CardioExchange Archive

The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s [AHA’s] better known Circulation) has announced the retraction of two substudies from the KYOTO HEART Study. The papers, according to the editor, “contain a number of serious errors in data analysis.” The announcement contained no additional information about the retractions.

Last March, following accusations by independent bloggers in Japan and Germany, the AHA issued an Expression of Concern about five papers published in AHA journals co-authored by Hiroaki Matsubara, who was a prominent cardiologist and researcher at Kyoto Prefectural University in Japan, the author of many papers exploring the basic science of the renin-angiotensin system, and the chief investigator of the KYOTO HEART Study, a randomized, open-label trial studying the add-on effect of valsartan to conventional therapy in high-risk hypertension.

These are the two papers retracted by Circulation Journal:

Shinzo Kimura, Takahisa Sawada, Jun Shiraishi, Hiroyuki Yamada, Hiroaki Matsubara; for the KYOTO HEART Study Group. Effects of valsartan on cardiovascular morbidity and mortality in high-risk hyper- tensive patients with new-onset diabetes mellitus: Sub-analysis of the KYOTO HEART Study. Circ J 2012 September 12 [Epub ahead of print].

Jun Shiraishi, Takahisa Sawada, Shinzo Kimura, Hiroyuki Yamada, Hiroaki Matsubara; for the KYOTO HEART Study Group. Enhanced cardiovascular protective effects of valsartan in high-risk hypertensive patients with left ventricular hypertrophy: Sub-analysis of the KYOTO HEART study. Circ J 2011; 75: 806 – 814.

It may be worth noting that the first paper was published in September 2012, several months after the AHA’s initial expression of concern about Matsubara’s publications.

Sripal Bangalore, who was a co-author of an editorial on the KYOTO HEART Study when it was initially published, said the new developments may raise questions about the main finding of the the study:

“This may be just the tip of the iceberg. We need to know more details about whether it was a ‘data analysis’ error or fradulent data. Nevertheless, it does cast a serious doubt on the main results also — which if you remember was a significant benefit for Valsartan that was not explained by blood pressure and the curves started separating within 3 months. However, this is conjecture at this point.”