Cholesterol-lowering medicines called statins can decrease heart disease, a major health problem. Studies suggest statins may also slightly increase diabetes, which has a contradictory increase in heart disease. In patients with rheumatoid arthritis (RA), the risk of heart disease, diabetes, and death are much higher than the general population, but there is little known as to whether statins have the same positive and negative effects in RA despite their common use. Our study will examine the net effects of statins in RA patients and compare them with the general population by using routinely collected health information from the Clinical Practice Research Datalink. We will first identify RA patients who have started statins. We will compare diabetes and heart disease risks of these patients with the general population (statin-user and non-user patients without RA) and statin non-user RA patients to see whether the effects of statins in RA are similar to the general population. We also expect to learn whether or not statins increase diabetes risk and if the overall heart disease benefit outweighs this negative diabetes risk.
Statins decrease cardiovascular (CV) morbidity and mortality while increasing the risk of type 2 diabetes mellitus (T2DM). Despite their frequent use, the net effect of statins in rheumatoid arthritis (RA) patients in which insulin resistance, T2DM, CV, and overall mortality risks are already increased due to chronic inflammation and glucocorticoid use, have not been evaluated comprehensively. We will compare effects of statins on incident T2DM, CV events, and mortality in RA patients in comparison with non-RA patients in the Clinical Practice Research Datalink. Statin-initiator RA patients without T2DM will be identified and each will be matched (1:5) with statin non-initiator RA patients, statin-initiator and non-initiator non-RA patients based on age, sex, study period, body mass index, other comorbidities and medications influencing the development of T2DM, CV events, and mortality. Cox proportional hazard models will be constructed to assess the statin-associated risks and benefits in each group. We will also calculate numbers needed to treat and harm with statins for each group. We will determine if statins increase T2DM risk with a more significant improvement in CV morbidity and mortality in RA patients, and identify potential risk factors for T2DM development with statins. Thereby, monitoring and preventive measures could be developed.
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Gulsen Ozen - Collaborator - University of Nebraska
Kaleb Michaud - Collaborator - University of Nebraska
Marie Hudson - Collaborator - McGill University
Rui Nie - Collaborator - McGill University
Sofia Pedro - Collaborator - National Databank fo Rheumatic Diseases
Sophie Dell'Aniello - Collaborator - McGill University
Abbas Kezouh - Collaborator - McGill University
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;MINAP