Frequency of Cancer Events with Saxagliptin in the SAVOR-TIMI 53 Trial.

Frequency of Cancer Events with Saxagliptin in the SAVOR-TIMI 53 Trial.
Diabetes Obes Metab. 2015 Oct 7;
Authors: Leiter LA, Teoh H, Mosenzon O, Cahn A, Hirshberg B, Stahre CA, Hoekstra JB, Alvarsson M, Im K, Scirica BM, Bhatt DL, Raz I, SAVOR-TIMI 53 Steering Committee, Investigators
Abstract
The SAVOR-TIMI 53 randomized trial of 16,492 (8,212 on placebo; 8,280 on saxagliptin) 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 1 cancer event was reported by 688 (4.1%) patients - 362 (4.3%) and 326 (3.8%) were 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 HbA1c and pharmacotherapy did not reveal any clinically meaningful differences between the two study arms. 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 modeling revealed that the male gender, dyslipidemia, and current smoking were independent predictors of cancer. These randomized data with adequate numbers of cancer are reassuring but limited, by short follow...

Source: Diabetes Metab - October 7, 2015 Category: Endocrinology Authors: Leiter LA, Teoh H, Mosenzon O, Cahn A, Hirshberg B, Stahre CA, Hoekstra JB, Alvarsson M, Im K, Scirica BM, Bhatt DL, Raz I, SAVOR-TIMI 53 Steering Committee, Investigators Tags: Diabetes Obes Metab Source Type: research