While clinical trials remain the gold standard for proving safety and efficacy, the scale, real-world mix of patients and relatively low costs associated with database-powered studies make them a useful option for researchers. This week a German team presented data from a database analysis study that found a link between a diabetes drug and a slight dip in the risk of developing Alzheimer's.
The study analyzed a database from Germany's biggest public health insurer to assess a possible link between the use of Takeda's diabetes drug Actos and development of dementia. Around 146,000 patients aged 60 or older were tracked from 2004 to 2010, over which time almost 14,000 people in the database developed dementia. Factoring prescriptions into the analysis showed the use of Actos was associated with a 6% decline in the likelihood of developing dementia. The risk fell with each additional three months of Actos use.
|Boston University professor Ben Wolozin|
On the strength of the data, a researcher from the German Center for Neurodegenerative Diseases concluded that long-term Actos use cuts the risk of dementia, but others have questioned the real-world significance of the results. "It's actually almost surprising to me that the lowering of relative risk was so weak," Boston University professor Ben Wolozin told Bloomberg. Wolozin doubts whether the 6% decline would result in a detectable difference in the real world. And it could be some time before anyone has a more definitive answer to whether Actos helps prevent dementia.
Takeda is recruiting 5,800 people for a 5-year study designed to provide additional evidence. An earlier study of GlaxoSmithKline's ($GSK) diabetes drug Avandia as an Alzheimer's prevention failed, but multiple studies have linked poor glucose control to dementia. With data from Takeda's trial still years away, retrospective database analyses are one way to gather more immediate evidence to support the use of Actos as a preventative measure.