Re: Statins for people at low risk | The BMJ

Originally published as a rapid response (letter to the editor) of The BMJ (Aug 9, 2015).
URL: http://www.bmj.com/content/351/bmj.h3908/rr-5
 

Dear Sirs, Independent statins review panel / Statins data campaign:

I would like to share the analysis of results of the JUPITER study publicly available at ClinicalTrials.gov (1)
“Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events” (ClinicalTrials.gov: NCT00239681).

1. Table 1 and Table 2: adverse events perhaps are higher than 18%. (2)

2. Not all adverse drug reactions reported to ClinicalTrials.gov were included in the two Tables attached to this letter.

3. Results available at ClinicalTrials.gov for the JUPITER study are not consistent with the results published in journal articles
(n = 21 | http://www.ncbi.nlm.nih.gov/pubmed/?term=NCT00239681)

One example (there are more): discordance between results reported in the number of patients diagnosed with diabetes mellitus.
(A) ClinicalTrials.gov: Placebo = 13; Rosuvastatin = 14
(B) 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.http://clinicaltrials.gov/archive/NCT00239681/2008_04_02/changes
(A) March 13, 2008. “Independent Data Monitoring Committee for JUPITER met and agreed that the study should continue as
planned.”
(B) April 2, 2008. “AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.”

6. Data collected for this analysis is open for public scrutiny: independent reviewers could confirm or refute the above statements.

References

1. Ramirez, Jorge H (2014): The pharmacology of statins in humans: a critical analysis. figshare.
http://dx.doi.org/10.6084/m9.figshare.1157386

2. Should people at low risk of cardiovascular disease take a statin? BMJ 2014; 348:g3329

Competing interests: http://chaoticpharmacology.com/disclaimer-coi/

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