Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study

Abstract

The Lancet published the Jikei Heart Study in April, 2007. 1 Mochizuki S Dahlof B Shimizu M et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007; 369: 1431-1439 Summary Full Text Full Text PDF PubMed Scopus (321) Google Scholar On July 31, 2013, we were informed by Professor Kazuhiro Hashimoto (Jikei University) that there had been a press conference on July 30 reporting an interim conclusion from an internal investigation into this research. The report considered that “The data on blood pressure are not reliable…”. Given this finding, we now wish to retract the Jikei Heart Study on the grounds that we no longer have confidence in the published results. RETRACTED: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality studyThe addition of valsartan to conventional treatment prevented more cardiovascular events than supplementary conventional treatment. These benefits cannot be entirely explained by a difference in blood pressure control. Full-Text PDF Retraction of the Jikei Heart Study: misquotation of a CommentThe Lancet Editors recently announced (Sept 7, p 843)1 the retraction of the Jikei Heart Study. The Editors stated that when the Jikei Heart Study2 was first published, “Staessen and Richart3 congratulated the investigators on their report.” However, this citation would have been much more balanced had the Editors also quoted the next sentence of our Comment:3 “Nevertheless, one should not accept at face value the main conclusions of the Jikei report”. We clearly listed the many weaknesses of the study, including inadequate sample size, insufficient dosing of study medications, the weakness of soft endpoints, the open-blinded-label endpoint assessment that did not account for bias in reporting endpoints by unblinded investigators, the between-group differences in blood pressure during the early phase of the randomised follow-up, and the lack of generalisability to general practice. Full-Text PDF Research misconduct and scientific integrity: a call for a global forumRecent data falsification in clinical trials of an antihypertensive drug—valsartan—including the Jikei Heart Study published in The Lancet, has damaged the scientific integrity of the Japanese medical community, but it has also provoked a discussion on how to prevent research misconduct.1–3 Such large-scale misconduct might not be an isolated event. It is critical for the Japanese Government and the medical community to examine and report exactly what happened to recover their credibility in clinical research. Full-Text PDF