Table 1. Clinical trials of first-generation ARBs in Japan that were followed by scandals.

Trial name	Trial’s purpose and conclusion	Publications, promotional use, and scandals
Jikei Hearta	In this trial, the researchers aimed to examine the effect of valsartan on cardiovascular disease in patients with hypertension and coronary heart disease or heart failure. The researchers wrote that “the addition of valsartan to conventional treatment prevented more cardiovascular events than supplementary conventional treatment.”	Publication: The results were presented at ISH2006,d and they were published in The Lancet in April 2007.
		Promotion: After ISH2006, the results were used for commercial promotional activities.
		Scandal: Because of fabricated data, the published report was retracted in September 2013.
Case-Jb	In this trial, the researchers aimed to examine the effect of candesartan on cardiovascular disease in high-risk patients with hypertension. The researchers wrote that “candesartan-based and amlodipine-based regimens produced no statistical differences in terms of the primary cardiovascular end point, whereas candesartan prevented new-onset diabetes more effectively than amlodipine.”	Publication: The results were presented at ISH2006, and they were published in Hypertension in February 2008.
		Promotion: After ISH2006, the results were used for commercial promotional activities.
		Scandal: Because of misuse of the trial’s results in commercial promotional activities, the government of Japan issued a business improvement order to the pharmaceutical company in May 2016.
Kyoto Heartc	In this trial, the researchers aimed to examine the effect of valsartan on cardiovascular disease in patients with uncontrolled hypertension. The researchers wrote that “valsartan add-on treatment to improve blood pressure control prevented more cardiovascular events than conventional non-ARB treatment in high-risk hypertensive patients in Japan.”	Publication: The results were presented at ESC2009,e and they were published in the European Heart Journal in October 2010.
		Promotion: After ESC2009, the results were used for commercial promotional activities.
		Scandal: Because of fabricated data, the published report was retracted in February 2013.

^aJikei Heart: Valsartan in a Japanese population with hypertension and other cardiovascular disease.

^bCASE-J: Candesartan Antihypertensive Survival Evaluation in Japan.

^cKyoto Heart: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks.

^dISH2006: The 21st Scientific Meeting of the International Society of Hypertension, which was held in October of 2006, in Fukuoka, Japan.

^eESC2009: The congress of the European Society of Cardiology that was held in September of 2009 in Barcelona, Spain.