Prospective Evaluation of Malignancy in 17,708 Patients Randomized to Ezetimibe Versus Placebo

Autor: Stephen D. Wiviott, Michael A. Blazing, Andrew M. Tershakovec, Robert M. Califf, Eugene Braunwald, Charles S. Fuchs, Jeong-Gun Park, Robert P. Giugliano, Christopher P. Cannon, Wolfram Goessling, Baris Gencer, Thomas Musliner
Rok vydání: 2020
Předmět:
lcsh:Diseases of the circulatory (Cardiovascular) system
medicine.medical_specialty
Statin
medicine.drug_class
BMI
body mass index
hs-CRP
high-sensitive C-reactive protein
Placebo
Malignancy
lcsh:RC254-282
Gastroenterology
Prospective evaluation
lipids
Ezetimibe
Internal medicine
polycyclic compounds
medicine
cancer
acute coronary syndromes
cardiovascular diseases
RR
risk ratio
PCSK9
proprotein convertase subtilisin kexin 9
Original Research
lipid-lowering therapy
business.industry
organic chemicals
statin
nutritional and metabolic diseases
Cancer
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
medicine.disease
HR
hazard ratio
PH
proportional hazard
CI
confidence interval
Stenosis
Oncology
lcsh:RC666-701
Simvastatin
KM
Kaplan-Meier
ACS
acute coronary syndrome
LDL-C
low-density lipoprotein cholesterol
lipids (amino acids
peptides
and proteins)
Cardiology and Cardiovascular Medicine
business
ezetimibe
malignancy
medicine.drug
Zdroj: JACC. CardioOncology, Vol 2, Iss 3, Pp 385-396 (2020)
JACC: CardioOncology
ISSN: 2666-0873
0020-2878
DOI: 10.1016/j.jaccao.2020.07.008
Popis: Background An increased risk of malignancy was reported with simvastatin/ezetimibe in 1,873 patients in the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial. Objectives The purpose of this study was to clarify this unexpected finding in a larger sample size of patients stabilized after acute coronary syndrome, we conducted a prospective systematic analysis of malignancy events in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Methods Within IMPROVE-IT, 17,708 patients post–acute coronary syndrome were randomized to either ezetimibe 10 mg or matching placebo on a background of simvastatin 40 mg who took ≥1 dose of the study drug. Suspected tumors (benign and malignant) reported by investigators or identified from a review of adverse events were adjudicated by oncologists without knowledge of drug assignment. The primary malignancy endpoint included new, relapsing, or progressive malignancies (excluding nonmelanotic skin malignancies). The secondary endpoint was death due to malignancy. Results In this trial, 1,470 patients developed the primary malignancy endpoint during a median 6 years of follow-up. The most common malignancy locations were prostate (18.9%), lung (16.8%), and bladder (8.8%) with no differences by treatment group (p > 0.05 for each location). Kaplan-Meier 7-year rates of malignancies were similar with ezetimibe and placebo (10.2% vs. 10.3%; hazard ratio: 1.03; 95% confidence interval: 0.93 to 1.14; p = 0.56), as were the rates for malignancy death (3.8% vs. 3.6%; hazard ratio: 1.04; 95% confidence interval: 0.88 to 1.23; p = 0.68). Conclusions Among 17,708 patients receiving simvastatin 40 mg daily, those randomized to ezetimibe 10 mg daily had a similar incidence of malignancy and deaths due to malignancy compared with those receiving placebo during a median follow-up of 6 years (96,377 patient-years). (IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin [Ezetimibe/Simvastatin] vs Simvastatin [P04103]; NCT00202878)
Central Illustration
Databáze: OpenAIRE
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