Repatha (Evolocumab) and Blood Sugar Levels in Patients with Diabetes
Evolocumab (Repatha) does not significantly affect blood sugar levels or increase the risk of new-onset diabetes in patients with diabetes or those with normal glycemic status. 1
Effects on Glycemic Parameters
- Evolocumab has been extensively studied in patients with various glycemic statuses, showing no significant differences in fasting plasma glucose, HbA1c, insulin, C-peptide, or HOMA indices compared to placebo after 52 weeks of treatment 2
- In the FOURIER cardiovascular outcomes trial, evolocumab demonstrated consistent efficacy in reducing cardiovascular events in both patients with and without diabetes, without worsening glycemic control 1
- The FDA label for Repatha notes that among patients without diabetes at baseline in cardiovascular outcome trials, the incidence of new-onset diabetes was 8.1% in evolocumab-treated patients compared with 7.7% in placebo-treated patients, showing no statistically significant difference 3
Cardiovascular Benefits in Diabetic Patients
- For patients with diabetes, evolocumab significantly reduced the primary composite endpoint of cardiovascular events (HR: 0.83,95% CI 0.75-0.93; p=0.0008) 1
- The 2023 American Diabetes Association guidelines acknowledge that PCSK9 inhibitors like evolocumab provide substantial LDL-C reduction and cardiovascular benefit when added to maximum tolerated statin therapy 4
- Evolocumab reduces LDL cholesterol by approximately 59% from baseline, achieving median LDL-C levels of 30 mg/dL in clinical trials 4
Safety Profile in Diabetic Patients
- The safety profile of evolocumab is similar between patients with and without diabetes, with no significant differences in adverse event rates 1
- Common adverse reactions in clinical trials included nasopharyngitis (4.0%), back pain (2.3%), and upper respiratory tract infection (2.1%), with no specific glycemia-related adverse effects reported 3
- In the FOURIER trial, the proportion of patients experiencing adverse events was nearly identical between evolocumab and placebo groups in both diabetic patients (78.5% vs. 78.3%) and non-diabetic patients (76.8% vs. 76.8%) 1
Clinical Application
- Evolocumab is FDA-approved as an adjunct to diet and maximally tolerated statin therapy for adults with established atherosclerotic cardiovascular disease or familial hypercholesterolemia who require additional LDL-C lowering 4
- The American College of Cardiology recommends evolocumab for high-risk patients unable to achieve >50% LDL cholesterol reduction on statin therapy 5
- Real-world data from the ZERBINI study showed that evolocumab treatment was associated with a 63.9% reduction in LDL-C within the first 3 months of treatment, with maintained efficacy throughout follow-up 6
Important Considerations
- When prescribing evolocumab, it's important to optimize statin therapy first before adding this PCSK9 inhibitor 7
- For patients with diabetes who have elevated cardiovascular risk, the European Society of Cardiology recommends lowering LDL-C to <1.4 mmol/L (<55 mg/dL) and reducing it by at least 50% from baseline 4
- While evolocumab is highly effective for LDL-C reduction, cost considerations may limit widespread use in some healthcare systems 4