Sattar N, et al. – This study was designed to gain an insight into the impacts of the PCSK9 inhibitor evolocumab on fasting plasma glucose [FPG], glycated hemoglobin (HbA1c), weight and new–onset diabetes mellitus. Findings demonstrated nil impact of evolocumab therapy on glucose homeostasis over 1 year of open–label treatment.

Methods

• Researchers pooled 1-year (48-week) data for participants who had completed an evolocumab parent study before entering an open-label extension (OLE) trial.

Results

• Data were available for 4,802 participants (1,602 on standard of care [SOC]; 3,200 on evolocumab plus SOC) in 2 OLE trials.
• Findings showed that evolocumab lowered LDL-cholesterol by approximately 60% compared to SOC alone.
• As per results, over the first year of the OLE trials, there was no difference in median (Q1, Q3) change in HbA1c(0.1% [–0.1, 0.2] for both SOC and evolocumab plus SOC) and FPG (0.06mmol/L [–0.28, 0.38 mmol/L] for SOC and 0.06mmol/L [–0.28, 0.44 mmol/L] for evolocumab plus SOC).
• Researchers found that mean weight change (standard error) at 1 year was –0.1kg (0.2) on SOC compared to 0.3kg (0.1) on evolocumab plus SOC.
• They also noted that the exposure-adjusted incidence rate (95% confidence intervals) for new-onset diabetes per 100 patient years was 3.7 (2.9-4.7) on control/SOC alone and 3.9 (3.2-4.6) on evolocumab/evolocumab plus SOC treatment.
• In addition, data highlighted that glycemic changes observed in 6,430 participants at week 12 in the parent studies were comparable to OLE trial findings.