Post market study results….
GLP-1 Agonists such as liraglutide (Victoza) and exenatide (Byetta and Bydureon) have been put under close watch by the FDA due to concerns of increased risk of pancreatitis and/or pancreatic cancer for those who take these drugs. Since early 2013, the FDA has watched the post market surveillance of incretin mimetics and has recommended post approval studies looking at pancreatic cancer and pancreatitis risks associated with the use of these types of drugs. Results from a recent ongoing post market study suggest that liraglutide (Victoza) does not pose any excessive increased risk of pancreatitis/pancreatic cancer when compared to comparator diabetes drugs.
The surveillance program will continue through 2014. So far, data has been collected and studied via a prospect cohort on persons 18+ years old who used liraglutide or a comparator drug (metformin, three sulfonylurea therapies, and pioglitazone, three DPP-4I’s and exenatide) from February 1, 2010 – December 31, 2012. The data was collected from the Optum Research Database of national commercial health insurance claims and baseline covariates were obtained through data collected from 6 months prior to drug initiation. Acute pancreatitis and pancreatic cancer were defined by hospitalization with primary ICD-9 code of 577.0x or 157.x, respectively. Poisson regression models were used to assess data with intention to treat model and estimated incidence rates (IR/100 000 person-years), rate ratios (RR) and 95% confidence intervals (CI) for liraglutide versus individual and pooled comparators were reported.
Exenatide and DPP-4I’s were excluded from the pooled comparator groups since they have been associated with increased risk of pancreatitis and pancreatic cancer, however, individual assessments were performed. When liraglutide was compared to the pooled comparator drugs, incidence of pancreatitis (IR per 100,000 person-years) was 187.5 compared with 154.4, respectively (adjusted RR 1.10; 95% CI 0.81–1.49). The IR for individual comparator drugs ranged 142.4 for metformin to 199.6 for pioglitazone. As for pancreatic cancer risk, the IR per 100,000 person-years was 19.9 for liraglutide as compared to 33.0 for pooled comparators (adjusted RR 0.65; 95% CI 0.26–1.60). Results were similar when analyzed as "as treated" as compared to intention to treat model.
Initial results from this ongoing post market surveillance study suggest that liraglutide is not any more strongly associated with pancreatitis or pancreatic cancer compared to comparator diabetes drug regimens. Researchers noted that those with diabetes are at an increased risk of developing pancreatitis and pancreatic cancer as compared to their non-diabetic counterparts so determining if this is a drug-associated outcome is important.
- Incretin mimetics have been placed on the FDA warning list for potential association with increased risk of pancreatic cancer and/or acute pancreatitis.
- Ongoing Phase IV study of liraglutide has preliminary data that suggests this GLP-1 agonist is not any more associated with pancreatitis/pancreatic cancer than its other diabetic medication comparators.
- Acute pancreatitis and pancreatic cancer are more frequent in those with diabetes but further research is needed to determine if this is a disease or drug related issue.
Funch, D. et al. A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. Diabetes, Obesity and Metabolism, 2013. Article first published online: 26 NOV 2013