9. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2018

Abstract

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

Efficacy and safety of alirocumab among individuals with diabetes mellitus and atherosclerotic cardiovascular disease in the ODYSSEY phase 3 trials

“…Individuals with both DM and ASCVD have a particularly high risk of events, compared with individuals with either DM alone or ASCVD alone, yet are often sub‐optimally treated in clinical practice and may benefit from additional lipid‐lowering therapy beyond statins, because of elevated numbers of atherogenic particles 7, 8, 9, 10, 15. In this analysis of alirocumab Phase 3 trials in a population of very high‐risk patients with both ASCVD and DM, alirocumab treatment was shown to significantly reduce levels of LDL‐C and other atherogenic lipid parameters compared with placebo or ezetimibe controls; reductions were maintained throughout the duration of the trials (24‐104 weeks depending on trial) and overall safety was comparable to controls.…”

“…International guidelines for ASCVD risk management place individuals with DM and ASCVD in the highest risk category and recommend treatment with maximally tolerated statin therapy to reduce levels of low‐density lipoprotein cholesterol (LDL‐C), thereby reducing ASCVD risk 7, 8, 9, 10. This is supported by data from randomized clinical trials and meta‐analyses showing that treatment with statins reduces LDL‐C levels and ASCVD risk in individuals with DM 11, 12, 13.…”

“…The proportion of participants in these trials who experienced adverse events was comparable with that of controls. Based on these data, guidelines have been updated and now propose that adding ezetimibe and/or a PCSK9 inhibitor should be considered if the individual does not attain sufficient LDL‐C reduction with maximally tolerated statins alone, for example, if they have insufficient response to statin therapy or are unable to tolerate high or any doses of statins 7, 8, 9, 10, 15…”

“…Subgroup analyses have suggested similar efficacy and tolerability of alirocumab in individuals with and without DM 26, 30, 31, 32, 33. However, it is important to examine the effects of alirocumab in the specific subgroup of individuals with both DM and ASCVD who are at particularly high risk and may benefit from additional lipid‐lowering therapy beyond a statin 7, 8, 9, 10, 15. This post‐hoc analysis used pooled data from 9 ODYSSEY Phase 3 trials to evaluate the efficacy and safety of alirocumab in individuals with both DM and ASCVD.…”

Implementing personalized medicine in diabetic kidney disease: Stakeholders' perspectives

“…The recent guidelines of the American Diabetes Association state that multiple‐drug therapy is generally required to achieve blood pressure targets. However, the combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB), and combinations of ACE inhibitors or ARBs with direct renin inhibitors should not be used 15. This recommendation is based on evidence that the risk of hyperkalaemia and/or acute kidney injury is increased with these combinations when compared to others 16.…”