Short answer: The large trials did not find a clear rise. The Repatha label reports new diabetes in 8.1% on Repatha vs 7.7% on placebo in FOURIER, and published analyses found no significant increase in new diabetes on Repatha or on Praluent, with HbA1c and fasting glucose similar to placebo. The Leqvio label gives no blood sugar data. People with diabetes are still advised to keep up their usual checks.
In FOURIER (27,525 adults with heart or blood vessel disease, median 24.8 months), the Repatha label lists diabetes among the common side effects reported more often than on placebo: 8.8% vs 8.2%. Among the 16,676 people without diabetes at the start, new diabetes developed in 8.1% on Repatha vs 7.7% on placebo. The Repatha Patient Information lists high blood sugar (diabetes) among its most common side effects.
The Praluent label does not list diabetes in its side effect tables, and the Leqvio label does not report blood sugar effects. Both Leqvio trials in heart disease enrolled many people with diabetes (45% and 35%), and the label says the LDL effect was similar with or without it.
| Analysis | People without diabetes at start | New diabetes | Blood sugar measures |
|---|---|---|---|
| FOURIER, Repatha (Sabatine 2017), median 2.2 years | 16,533 | Hazard ratio 1.05 (0.94 to 1.17), not significant; 1.00 in people with prediabetes | HbA1c and fasting glucose similar to placebo over time |
| ODYSSEY OUTCOMES, Praluent (Ray 2019), median 2.8 years | 13,480 | 9.6% on Praluent vs 10.1% on placebo; hazard ratio 1.00 (0.89 to 1.11) | Planned analysis by blood sugar group |
A hazard ratio of 1.00 means no difference; the ranges in brackets show the statistical uncertainty. Both analyses were planned in advance and funded by the medicines' makers.
Both heart outcome trials measured blood sugar on a set schedule and had possible new cases of diabetes checked, so the question was looked at closely. The trial data cover about 2 to 3 years of treatment; they cannot rule out a small effect over many more years.
Both analyses also looked at heart outcomes. In FOURIER, Repatha lowered heart events by a similar relative amount in people with and without diabetes. In ODYSSEY OUTCOMES, the absolute drop in events was larger in people with diabetes (2.3 percentage points) than in those without, because their starting risk was higher.
The labels do not call for extra blood sugar tests on a PCSK9 shot. People with diabetes or prediabetes keep the HbA1c and glucose checks their prescriber has set. Dose Track can log lab results such as HbA1c next to injection dates, which makes a long-term trend easy to see.
Read more on Dose Track: Repatha side effects · Praluent side effects · HbA1c · Blood sugar