Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials
Jones PH, Bays HE, Chaudhari U, Pordy R, Lorenzato C, Miller K, Robinson JG
The American journal of cardiology · 77 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
- 2016-09-16 · Am J Cardiol · vol. 118 · número 12 · págs. 1805–1811
- Editorial
- Elsevier BV
- Citado
- 96 citas · más que el 100% de estudios similares · 17.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 22 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Pharmacovigilance and Adverse Drug Reactions · Lipid metabolism and disorders
- Palabras clave
- alirocumab, PCSK9 inhibitors, monoclonal antibodies, drug safety, treatment-emergent adverse events, ezetimibe, LDL cholesterol lowering, major adverse cardiovascular events, injection site reactions, pruritus, upper respiratory tract infection, hypertriglyceridemia, hypercholesterolemia
- MeSH
- humans, respiratory tract infections, urinary tract infections, nasopharyngitis, back pain, coronary disease, angina, unstable, myocardial infarction, pruritus, diabetes mellitus, type 2, hypercholesterolemia, antibodies, monoclonal, anticholesteremic agents, hydroxymethylglutaryl-coa reductase inhibitors, comorbidity, aged, middle aged, influenza, human, randomized controlled trials as topic, clinical trials, phase ii as topic, clinical trials, phase iii as topic, stroke, acute coronary syndrome, antibodies, monoclonal, humanized, ezetimibe
7 autores
- Peter H. Jones🇺🇸 · autor de correspondenciaBaylor College of Medicine
- Harold Edward Bays🇺🇸Louisville Metabolic and Atherosclerosis Research Center
- Umesh Chaudhari🇺🇸Sanofi (United States)
- Robert C. Pordy🇺🇸Regeneron (United States)
- Christelle Lorenzato🇫🇷Sanofi (France)
- Kathryn Miller🇺🇸Regeneron (United States)
- Jennifer G. Robinson🇺🇸University of Iowa
Resumen
El texto original del estudio, en el idioma en que se publicó.
Previous individual trials of alirocumab (a PCSK9 monoclonal antibody) showed significant low-density lipoprotein cholesterol reductions with overall treatment-emergent adverse event (TEAE) rates comparable with controls. This analysis evaluated safety data from 14 trials (4 phase 2 and 10 phase 3, 8 to 104 weeks; n = 5,234), in 2 pools according to control (placebo/ezetimibe). Overall, 3,340 patients received alirocumab (4,029 patient-years' exposure), 1,276 received placebo, and 618 received ezetimibe. Incidence of deaths, serious TEAEs, discontinuations because of TEAEs, and overall TEAEs were similar between alirocumab and control groups. Alirocumab was associated with a higher incidence of local injection site reactions (7.4% vs 5.3% with placebo; 3.1% vs 2.3% with ezetimibe), pruritus (1.3% vs 0.4% placebo; 0.9% vs 0.5% ezetimibe), and upper respiratory tract infection signs and symptoms (2.1% vs 1.1% placebo; 1.3% vs 0.8% ezetimibe). Incidence of musculoskeletal, neurologic, neurocognitive, ophthalmologic, hepatic events, and TEAEs related to diabetes/diabetes complications was similar between alirocumab and control groups. In a prespecified analysis of phase 3 studies, adjudicated major adverse cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, and unstable angina requiring hospitalization) occurred in 1.8% alirocumab versus 2.6% placebo patients (hazard ratio 0.69, 95% confidence interval 0.43 to 1.11) and 2.8% alirocumab versus 1.5% ezetimibe patients (hazard ratio 1.4, 95% confidence interval 0.65 to 3.02). In conclusion, pooled safety data from 14 trials demonstrate that alirocumab is generally well tolerated with a favorable safety profile.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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