Supplemental Benefit of an ARB in Hypertensive Patients With Stable Heart Failure Using Olmesartan | Clinical Trial - SUPPORT

Feb 26, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Ministry of Health, Labour, and Welfare; Ministry of Education, Culture, Sports, Science, and Technology, Japan
Date Published:
01/31/2015
Original Posted Date:
02/26/2015
References

Description:

The goal of the trial was to evaluate treatment with olmesartan compared with control among hypertensive patients with chronic heart failure (CHF) on a background therapy of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, or both.

Contribution to the Literature: The SUPPORT trial showed that the addition of olmesartan to standard heart failure therapy (ACE inhibitors and beta-blockers) increased adverse events.

Study Design

Patients with hypertension and CHF on optimal medical therapy were randomized to olmesartan (n = 578) versus control (n = 569). Olmesartan was started at 5-10 mg daily and titrated to 40 mg daily.

Patient Population:

  • Total number of enrollees: 1,147
  • Duration of follow-up: Median 4.4 years
  • Mean patient age: 66 years
  • Percentage female: 25%
  • Percentage diabetics: 49%
  • Mean left ventricular ejection fraction (LVEF) = 55%

Inclusion criteria:

  • Hypertensive patients 20-79 years of age with chronic stable heart failure (New York Heart Association class II-IV symptoms)
  • Treatment with ACE inhibitors and/or beta-blockers

Exclusion criteria:

  • Renal or liver dysfunction
  • History of angioedema
  • Life-threatening illness
  • Pregnant
  • Cardiovascular surgery, myocardial infarction (MI), or percutaneous coronary intervention within the previous 6 months

Principal Findings:

The primary outcome, all-cause death, MI, stroke, or hospitalization for heart failure occurred in 33.2% of the olmesartan group versus 29.2% of the control group (p = 0.006).

Secondary outcomes:

  • All-cause death: 19.4% vs. 13.5% (p = 0.046), respectively
  • Renal dysfunction: 21.1% vs. 12.5% (p = 0.003), respectively

Interpretation:

Among patients with hypertension and CHF on standard medical therapy, the addition of olmesartan was not beneficial. In fact, addition of olmesartan was associated with an increase in all-cause mortality and renal dysfunction. The mean LVEF was 55%; therefore, the findings mainly apply to patients with heart failure with preserved ejection fraction. Several lines of evidence have revealed a harmful effect of adding an angiotensin-receptor blocker to an ACE inhibitor.

References:

Sakata Y, Shiba N, Takahashi J, et al. Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotension receptor blocker in hypertensive patients with stable heart failure using olmesartan. Eur Heart J 2015;Jan 31:[Epub ahead of print].M

Keywords: Heart Failure, Angiotensin-Converting Enzyme Inhibitors, Hypertension, Hospitalization, Stroke, Adrenergic beta-Antagonists, Secondary Prevention, Control Groups


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