PCSK9 inhibitor and statins highly effective in people with diabetes with ACSNews - June 25, 2018
People with diabetes who have experienced recent acute coronary syndrome (ACS) and take a combination of alirocumab and statins may reduce their risk of future cardiac events by more than double that of people on the same medication regimen who have similar cardiac histories, but have prediabetes or normal blood glucose levels, according to prespecified analyses of ODYSSEY OUTCOMES trials, presented June 24 at the American Diabetes Association’s® (ADA’s) 78th Scientific Sessions® in Orlando, FL, USA.
People who have experienced recent ACS are at an increased risk of future heart attacks and strokes, compared to people who have never experienced ACS. If a person has experienced recent ACS and has diabetes, then the risk of future CV events is even higher.
The results of the ODYSSEY OUTCOMES trial, first presented in March 2018, showed that among patients who experienced recent ACS, an injection of alirocumab (a PCSK9 inhibitor) once every two weeks plus maximum-tolerated statin medication significantly reduced future major adverse cardiac events (MACE), compared to a placebo. The 18,924 study participants had baseline LDL-c levels above 70mg/dL and had experienced ACS within one to 12 months prior to the beginning of the study. In addition to maximum-tolerated statin therapy, participants were administered alirocumab subcutaneously, with the dose titrated between 75 and 150 mg every 2 weeks to achieve an LDL cholesterol level of 25-50mg/dL. The primary endpoint was the length of time to the first MACE. The current analysis of the study evaluated the participants’ absolute risk reduction (ARR), grouping results by whether the participants had diabetes, prediabetes or normoglycemia.
Of the ODYSSEY OUTCOMES trial participants, 5,444 (28.8%) had diabetes, 8,246 (43.6%) had prediabetes, and 5,234 (27.7%) had normal glucose levels. The data indicates the patients with diabetes who were in the alirocumab group had the greatest ARR. Researchers concluded the medication regimen may almost double the ARR (2.3%) in people with diabetes who have experienced recent ACS, compared to people with recent ACS and prediabetes (ARR = 1.2%) or people with normal glucose levels (ARR = 1.2% ).
“The analyses show adding alirocumab to maximally tolerated statins reduced the overall incidence of MACE, and the absolute risk reduction was highest among those with diabetes when compared to people with prediabetes or people without diabetes,” said Kausik Ray, MD, ChB, professor of public health, department of public health and primary care at the School of Public Health of Imperial College in London. “One reason for the success of the medication combination in this group is that their absolute risk was so high; the other groups that took the alirocumab also derived benefit, but the benefit was slightly less because their risk was lower. Additionally, some genetic studies have suggested that lowering LDL-c with PCSK9 inhibitor therapy might push people with prediabetes to diabetes. We found no evidence of new onset diabetes for the people in the study who took alirocumab. These results suggest intensive cholesterol-lowering using the combination of statins and alirocumab offers us a means to significantly reduce heart disease risk in this patient population.”