Reanalysis of JUPITER clinical trial (NCT00239681)- Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

Table: Reanalysis of adverse events
NCT00239681: JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

Chi-square statistics

______

1. Not all adverse drug reactions are included in this Table.

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