Lancet retracts Jikei Heart Study - Steve Stiles

 Lancet retracts Jikei Heart Study as scandal cuts swath across journals

         London, UK - The editors of the Lancet have formally retracted its publication of the Jikei Heart Study [1], the latest and perhaps climactic chapter in a scandal involving researchers in Japan that already had driven the European Heart Journal to pull the Kyoto Heart Study from the record earlier this year [2].

The broader story about apparent improprieties in the conduct of the trials [3,4], both of which were on the angiotensin-receptor blocker valsartan (Diovan, Novartis) in Japanese hypertension patients and which share some investigators, also includes allegations of fraud involving five papers in Circulation and other American Heart Association journals that were coauthored by Kyoto senior author Dr Hiroaki Matsubara (Kyoto Prefectural University School of Medicine, Japan).
 
The Lancet retraction was initially covered by Retraction Watch [5], which along with Cardiobrief and other blog sites has been closely tracking the larger story cutting across different journals.

Sources

1. The Lancet editors. Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): A randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 2013; DOI:10.1016/S0140-6736(13)61847-4. Available here.
2. Retraction of: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study. Eur Heart J 2013; 34:1023.
3. 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.
4. Sawada T, Yamada H, Dahlof B, Matsubara H. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: Kyoto Heart Study. Eur Heart J 2009; 30: 2461-2469.
5. Retraction Watch. Lancet retracts Jikei Heart Study of valsartan following investigation. Available here.

Related links

• Diovan data-manipulation scandal touches Novartis in Japan
  [Hypertension > Hypertension; Jul 19, 2013]
• AHA concerned over possible image fraud in five papers
  [heartwire > News; Mar 13, 2012]
• KYOTO and JIKEI HEART analyses show benefit of valsartan in Japanese hypertensive patients
  [Hypertension > Hypertension; Sep 01, 2010]
• Valsartan plus optimal medical therapy provides additional cardiovascular benefit in Japanese population
  [heartwire > News; Apr 26, 2007]
• KYOTO HEART study not quite sufficient to extend the role of ARBs to first-line therapy
  [Acute Coronary Syndromes > Acute coronary syndromes; Sep 01, 2009]
• Cardiovascular benefit of adding valsartan to optimal therapy in Japanese hypertensive population
  [heartwire > News; Sep 11, 2006]