ADOPT - Avandia "Wins" If You Ignore the Doubled Bone Fractures

Following the publication of the results of the ADOPT study, GlaxoKlineSmith, the makers of Avandia have been touting the finding that Avandia delayed the progression from "Monotherapy" i.e. taking one drug to taking additional drugs better than Metformin.

In the diabetes oral drug sweepstakes, they'd have you believe that Avandia is the "winner." What was missed in this interpretation was that this same study also found that women taking Avandia had twice as many bone fractures as those taking Metformin and three times as many as those taking glyburide.

Here's an excerpt from the story as it ran on several news sites. This one is from Yahoo News.

"After the five-year period of study, commonly reported adverse events across the treatment groups were oedema (rosiglitazone 14.1 percent; glyburide 8.5 percent; metformin 7.2 percent); weight gain (rosiglitazone 6.9 percent; glyburide 3.3 percent; metformin 1.2 percent); gastrointestinal side effects (metformin 38.3 percent; rosiglitazone 23.0 percent; glyburide 21.9 percent); and hypoglycaemia (glyburide 38.7 percent; metformin 11.6 percent; rosiglitazone 9.8 percent).1

[emphasis mine] Recent further analysis showed a lower rate of fractures reported as adverse events in women taking glyburide or metformin versus rosiglitazone (glyburide 3.5 percent; metformin 5.1 percent; rosiglitazone 9.3 percent), most commonly involving fractures of the foot and upper limb bones.1 There was no observed difference among treatment groups in the number of fractures reported in men.1"

This says that women on Avandia (rosiglitazone) had twice as many fractures as those on Metformin and almost 3 times as many as those on Amaryl (glyburide.)

The total number of fractures was not huge, but this finding takes on more importance when linked to a previous study, published in November that also found that Avandia and Actos increased the incidence bone fractures in older women in nursing homes who had been taking it.

Here is a report of that study, as reported in the Diabetes in Control newsletter: TZD’s Can Increase Bone Loss in Type 2 Women

The reason why this might be happening as reported in the nursing home study was that Avandia apparently disrupts the parathyroid hormone that regulates calcium.

This is very disturbing because it may mean that in people who are taking Avandia, it is very slowly and without anyone observing it causing bone to be remodeled in a way that will not become obvious for years to come but will eventually ruin lives.

By the time the bone changes do become obvious, the old ladies who have taken Avandia for a decade will begin to break their hips and die, but it will be too late. Their bones will have already been weakened.

That the drug manufacturer completely fails to mention this new, and dangerous side effects in its hail of advertising to physicians and its press releases to the public is very troubling.

If nothing else, if you have been taking Avandia for any length of time, insist on having your doctor order a bone scan and have it repeated every couple years to be sure that that you aren't developing early signs of osteoporosis that won't otherwise be detectable for many more years. Osteoporosis causes fractures in older people that lead to death in 25% of all cases in people over age 50 and more in the more elderly.