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PurposeAn important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.MethodsThis was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post‐Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness.ResultsOf the 872 records in the EU PAS Register, 19 studies evaluating the effectiveness of RMMs were included. Eleven were cross‐sectional surveys and 8 used secondary data sources. Eighty‐nine percent (17/19) evaluated additional RMMs (used when routine RMMs are considered insufficient), and 36% (7/19) evaluated changes in routine RMMs (applicable to all medicinal products). A total of 42 effectiveness indicators were identified: 18 process and 24 outcomes. Half of the indicators (21/42) were successful; 2% (1/42) indicators were partially successful; 17% (7/42) indicators were inconclusive. Effectiveness of the remaining 31% (13/42) indicators could not be determined owing to limited information. The United Kingdom was the most frequent country for the conduct of RM effectiveness studies.ConclusionsMost of the included studies evaluated additional RMMs. Half of the effectiveness indicators (process and/or outcome) were reported as successful. This review provides evidence to support the development of future guidance on the effectiveness of RM in Europe.

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Introduction: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in people with type 2 diabetes mellitus (T2DM). The objectives of this systematic literature review were to identify and synthesize published data describing the epidemiology and mortality of CVD in the T2DM population and the associated economic burden. Methods: We conducted a systematic review searching the PubMed and MEDES databases from 2009 to 2019 using predefined selection criteria. Peer-reviewed observational studies reporting primary or secondary data on CVD prevalence, incidence, mortality, resource use and costs in patients with T2DM in Spain, written in English and Spanish, were included. Data were tabulated and summarized descriptively. Results: Of 706 articles identified, 52 were included in the review. Most studies were based on data from hospital discharge databases and registries. The reported prevalence of CVD among patients with T2DM ranged from 6.9 to 40.8%. The prevalence of coronary heart disease ranged from 4.7 to 37%, stroke from 3.5 to 19.6%, peripheral artery disease from 2.5 to 13.0%, and heart failure from 4.3 to 20.1%. Inhospital CVD mortality rates ranged from 5.6 to 10.8%. Direct costs due to CVD in hospitalized patients with T2DM were increased ([ 50%) compared with patients without CVD. No studies analysed indirect costs of CVD in patients with T2DM. Conclusions: The burden of CVD among patients with T2DM, combined with the elevated costs of care, highlights the importance of early prevention as part of integrated management of the disease to improve clinical and economic outcomes.