Thursday, October 01, 2015 1:59:35 PM
"Patients with MACE showed significantly higher TG level at 4 weeks (149.6±81.4 vs. 119.3±58.9 mg/dL, p=0.026) than those without. High on-treatment TG level (≥150 mg/dL) were associated with increased adverse events compared to lower TG level in a univariate analysis (hazard ratio [HR], 3.3; p<0.001). In a multivariate analysis, high 4-week TG level after statin treatment was an independent predictor for MACE (HR, 4.01; 95% confidence interval, 1.85 to 9.06; p=0.001),"
"At 4 weeks, the mean LDL-C level was 72.5±23.8 mg/dL and the mean TG was 123.2±62.8 mg/dL. Of the patients, 49.8% had LDL-C ≥70 mg/dL, and 24.3% had TG ≥150 mg/dL. The patients with MACE had significantly higher on-treatment TG level than did those without (149.6±81.4 vs. 119.3±58.9 mg/dL, p=0.026, Table 2). Low on-treatment LDL-C (<70 mg/dL) was not associated with MACE compared to higher LDLC in a univariate analysis."
See Table 2 of the following link,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2784976/
So seems like 5.2-5.9% R-IT placebo group event rate is very achievable as I believe Kiwi had mentioned R-IT strives to recruit patients with prior CVD and stent procedures done. Moreover, Amarin seems to pick the right TG threshold of >150 with mean and median exceeding 200 for R-IT patients. I am shocked that no US/EU BP has ever conducted a high trig. CVOT utill R-IT. Aren't scientists and healthcare professionals curious at all? I don't care what's AMRN stock price now. I just glad I am a shareholder.
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