Liraglutide, a glucose-lowering drug, has been shown to safely and effectively lower overall heart attack, stroke or cardiovascular death among oeople with T2DM at high risk for cardiovascular disease, according to results from Liraglutide Effect and Action in Diabetes - Evaluation of Cardiovascular Outcome Results (LERADER) trial.
Additionally there was a reduction in all cause mortality and kidney disease.
In this double-blind randomized study, 9340 adults with T2DM at high risk for heart disease were assigned to etiher liraglutide n 4668 or placebo n 4672, and followed for an average of 3,8 years.
Patients in L arm received daily sc injections at initial dose of 0,6 mg for the first week, 1,2 mg for the scond week and up to 1,8 mg thereafter, based on tolerance.
Participants were seen at 410 sites in 32 countries, had an average of 64 years, were 64 percent male. The study was designed after regulatory questions from FDA.
• T2DM, DCCT HbA1c 7,0 % or higher
• Antidiabetic drug naive or OADs and or basal/premix insulin,
• Age 50 years or older and established CV disease or renal failure,
• Age 60 years or older and risk factors for CV disease
Patients were assessed for clinical events, compliance with the study drug and other medication usage during visits at one, 3 and 6 months initially, then every 6 months for up to 5 years. The average duration was 3,8 years.
Patients taking L experience
1) 13% lower risk of time-first occurrence of cardiovascular death, non-fatal stroke or non-fatal heart attack (Major Advanced Cardiovasular Events MAGE), compared to those who were in the placebo group, which was the study’s primary outcome
2) The study demonstrated in addition a 22 % lower risk of cardiovascular mortality, 15% lower risk of all-cause mortality and
3) 22% lower risk of new evidence of advanced kidney disease for patients in the L arm in comparison to the placebo arm.
4) Confirmed hypoglycemia was sign reduced with 20% in L arm
5) DCCT HbA1c was reduced with 0,4%, p less than 0.001
6) Body weight reduced by 2,3 kg, p less than 0,001
7) Numbers Needed to Treat for 3 years to prevent one MACE 66, CV death 104, All-cause death 98.
No significant indications of safety isues were found among the patients in the L group. The effects started after 12 monts and then diverged more and more.
”Our results should give patients and providers comfort that L can safely improve outcomes beyond the core treatment of T2DM, said lead investigator John Buse, Prof, Chapel Hill.
”In addition, L reduced the risk of the most serious complications associated with T2DM, including the risk of death. It is exciting to see such a broad-based benefit for patients who took L because most prior trial of diabetes medications hasnot shown such benefits”
After the session the article appeared free on line on N Engl J Med website. Read more online
After the results long applause from the audience. In the back colleagues were standing up with applause.
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