[SpAsMaN*]

Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochloride http://www.blackwell-synergy.com/doi/abs/1...journalCode=ajg

quote:Results: There were 3631 alosetron users among members of UnitedHealthcare from March through December, 2000, and we identified 2480 comparison IBS-only patients; follow-up time averaged about 5 months in both groups. There were no instances of colonic ischemia in either cohort. Thirty instances of bowel surgery occurred, giving rates of 10.2/1000 person-yr in the alosetron cohort and 11.8/1000 person-yr in the IBS/no alosetron cohort. There were three cases of hospitalized complications of constipation. The incidence rates were essentially the same in alosetron users (1.24/1000 person-yr) and in IBS patients with no alosetron use (0.92/1000 person-yr).

It look like Alosetron is safer than first tougth because it has the same rate of colonic ischemia than placebo.Perhaps IBSers simply get more ischemia than the normal population.

 

[SpAsMaN*]

In fact we get more chance of getting it compare to the normal population. Occurrence of Colon Ischemia in Relation to Irritable Bowel Syndrome http://www.blackwell-synergy.com/doi/abs/1...journalCode=ajg

quote:RESULTS: There were 740 cases of colon ischemia during 8.5 million person-years of observation in 5.4 million persons. The crude incidence rate was 42.8 cases per 100,000 person-years for IBS patients. By comparison, the incidence rate was 7.2 per 100,000 person-years in the general population. After adjustment for age, sex, and calendar year, the incidence of colon ischemia in people with IBS was 3.4 times higher than in persons without (95% CI 2.6â€"4.5).

 

[jjohnson]

Spasman,Thanks for taking the time to post this. I know you have IBS-C so this doesn't affect you personally.I remember from the time I was following cilansetron that the FDA had challenged this position. All of the placebo controlled studies with alosetron and cilansetron showed a much higher rate of IC. And some other meta-analyses showed a higher rate with alosetron, though maybe not as high as initially thought. I think the bottom line is that to the extent that the FDA has given credence to these studies (if they have at all,) it's still not enough to get the restrictions on Lotronex eased in any way.I think it is necessary to understand why the IC is occurring, and based on that, to try to identify those at risk. I've commented quite a lot on this topic and personally I am losing hope that they will ever achieve this.

 

[SpAsMaN*]

Well who knows,i could end up with ischemic bowel one day.According to the research it's a possibility.I've seen a programm on TV where a woman died from ischemic bowel in her sleep.It has been hard to diagnose at the pathology lab.A part of the bowel literrally died from lack of blood du to a blood cloth.

 

[jjohnson]

Hey Spasman,I only meant it wouldn't affect you with regard to alosetron.

I suppose you're right, though. We might all be at risk no matter what subtype we have or what drugs we are taking.