the treatment and prevention trials; 2569 patients with clinical signs of heart failure and established left ventricular dysfunction entered the treatment trial.

Main outcome measures: Discontinuation during the test dose period. Discontinuation or reduction of dose during the first year of treatment for heart failure. Costs of diagnosis and titration of treatment.

Results: During the test dose phase, 585 patients (7.8%) reported side effects; 136 (1.8%) of these discontinued because of severe side effects. During the titration phase, compared with placebo, enalapril was associated with an increased risk of dose reduction due to hypotension (odds ratio 2.09, 95% confidence interval 1.15 to 3.82). However, overall, there was no difference in the rates of side effects leading to dose reduction or withdrawal between the enalapril and placebo groups. The costs of diagnosing heart failure with left ventricular systolic dysfunction and initiating and titrating an angiotensin converting enzyme inhibitor in primary care are £300 to £400.

Conclusions: Treatment with angiotensin converting enzyme inhibitors can be safely started for patients with heart failure and left ventricular systolic dysfunction in primary care.

Footnotes

  • Funding This study was funded through an unrestricted research grant from Servier Laboratories.

  • Competing interests JM and NF have received fees and expenses for research and consultancy work from pharmaceutical companies who manufacture treatments for heart failure, from the Department of Health, and from medical charities. RH is a member of the European Society of Cardiology working party on heart failure, is chair-elect of the British Primary Care Cardiovascular Society, and has received travel sponsorship and honorariums from several biotechnology and pharmaceutical companies with cardiovascular products for plenary talks and attending major cardiology scientific congresses and conferences.

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