Pelacarsen did not lower major cardiovascular event risk
Major cardiovascular events occurred in 12.3% of pelacarsen recipients and 12.1% of placebo recipients over a median 4.7 years.
Our read
Interventions- Studied:
- Randomized trial in 8,322 patients with cardiovascular disease and high lipoprotein(a) (Placebo-controlled, registered NCT04023552)
- What changed:
- Major cardiovascular events did not differ: 12.3% with pelacarsen against 12.1% with placebo
- The catch:
- The efficacy analysis included only 8,322 of the 8,350 randomized patients
- In the record:
- The 14th paper on pelacarsen with results in people; 23 on record in all. Its result on lipoprotein agrees with all 11 other findings on record.
- Why it’s aging research:
- It bears on staying healthy in midlife and later life.
Editor of record: Boris Djordjevic · AgingResearch.News
Among 8,350 patients with existing cardiovascular disease and lipoprotein(a) levels of at least 70 mg per deciliter, an international randomized trial compared monthly 80-mg pelacarsen injections with placebo. Lipoprotein(a) is a particle that carries fat in the blood. Participants averaged 59.7 years old, and 27.0% were women.
The efficacy analysis included 8,322 patients. The main outcome combined cardiovascular death, nonfatal heart attack, nonfatal stroke or an urgent procedure to restore blood flow to the heart. Pelacarsen did not lower this risk over a median 4.7 years. At 12 months, lipoprotein(a) levels were 64.4 nanomoles per liter with pelacarsen and 233.4 with placebo. Serious adverse events occurred in 1,553 of 4,166 pelacarsen recipients (37.3%) and 1,709 of 4,154 placebo recipients (41.1%).
Why it matters
For people growing older with cardiovascular disease, the trial addressed whether lowering lipoprotein(a) could help prevent further serious cardiovascular events.
Caveats
The efficacy analysis included 8,322 of the 8,350 randomized patients. Participants already had cardiovascular disease and high lipoprotein(a), so the results do not address prevention in people without cardiovascular disease.
Where the evidence stands
Pelacarsen
- 6 independent labs in 2 countries
- 12 trials, 2 with no results posted
- Funders: Novartis and 1 more
- 5 of 8 findings with company ties
- 11 of 12 trials sponsored by its developers
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