RE:HERE IS THE AWNSERBump up !
Great post from Philippe on the Yahoo board. I think he found the possible answer. He also stated that he communiacated with management to share is theory. I will agree that this could be the more logical explanation for the 5 sites / 25 patient / 4 weeks effect
"The wording with regards to statins can easily be misinterpreted and I believe the problem at the 5 sites lies there. Read carefully: 'Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator AT TIME OF SCREENING.'
The way the trial was designed was to allow for statins to be initiated 8-9 weeks BEFORE randomization in order for them to reach full effect on lipid profile and stabilize lipid profile before randomization. However it may have been interpreted at some sites that the physician would decide at the time of screening if patient would be initiated on statins, but those physicians would have instructed patients to start statins treatment only at randomization (when trial starts), therefore increasing response in both placebo AND CaPre arm, which is what has been seen. Also supports the fact that most of the placebo effect was seen in the first 4 weeks, which would be normal if placebo patients had just started statins."