Avandia scare casts doubt over its future for Alzheimer’s
pharmafile | June 13, 2007 | News story | Sales and Marketing | Avandia, diabetes, safety
New safety warnings about cardiovascular side-effects seen in patients taking Avandia have cast a shadow over the drug’s future as a possible Alzheimer’s treatment.
Currently marketed exclusively for diabetes, researchers at GlaxoSmithKline have been investigating its potential to treat Alzheimers disease, set to be an increasing problem for the world’s ageing population.
Avandia took a serious knock after a study suggesting the drug significantly raised the risk of a heart attack was published in the New England Journal of Medicine on 21 May.
The EMEA and FDA both concluded a withdrawal, or any other immediate action, was not required. But in the long-term, it may have to carry a new ‘black box’ safety warning.
GSK said fears about the drug’s safety were exaggerated, but it has been unable to calm the market, which has seen the company’s share price drop several times as early sales data shows US prescribers steering clear of the drug.
In diabetes, Avandia (rosiglitazone) lowers blood sugar by helping cells use insulin more efficiently to remove excess sugar from the blood, but it may also influence inflammation and other brain cell processes potentially related to the development of Alzheimer’s disease.
A phase II safety and tolerability trial of Avandia’s extended release form in mild-to-moderate Alzheimer’s found it generally well tolerated with a compared safety profile to that established in type II diabetes. However, 7% of patients withdrew from the trial due to adverse effects, of which the most common was peripheral oedema or fluid retention.
The study was presented at the Alzheimer’s Association International Conference on Prevention of Dementia, which also heard positive trial results from another, more advanced potential treatment.
A phase II trial of Medivation’s Dimebon showed it had statistically significant benefits in treating all of the most frequently studied aspects of in mild-to-moderate Alzheimer’s.
The trials were carried out in Russia, where Dimebon has been approved for use as an anti-histamine since 1983. More recently, Dimebon was shown to bind to two validated targets for the treatment of Alzheimer’s disease.
Every year around 800,000 new patients are affected by Alzheimer’s disease in Europe, but current treatments can only offer symptomatic relief.
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