{"id":7667,"date":"2025-06-27T16:40:12","date_gmt":"2025-06-27T13:40:12","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=7667"},"modified":"2025-06-27T16:40:12","modified_gmt":"2025-06-27T13:40:12","slug":"bmj-investigation-finds-more-concerns-in-ticagrelor-trials","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/bmj-investigation-finds-more-concerns-in-ticagrelor-trials\/","title":{"rendered":"BMJ Investigation Finds More Concerns in Ticagrelor Trials"},"content":{"rendered":"
BMJ Investigation Finds More Concerns in Ticagrelor Trials<\/div>\n
Date: June 19 , 2025<\/div>\n
Source: The BMJ<\/div>\n
<\/div>\n
Scientific Summary (Key Points):<\/div>\n
1. Context:<\/span><\/div>\n
A new BMJ investigation raises serious concerns about the integrity of clinical trials that led to the approval of ticagrelor (Brilinta), especially as generics are now entering the market.<\/div>\n
2. Lead Investigator:<\/span><\/div>\n
Peter Doshi, PhD, senior editor at The BMJ, questions the reliability of data from key studies: PLATO (2009), ONSET\/OFFSET, and RESPOND.<\/div>\n
3. Key Findings:<\/span><\/div>\n
\u2022 PLATO study (NEJM 2009): Previously criticized for data inconsistencies and omissions.<\/span><\/div>\n
\u2022 RESPOND trial: Originally nonsignificant primary outcome (P = 0.157) was changed without disclosure and later reported as significant (P = 0.005) in Circulation.<\/span><\/div>\n
\u2022 ONSET\/OFFSET trial: Patient exclusions were not reported transparently; labeled as \u201cintention-to-treat\u201d despite exclusions. Implausible data were transformed through unpublished analysis.<\/span><\/div>\n
4. Missing FDA Data:<\/span><\/div>\n
\u2022 Doshi reviewed platelet function machine outputs and found 60+ out of 282 readings missing from the FDA-submitted dataset.<\/span><\/div>\n
\u2022 These omitted data showed significantly higher platelet activity than reported, suggesting rebound effects that could raise risks of thrombosis or bleeding.<\/span><\/div>\n
5. Authorship Concerns:<\/span><\/div>\n
\u2022 A trial investigator was not listed as an author.<\/span><\/div>\n
\u2022 One listed author claimed he was not involved in the study.<\/span><\/div>\n
6. Reactions:<\/span><\/div>\n
\u2022 Dr. Victor Serebruany (Johns Hopkins): Warned that if physicians had known the full data, \u201cthey would never have used ticagrelor.\u201d<\/span><\/div>\n
\u2022 Dr. Eric Bates (University of Michigan): Suggested the clinical support for ticagrelor over clopidogrel may be overstated and now recommends guideline review.<\/span><\/div>\n
7. Industry Response:<\/span><\/div>\n
\u2022 AstraZeneca, Circulation, and several original investigators declined to comment or were unreachable.<\/span><\/div>\n
8. Regulatory Background:<\/span><\/div>\n
\u2022 Ticagrelor faced an initial FDA rejection and a US DOJ investigation in 2013 (closed in 2014 without action<\/span><\/div>\n
https:\/\/www.bmj.com\/content\/389\/bmj.r1201<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

BMJ Investigation Finds More Concerns in Ticagrelor Trials Date: June 19 , 2025 Source: The BMJ Scientific Summary (Key Points): 1. Context: A new BMJ investigation raises serious concerns about the integrity of clinical trials that led to the approval of ticagrelor (Brilinta), especially as generics are now entering the market. 2. Lead Investigator: Peter […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7667","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7667","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=7667"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7667\/revisions"}],"predecessor-version":[{"id":7671,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7667\/revisions\/7671"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=7667"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=7667"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=7667"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}