Efficacy and safety of alirocumab and evolocumab: a systematic review and meta-analysis of randomized controlled trials
Guedeney P, Giustino G, Sorrentino S, Claessen BE, Camaj A, Kalkman DN, Vogel B, Sartori S, De Rosa S, Baber U, Indolfi C, Montalescot G, Dangas GD, Rosenson RS, Pocock SJ, Mehran R
European heart journal · 139 citas
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Cómo se estudió
- Diseño
- Metaanálisis (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2019-06-11 · Eur Heart J · vol. 43 · número 7 · págs. e17–e25
- Editorial
- Oxford University Press
- Citado
- 207 citas · más que el 99% de estudios similares · 5.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 27 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · OTHER-OA
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Acute Myocardial Infarction Research · Atherosclerosis and Cardiovascular Diseases
- Palabras clave
- alirocumab, evolocumab, PCSK9 inhibitors, LDL cholesterol lowering, dyslipidemia, atherosclerotic cardiovascular disease, myocardial infarction, ischemic stroke, coronary revascularization, all-cause mortality, cardiovascular mortality, drug safety, adverse events, lipid-lowering therapy, PCSK9 inhibition
16 autores
- Paul Guedeney🇫🇷🇺🇸Inserm; Sorbonne Université; Assistance Publique – Hôpitaux de Paris; Pitié-Salpêtrière Hospital; Icahn School of Medicine at Mount Sinai
- Gennaro Giustino🇺🇸Icahn School of Medicine at Mount Sinai
- Sabato Sorrentino🇮🇹🇺🇸Magna Graecia University; Icahn School of Medicine at Mount Sinai
- Bimmer E.P.M. Claessen🇺🇸Icahn School of Medicine at Mount Sinai
- Anton Camaj🇺🇸Icahn School of Medicine at Mount Sinai
- Deborah N. Kalkman🇳🇱🇺🇸Amsterdam UMC Location University of Amsterdam; University of Amsterdam; Icahn School of Medicine at Mount Sinai
- Birgit Vogel🇺🇸Icahn School of Medicine at Mount Sinai
- Samantha Sartori🇺🇸Icahn School of Medicine at Mount Sinai
- Salvatore De Rosa🇮🇹Magna Graecia University
- Usman Baber🇺🇸Icahn School of Medicine at Mount Sinai
- Ciro Indolfi🇮🇹Magna Graecia University
- Gilles Montalescot🇫🇷Inserm; Sorbonne Université; Assistance Publique – Hôpitaux de Paris; Pitié-Salpêtrière Hospital
- George Dangas🇺🇸Icahn School of Medicine at Mount Sinai
- Robert S. Rosenson🇺🇸Icahn School of Medicine at Mount Sinai
- Stuart Pocock🇬🇧London School of Hygiene & Tropical Medicine
- Roxana Mehran🇺🇸 · autor de correspondenciaIcahn School of Medicine at Mount Sinai
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
The effect of low-density lipoprotein cholesterol-lowering therapy with alirocumab or evolocumab on individual clinical efficacy and safety endpoints remains unclear. We aimed to evaluate the efficacy and safety of alirocumab and evolocumab in patients with dyslipidaemia or atherosclerotic cardiovascular disease.
Methods and results
We performed a review of randomized controlled trials (RCTs) comparing treatment with alirocumab or evolocumab vs. placebo or other lipid-lowering therapies up to March 2018. Primary efficacy endpoints were all-cause death, cardiovascular death, myocardial infarction (MI), and stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included 39 RCTs comprising 66 478 patients of whom 35 896 were treated with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors (14 639 with alirocumab and 21 257 with evolocumab) and 30 582 with controls. Mean weighted follow-up time across trials was 2.3 years with an exposure time of 150 617 patient-years. Overall, the effects of PCSK9 inhibition on all-cause death and cardiovascular death were not statistically significant (P = 0.15 and P = 0.34, respectively). Proprotein convertase subtilisin-kexin type 9 inhibitors were associated with lower risk of MI (1.49 vs. 1.93 per 100 patient-year; RR 0.80, 95% CI 0.74-0.86; I 2 = 0%; P < 0.0001), ischaemic stroke (0.44 vs. 0.58 per 100 patient-year; RR 0.78, 95% CI 0.67-0.89; I 2 = 0%; P = 0.0005), and coronary revascularization (2.16 vs. 2.64 per 100 patient-year; RR 0.83, 95% CI 0.78-0.89; I 2 = 0%; P < 0.0001), compared with the control group. Use of these PCSK9 inhibitors was not associated with increased risk of neurocognitive adverse events (P = 0.91), liver enzymes elevations (P = 0.34), rhabdomyolysis (P = 0.58), or new-onset diabetes mellitus (P = 0.97).
Conclusion
Proprotein convertase subtilisin-kexin type 9 inhibition with alirocumab or evolocumab was associated with lower risk of MI, stroke, and coronary revascularization, with favourable safety profile.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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