Recycline - Combination Rebif + Minocycline [Fail]

[12321]

Recycline -Combination Rebif + Minocycline - Phase II completed recently. The lead investigator, Sorensen, said the results will be released in October at the ECTRIMS conference in Lyon.





***update from Lyon = Fail/no efficacy

http://www.peerviewpress.com/adding-min ... lerosis-pr

[12321]

No efficacy -

http://www.peerviewpress.com/adding-min ... lerosis-pr

[Scott1]

It's a strange conclusion seeing they said-

"More patients in the minocycline group withdrew because of adverse events (20% vs 32%), although more in the placebo arm withdrew because of lack of efficacy (8% vs 1%).

These high withdrawal rates, and the relatively low annualised relapse rates in both treatment arms also contributed to the study being underpowered."

There's a lesson in every study but the conclusion is more definite than study by the look of it.

Regards

[12321]

It's a strange conclusion seeing they said-

"More patients in the minocycline group withdrew because of adverse events (20% vs 32%), although more in the placebo arm withdrew because of lack of efficacy (8% vs 1%).

These high withdrawal rates, and the relatively low annualised relapse rates in both treatment arms also contributed to the study being underpowered."

There's a lesson in every study but the conclusion is more definite than study by the look of it.

Regards

Efficacy definition: "Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances."

"Beneficial trends toward minocycline add-on that did not reach significance were seen in the annual rate of qualifying relapses (0.28 vs 0.18 for placebo and minocycline, respectively; P = .37), clinically disease-free patients (29.6% vs 47.8%; P = .22), and annual rate of reported relapses (0.40 vs 0.27; P = .08)."

You could measure how "definite" the results are by looking at the p value. And while the p value of what they consider a "qualifying" relapse is .37, the reported relapse P value is .08.