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Another trial in HFpEF, another surprise? To the contrary, the TOPCAT data on heart failure with preserved ejection fraction were in line with prior trials in the diastolic heart failure space. At long last, heart failure hospitalizations, if not mortality, were decreased. Of course, that finding may not be reproducible in the real world. If spironolactone becomes widely used in patients with preserved LV function, does anyone think that hyperkalemia won’t be a problem? It was after the Randomized Aldactone Evaluation Study (RALES) was published (N. Engl. J. Med. 1999;341:709-17; N. Engl. J. Med. 2004;351:543-51).
TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) also had the usual array of strange subgroups based on site: Eastern European sites were outliers this time with an unexpectedly low event rate in the placebo arm. (I’ll have more on this issue – the negative aspects of international randomized clinical trials – in some future column.) But the bottom line remains the same. There is little reason to think that our approach to HFpEF patients will significantly change. Indeed, if a pharmaceutical company had a new drug for HFpEF, I would advise them to think very carefully about whether it was worth the financial risk of conducting a large outcomes trial. Even if the trial name had no embedded CAT, odds are the trial would still be a dog.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital. He is an associate editor for Circulation: Heart Failure and blogs while staring out his office window at the Arch. Write to Dr. Hauptman at cardnews@frontlinemedcom.com.
Another trial in HFpEF, another surprise? To the contrary, the TOPCAT data on heart failure with preserved ejection fraction were in line with prior trials in the diastolic heart failure space. At long last, heart failure hospitalizations, if not mortality, were decreased. Of course, that finding may not be reproducible in the real world. If spironolactone becomes widely used in patients with preserved LV function, does anyone think that hyperkalemia won’t be a problem? It was after the Randomized Aldactone Evaluation Study (RALES) was published (N. Engl. J. Med. 1999;341:709-17; N. Engl. J. Med. 2004;351:543-51).
TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) also had the usual array of strange subgroups based on site: Eastern European sites were outliers this time with an unexpectedly low event rate in the placebo arm. (I’ll have more on this issue – the negative aspects of international randomized clinical trials – in some future column.) But the bottom line remains the same. There is little reason to think that our approach to HFpEF patients will significantly change. Indeed, if a pharmaceutical company had a new drug for HFpEF, I would advise them to think very carefully about whether it was worth the financial risk of conducting a large outcomes trial. Even if the trial name had no embedded CAT, odds are the trial would still be a dog.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital. He is an associate editor for Circulation: Heart Failure and blogs while staring out his office window at the Arch. Write to Dr. Hauptman at cardnews@frontlinemedcom.com.
Another trial in HFpEF, another surprise? To the contrary, the TOPCAT data on heart failure with preserved ejection fraction were in line with prior trials in the diastolic heart failure space. At long last, heart failure hospitalizations, if not mortality, were decreased. Of course, that finding may not be reproducible in the real world. If spironolactone becomes widely used in patients with preserved LV function, does anyone think that hyperkalemia won’t be a problem? It was after the Randomized Aldactone Evaluation Study (RALES) was published (N. Engl. J. Med. 1999;341:709-17; N. Engl. J. Med. 2004;351:543-51).
TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) also had the usual array of strange subgroups based on site: Eastern European sites were outliers this time with an unexpectedly low event rate in the placebo arm. (I’ll have more on this issue – the negative aspects of international randomized clinical trials – in some future column.) But the bottom line remains the same. There is little reason to think that our approach to HFpEF patients will significantly change. Indeed, if a pharmaceutical company had a new drug for HFpEF, I would advise them to think very carefully about whether it was worth the financial risk of conducting a large outcomes trial. Even if the trial name had no embedded CAT, odds are the trial would still be a dog.
Dr. Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University and director of heart failure at Saint Louis University Hospital. He is an associate editor for Circulation: Heart Failure and blogs while staring out his office window at the Arch. Write to Dr. Hauptman at cardnews@frontlinemedcom.com.