1/6 Critical interpretation of the findings in the Fourier trial for Repatha (PCSK9) as follows:
* LDL-C levels were 60 mg/dL lower in the Repatha group than in the placebo group at the first laboratory examination and thereafter during the study period,
* LDL-C levels were 60 mg/dL lower in the Repatha group than in the placebo group at the first laboratory examination and thereafter during the study period,
2/6 which would allow investigators to easily guess a patients study group allocation; thus, double blinding could have been compromised.
*The composite end point included measures that were less objective; hence, the accuracy of these measures as used across 49 different
*The composite end point included measures that were less objective; hence, the accuracy of these measures as used across 49 different
3/6 countries could have been biased, with the exception of mortality. For example, troponin level is known to be elevated after coronary angioplasty, leading to more frequent diagnosis of MI in the placebo group.
4/6 * The termination of treatment at 2.2 years was premature because the difference in cumulative incidence between the 2 groups is decreasing compared with that in earlier periods.
5/6 * Problematically, ASCVD mortality and all-cause mortality tended to be LOWER in the PLACEBO group.
*There may be serious reporting bias for adverse events in the FOURIER trial. In the many phase II studies of Repatha, infections and neurocognitive events
*There may be serious reporting bias for adverse events in the FOURIER trial. In the many phase II studies of Repatha, infections and neurocognitive events
6/ 6 and injuries were more frequently reported in the PCSK9 inhibitor groups than in the placebo groups; however, these events were not well documented in the FOURIER trial.
