There is a new study reported in Bloomberg this morning that Sanofi’s Lantus Doubled Cancer Risk in Study of Diabetics. The study, which was presented yesterday at the San Antonio Breast Cancer Symposium retrospecitvely evaluated medical records of 23,266 patients in southern Sweden and determined that diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk.
I have previously blogged about this back in 2009 when the first reports surfaced about the link between Lantus and cancer. (See A New Problem With Insulin: Cancer , Lantus Causes Cancer! Why Doesn't Anyone Seem Care? and Lantus and Cancer- A Closer Look Is Not Reassuring )
Back in 2009, when the story broke, the FDA acknowledged the potential link but stated that the data was insufficient and recommended that patients not stop taking Lantus, at least without discussing this with their physicians. They stated that they were "currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus." However, we didn't hear much until January, 2011 when they released an update declaring that they had reviewed the four 2009 studies and has "determined that the evidence presented in the studies is inconclusive", and in addition had reviewed results from a 5 year study (sponsored by the makers of Lantus) which did not show an increased risk but was "not specifically designed to evaluate cancer outcomes," concluding, "at this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial." With the new study reported today, it will be interesting to see whether the FDA chooses to give and update or reveals and additional information, such as a VA data set they are supposed to be evaluating.
According to the Bloomberg article, a Sanofi study from Sweden, Norway, Finland, Denmark and Scotland is complete and will be submitted to health authorities this month. In addition, U.S. study will be finished in early 2012, while a final report from Europe will come later. All of these studies combined will involve more than a million patients, which will hopefully be enough to give a more conclusive answer.
To be clear, I am not 100% convinced that Lantus causes cancer. However, there is another long acting insulin (Levemir) which has similar efficacy to Lantus, has not been associated with cancer, and has a substantially different affinity for the insulin like growth factor (IGF) receptors that are implicated in the possible connection. Given the mounting evidence of a cancer link with an equally effective product that appears to be safer, I can't see any reason to prescribe Lantus when Levemir is available.
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7 comments:
Thank you for the update and agree there is no reason to use Lantus when the safer Levemir is available.
There is when Levemir doesn't work for you. I guess you have to be a Type 1 to know that.
A recent meta analysis was presented at the IDF meeting showing no association of cancer at all in about 50K patients over a million patient years. This last study was very, very small in comparison.
It looks to me that if an association exists, at all, it is extraordinarily small.
You cant compare an insulin to metformin and draw any conclusions from it, except that insulin or the people that need to take it have a higher risk of cancer perhaps. In order to determine if one insulin is more at risk over another, you have to compare them all. NPH, Lantus and Levemir. From what I understand, Lantus has a big study comparing against NPH and cancer rates are not significantly different. Levemir is vastly understudied compared to Lantus and efficacy is worse than Lantus.
Actually Levemir has 30+ documented studies so I disagree with the statement that it is understudied. Most docs have moved away from using NPH so the fact that the cancer rates of Lantus are similar to NPH is really insignificant. Levemir has over 7 years of data, in addition to the clinical trials conducted prior to it's entry into the market. There are studies that show a greater A1C reduction as compared to Lantus. Of course there are also studies which show less or similar A1C reduction as well. The same can be said for Lantus. But to make a broad statement that the efficacy of Levemir is worse than Lantus is outright false. Every patient is different & neither Levemir nor Lantus work for EVERY patient- that's just common sense. It's nice to have options, especially one such as Levemir, which has never shown an increased risk for cancer, coupled with a low affinity for the IGF-1 receptor.
So why not just bring back Ultra Lente? There is no perfect insulin out there, but I have read that human insulin is generally safer than synthetic insulins.
Ultralente is a reasonable alternative. I would favor Levemir, since it has a very similar and favorable profile like Lantus, but does not appear to be associated with the cancer concerns.
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