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Increased risk for cancer not found with Onglyza
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BOSTON – Cancer and cancer mortality rates were not elevated among patients with type 2 diabetes and high cardiovascular risk following treatment with Onglyza, according to study findings presented here.
“Very few large randomized controlled trials have directly assessed the effects of specific antihyperglycemic agents on cancer rates in patients with type 2 diabetes,” Lawrence A. Leiter, MD, of Saint Michael’s Hospital, University of Toronto, said during a presentation. “Amongst the established antihyperglycemic agents there have been reports demonstrating increased, decreased and no inputs on cancer risk ever.”
Lawrence A. Leiter
Leiter and colleagues evaluated 16,413 adults from the SAVOR-TIMI 53 cohort to determine the effect of placebo (n = 8,173) vs. Onglyza (saxagliptin, AstraZeneca; n = 8,240) on the risk for cancer.
The SAVOR-TIMI 53 trial was a large cardiovascular study that evaluated 16,500 patients with type 2 diabetes who were over the age of 40 years.
Thirty-three percent of participants were women, had a mean age 65 years, and had type 2 diabetes for approximately 12 years. Study participants had HbA1c levels of at least 8%, with blood pressure of 137 mm Hg/79 mm Hg in both groups. Sixty-nine percent of participants were on metformin, 40% on sulfonylurea and 41% on insulin at baseline.
After approximately 2.1 years of patient follow-up, at least one cancer event developed in 4.2% of participants (47.4% on saxagliptin vs. 52.6% on placebo; HR = .89; 95% CI, 0.77-1.04).
Overall, cancer-associated deaths were low in both groups (0.6% for saxagliptin vs. 0.7% for placebo).
Compared with the placebo group, the risks for the following cancers were lower in the saxagliptin group: breast (HR = 0.68; 95% CI, 0.31-1.45), colon (HR = 0.51; 95% CI, 0.27-0.92), gastrointestinal tract (HR = 0.62; 95% CI, 0.27-1.35), hematologic (HR = 0.86; 95% CI, 0.46-1.58), hepatic and biliary (HR = 0.74; 95% CI, 0.3-1.76), lung (HR = 0.91; 95% CI, 0.63-1.32), skin (HR = 1.03; 95% CI, 0.75-1.4), squamous cell carcinoma (HR = 0.65; 95% CI, 0.38-1.89) and urinary tract and bladder (HR = 0.62; 0.34-1.1).
Compared with the placebo group, the risks for the following cancers were higher in the saxagliptin group: melanoma (HR = 1.34; 95% CI, 0.62-2.98), basal cell carcinoma (HR = 1.23; 95% CI, 0.82-1.86) and other (HR = 1.19; 95% CI, 0.82-1.75).
“In conclusion, the use of saxagliptin was neutral with regards to the incidence of cancer or cancer mortality in the large, [high-CV risk] SAVOR-TIMI 53 type 2 diabetes cohort over a median follow-up of 2.1 years,” Leiter said. “The findings are limited by the small number of individual cancer types and the short duration of follow-up.” – by Amber Cox
Reference:
Leiter LA, et al. Abstract 11-OR. Presented at: American Diabetes Association’s 75th Scientific Sessions; June 5-9, 2015; Boston.
Disclosure: Leiter reports various financial ties with Abbott, Amgen, Inc., AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck & Co., Inc., Novo Nordisk, Inc., Sanofi U.S., Servier, Takeda Pharmaceuticals U.S.A, Inc., and Valeant.
Perspective
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Anthony L. McCall, MD, PhD
Leiter presented an analysis of the effects of saxagliptin on the cancer risk in the SAVOR-TIMI cohort. The major finding was no evidence for increased cancer risk. This is what would be termed a "neutral result," an important study, which suggests no signal of increase in any of more than a dozen cancer types and provides an increased confidence of safety of this medicine.
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