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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Another outrageous and potentiall quite dangerous violoation of medical, scientific, and human ethics by Big Pharma trying to sell their products.

Larry Husten, at Cardiobrief, has been following the story in detail, and notes that the saga began with questions about papers by Hiroaki Matsubarawho now has eight retractions. There should be some accountability here by executuves at Novartis.

If the CNS journals did the right thing, we would have seen several sttudy retractions recently McGill etc.

Matsubara is not an author on the Jikei study. By using this form you agree with the storage and handling of your data by this website per the terms of our privacy policy: We wrote again on June 4 and June 19 asking when the investigation might be completed.

Sorry, your blog cannot share posts by email. Too much skin in the game, as duplications force retraction of psoriasis paper. Sub-studies will explore the effect in patients with diabetes mellitus, hyperlipidemia and the effects of combination of drugs. Improved prognosis would confirm the role of angiotensin II receptor blockers in the treatment of the cardiovascular disease in Japanese patients.

The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker, in addition to conventional treatment, will improve the prognosis of Japanese patients with cardiovascular diseases hypertension, ischemic heart disease, congestive heart failure. But we soon became aware that there was concern in Japan about the trial.


The follow-up period will jikkei three years. Your email address will not be published. Accumulated sales of Diovan in Japan reaches 12 billion dollars US! 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.

I hope many more journals will take the same detailed approach.

Concerns about the Jikei Heart Study. Sum and substance in the Jikei Heart Study. Of course, The Lancet has been burned before Wakefield… and this is a clinical trial not basic science — hence sanity has prevailed. Learn how your comment data is processed.

The Lancet deserves a tip of our stuudy for such a detailed note. An investigating committee headed by Professor Hashimoto from Jikei University was established.

Lancet retracts Jikei Heart Study of valsartan following investigation

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

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The report also comments on the affiliation of the person entrusted with the statistical analysis, Nobuo Shirahashi. When the Jikei Heart Study was first published, Staessen and Richart 2 congratulated the investigators on their report. Papers on potential cancer drugs retracted for image manipulation. 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.


Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study: Follow Follow this blog Get every new post delivered right to your inbox. The primary endpoint will be the onset of any cardiovascular event.

Eur Heart J ; This is outragenous given all those incomes come from healthinsurance and copay form patients. Several recent clinical trials have demonstrated that angiotensin II receptor blockers ARBs have cardiovascular as well as renal protective effects.

We wrote again on July 31 after we were made aware that a press conference had been held. 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 invited the authors to comment. It is therefore important to verify that the results of these studies are also valid for Japanese patients.

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.

He held the position until Although we were initially satisfied with their response, in we published a letter from Dr Yui reporting further concerns.

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.

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

This site uses Akismet to reduce spam. The government is now investigating how to recover monies from Novaritis, a company obtaines so much moneny based on false and fabrictated data. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: