Short answer: Slightly more often than placebo in the labels. Muscle pain was reported in 4% on Praluent vs 3% on placebo, and 6% vs 5% in its heart outcomes trial. Repatha's 52-week trial reported 4.0% vs 3.0%. Leqvio's label lists joint pain (5% vs 4%) but not muscle pain. In two trials of people who had muscle symptoms on statins, muscle complaints were less common on a PCSK9 antibody than on a statin or similar to ezetimibe.
| Medicine and trial | Side effect | Medicine | Placebo |
|---|---|---|---|
| Praluent, pooled placebo trials (median 65 weeks) | Muscle pain (myalgia) | 4% | 3% |
| Praluent, pooled placebo trials | Muscle spasms | 3% | 2% |
| Praluent, ODYSSEY OUTCOMES (median 31 months) | Muscle pain | 6% | 5% |
| Repatha, 52-week trial | Muscle pain | 4.0% | 3.0% |
| Repatha, 52-week trial | Musculoskeletal pain | 3.3% | 3.0% |
| Repatha, pooled 12-week trials | Muscle spasms | 1.3% | 1.2% |
| Leqvio, 3 trials (about 18 months) | Joint pain (arthralgia) | 5% | 4% |
The differences are about 1 percentage point. In Repatha's 52-week trial, muscle pain was the most common side effect that led people to stop more often than placebo, at 0.3% vs 0%. Neither the Praluent nor the Repatha label lists muscle injury as a warning.
Many people asking this question have had muscle aches on statins. Two trials looked at that group directly, both over 24 weeks.
| Trial | People | Muscle finding |
|---|---|---|
| GAUSS-3 (Nissen 2016) | 218 people, nearly all with muscle symptoms on atorvastatin but not on placebo in a blinded test | Muscle symptoms in 20.7% on Repatha vs 28.8% on ezetimibe (not a significant difference); stopped for muscle symptoms: 1 of 145 vs 5 of 73 |
| ODYSSEY ALTERNATIVE (Moriarty 2015) | 361 people unable to take at least 2 statins because of muscle symptoms entered the trial | Muscle-related events less frequent on Praluent than on atorvastatin 20 mg |
GAUSS-3 also showed how common statin muscle symptoms are even in this group: in its blinded first phase, 42.6% had symptoms on atorvastatin but not on placebo. Both trials were funded by the makers of the medicines tested.
The placebo groups reported muscle aches too, at 3% to 5%, so many aches during treatment would have happened anyway. The labels show a small difference, and the statin-intolerance trials suggest that muscle complaints on a PCSK9 antibody are less frequent than on a statin rechallenge. They do not show that a given ache is or is not caused by the shot.
Whether a muscle complaint needs a blood test, a pause or a different medicine is a decision for the prescriber. A note of when the aches started, where they are and how they relate to each injection makes that conversation easier. Dose Track keeps a side-effect log with a severity for each entry, tied to the dose it followed.
Read more on Dose Track: Praluent side effects · Repatha side effects · Leqvio side effects · Placebo