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BMC Medicine
Published in: BMC Medicine 1/2018

Open Access 01-12-2018 | Research article

Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice – the ECSTATIC study: a cluster randomised non-inferiority trial

Authors: Clare H. Luymes, Rosalinde K. E. Poortvliet, Nan van Geloven, Margot W. M. de Waal, Yvonne M. Drewes, Jeanet W. Blom, Nynke Smidt, Willem J. J. Assendelft, Wilbert B. van den Hout, Wouter de Ruijter, Mattijs E. Numans

Published in: BMC Medicine | Issue 1/2018

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Abstract

Background

The use of cardiovascular medication for the primary prevention of cardiovascular disease (CVD) is potentially inappropriate when potential risks outweigh the potential benefits. It is unknown whether deprescribing preventive cardiovascular medication in patients without a strict indication for such medication is safe and cost-effective in general practice.

Methods

In this pragmatic cluster randomised controlled non-inferiority trial, we recruited 46 general practices in the Netherlands. Patients aged 40–70 years who were using antihypertensive and/or lipid-lowering drugs without CVD and with low risk of future CVD were followed for 2 years. The intervention was an attempt to deprescribe preventive cardiovascular medication. The primary outcome was the difference in the increase in predicted (10-year) CVD risk in the per-protocol (PP) population with a non-inferiority margin of 2.5 percentage points. An economic evaluation was performed in the intention-to-treat (ITT) population. We used multilevel (generalised) linear regression with multiple imputation of missing data.

Results

Of 1067 participants recruited between 7 November 2012 and 18 February 2014, 72% were female. Overall, their mean age was 55 years and their mean predicted CVD risk at baseline was 5%. Of 492 participants in the ITT intervention group, 319 (65%) quit the medication (PP intervention group); 135 (27%) of those participants were still not taking medication after 2 years. The predicted CVD risk increased by 2.0 percentage points in the PP intervention group compared to 1.9 percentage points in the usual care group. The difference of 0.1 (95% CI -0.3 to 0.6) fell within the non-inferiority margin. After 2 years, compared to the usual care group, for the PP intervention group, systolic blood pressure was 6 mmHg higher, diastolic blood pressure was 4 mmHg higher and total cholesterol and low-density lipoprotein-cholesterol levels were both 7 mg/dl higher (all P < 0.05). Cost and quality-adjusted life years did not differ between the groups.

Conclusions

The results of the ECSTATIC study show that an attempt to deprescribe preventive cardiovascular medication in low-CVD-risk patients is safe in the short term when blood pressure and cholesterol levels are monitored after stopping. An attempt to deprescribe medication can be considered, taking patient preferences into consideration.

Trial registration

This study was registered with Dutch trial register on 20 June 2012 (NTR3493).
Appendix
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Metadata
Title
Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice – the ECSTATIC study: a cluster randomised non-inferiority trial
Authors
Clare H. Luymes
Rosalinde K. E. Poortvliet
Nan van Geloven
Margot W. M. de Waal
Yvonne M. Drewes
Jeanet W. Blom
Nynke Smidt
Willem J. J. Assendelft
Wilbert B. van den Hout
Wouter de Ruijter
Mattijs E. Numans
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2018
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-017-0988-0

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