ConClusions: Evidence suggests no increased risk of cardiovascular MI/mortality/congestive-heart failure/angina-pectoris with saxagliptin 2.5/5mg in T2DM patients. However, limited evidence suggests that saxagliptin 5mg is associated with increased risk of heart failure among T2DM patients.
Objectives: A structured and comprehensive assessment of disease management implementations is not straightforward due to the broadness of the interventions and the various evaluation possibilities. The aim of this study was to develop a comprehensive framework for outcome measurement of disease management programs based on the triple aim framework of the Institute for Healthcare Improvement to facilitate future performance assessment using multi-criteria decision analysis (MCDA). MethOds: Based on literature review and our expertise in performing economic evaluations in disease management we identified domains of outcomes for each aim of the triple aim framework. For each domain we identified indicators to assess the performance of disease management programs. Results: The first aim of the framework, population health improvement, was subdivided into the domains health-adjusted life years, mortality, wellbeing, health-related quality of life (HrQol), complications, symptoms, clinical outcomes, healthy behaviour, knowledge, and self-management skills. The second aim, improvement of patient experience, was subdivided into patient involvement, patient centeredness, continuity of care, coordination, communication, information systems, safety and access. The third aim of cost reductions distinguished program, medical and nonmedical costs. Potential Indicators of the identified sub-criteria include the ASCOT (Adult Social Care Outcomes Toolkit) for measuring wellbeing, smoking rates and BMI (Body Mass Index) to measure healthy behaviour, the EuroQol-5D and Short Form-36 for measuring physical, mental and social HrQol, different dimensions of the PACIC (Patient Assessment of Chronic Illness Care) and CAHPS (Consumer Assessment of Healthcare Providers and Systems) for measuring patient experience and several measurement tools for measuring friction costs and costs of informal care. cOnclusiOns: In designing a structured outcome-based framework for the performance evaluation of disease management programs we paved the way for future work including a comprehensive evaluation of disease management using MCDA. MCDA not only requires measurement of indicators but also weighting of their relative importance.
IntroductIon: The three main novel anticoagulants (NOACs) currently licensed in Europe, apixaban, dabigatran and rivaroxaban, have all been directly compared against warfarin in randomised controlled trials. However, none of the three drugs have been directly compared against each other. Thus, there has been an increase in the number of meta-analyses and indirect comparisons published comparing the relative efficacy and safety of these novel anticoagulants against each other via warfarin as a common comparator. objectIves: Systematically review all meta-analyses and indirect comparisons evaluating the NOACs against warfarin for the prevention of stroke in patients with AF and critically appraise the statistical methods used to do so. Methods: Systematic searches of EMBASE, MedLine, EBM Reviews, EconLIT as well as manual searches of ClincalTrials. gov, the Cochrane Library, CADTH, NICE, NHSEED and HTA were conducted. Data was abstracted from any citation applying statistical methods to compare the efficacy and safety of NOACs for the prevention of AF-related stroke. Information regarding the statistical approach; model assumptions; data presentation; interpretation of the evidence; and discussions of internal and external validity was used to quality rate each study. results: Bucher's method of adjusted indirect comparison was most widely used. There were generally three main model assumptions required: the similarity, homogeneity and consistency assumptions, each being investigated with varying scrutiny in the studies reviewed. According to the quality assessment, the indirect comparison conducted by Wells and colleagues (2012) is of the highest relative quality. conclusIons: The limited number of RCTs available comparing the NOACs to standard therapy, creates considerable uncertainty surrounding the comparative efficacy and safety of these anticoagulants. In order to establish which individual NOAC is most likely to benefit a given patient population, indirect comparisons and meta-analyses are increasingly used. However, the quality of indirect comparison studies are variable and results should be interpreted with care.
A 3 4 7 -A 7 6 6 A667 second and third line agents. The objective was to determine the relative efficacy and safety, after six and 12 months of treatment, of linagliptin, empagliflozin and the fixed dose combination of empagliflozin and linagliptin versus other sodium glucose co-transporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors. Methods: A systematic review was performed to identify randomised controlled trials (RCTs) in adult patients with T2DM experiencing inadequate HbA1c control despite a diet and exercise program, as well as a stable regimen of metformin (with or without a sulfonylurea) or a DPP-4 inhibitor based regimen (with or without other antidiabetic agents). Treatment networks of the evidence base were produced and Bayesian network meta-analyses (NMA) were conducted for efficacy and safety outcomes, including mean change from baseline in HbA1c, weight, systolic blood pressure (SBP), body mass index (BMI), cholesterol and adverse events. Results: In those failing to achieve optimal glycaemic control using metformin or metformin plus sulfonylurea therapy, empagliflozin and linagliptin perform well compared to placebo and equally as well as other SGLT2 or DPP-4 inhibitors. All SGLT2 agents perform well in reducing weight and SBP. The fixed-dose combination of empagliflozin and linagliptin has additive benefits and generally outperforms single agents. The fixed-dose combination of empagliflozin and linagliptin also appears to be associated with a safety profile similar to the single agents. ConClusions: The results of our analyses therefore suggest that these agents (empagliflozin, linagliptin and empagliflozin with linagliptin) would be appropriate agents as second line treatment in patients with T2DM.
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