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In October 2013 The New England Journal of Medicine reported on a large, randomized, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of Onglyza and Kombiglyze in adult patients with type 2 diabetes mellitus. The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial was conducted as a result of the 2008 FDA guidance, Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. This guidance mandated that sponsors of new antidiabetic therapies used to treat type 2 diabetes establish the safety of those drugs by ensuring they are not associated with an unacceptable increase in cardiovascular risk.
Diabetes Mellitus has become a widespread epidemic in the United States. It is a chronic metabolic disorder characterized by hyperglycemia caused by defective insulin secretion, resistance to insulin action, or a combination of both. The leading cause of mortality among this patient population is cardiovascular disease. As such, the mortality rates associated with diabetes accounts for a substantial portion of health care expenditures. In an effort to reduce these risks and the healthcare costs associated with them, the FDA set forth recommended development programs for new clinical studies for new type 2 antidiabetic therapies.
In accordance with this guidance, AstraZeneca and Bristol-Myers Squibb funded the SAVOR-TIMI 53 clinical trial which looked at the increased risk of cardiovascular disease among patients with type 2 diabetes, who had a history of or were at risk for cardiovascular events, and were taking Saxagliptin (the active ingredient in Onglyza and Kombiglyze). The results of the clinal trial were published in the New England Journal of Medicine and found saxagliptin treatment was associated with an increased risk for hospitalization for heart failure. Scirica, Benjamin M. et al., Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, N. Engl. J. Med., 369;14, October 3, 2013. This increased risk was highest among patients with elevated levels of natriuretic peptides, prior heart failure, or chronic kidney disease.
The SAVOR clinical trial involved 16,492 patients with type 2 diabetes who were randomly selected to receive saxagliptin or a placebo and were followed for a median of 2.1 years. The primary endpoint for the trial cohort was cardiovascular death, myocardial infarction, or ischemic stroke. More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%, according to 2-year Kaplan–Meier estimates; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Also noteworthy, significantly more patients in the saxagliptin group than in the placebo group reported at least one hypoglycemic event (1264 patients [15.3%] vs. 1104 patients [13.4%], P<0.001); major hypoglycemic events occurred in 177 patients (2.1%) in the saxagliptin group as compared with 140 patients (1.7%) in the placebo group (P=0.047).
Another large clinical trial, EXAMINE, The Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome, found results similar to that of the SAVOR clinical trials with alogliptin, another DPP-4 class drug. EXAMINE was also a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 5,380 patients with type 2 diabetes who had established cardiovascular disease with a recent acute coronary syndrome event. Significantly more patients randomized to the alogliptin group in this clinical trial also experienced at least one hospitalization for heart failure compared to patients randomized to the placebo group.
As a result of these clinical trials The FDA conducted a safety review concerning drugs antidiabetic drugs containing saxagliptin, including Onglyza and Komgiblyze, and ultimately mandated a label change warning users and prescribers of these medications of the increased cardiovascular risks. Read more about the FDA warnings and changes in the warning labels for these drugs HERE.
If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. If you believe you or a loved one may have a claim, contact us today.
There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.
Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.
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If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.
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