Statin use in the secondary prevention of coronary heart disease in primary care: cohort study and comparison of inclusion and outcome with patients in randomised trialsBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.38398.408032.8F (Published 07 April 2005) Cite this as: BMJ 2005;330:821
- Li Wei, research fellow1,
- Shah Ebrahim, professor2,
- Christopher Bartlett, research associate2,
- Peter D Davey, professor1,
- Frank M Sullivan, professor3,
- Thomas M MacDonald, professor ()1
- 1 Medicines Monitoring Unit, Health Informatics Centre, Division of Medicine and Therapeutics, Ninewells Hospital and Medical School, Dundee DD1 9SY,
- 2 MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol BS8 2PR,
- 3 Tayside Centre for General Practice, Division of Community Health Sciences, University of Dundee, Dundee DD2 4BF
- Correspondence to: T M MacDonald
- Accepted 20 January 2005
Objective To compare the social and demographic profiles of patients who receive statin treatment after myocardial infarction and patients included in randomised trials. To estimate the effect of statin use in community based patients on subsequent all cause mortality and cardiovascular recurrence, contrasting effects with trial patients.
Design Observational cohort study using a record linkage database.
Setting Tayside, Scotland (population size and characteristics: about 400 000, mixed urban and rural).
Subjects 4892 patients were discharged from hospital after their first myocardial infarction between January 1993 and December 2001. 2463 (50.3%) were taking statins during an average follow-up of 3.7 years (3.1% in 1993 and 62.9% in 2001).
Main outcome measures All cause mortality and recurrence of cardiovascular events.
Results 319 deaths occurred in the statin treated group (age adjusted rate 4.1 per 100 person years, 95% confidence interval 3.2 to 4.9), and 1200 in the statin untreated group (12.7 per 100 person years, 11.1 to 14.3). More older people and women were represented in the population of patients treated with statins than among those recruited into clinical trials (mean age 67.8 v 59.8; women 39.6% v 16.9%, respectively). The effects of statins in routine clinical practice were consistent with, and similar to, those reported in clinical trials (adjusted hazard ratio for all cause mortality 0.69, 95% confidence interval 0.59 to 0.80; adjusted hazard ratio for cardiovascular recurrence 0.82, 0.71 to 0.95).
Conclusions The community effectiveness of statins in those groups that were not well represented in clinical trials was similar to the efficacy of statins in these trials.
Contributors LW carried out the statistical analysis and wrote the first draft of the paper. SE, CB, PGD, FMS, and TMM were involved in the design of the study, interpretation of results, and redrafting of the paper. TMM is guarantor.
Funding This study is part of a project investigating exclusions from trials funded by the NHS R&D HTA Programme (98/24/02) led by Paul Dieppe, MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol. The Department of Social Medicine of the University of Bristol is the lead centre of the MRC Health Services Research Collaboration. The Tayside Medicines Monitoring Unit (MEMO) is a member of the MRC Health Services Research Collaboration.
Competing interests TMM has received honorariums for lectures and advisory boards in the last year from Pfizer, Roche, Speedel, Medeus, Novartis, and Sankyo. PGD serves on advisory boards for Aventis and Pfizer
Ethical approval Tayside Research Ethics Committee and the Tayside Caldicott Guardians.
- Accepted 20 January 2005