Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial.
Bottom Line: We examined whether an additive treatment with an angiotensin receptor blocker, olmesartan, reduces the mortality and morbidity in hypertensive patients with chronic heart failure (CHF) treated with angiotensin-converting enzyme (ACE) inhibitors, β-blockers, or both.The primary endpoint was a composite of all-cause death, non-fatal acute myocardial infarction, non-fatal stroke, and hospitalization for worsening heart failure.Particularly, the triple combination therapy with olmesartan, ACE inhibitors and β-blockers was associated with increased adverse cardiac events.
Affiliation: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.Show MeSH
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Mentions: The SUPPORT trial was a prospective, randomized, open-label blinded endpoint study,11 which was conducted according to the ethical principles described in Declaration of Helsinki. The study protocol was approved by the institutional ethics committees of the 17 participating institutions in the Tohoku District of Japan (Appendix). The primary objective of the study was to examine whether an additive treatment with an ARB, olmesartan, reduces the mortality and morbidity of hypertensive patients with stable CHF (NCT00417222). The inclusion criteria were designed to enroll hypertensive patients aged 20–79 with symptomatic CHF but in stable condition and were treated with ACE inhibitors and/or β-blockers, while the exclusion criteria were designed to exclude patients with substantive confounding medical conditions or an inability to meaningfully participate in the SUPPORT trial (Table 1). Finally, a total of 1147 symptomatic CHF patients with a history of hypertension who met the inclusion and exclusion criteria and gave written informed consent for the trial were assigned to either the olmesartan or the control group according to a 1 : 1 ratio of olmesartan to control, through stratification by participating institute, sex and age between October 2006 and March 2010. The patients were followed up until the study ended on 31 March 2013 (Figure 1). If contact could not be made at the end of the study, data of these patients were censored at the date when they were known to be alive last. Olmesartan was initiated at a dose of 5–10 mg/day, and then up titrated to 40 mg/day, if tolerable, in the olmesartan group, while no ARB use was allowed in the control group. The diagnosis of HF was made based on the criteria of the Framingham study12 by an attending physician at each hospital. All physicians were encouraged to control blood pressure of the patients in each group according to the recommendations in the JNC7.13 The primary endpoint was the composite of all-cause death, non-fatal acute myocardial infarction, non-fatal stroke, and worsening HF requiring hospitalization, while secondary endpoints consisted of the modes of death, hospitalization for cardiovascular reasons, surrogate markers for HF and development of cardiovascular disease, atrial fibrillation, diabetes, and renal dysfunction (see Supplementary material online, Table S1).Table 1
Affiliation: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan.