Abstract
Background: Statin use has been reported to have modest adverse effects on glycemia and incidence of diabetes mellitus (DM). We assessed effects of alirocumab (ALI), a PCSK9 inhibitor with substantial effect on LDL-C, on development of incident DM or impaired glucose control (IGC) in patients without diabetes at baseline in 10 trials in the ODYSSEY Phase 3 program. Methods: Five trials were controlled with placebo (N=2318 ALI vs 1174 placebo), and 5 with ezetimibe (N=864 ALI vs 618 ezetimibe), ranging in length from 24 to 104 wks. Most patients were receiving background statin. Different ways of assessing ALI effect on glycemic measures were used, including occurrence of treatment-emergent adverse events (TEAEs) related to DM, and fasting plasma glucose (FPG) and HbA1c measured at baseline and every 12-24 wks thereafter. Additional analysis using all 3 parameters was conducted (see Table footnote). Results: Duration of exposure is shown in the Table. At baseline, 32.8% of patients had DM, 93% based on medical history. Another 37.4% had IGC at baseline, based on laboratory data (93.6%) or medical history (6.4%). In patients without DM at baseline, there was no difference between ALI and control groups in occurrence of TEAEs related to DM with HR (95% CI) = 0.79 (0.44-1.43) in the placebo-controlled pool and 0.55 (0.22-1.41) in the ezetimibe-controlled pool. Mean change in FPG and HbA1c over time showed no meaningful differences between treatment groups by baseline glycemic status. In the additional analysis shown in the Table, there was no notable difference between ALI and control groups in % of patients with baseline normoglycemia developing DM or IGC, or those with baseline IGC developing DM. Conclusions: In 10 studies involving 4974 patients comparing ALI to either placebo or ezetimibe (median exposure 66 or 27 wks, respectively), data show no significant effect of ALI on transition to IGC or DM. Longer follow up with larger numbers is needed to conclusively rule out an effect.
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