The pharmacology of statins in humans: a critical analysis

Table 1. Reanalysis of rosuvastatin serious adverse events. Table 2. Reanalysis of rosuvastatin non-serious adverse events. Statistical analysis: Chi-square _________________________________ Databases: Open (worldwide) - comments allowed 1st URL: Google Spreadsheet - Analysis of the JUPITER trial (rosuvastatin) - NCT00239681 2nd URL: Google Spreadsheet - Statin registered studies at ClinicalTrials.gov and WHO ICTRP 3rd URL: JUPITER complete database downloaded from ClinicalTrials.gov ____________________________ Comments about rosuvastatin JUPITER clinical trial 1. Not all adverse drug reactions are included in Tables 1 and 2. 2. Adverse events appear to be much higher than 18%. (1) 3. Results available at ClinicalTrials.gov for the JUPITER study are not consistent with publications reporting the results of this trial. http://www.ncbi.nlm.nih.gov/pubmed/?term=NCT00239681 For example: Discordance between results reported in the number of patients diagnosed with diabetes mellitus. 1. ClinicalTrials.gov: Placebo=13; Rosuvastatin=14 | 2. Article (PMID: 22883507): Placebo=216; Rosuvastatin=270) 4. Primary outcome was modified in the registry history available at ClinicalTrials.gov http://clinicaltrials.gov/archive/NCT00239681/2014_03_21/changes 5. It is not clear why this study was terminated. March 13, 2008."Independent Data Monitoring Committee for JUPITER met and agreed that the studyshould continue as planned." April 2, 2008."AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinicalstudy early based on a recommendation from an Independent Data Monitoring Boardand the JUPITER Steering Committee, which met on March 29, 2008. The study willbe stopped early because there is unequivocal evidence of a reduction incardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo." http://clinicaltrials.gov/archive/NCT00239681/2008_04_02/changes References 1. Should people at low risk of cardiovascular disease take a statin? BMJ 2014; 348:g3329