Reduction of Cardiovascular Disease and Mortality Versus Risk of New‐Onset Diabetes Mellitus With Statin Use in Patients With Rheumatoid Arthritis

Abstract

Objective. To assess the effect of statin use on the risk of cardiovascular disease (CVD), all-cause mortality, and type 2 diabetes mellitus (DM) in patients with rheumatoid arthritis (RA).Methods. We identified a cohort of patients with RA between 1989 and 2018, within the UK Clinical Practice Research Datalink. We employed a prevalent new-user cohort design by which patients initiating statins were each matched to 2 concurrent nonusers by the time-conditional propensity score (TCPS). Patients were followed until the occurrence of the composite end point of myocardial infarction, stroke, hospitalized heart failure or CVD mortality, all-cause mortality, and incident type 2 DM. The Cox proportional hazards model was used to estimate the hazard ratio (HR) of each outcome associated with as-treated statin use, with adjustment for TCPS deciles and imbalanced covariables.Results. Among 1,768 statin initiators and 3,528 nonusers, 63 versus 340 CVD (3.0 per 100 person-years versus 2.7 per 100 person-years) and 62 versus 525 deaths (2.8 per 100 person-years versus 4.1 per 100 person-years) occurred. Incident type 2 DM was noted in 128 of 3,608 statin initiators (3.0 per 100 person-years) and 518 of 7,208 nonusers (2.0 per 100 person-years). Statin initiation was associated with 32% (HR 0.68 [95% confidence interval (95% CI) 0.51-0.90]) reduction in CVD, 54% ) reduction in all-cause mortality, and 33% increase in type 2 DM ). The number needed to treat/number needed to harm to prevent a CVD or all-cause mortality or to cause type 2 DM in 1 year was 102, 42, and 127, respectively.Conclusion. Statins are associated with important reductions in CVD and mortality that outweigh the modest increase in type 2 DM risk in RA patients.

Short-term, intermediate-term and long-term risks of acute coronary syndrome in cohorts of patients with RA starting biologic DMARDs: results from four Nordic countries

“…Then, an ‘ever since treatment start’ approach was used in which any drug discontinuation disregarded was also used with a maximum of (3) 1-year, (4) 2-year and (5) 5-year follow-up (online supplemental figure 1). The ‘on-drug’ approach is conceptually similar to an ‘as-treated’ approach used in randomised controlled trials (RCT), while the ‘ever since treatment start’ is similar to an intention-to-treat approach 32. This latter approach could result in one event being attributed to more than one medication.…”

Prevalent new user designs: A literature review of current implementation practice

“…The final step of the PNU process involves creation of a matched cohort based on matching study drug users to comparator drug users based on the TCPSs. Whilst the majority of studies (60%) implemented one‐to‐one (1:1) matching without replacement (which is consistent with the Suissa et al proposal), studies also matched one‐to many (1: m ; m ranging from 2 to 4) 6,7,21,23,24 . Of the studies matching 1: m , it was not always clear how this was achieved, for example, if investigators attempted to obtain matches iteratively or all at once.…”

“…The PNU design has been implemented in both electronic health records systems (e.g., in the United Kingdom and Hong Kong) [6][7][8] and administrative databases (e.g., in Taiwan, the United States and Canada). 4,[9][10][11][12] Most studies (73%) included use of an electronic health record (EHR) or detailed longitudinal registry database, rather than administrative insurance claims database.…”

Effect of Statins on All-Cause Mortality in Adults: A Systematic Review and Meta-Analysis of Propensity Score-Matched Studies

“…A total of 665 citations were identified, and 210 potentially eligible articles were retrieved in full text. Overall, 54 studies were included in the review ( Figure 1 ) [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 ]. Risk of bias assessment using NOS showed that the studies have low risk of bias.…”