MACE reduced by alirocumab plus statin in diabetic patients and

In a new badysis of the study "ODYSSEY Outcomes", patients with recent acute coronary syndrome (ACS) and diabetes have benefited the most in terms of adverse cardiac events (MACE) after treatment with the inhibitor PCSK9 alirocumab combined with the highest tolerance therapy with statins compared to patients with SCA and prediabetes or normal glucose levels. The data is presented in Orlando at the 78th Congress of the American Diabetes Association (ADA).

In a new badysis of the study "ODYSSEY Outcomes", patients with recent acute coronary syndrome (ACS) and diabetes benefit the most, in terms of major adverse cardiac events (MACE) after treatment with the PCSK9 alirocumab inhibitor combined with the maximum statin therapy tolerated compared to patients with SCA and prediabetes or normal glucose levels. The data is presented in Orlando at the 78th Congress of the American Diabetes Association (ADA).

As is known, the overall results of ODYSSEY Outcomes, presented at the Scientific Session of the American College of Cardiology (ACC) in March showed that LDL reduction at very low levels with injections under -cutaneous alirocumab every 2 weeks reduced the risk of MACE and all-cause mortality in patients with SCA at the highest tolerated dose of statins

Results' based on the glycometabolic state
This new pre-specified badysis examined absolute risk reduction with alirocumab plus statin therapy based on glycometabolic status. Of the 18,924 patients whose LDL levels were above 70 mg / dL and who had ACS 1 to 12 months prior to inclusion in ODYSSEY, 27.7% had normal blood glucose levels, 28, 8% had diabetes. and 43.6% had prediabetes

The absolute risk reduction for MACE almost doubled in patients with recent diabetes and SCA: 2.3% (RR = 0.84, 95% CI, 0 , 74- 0.97) against 1.2% in those with prediabetes (HR = 0.86, 95% CI, 0.74-1) and 1.2% in those with normal blood glucose (HR = 0.85%, 0.7-1.03). The median follow-up was 34 months

Increased benefits in the growth of blood glucose
"According to the basic glyco-metabolic state, from normoglycemia to prediabetes and diabetes, the rates of events for MACE are almost double when it comes to diabetes, "said in his presentation Kausik K. Ray Professor of Public Health at the Department of Public Health and Primary Care of the # Imperial College London.

"The overall effect of treating 4 MACE points in about 30 months is a relative risk reduction of 15%. There is no interaction between the three groups, which means the benefit is absolutely constant, "he added." If you focus on absolute profit, what you notice is a much greater absolute benefit in people with diabetes – twice as much as the other two groups. "

In other findings, combined treatment produces similar reductions in LDL in all three groups and no difference in HbA1c change or fasting glucose during follow-up, according to Ray.

Researchers also examined new onset diabetes, judged by a masked committee, and no increased risk was detected
Patients enrolled in ODYSSEY Outcomes received their doses of alirocumab titrated between 75 mg and 150 mg every 2 weeks to reach an LDL level of 25-50 mg / dL.

The primary outcome was the deadline of a first event MACE, defined as death from coronary artery disease, non-fatal myocardial infarction, ischemic stroke or unstable angina requiring hospitalization

Novelties for clinical practice
"In a population with diabetes and SCA with higher LDL At 70 mg / dL, the recommendations of the American Association of Clinical Endocrinologists (AACE) recommend an LDL target of about 55 mg / dL for this population of patients at extreme risk, "Ray said.

"Current evidence suggests that moving this target to 25-50 mg / dL would provide a greater absolute advantage in a high-risk population, even if the relative risk remains constant," he said.

"We can now effectively provide really solid insurance – by constantly observing HbA1c and blood glucose levels during the trial and through the selection committee we have badembled to evaluate the new diabetes – that there are no adverse effects on glycero-metabolic control over a period of 3 years "using alirocumab in combination with statins at the maximum tolerated dose, concluded Ray

Ray KK, et al.6-LB Presented at: 78th Scientific Sessions of the American Diabetes Association; June 22-26, 2018; Orlando, Florida.