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Misrepresentation of vital status follow-up: challenging the integrity of the PLATO trial and the claimed mortality benefit of ticagrelor versus clopidogrel
JJ. DiNicolantonio, A. Tomek,
Jazyk angličtina Země Nizozemsko
Typ dokumentu srovnávací studie, časopisecké články
- MeSH
- adenosin škodlivé účinky analogy a deriváty terapeutické užití MeSH
- antagonisté purinergních receptorů P2Y terapeutické užití MeSH
- hodnocení rizik MeSH
- klinické zkoušky jako téma kontraindikace etika normy MeSH
- lidé MeSH
- mortalita trendy MeSH
- následné studie MeSH
- poradní výbory normy MeSH
- schvalování léčiv * MeSH
- statistika přirozeného pohybu MeSH
- tiklopidin škodlivé účinky analogy a deriváty terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
CONTEXT: Ticagrelor, a novel, reversible, and oral P2Y12 receptor antagonist, was claimed to reduce all-cause mortality compared to clopidogrel in the PLATO trial. OBJECTIVE: We sought to ascertain vital status follow-up for clopidogrel and ticagrelor to determine if any discrepancy existed by reviewing data from the FDA Complete Response Review. RESULTS: The FDA Complete Response Review indicated misrepresentation of vital status follow-up by the sponsor's presenter at the Cardiovascular and Renal Drugs Advisory Committee. Instead of five patients with missing vital status follow-up, the FDA primary efficacy reviewer indicated that there was a minimum of 106 patients. Additionally and more concerning was the fact that significantly more patients on ticagrelor (3.1%, n = 289 patients) had incomplete vital status follow-up versus clopidogrel (2.6%, n = 242 patients, p = 0.04 for the difference). CONCLUSIONS: The Advisory Committee that voted in favor to approve ticagrelor was given misrepresented data, which may have affected the approval of ticagrelor. The fact that significantly more patients on ticagrelor had incomplete vital status follow-up versus clopidogrel challenges the claimed mortality benefit of ticagrelor and the approval of the PLATO trial.
Citace poskytuje Crossref.org
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- $a DiNicolantonio, James J $u Independent Researcher, Ithaca, NY, United States; Department of Neurology, Charles University in Prague, 2nd Faculty of Medicine, University Hospital Motol, Czech Republic. Electronic address: jjdinicol@gmail.com.
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- $a CONTEXT: Ticagrelor, a novel, reversible, and oral P2Y12 receptor antagonist, was claimed to reduce all-cause mortality compared to clopidogrel in the PLATO trial. OBJECTIVE: We sought to ascertain vital status follow-up for clopidogrel and ticagrelor to determine if any discrepancy existed by reviewing data from the FDA Complete Response Review. RESULTS: The FDA Complete Response Review indicated misrepresentation of vital status follow-up by the sponsor's presenter at the Cardiovascular and Renal Drugs Advisory Committee. Instead of five patients with missing vital status follow-up, the FDA primary efficacy reviewer indicated that there was a minimum of 106 patients. Additionally and more concerning was the fact that significantly more patients on ticagrelor (3.1%, n = 289 patients) had incomplete vital status follow-up versus clopidogrel (2.6%, n = 242 patients, p = 0.04 for the difference). CONCLUSIONS: The Advisory Committee that voted in favor to approve ticagrelor was given misrepresented data, which may have affected the approval of ticagrelor. The fact that significantly more patients on ticagrelor had incomplete vital status follow-up versus clopidogrel challenges the claimed mortality benefit of ticagrelor and the approval of the PLATO trial.
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