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12:00 AM
Jul 06, 2009
 |  BioCentury  |  Regulation

Avoiding the panic button

Unlike the panic that ensued from a retrospective analyses that concluded diabetes drug Avandia posed unacceptable cardiovascular risks, retrospective analyses showing a potential cancer signal for Lantus insulin glargine from sanofi-aventis Group were met with caution, even from the study authors themselves.

Indeed, the company's exhortations for caution due to flaws and holes in the datasets were seconded by regulatory agencies, physicians and the publishers of Diabetologia, the journal of the European Association for the Study of Diabetes, in which the studies appeared.

The response was a sharp contrast to the medical and political pandemonium that surrounded the retrospective analyses that alleged increased CV risk for Avandia rosiglitazone from GlaxoSmithKline plc.The difference may illustrate that how the data are presented can be just as important as the data themselves.

Four studies of the long-acting insulin analog were published online June 26. The first of these was an observational study conducted using records from 127,031 Type II diabetics in a German insurance registry from 2000 through 2005. It suggested Lantus produced a dose-dependent increase in cancer risk compared with human insulin.

In fact, Lantus was associated with a significantly lower risk of cancer than human insulin in an unadjusted analysis of the data. However, once the analysis took into account the fact insulin patients were receiving higher doses, the results indicated patients receiving 50 U/day Lantus had a 31% higher risk of cancer than patients taking a similar dose of insulin (p<0.0001).

After the study was submitted for publication, the EASD convened a special advisory group that decided it would be premature to publish the results in isolation and that replication was needed. The group thus commissioned three separate observational studies that were carried out using databases of patients in Sweden, Scotland and the U.K.

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