JIKEI HEART STUDY PDF

The addition of valsartan to optimized therapy in a cohort of Japanese patients with coronary heart disease and hypertension provides. Description: RETRACTION: The editors of the European Heart Journal have retracted the article reporting data/results of the Jikei Heart Study. The Lancet has formally retracted the Jikei Heart Study paper, originally published in The retraction had been widely anticipated for more.

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Sorry, your blog cannot share posts by email. But we soon became aware that there was concern in Japan about the trial. If the CNS journals did the right thing, we would have seen several more retractions recently McGill etc.

He held the position until Matsubara is not an author on the Jikei study. Dr Azam also told us: Eur Heart J ; Follow Follow this blog Get every new post delivered right to your inbox.

Accumulated sales of Diovan in Japan reaches 12 billion dollars US! An investigating committee headed by Professor Stuy from Jikei University was established.

Lancet retracts Jikei Heart Study of valsartan following investigation

I hope many more journals will take the same detailed approach. Although we were initially satisfied with their response, in we published a letter from Dr Yui reporting further concerns. The primary endpoint will be the onset of any cardiovascular event. Leave a Reply Cancel reply Your email address will not be published.

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The report identifies concern over the reliability of the blood pressure data: Our attempts to obtain a response from Mr Shirahashi were hindered by his recent retirement from Novartis, but the Global Head of Medical Affairs, Dr Usman Azam, did share with The Lancet that Mr Shirahashi had been employed by Novartis throughout jjkei period of the trial and its publication.

Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: We became aware of this development on April 29,and on May 2 we wrote to Jikei University asking for details of the investigation and requesting that we be kept informed. Concerns about the Jikei Heart Study. Secondary endpoints will include death from any cause, changes in left ventricular size and function, renal function, changes in neuro-hormonal levels and quality-of-life assessments.

Taken together, these findings indicate that there is now sufficient doubt as to the integrity of the Jikei Heart Study and the obfuscation over affiliation of the study statistician for The Lancet formally to retract the paper from the scientific record. The report also comments on the affiliation of the person entrusted with the statistical analysis, Nobuo Shirahashi.

Sub-studies will explore the effect in patients with diabetes mellitus, hyperlipidemia and the effects of combination of drugs.

Of course, The Lancet has been burned before Wakefield… and this is a clinical trial not basic science — hence sanity has prevailed. Larry Husten, at Cardiobrief, has been following the story nikei detail, and notes that the saga began with questions about papers by Hiroaki Matsubarawho now has eight retractions.

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Lancet retracts Jikei Heart Study of valsartan following investigation – Retraction Watch

Another outrageous and potentiall quite jiiei violoation of medical, scientific, and human ethics by Big Pharma trying to sell their products. Sum and substance in the Jikei Heart Study. The government is now investigating how to recover monies from Novaritis, a company obtaines so much moneny based on false and fabrictated data.

In October,we received correspondence expressing concern about the similarity of the standard deviations of the mean blood pressure measurements in the two studies, and we jiikei the authors to comment.

The Lancet deserves a tip of our hat for such a detailed note. Your email address will not be published.

We wrote again on June 4 and June 19 asking when the investigation might be completed. There should be some accountability here by executuves at Novartis. Too much skin in the game, as duplications force retraction of psoriasis paper.

Asian patients including Japanese were under-represented in these trials, however, and no large-scale clinical trials of ARBs have yet been performed in Japan.