Frequency of cancer events with saxagliptin in the SAVOR-TIMI 53 trial

The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)–Thrombolysis in Myocardial Infarction (TIMI) 53 trial randomized trial of 16 492 patients (placebo, n = 8212; saxagliptin, n = 8280) treated and followed for a median of 2.1 years afforded an opportun...

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Published in:	Diabetes, obesity & metabolism Vol. 18; no. 2; pp. 186 - 190
Main Authors:	Leiter, L. A., Teoh, H., Mosenzon, O., Cahn, A., Hirshberg, B., Stahre, C. A. M., Hoekstra, J. B. L., Alvarsson, M., Im, K., Scirica, B. M., Bhatt, D. L., Raz, I.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-02-2016 Wiley Subscription Services, Inc
Subjects:	Adamantane - administration & dosage Adamantane - adverse effects Adamantane - analogs & derivatives Adamantane - therapeutic use Aged antihyperglycemic agents Cancer Cohort Studies Diabetes Diabetes mellitus Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - physiopathology Diabetic Nephropathies - complications Dipeptides - administration & dosage Dipeptides - adverse effects Dipeptides - therapeutic use Dipeptidyl-Peptidase IV Inhibitors - administration & dosage Dipeptidyl-Peptidase IV Inhibitors - adverse effects Dipeptidyl-Peptidase IV Inhibitors - therapeutic use Dose-Response Relationship, Drug Double-Blind Method Drug therapy Dyslipidemia Dyslipidemias - complications Female Follow-Up Studies Gender Glomerular Filtration Rate Heart attacks Hemoglobin Humans Kidney - physiopathology Male Malignancy Medicin och hälsovetenskap Middle Aged Mortality Myocardial infarction Neoplasms - chemically induced Neoplasms - complications Neoplasms - epidemiology Neoplasms - mortality Placebos Risk Factors saxagliptin Sex Factors Smoking - adverse effects Thrombolysis antihyperglycemic agents saxagliptin cancer
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Summary:	The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)–Thrombolysis in Myocardial Infarction (TIMI) 53 trial randomized trial of 16 492 patients (placebo, n = 8212; saxagliptin, n = 8280) treated and followed for a median of 2.1 years afforded an opportunity to explore whether there was any association with cancer reported as a serious adverse event. At least one cancer event was reported by 688 patients (4.1%): 362 (4.3%) and 326 (3.8%) in the placebo and saxagliptin arms, respectively (p = 0.13). There were 59 (0.6%) deaths adjudicated as malignancy deaths with placebo and 53 (0.6%) with saxagliptin. Stratification by gender, age, race and ethnicity, diabetes duration, baseline glycated haemoglobin and pharmacotherapy did not show any clinically meaningful differences between the two study arms. The overall number of cancer events and malignancy‐associated mortality rates were generally balanced between the placebo and saxagliptin groups, suggesting a null relationship with saxagliptin use over the median follow‐up of 2.1 years. Multivariable modelling showed that male gender, dyslipidaemia and current smoking were independent predictors of cancer. These randomized data with adequate numbers of cancer cases are reassuring but limited, by the short follow‐up in a trial not designed to test this hypothesis.
Bibliography:	Bristol-Myers Squibb GlaxoSmithKline Medtronic Pfizer The Medicines Company Sanofi Aventis Daiichi-Sankyo Eisai Johnson and Johnson Bayer Healthcare Merck Figure S1. Cancer event rates in the SAVOR-TIMI 53 cohort over the median follow-up duration of 2.1 years. Data are stratified by (A) gender, (B) age, (C) duration of type 2 diabetes and (D) baseline vasculoprotective therapy.Table S1. Malignancy-associated deaths. ark:/67375/WNG-FJRBHVCZ-S Roche Ethicon ArticleID:DOM12582 Amarin Forest Laboratories AstraZeneca Gilead Ischemix istex:B82D46F07FCBF8C6E8C22595AC648272FC9A5445 SourceType-Other Sources-1 ObjectType-Article-2 ObjectType-Correspondence-1 ObjectType-News-3 content type line 66
ISSN:	1462-8902 1463-1326 1463-1326
DOI:	10.1111/dom.12582