![topcat spironolactone topcat spironolactone](https://ars.els-cdn.com/content/image/1-s2.0-S2213177919300095-gr2b.jpg)
Overall, a pretty reasonable set of exclusions. things that make spironolactone a not-great idea). things that modify prognosis), as well as history of hyperkalemia or glomerular filtration rate < 30mL/min (i.e. They were excluded for acute coronary syndrome or revascularization in the past 90 days, severe COPD, known infiltrative cardiomyopathy (i.e. have a reasonable chance at tolerating spironolactone). have treatment to the existing standard of care), as well as have a serum potassium < 5.0 mmol/L (i.e. Patients also had to have a systolic blood pressure < 140 or be on at least three agents for BP control (i.e. Read those last two requirements again and note how while both are objective criteria, one is more objective than the other. In TOPCAT, investigators recruited patients 50 years of age or older with at least one sign (jugular venous distension, chest X-ray with pulmonary edema, or lower extremity edema) and one symptom (orthopnea, paroxysmal nocturnal dyspnea, or dyspnea on moderate exertion) of heart failure, with EF 45% or better based on echocardiography or nuclear study, and with either hospitalization in the last 12 months for which heart failure was a major component or elevated serum BNP level in the last 30 days. Patients, Intervention, Comparator, and Outcomes This is illustrative of the problems of recruiting for multinational trials in places whose medical culture and practice may be different than ours. As such, we can wonder if spironolactone does actually have a benefit for HFpEF, though this should be reproduced in future studies. Given that patients in these regions had much lower rates of the primary outcome than those in other regions, as well as new revelations that Russian/Georgian patients were significantly less likely to have serum levels of spironolactone metabolites consistent with their reported dose of the drug, it is reasonable to wonder if these patients were recruited or treated in a manner inconsistent with the study protocol.
#Topcat spironolactone trial#
The TOPCAT trial of spironolactone versus placebo in patients with heart failure with a preserved ejection fraction demonstrated decreased rates of hospitalization but no difference in a composite primary outcome of hospitalization, cardiovascular mortality, or cardiac arrest. However, the trial would have been positive with a hazard ration of 0.82 and a NNT for one year of just 46 if the patients from Russian and Georgian centers had been excluded. If You’re Only Going to Read One Paragraph Apparently not everyone knows about this ancient and moderately terrible cartoon, but the theme song has been stuck in my head literally the entire time I’ve been writing this and I wanted you to suffer with me. But what if you had, like, a really really good reason? Let’s take a look.Īnd let’s just get this out of the way right now.
![topcat spironolactone topcat spironolactone](https://www.frontiersin.org/files/Articles/449658/fphys-10-01347-HTML/image_m/fphys-10-01347-g001.jpg)
But when you exclude the 1700 or so patients recruited from Russia and Georgia? Positive trial. Granted, that’s not how science works you don’t just get to exclude half of your patients post-hoc because it makes your data look better. You see, TOPCAT was a negative trial - the primary outcome was no different between spironolactone and placebo. But how can I justify talking about a three year-old trial on a blog about the new hot evidence? Simple: there’s new correspondence from the study authors, and it is super cool, albeit in a moderately awful kind of way. The TOPCAT trial by Bertram Pitt and colleagues (published wayyyy back in April of 2014 - more of a lukewarm trial than a Hot one) was a multinational RCT of spironolactone versus placebo for HFpEF patients. It has been frustrating.īut when some surrogate endpoint data demonstrated echocardiographic and exercise tolerance improvement with aldosterone antagonist therapy, cardiologists began to hope that maybe at least one therapy used in patients with a decreased EF might benefit HFpEF patients as well. So the treatment of heart failure with a preserved ejection fraction (HFpEF) has historically been diuretics, blood pressure control, and a can-do attitude. Yet the efficacy of most therapies with a mortality benefit in CHF, from beta blockers to ACE inhibitors to implantable cardiac defibrillators, appears to be limited only to patients with a reduced EF.
![topcat spironolactone topcat spironolactone](https://www.cardiologie-pratique.com/sites/www.cardiologie-pratique.com/files/styles/complet_282_188/public/legacy/direct_congres/articles/x2_pfeffer_spironolactone.png)
It’s well-established that congestive heart failure (CHF) can occur in patients whose EF is normal, and that these patients have symptoms and prognoses not dissimilar to patients with a decreased EF.
![topcat spironolactone topcat spironolactone](https://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2017/nejm_2017.376.issue-17/nejmc1612601/20180122/images/img_small/nejmc1612601_f1.jpeg)
HFpEF - the thing you write on your admission H&P when your patient’s ejection fraction (EF) looks better than the patient himself.