These patients had the worst prognosis among the patients enrolled (HR 2.10, 95% CI 1.26-3.5, p = 0.004). HFpEF phenotype suggestive of amyloid: Among 590 patients with detailed echocardiography data, 23% had echo phenotype suggestive of amyloid (septal thickness ≥1.2 cm, s’ velocity ≤6 cm/s). placebo based on gender: women, 25.1% vs. Women were older with fewer comorbidities. There was no effect modification by AF for the primary endpoint for spironolactone vs. Post-randomization AF occurred in 6.3% of patients and was associated with an increased early risk of the primary outcome (HR 2.32, 95% CI 1.59-3.40, p < 0.0001). Patients with any history/prevalent AF had numerically higher incidence of the primary endpoint (12.1% vs. These patients had higher left atrial volumes than patients without AF. Influence of AF: AF was common, either based on ECG at enrollment (25%) or based on history (18%). 9.1%, p 2 upper limit of normal were both significantly higher in the spironolactone arm. CHF hospitalizations were lower (12.0% vs. 5 events, p = 0.48) were similar between the two arms. p = 0.35) and aborted cardiac arrest (3 vs. Individual components including CV mortality (9.3% vs. The primary endpoint of CV death, chronic HF (CHF) hospitalization, or resuscitated cardiac arrest over 6 years was similar between the spironolactone and placebo arms (18.6% vs. Close to 29% of patients were enrolled into stratum II (elevated B-type natriuretic peptide /N-terminal proBNP).
Coexisting coronary artery disease was noted in 59% and atrial fibrillation (AF) in 35%. Hypertension was present in 92% of patients, with median blood pressure (BP) of 130/80 mm Hg. The baseline EF was 56%, 52% were female, and nearly two-thirds of the patients had New York Heart Association (NYHA) class II symptoms. Baseline characteristics were fairly similar between the two arms. Concomitant Medications:Īngiotensin-converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB) (84%), diuretic (82%), and statin (53%)Ī total of 3,445 patients were randomized at 233 sites in six countries: 1,722 to spironolactone and to 1,723 to placebo. Spironolactone was initiated at a dose of 15 mg/day and uptitrated to a maximum of 45 mg daily during the first 4 months of randomization. Patients were randomized in 1:1 fashion to either spironolactone versus placebo.
#Topcat spironolactone trial#
Interestingly, the US Food and Drug Administration is having an advisory committee in December, and on one of the 2 days of that advisory committee, they will be reviewing the TOPCAT trial data to see whether there might be an indication for spironolactone in patients with heart failure with preserved ejection fraction, or at least for some of those patients. Therefore, if you look at just the patients enrolled in North America and South America, then the trial would be positive, there would be a benefit to spironolactone. In fact, I won’t go into all the detail, but there is good evidence that both of those things I said are correct. As it turned out, the patients who were enrolled in Russia and Georgia perhaps didn’t have heart failure and maybe didn’t take their spironolactone, so they had a very low event rate, and there was no difference between spironolactone and placebo. The TOPCAT trial was an interesting trial because it was conducted in the, Canada, Brazil, and Argentina, as well as in Russia and Georgia. In other words, there was not a significant reduction in the primary composite end point, although there was a nominally significant reduction in heart failure hospitalization of around 15%. That trial compared spironolactone, a mineralocorticoid receptor antagonist or aldosterone antagonist, to placebo, and the overall result of the trial was not significant. John McMurray, MBChB: One of the large trials conducted in patients with HFpEF was the TOPCAT trial, which enrolled just under 3500 patients with heart failure and an ejection fraction of 45% or above.
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