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Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials

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,... Full description

Journal Title: The American Journal of Cardiology 2016-12-15, Vol.118 (12), p.1805-1811
Main Author: Jones, Peter H
Other Authors: Bays, Harold E , Chaudhari, Umesh , Pordy, Robert , Lorenzato, Christelle , Miller, Kathryn , Robinson, Jennifer G
Format: Electronic Article Electronic Article
Language: English
Subjects:
Abridged Index Medicus
Acute Coronary Syndrome - epidemiology
Aged
Analysis
Angina, Unstable - epidemiology
Antibodies, Monoclonal - adverse effects
Anticholesteremic Agents - adverse effects
Antilipemic agents
Atherosclerosis
Back Pain - chemically induced
Cardiology
Cardiovascular Medicine
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Comorbidity
Confidence intervals
Coronary Disease - epidemiology
Coronary heart disease
Diabetes
Diabetes Mellitus, Type 2 - epidemiology
Drug dosages
Ezetimibe - adverse effects
FDA approval
Health aspects
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hypercholesterolemia - drug therapy
Hypercholesterolemia - epidemiology
Influenza, Human - chemically induced
Low density lipoproteins
Medical colleges
Middle Aged
Monoclonal antibodies
Myocardial Infarction - epidemiology
Nasopharyngitis - chemically induced
Patients
Pruritus
Pruritus - chemically induced
Randomized Controlled Trials as Topic
Respiratory Tract Infections - chemically induced
Stroke (Disease)
Stroke - epidemiology
Studies
Urinary Tract Infections - chemically induced
Publisher: United States: Elsevier Inc
ID: ISSN: 0002-9149
Link: https://www.ncbi.nlm.nih.gov/pubmed/27729106
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recordid: cdi_proquest_miscellaneous_1850780331
title: Safety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials
format: Article
creator:
  • Jones, Peter H
  • Bays, Harold E
  • Chaudhari, Umesh
  • Pordy, Robert
  • Lorenzato, Christelle
  • Miller, Kathryn
  • Robinson, Jennifer G
subjects:
  • Abridged Index Medicus
  • Acute Coronary Syndrome - epidemiology
  • Aged
  • Analysis
  • Angina, Unstable - epidemiology
  • Antibodies, Monoclonal - adverse effects
  • Anticholesteremic Agents - adverse effects
  • Antilipemic agents
  • Atherosclerosis
  • Back Pain - chemically induced
  • Cardiology
  • Cardiovascular Medicine
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Comorbidity
  • Confidence intervals
  • Coronary Disease - epidemiology
  • Coronary heart disease
  • Diabetes
  • Diabetes Mellitus, Type 2 - epidemiology
  • Drug dosages
  • Ezetimibe - adverse effects
  • FDA approval
  • Health aspects
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
  • Hypercholesterolemia - drug therapy
  • Hypercholesterolemia - epidemiology
  • Influenza, Human - chemically induced
  • Low density lipoproteins
  • Medical colleges
  • Middle Aged
  • Monoclonal antibodies
  • Myocardial Infarction - epidemiology
  • Nasopharyngitis - chemically induced
  • Patients
  • Pruritus
  • Pruritus - chemically induced
  • Randomized Controlled Trials as Topic
  • Respiratory Tract Infections - chemically induced
  • Stroke (Disease)
  • Stroke - epidemiology
  • Studies
  • Urinary Tract Infections - chemically induced
ispartof: The American Journal of Cardiology, 2016-12-15, Vol.118 (12), p.1805-1811
description: 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.
language: eng
source:
identifier: ISSN: 0002-9149
fulltext: no_fulltext
issn:
  • 0002-9149
  • 1879-1913
url: Link


