semaglutide and dulaglutide in terms of patient baseline characteristics. In an unpublished NMA feasibility analysis for comparison of GLP‐1 RAs, substantial heterogeneity was identified between CVOTs for s.c. MAIC addresses differences in patient populations using a propensity score‐based approach, which can provide a less biased estimate by weighting the IPD for an index treatment to match the aggregate baseline characteristics for a comparator. Matching‐adjusted indirect comparison (MAIC) is an alternative method that can be used when individual patient data (IPD) are available for a treatment of interest and only published aggregate data (collated by treatment arm) are available for the comparator. Alternative indirect comparative methods are available that seek to overcome heterogeneity, and the choice of an appropriate method will be determined by the type of evidence available, as described by Lingvay et al, 2020. When significant heterogeneity exists between trials, NMA is rendered inappropriate. However, NMA adopts assumptions of homogeneity and similarity to provide unbiased estimates of treatment effects, and there must be no relevant heterogeneity between trials, which must have similar study designs, patient populations and outcome measures, and must be comparable on effect modifiers. Recently published NMAs have compared CVOTs to assess the effect of glucose‐lowering drugs on CV outcomes. Network meta‐analysis (NMA) is a well‐established method for conducting indirect treatment comparisons in the absence of head‐to‐head trials between treatments. semaglutide with dulaglutide, an indirect comparison of these treatments based on their respective CVOTs could help to determine the most suitable GLP‐1 RA for patients with T2D at high CV risk. In the absence of head‐to‐head data comparing s.c. The CV effects of dulaglutide were assessed in REWIND, which reported a statistically significant 12% reduction in the risk of 3P MACE with dulaglutide versus placebo with established CVD and/or CV risk factors. semaglutide were assessed in SUSTAIN 6, which demonstrated a statistically significant 26% reduction in the risk of three‐point (3P) major adverse cardiovascular events (MACE) (CV death, non‐fatal myocardial infarction or non‐fatal stroke) versus placebo in patients with T2D with established CVD and/or CV risk factors. In early 2020, two GLP‐1 RAs with once‐weekly dosing regimens, subcutaneous (s.c.) semaglutide and dulaglutide, were both approved by the FDA in this indication. Guidelines from the ADA and EASD specify that the GLP‐1 RA products used to treat patients with T2D and established CVD or at high risk of CVD should have proven CVD benefit, defined as having a label indication of reducing CVD events. Robust, within‐class comparison could help to guide decisions on which product in a treatment class should be used to treat individual patients with T2D with CVD or CV risk factors. There are currently no head‐to‐head randomized controlled trials (RCTs) comparing CV benefit within treatment classes, and, in the absence of Food and Drug Administration (FDA) guidance on a standardized approach to the design of CVOTs, differences in study design between some CVOTs can make indirect comparison challenging. However, based on findings of CVOTs, the ADA and EASD recommend GLP‐1 RAs as the preferred option when atherosclerotic CVD predominates and SGLT‐2is as the preferred option when heart failure (HF) or chronic kidney disease predominates.Īs well as differences between treatment classes, previous analyses suggest that CV benefit may vary within treatment class. These include glucagon‐like peptide receptor agonists (GLP‐1 RAs) and sodium‐glucose co‐transporter‐2 inhibitors (SGLT‐2is).įor patients with T2D who have established CVD or indicators of high risk of CVD, GLP‐1 RAs and SGLT‐2is are recommended by the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD), European Society of Cardiology and American College of Cardiology. However, more recently, some glucose‐lowering medication classes have demonstrated significant CV benefit versus placebo in far shorter timeframes in their cardiovascular outcomes trials (CVOTs). Its effect on macrovascular complications is only observed in the longer term for some cardiovascular (CV) outcomes. Previous studies have shown that, while the effect of intensive blood glucose control decreases the risk of microvascular complications after a median of 5 years of follow‐up, Type 2 diabetes (T2D) is a chronic and progressive metabolic disorder associated with an elevated risk of microvascular and macrovascular complications, including cardiovascular disease (CVD), which can result in considerable morbidity and mortality.
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