Lantus Doesn't Reduce Heart-Attack Risk in Diabetes Study
06/11/2012| 04:05pm US/Eastern
--Lantus was studied at earlier stages of diabetes and in "pre-diabetes"
--Study found no increased risk of cardiovascular, cancer risk for Lantus
--Use of omega-3 fatty acids also fails to reduce cardiovascular risk in diabetes
Early use of Sanofi's (SNY) Lantus insulin failed to reduce the risk of heart attacks and strokes in people with diabetes or blood-sugar problems, compared with standard treatment, in a large, long-term study.
But the 12,500-patient clinical trial also found no significant increased risk of cardiovascular problems or cancer versus standard treatment, which Sanofi hopes will help put to rest safety concerns surrounding its top-selling product.
The results may not have much impact on Lantus sales because the study tested it at earlier stages of disease than when the drug is typically used. The data were presented Monday at the annual scientific meeting of the American Diabetes Association in Philadelphia and simultaneously published online by The New England Journal of Medicine.
Lantus is a long-acting form of artificial insulin known as insulin glargine, which is typically injected once a day. France-based Sanofi recorded Lantus sales of EUR3.92 billion, or about $4.9 billion at current exchange rates, for 2011.
Lantus and other forms of insulin aren't commonly introduced into the treatment of type 2 diabetes for several years after a patient is diagnosed, after certain non-insulin drugs fail to adequately control blood sugar levels.
But Sanofi studied whether introducing Lantus earlier in the course of treatment--including for people with abnormal blood sugar who haven't been diagnosed with diabetes--would help reduce cardiovascular risk. People with type 2 diabetes are at increased risk of cardiovascular problems.
Prior studies and analyses have suggested insulin could promote cardiovascular disease and cancers, though some research has suggested a cardiovascular benefit associated with insulin, and the potential cancer link appears inconclusive.
The "Origin" trial tried to shed light primarily on the cardiovascular effects. The study enrolled people with cardiovascular risk factors such as high blood pressure, who had impaired glucose levels or type 2 diabetes. Some were given Lantus once daily, while others received standard treatment including the drug metformin.
Researchers tracked patients for a median duration of more than six years. A primary goal was to see whether Lantus users had lower rates of heart attacks, strokes and deaths from cardiovascular causes, compared with the standard treatment group.
The study found that 16.6% of Lantus users experienced these events, versus 16.1% of those on standard treatment, a statistically insignificant difference.
While the study didn't meet its goal of demonstrating a reduction in cardiovascular risk, Sanofi and researchers said it was reassuring to see no significant increased cardiovascular risk.
"This insulin used once a day does not cause cardiovascular outcomes," said Hertzel Gerstein, a professor of medicine at McMaster University in Hamilton, Ontario, and a lead investigator of the Origin trial.
The study also found no difference in the rates of cancer and cancer deaths between Lantus users and those on standard treatment. Other studies of the potential cancer risk associated with Lantus are scheduled to be released later Monday.
Lantus showed certain benefits in people who didn't have diabetes at the start of the trial. Among about 1,450 patients with no diagnosed diabetes at the start of the study, those who received Lantus were 28% less likely to develop diabetes by the time of their first oral glucose tolerance test, compared with those on standard treatment.
But as has been shown in other studies, Lantus was associated with higher rates of hypoglycemia, or excessively low blood sugar, as well as weight gain, versus standard treatment. Hypoglycemia can cause fainting, and severe cases can be deadly. Researchers said the absolute rate of hypoglycemia in Lantus users was low, and weight gain was modest.
Dennis Urbaniak, head of Sanofi's U.S. diabetes business, said Sanofi is in discussions with regulatory agencies about the results.
Another aspect of the Origin study found that the use of omega-3 fatty acids in people with type 2 diabetes also failed to reduce cardiovascular risk, versus a placebo. The omega-3 capsules for the trial were supplied by Pronova BioPharma ASA. GlaxoSmithKline PLC (GSK) sells a version of omega-3 under the brand Lovaza.
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