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Kamis, 12 September 2013
International Society of Hypertension- Hypertension News

Sadly, this time we have three reports covering serious concerns about the validity of data published from cardiovascular trials: (1)The KYOTO HEART Study, (2) The Jikei Heart Study, and (3) the DECREASE Studies.

The Kyoto Heart Study

The Kyoto Heart Study, published in 2009, was a randomized controlled study, comparing valsartan with non-ARB treatment in patients (n=3 031) with cardiovascular disease for 3.3 years. Despite similar blood pressure in the two treatment arms, the hazard ratio for the primary composite cardiovascular endpoint was 0.55 (95% CI 0.42-0.72) in patients randomized to valsartan compared with patients given non-ARB.

However, since “critical problems existed with some of the data reported in the paper”, the article has now been retracted by the European Heart Journal.

The Jikei Heart Study

In the Jikei Heart Study, published 2007, patients (n=3 081) with hypertension, heart failure or coronary artery disease were randomized to valsartan or non-ARB treatment for 3.1 years. Despite similar blood pressure in the two treatment arms, the hazard ratio for the primary composite cardiovascular endpoint was 0.61 (95% CI 0.47-0.79) in patients randomized to valsartan compared with patients randomized to non-ARB. However, recently, doubts have been expressed about the validity of the study data after they have been re-examined. The Lancet retracted the paper on 7th September 2013.

The Decrease-1 study

In the DECREASE-1-trial, patients (n=112) undergoing vascular surgery were randomized to perioperative treatment with the beta-blocker bisoprolol or placebo [3]. This treatment reduced the risk for perioperative death or myocardial infarction from 34 % in patients randomised to placebo to 3 % in those who received bisoprolol [3]. DECREASE-1 is one out of a “family” of DECREASE studies where different approaches to reduce perioperative morbidity in vascular surgery were studied. However, in a recent publication in The Heart, it is reported that the results of ”all studies investigated in the DECREASE “family” for which data had not been lost, were found to be insecure because of serious flaws”.

Previous meta-analyses have shown a positive effect of perioperative treatment with beta-blockers on the incidence of myocardial infarction, but no effect on mortality. However, according to a recent meta-analysis, where the DECREASE-1 data were excluded, perioperative treatment with beta-blockers increased (!) total mortality with 27%. Hence, preoperative treatment with beta-blockers should not be recommended.

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