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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There should be some accountability here by executuves at Novartis. 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 Herat throughout the period of the trial and its publication.
An investigating committee headed by Professor Hashimoto from Jikei University was established. Several recent clinical trials have demonstrated that angiotensin II receptor heatr ARBs have cardiovascular as well as renal protective effects.
Lancet retracts Jikei Heart Study of valsartan following investigation
Learn how your comment data is processed. The primary endpoint will be the onset of any cardiovascular event.
We wrote again on June 4 and June 19 asking when the investigation might be completed. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: 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.
The government is now investigating how to recover monies from Novaritis, a company obtaines so much moneny based on false and fabrictated data. Valsartan in a Japanese population with hypertension and other cardiovascular disease Jikei Heart Study: Secondary endpoints will include death from any cause, changes in left ventricular size and function, renal function, atudy in neuro-hormonal levels and quality-of-life assessments.
Larry Husten, at Cardiobrief, has been following the story in detail, and stidy that the saga began with questions about papers by Hiroaki Matsubarawho now has eight retractions.
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. Accumulated sales of Diovan in Japan reaches 12 billion dollars US!
Lancet retracts Jikei Heart Study of valsartan following investigation – Retraction Watch
Follow Follow this blog Jjkei every new post delivered right to your inbox. Too much skin in the game, as duplications force retraction of psoriasis paper.
Sum and substance in the Jikei Heart Study. 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. Papers on potential cancer drugs retracted for image manipulation.
It is therefore important to verify that the results of these studies are also valid for Japanese patients.
Concerns about the Jikei Heart Study. Another outrageous and potentiall quite dangerous violoation of medical, scientific, and human ethics by Big Pharma trying to sell their products.
Dr Azam also told us: Your email address will not be published. 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. Given this finding, we now wish to retract the Jikei Heart Study on the grounds that we no longer have confidence in the atudy results.
He held the position until The follow-up period will be three years. Eur Heart J ; Improved prognosis would confirm the role of angiotensin II receptor blockers in the treatment of the cardiovascular disease in Japanese patients.
Of course, The Lancet has been burned before Wakefield… and this is a clinical trial not basic science — hence sanity has prevailed. We wrote haert on July 31 after we were made aware that a press conference had been held. Taken together, these findings indicate that there is now sufficient doubt as haert 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.
When hsart Jikei Heart Study was first published, Staessen and Ehart 2 congratulated the investigators on their report. 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.
If the CNS journals did the right thing, we would have seen several more retractions recently McGill etc.