Antibe Therapeutics Inc(Pre-Merger) ATBPF

RE:RE:RE:ATE Longs: Read posts carefully!

[Actuarial]

I am an actuary so I know exactly this trial is flawed and it is meaningless from the very beginning.

BlueCello wrote:

Actuarial wrote:

The PRECISION trial had limitations. Adherence and retention were lower than in most trials that assess cardiovascular outcomes, which reflects the challenges of long-term treatment of a painful condition in patients who frequently experience frustration with unrelieved symptoms and switch therapies or leave the trial. Low levels of adherence and retention have also been found in previous pain studies.9 Although the similarity in the results for the intention-to-treat and on-treatment populations suggests that low adherence was unlikely to have influenced the principal conclusions, the high levels of nonretention make interpretation of the findings challenging. Although the rates of nonretention were similar for all three treatments, the possibility of informative censoring (i.e., the bias that is created when participants drop out of a study because of factors related to the study itself) cannot be ruled out. The large number of comparisons without adjustment for multiplicity increases the possibility of false positive findings.

The dose of celecoxib was limited by regulatory restrictions to 200 mg daily for most patients, which may have provided a potential safety advantage for celecoxib, although the mean doses for both nonselective NSAIDs were also submaximal. Three previous trials assessed higher doses of celecoxib (400 to 800 mg per day),4,10,11 one of which showed a significantly higher risk of cardiovascular events in association with the unapproved 800-mg dose than with placebo, although the trial included only a small number of events. Our results provide reassurance regarding the safety of moderate doses of celecoxib but not the safety of high doses of celecoxib. Although ibuprofen and naproxen have been reported to potentially interfere with the antiplatelet effects of aspirin,12 we found no statistical interaction for aspirin use (Fig. S4 in the Supplementary Appendix). However, the trial was not specifically designed to assess the effects of aspirin on the relative safety of NSAIDs. Although enrollment was stratified according to aspirin use to ensure equal distribution of aspirin use among the treatment groups, patients were not randomly assigned to receive or not receive aspirin.

JOM, and from another posting:

This is probably the source:

https://www.cbsnews.com/news/celebrex-arthritis-nsaid-drug-study-surprises-cardiovascular-heart-experts/

And here are three bits, in quotes, missing from Approved's posting:

"The patients were treated and followed up anywhere from 20 to 34 months, during which time they were monitored for gastrointestinal and kidney side effects. During the trial, almost 69 percent dropped out; 2.5 percent of the patients died."

"The difference between the three drugs was not statistically significant but it did trend in a direction that was more favorable for Celebrex, said Nissen."

"Doses of Celebrex higher than those used in the study have been shown to cause heart risks in one previous trial, the study authors warned. Nissen also warned against turning to opioids for pain relief."

Draw your own conclusions.