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HF hospitalization: 20.8% vs 24.5%, HR 0.82 (0.67-0.99) (NNT=28 over 3.3 years)Įxclusion of the Russia/Georgia participants renders the primary outcome statistically significant, but does not materially affect the effect estimate for the primary or secondary outcomes.
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Therefore, the results of the 'Americas' subgroup may be the most accurate reflection of the effect of spironolactone in HFpEF. This indicates that significantly more participants from Russia did not receive the study drug, and raises the potential of misconduct at these study sites. Russia/Georgia: 9.3% vs 8.4%, HR 1.10 (0.79-1.51)Ĭredibility of this subgroup effect has been increased by a substudy demonstrating that participants from Russia were far more likely than those from North America to have no detectable serum concentrations of spironolactone metabolites. Subgroup analysis: Primary outcome varied based on region (Americas vs Russia/Georgia, p<0.001 for interaction)Īmericas: Spironolactone 27.3% vs placebo 31.8%, HR 0.82 (0.69-0.98) (NNT=23) Unclear risk of bias: Loss-to-follow-up on vital status ~4%
#Topcat spironolactone trial
Low risk of bias characteristics: Randomized, allocation-concealed, double-blind trial analyzed using intention-to-treat population Heart transplant recipient or currently implanted LVADĬhronic pulmonary disease: Requiring home O2 or PO steroids, hospitalization for exacerbation within 12 months, or significant in the opinion of the investigator Infiltrative or hypertrophic obstructive cardiomyopathy (HoCM) Hemodynamically significant uncorrected primary valvular heart disease Heart failure with preserved ejection fraction (HFpEF):ĭefined as a clinical syndrome of signs & symptoms of HF with normal systolic function (LVEF >50% & LV end-diastolic volume index 45% (measured within 6 months prior to randomization & after any prior ACS)Ĭontrolled SBP (100 pg/mL (or N-terminal pro-BNP >360 pg/mL) within 30 days, not explained by another disease entity The label of "HFpEF" does not yet offer an actionable management plan. In this context, spironolactone remains useful for patients with HFpEF & resistant hypertension. This complex, multiorgan medical syndrome is most common in individuals over the age of 65. Consistent with other "negative" studies in HFpEF, the results of TOPCAT supports the notion that patients with "HFpEF" should receive symptomatic treatment for HF, & interventions to reduce morbidity & mortality according to the underlying etiology. Heart Failure (HF) continues to generate vast quantities of clinical investigation due to its global burden as a longitudinal epidemic in modern public health. Spironolactone does not noticeably improve quality of life in HFpEF. Bottom line: In patients with HFpEF, spironolactone did not reduce the risk of death or hospitalization over 3.3 years. Spironolactone for heart failure with preserved ejection fraction.
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“The implications of worsening renal function are less ominous in patients treated with spironolactone than if it happens in patients treated with placebo,” Desai told Healio.įuture studies investigating epidemiology, pathophysiology and treatment strategies related to renal dysfunction in HFpEF are warranted, the researchers wrote.Pitt B, et al.
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001) compared with those assigned placebo. 003) and all-cause mortality ( P for interaction =. 11), but among patients who had worsening renal function, those assigned spironolactone had lower risk for CV death ( P for interaction =. The researchers wrote that there was no interaction between treatment assignment and worsening renal function for the primary endpoint ( P for interaction =. Irrespective of treatment, incident worsening renal function was linked to increased risk for the primary endpoint of CV death, HF hospitalization or aborted cardiac arrest (HR = 2.04 95% CI, 1.52-2.72 P <. The spironolactone group experienced worsening renal function more frequently compared with the placebo group (spironolactone, 17.8% placebo, 11.6% OR = 1.66 95% CI, 1.27-2.17 P <. We were interested in exploring whether these changes in renal function that are known to be observed with treatment are clinically meaningful or whether they are simply hemodynamic changes,” Akshay Desai, MD, MPH, medical director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, told Healio. “The observation from the primary TOPCAT trial was that there was more frequent worsening of renal function by the study definition in the spironolactone-treated patients with HFpEF.