Diabetes: March essentials and expert commentary

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The top new studies selected from scanning more than 995 clinical articles on Diabetes in the past month.

Expert Comment: Early intensive treatment in T1DM
by Vivian Fonseca, MD, FRCP
We have learnt a lot from the landmark DCCT trial and continue to be informed on how to treat diabetes on the follow-up of these patients (see summary of latest report from Diabetes Care, below). Importantly, post trial the glycemia levels are equal in both the former intensive and standard treated groups. Even so, difference remain for a wide range of complications, suggesting that early intensive treatment is not only important at that time, but has benefits over the next 30 years. Importantly, the DCCT was done in relatively young people and therefore cardiovascular event rates were too low to see a benefit in the trial but differences appeared as these patients aged, and now are clearer after 30 years. The rates are still low and further dispel myths about insulin causing atherosclerosis. The association of renal disease with CV events is important because it highlights what has been observed in other studies and suggests that early intensive treatment may indirectly reduce CV events by reducing development of albuminuria (something that occurs early and is easily measured in practice). 


Efforts should be made to attain early intensive glycemic control in order to reduce adverse cardiovascular events in patients with type 1 diabetes 

Source: Diabetes Care                                                                                                            

Key results

  • During 30 years of follow-up in DCCT and EDIC, 149 cardiovascular disease (CVD) events occurred in 82 former intensive treatment group subjects versus 217 events in 102 former conventional treatment group subjects.
  • Intensive therapy reduced the incidence of any CVD by 30% (P=.016), and the incidence of major cardiovascular events by 32% (P=.07).
  • Lower hemoglobin A1c levels during DCCT/EDIC account for all of the observed treatment effect on CVD. Increased albuminuria was also independently associated with CVD risk.

Study design

  • The DCCT randomly assigned 1,441 patients with type 1 diabetes to intensive versus conventional therapy for a mean of 6.5 years, after which 93% have been monitored in the observational Epidemiology of Diabetes Interventions and Complications (EDIC) study.
  • Cardiovascular disease (nonfatal myocardial infarction and stroke, cardiovascular death, confirmed angina, congestive heart failure, and coronary artery revascularization) was adjudicated using standardized measures.

Why this matters

  • People with type 1 diabetes are at increased risk for CVD, the leading cause of death for men and women.

PubMed Abstract


American Diabetes Association standards of medical care in diabetes recommendations highlight individualized care to manage, prevent or delay complications, and improve outcomes 

Source: Ann Intern Med                                                    

Recommendations

  • Diagnosis, including classifying patients as type 1 or 2, and a recommendation to screen at-risk women for undiagnosed type 2 diabetes during pregnancy.
  • Assessment of glycemic targets via self-monitoring of blood glucose and hemoglobin A1c testing, with goal of A1c less than 7% for most nonpregnant adults.
  • Vigilance is urged in avoiding hypoglycemia and treating rapidly when necessary.
  • Medical management includes individualized multiple-dose insulin regimens for type 1 diabetes and patient-centered pharmacologic approaches for type 2 diabetes.
  • Cardiovascular risk factor management includes lifestyle modification, targeting blood pressure to <140/90 mmHg, statins for most over age 40 years, and aspirin (75-162 mg/day) for primary prevention.
  • Annual screening for microvascular complications retinopathy, neuropathy, and foot sensation, with followup as necessary.
  • Hospital glucose goals include target of 140-180 mg/dL for most noncritical patients. Structured plan for transition of care advised. 

Study design

  • Systematic search on MEDLINE to revise or clarify recommendations based on new evidence.
  • Standards approved by the Executive Committee of the ADA Board of Directors, which includes health care professionals, scientists, and laypersons.
  • Feedback from the larger clinical community was incorporated into the 2016 revision.

PubMed Abstract
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Findings would bolster the role of liraglutide as a beneficial treatment option for patients with type 2 diabetes who have additional cardiovascular risk factors

Source: Novo-Nordisk  

Key results             

  • The trial met criteria for both noninferiority and superiority for all three endpoint components.
  • Safety profile was consistent with previous liraglutide trials.

Study design

  • 5-year, multicenter, International Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation (LEADER) trial
  • Randomly assigned 9340 high-risk adults with type 2 diabetes to liraglutide or placebo, along with standard treatment.
  • Primary endpoint is the composite outcome of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Why this matters

  • Since 2008, the US Food and Drug Administration has required manufacturers to conduct cardiovascular safety trials in all new medications for treating type 2 diabetes.
  • Liraglutide would become the third diabetes drug to show cardiovascular benefit, after empagliflozin and pioglitazone. 
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