The pharmacology of statins in humans: a critical analysis

<strong>Table 1.</strong> Reanalysis of rosuvastatin serious adverse events. <strong>Table 2.</strong> Reanalysis of rosuvastatin non-serious adverse events. <strong>Statistical analysis: Chi-square</strong> <strong>_________________________________<br> </strong> <strong>Databases: Open (worldwide) - comments allowed</strong> <strong><br>1st URL:</strong> Google Spreadsheet - Analysis of the JUPITER trial (rosuvastatin) - NCT00239681 <strong>2nd URL:</strong> Google Spreadsheet - Statin registered studies at ClinicalTrials.gov and WHO ICTRP <strong>3rd URL:</strong> JUPITER complete database downloaded from ClinicalTrials.gov ____________________________ <strong>Comments about rosuvastatin JUPITER clinical trial</strong> <strong>1. Not all adverse drug reactions are included in Tables 1 and 2.</strong> <strong>2. Adverse events appear to be much higher than 18%. (1)</strong> <strong>3. Results available at ClinicalTrials.gov for the JUPITER study are not consistent with publications reporting the results of this trial.</strong> 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) <strong>4. Primary outcome was modified in the registry history available at ClinicalTrials.gov</strong> http://clinicaltrials.gov/archive/NCT00239681/2014_03_21/changes <strong>5. It is not clear why this study was terminated.</strong> March 13, 2008.<br><em>"Independent Data Monitoring Committee for JUPITER met and agreed that the studyshould continue as planned."</em> April 2, 2008.<br><em>"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."</em> http://clinicaltrials.gov/archive/NCT00239681/2008_04_02/changes <strong>References</strong> 1. Should people at low risk of cardiovascular disease take a statin? BMJ 2014; 348:g3329