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titleSafety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials
creatorJones, Peter H ; Bays, Harold E ; Chaudhari, Umesh ; Pordy, Robert ; Lorenzato, Christelle ; Miller, Kathryn ; Robinson, Jennifer G
creatorcontribJones, Peter H ; Bays, Harold E ; Chaudhari, Umesh ; Pordy, Robert ; Lorenzato, Christelle ; Miller, Kathryn ; Robinson, Jennifer G
descriptionPrevious 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.
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subjectAbridged Index Medicus ; Acute Coronary Syndrome - epidemiology ; Aged ; Analysis ; Angina, Unstable - epidemiology ; Antibodies, Monoclonal - adverse effects ; Anticholesteremic Agents - adverse effects ; Antilipemic agents ; Atherosclerosis ; Back Pain - chemically induced ; Cardiology ; Cardiovascular Medicine ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Comorbidity ; Confidence intervals ; Coronary Disease - epidemiology ; Coronary heart disease ; Diabetes ; Diabetes Mellitus, Type 2 - epidemiology ; Drug dosages ; Ezetimibe - adverse effects ; FDA approval ; Health aspects ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hypercholesterolemia - drug therapy ; Hypercholesterolemia - epidemiology ; Influenza, Human - chemically induced ; Low density lipoproteins ; Medical colleges ; Middle Aged ; Monoclonal antibodies ; Myocardial Infarction - epidemiology ; Nasopharyngitis - chemically induced ; Patients ; Pruritus ; Pruritus - chemically induced ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections - chemically induced ; Stroke (Disease) ; Stroke - epidemiology ; Studies ; Urinary Tract Infections - chemically induced
ispartofThe American Journal of Cardiology, 2016-12-15, Vol.118 (12), p.1805-1811
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6Robinson, Jennifer G
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descriptionPrevious 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.
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1Acute Coronary Syndrome - epidemiology
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4Angina, Unstable - epidemiology
5Antibodies, Monoclonal - adverse effects
6Anticholesteremic Agents - adverse effects
7Antilipemic agents
8Atherosclerosis
9Back Pain - chemically induced
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11Cardiovascular Medicine
12Clinical Trials, Phase II as Topic
13Clinical Trials, Phase III as Topic
14Comorbidity
15Confidence intervals
16Coronary Disease - epidemiology
17Coronary heart disease
18Diabetes
19Diabetes Mellitus, Type 2 - epidemiology
20Drug dosages
21Ezetimibe - adverse effects
22FDA approval
23Health aspects
24Humans
25Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
26Hypercholesterolemia - drug therapy
27Hypercholesterolemia - epidemiology
28Influenza, Human - chemically induced
29Low density lipoproteins
30Medical colleges
31Middle Aged
32Monoclonal antibodies
33Myocardial Infarction - epidemiology
34Nasopharyngitis - chemically induced
35Patients
36Pruritus
37Pruritus - chemically induced
38Randomized Controlled Trials as Topic
39Respiratory Tract Infections - chemically induced
40Stroke (Disease)
41Stroke - epidemiology
42Studies
43Urinary Tract Infections - chemically induced
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titleSafety of Alirocumab (A PCSK9 Monoclonal Antibody) from 14 Randomized Trials
authorJones, Peter H ; Bays, Harold E ; Chaudhari, Umesh ; Pordy, Robert ; Lorenzato, Christelle ; Miller, Kathryn ; Robinson, Jennifer G
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1Acute Coronary Syndrome - epidemiology
2Aged
3Analysis
4Angina, Unstable - epidemiology
5Antibodies, Monoclonal - adverse effects
6Anticholesteremic Agents - adverse effects
7Antilipemic agents
8Atherosclerosis
9Back Pain - chemically induced
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11Cardiovascular Medicine
12Clinical Trials, Phase II as Topic
13Clinical Trials, Phase III as Topic
14Comorbidity
15Confidence intervals
16Coronary Disease - epidemiology
17Coronary heart disease
18Diabetes
19Diabetes Mellitus, Type 2 - epidemiology
20Drug dosages
21Ezetimibe - adverse effects
22FDA approval
23Health aspects
24Humans
25Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
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27Hypercholesterolemia - epidemiology
28Influenza, Human - chemically induced
29Low density lipoproteins
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34Nasopharyngitis - chemically induced
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39Respiratory Tract Infections - chemically induced
40Stroke (Disease)
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42Studies
43Urinary Tract Infections - chemically induced
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abstractPrevious 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.
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doi10.1016/j.amjcard.2016.08.072
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