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Further warning on Januvia


Merck & Co’s diabetes drug Januvia® (sitagliptin) has made a big impact on the market since it was launched last October but an influential US consumer group says that patients should steer clear of the treatment for seven years until its long-term safety is proved.

In a posting on its website, Public Citizen claims patients in clinical studies who were given Januvia, a dipeptidyl peptidase-4 inhibitor, experienced an increase in creatinine, which is found in the blood, and such rises are often an early indicator of kidney problems. Because the drug is new, the group says more serious adverse effects may not become apparent until Januvia is used by a large number of patients, so patients are advised to wait before taking it.

Indeed, Dr Sidney Wolfe, director of the health research group at Public Citizen, says that “individuals with type 2 diabetes should wait seven years before taking Januvia”, adding that “they should not be human guinea-pigs and risk being harmed by the adverse effects associated with Januvia that may be magnified with time, as they were with Avandia”.

The Avandia (rosiglitazone) reference comes at a time when GlaxoSmithKline’s diabetes drug has been in the public eye since a meta-analysis of studies on the treatment published in the New England Journal of Medicine suggested it might significantly increase the risk of heart attacks. Public Citizen noted that it warned people not to use Avandia more than two years ago as it believes the drug causes heart failure “and is less effective in treating the disease than older, better-known drugs”.

The consumer group’s belief that newer type 2 diabetes drugs are often no more potent or effective than the older treatments, such as insulin, the sulfonylureas and the biguanides, includes Januvia. It is “not a ‘breakthrough’ drug”, the group argues, and Dr Wolfe concluded by advising patients to wait to see if it is truly as safe as Merck claims.

Public Citizen’s view of Januvia would not appear to be shared by the vast majority of physicians and following its launch in October, it recorded sales of £87m for the first quarter. This figure could rise considerably in the next few quarters especially as many analysts believe Januvia will be the chief beneficiary of the woes caused to GSK by the Avandia saga.

Sticking with diabetes, Japanese drug firm Takeda has terminated development of a combination of Actos® (pioglitazone) with its novel investigational drug TAK-536, an angiotensin-receptor blocker.

The company did not expand greatly on the reasons for discontinuing the project, limiting itself to saying that after a phase III trial conducted in the USA it “found out that an improvement in pharmaceutical formulation is needed” for the fixed combination. Takeda added that it will now focus on TAK-475 for hypercholesterolaemia, TAK-491 for hypertension and the diabetes drug SYR-322, which is also a DPP-4 inhibitor.

PharmaTimes 5/6/2007


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