Saturday, June 16, 2007

New Era Of Hope: Diabetes drug Avandia
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Rosiglitazone, brand name Avandia is already approved for treatment of type 2 diabetes (but not for Alzheimer's). It lowers blood sugar by helping cells use insulin more effectively.

Scientists have speculated that Avandia may also be able to help Alzheimer's patients because of its effect on brain inflammation and other processes associated with neurodegenerative diseases. However, in recent months, Avandia has been in the spotlight because a recent study that reviewed the available published research suggested that diabetes patients on Avandia were at increased risk of heart attack and death from cardiovascular causes.

Researchers studied the effect of an extended release form of Avandia (Rosiglitazone XR) on Alzheimer's patients for 12 months. This was a follow up open lable extension to a randomized controlled trial. The results suggested that Avandia may help some Alzheimer's patients depending on their genetic make up. Patients that were "APOE e4 negative" did benefit from the treatment, they showed some improvement. But patients who were "APOE e4 positive" either did not improve or continued to decline.

The key points of the study were:
- 337 patients with mild to moderate Alzheimer's enrolled in the study and 82 per cent of them completed it.
- 7 per cent pulled out because of adverse events.
- 48 per cent had one or more adverse events (mostly peripheral oedema, or fluid accumulation, in the legs or sacral region, nasopharyngitis or inflammatioon of the nasal passages and pharynx).
- 9 per cent had one or more severe adverse events, each of which occurred in 1 per cent or less of the patients (except for fractures, 2 per cent).
- Few patients had clinically significant changes in heart rate (less than 1 per cent) or abnormal ECG readings (2 per cent).

Global Clinical Vice President, Neurology, at GlaxoSmithKline, Dr Michael Gold said that Avandia appeared to have a safety profile similar to that already seen in diabetes type 2 patients. He added that: "Rosiglitazone XR (Avandia) appeared to be generally well tolerated in subjects with Alzheimer's for up to 72 weeks."


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