Inappropriate Spironolactone Use in Heart Failure
Inappropriate Spironolactone Use in Heart Failure
Objectives: This study was designed to investigate the appropriateness and complications of the use of spironolactone for heart failure (HF) in clinical practice.
Background: Spironolactone was reported by one prospective randomized trial to decrease morbidity and mortality in patients with New York Heart Association (NYHA) class III and IV HF. With this report (Randomized Spironolactone Evaluation Study [RALES] trial), we noted a marked increase in widespread use of spironolactone in patients with HF. Long-term outcome data with respect to safety and utilization of this medication in HF are not available.
Methods: To investigate the use of spironolactone for HF in a clinical setting, we analyzed the application of the RALES trial protocol to the care of 104 patients, whom we identified as being started on spironolactone for HF after prerelease of the RALES trial.
Results. We found broader use, less intensive follow-up, and increased complications with spironolactone treatment compared with the RALES trial. Cardiologists provided more appropriate care than did primary care providers.
Conclusions: These data suggest that spironolactone is being used widely in HF without consideration of the NYHA class and ejection fraction, and without optimization of background treatment with angiotensin-converting enzyme inhibitors and
blockers. Clinical follow-up does not adhere to the RALES trial guidelines, resulting in higher complications. We conclude that long-term studies with further safety and efficacy data are needed. Bozjurt B, Agoston I, Knowlton AA. Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines. J Am Coll Cardiol. 2003;4(12):211-214.
In 1999 the results of the RALES trial were published. This trial looked at patients who had symptomatic NYHA class III and IV congestive HF due to systolic dysfunction. The data presented from this trial showed a significant benefit to be gained by the introduction of spironolactone into the regimen of patients, hitting a very specific group of HF patients with significant left ventricular systolic dysfunction.
Because spironolactone has been around for many years and is a very inexpensive and commonly used product, it may have gained increased utilization in clinical settings that was not appropriate. To determine whether or not this is so, the authors designed this trial to look at the use of spironolactone for HF in their home institution. Their patient population consisted of 104 patients who had been started on this agent for "HF."
When they analyzed their data, they found that the patients now receiving spironolactone for therapy of HF were less intensively followed and the indications for its initiation were much less stringent. Of major issue was that there was a marked increase in complications in patients treated with this type of therapy when compared with the data from the RALES trial. They also found that when patients were cared for by a subspecialist in cardiovascular diseases the guidelines suggested by the initial investigation data were much more stringently applied than they were among patients who were started on spironolactone by their primary care providers.
Based on their study, the authors concluded that spironolactone may have significant benefit in a specific subset of patients with systolic dysfunction, but it is now being widely used without adhering to the guidelines set forth by the initial investigative data. We have developed a level of respect for evidence-based medicine in the cardiovascular community. Dating back almost 15 years, we learned from the Cardiac Arrhythmia Suppression Trial (CAST) that intuitive thinking in medicine may be very helpful, but there are many times that we should pursue a scientific approach rather than go with a "gut instinct." While it may make sense that the data from the RALES trial could be more broadly applied with equal benefit, these data suggest that this theory is incorrect. Furthermore, it suggests that whenever introducing new therapies for patients, especially those as sick as HF patients, we should try to closely adhere to information provided by the clinical trials and the investigators using those drugs initially. The study showed that subspecialists may have a better understanding of this and therefore should have a greater responsibility when treating patients with newer modalities of intervention. Clinicians must use greater caution in extrapolating data from clinical trials. Nuances that may seem irrelevant frequently have great clinical impact and will affect outcomes. Clearly in this regard, further investigation would be helpful to optimize outcomes.
Objectives: This study was designed to investigate the appropriateness and complications of the use of spironolactone for heart failure (HF) in clinical practice.
Background: Spironolactone was reported by one prospective randomized trial to decrease morbidity and mortality in patients with New York Heart Association (NYHA) class III and IV HF. With this report (Randomized Spironolactone Evaluation Study [RALES] trial), we noted a marked increase in widespread use of spironolactone in patients with HF. Long-term outcome data with respect to safety and utilization of this medication in HF are not available.
Methods: To investigate the use of spironolactone for HF in a clinical setting, we analyzed the application of the RALES trial protocol to the care of 104 patients, whom we identified as being started on spironolactone for HF after prerelease of the RALES trial.
Results. We found broader use, less intensive follow-up, and increased complications with spironolactone treatment compared with the RALES trial. Cardiologists provided more appropriate care than did primary care providers.
Conclusions: These data suggest that spironolactone is being used widely in HF without consideration of the NYHA class and ejection fraction, and without optimization of background treatment with angiotensin-converting enzyme inhibitors and
blockers. Clinical follow-up does not adhere to the RALES trial guidelines, resulting in higher complications. We conclude that long-term studies with further safety and efficacy data are needed. Bozjurt B, Agoston I, Knowlton AA. Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines. J Am Coll Cardiol. 2003;4(12):211-214.
In 1999 the results of the RALES trial were published. This trial looked at patients who had symptomatic NYHA class III and IV congestive HF due to systolic dysfunction. The data presented from this trial showed a significant benefit to be gained by the introduction of spironolactone into the regimen of patients, hitting a very specific group of HF patients with significant left ventricular systolic dysfunction.
Because spironolactone has been around for many years and is a very inexpensive and commonly used product, it may have gained increased utilization in clinical settings that was not appropriate. To determine whether or not this is so, the authors designed this trial to look at the use of spironolactone for HF in their home institution. Their patient population consisted of 104 patients who had been started on this agent for "HF."
When they analyzed their data, they found that the patients now receiving spironolactone for therapy of HF were less intensively followed and the indications for its initiation were much less stringent. Of major issue was that there was a marked increase in complications in patients treated with this type of therapy when compared with the data from the RALES trial. They also found that when patients were cared for by a subspecialist in cardiovascular diseases the guidelines suggested by the initial investigation data were much more stringently applied than they were among patients who were started on spironolactone by their primary care providers.
Based on their study, the authors concluded that spironolactone may have significant benefit in a specific subset of patients with systolic dysfunction, but it is now being widely used without adhering to the guidelines set forth by the initial investigative data. We have developed a level of respect for evidence-based medicine in the cardiovascular community. Dating back almost 15 years, we learned from the Cardiac Arrhythmia Suppression Trial (CAST) that intuitive thinking in medicine may be very helpful, but there are many times that we should pursue a scientific approach rather than go with a "gut instinct." While it may make sense that the data from the RALES trial could be more broadly applied with equal benefit, these data suggest that this theory is incorrect. Furthermore, it suggests that whenever introducing new therapies for patients, especially those as sick as HF patients, we should try to closely adhere to information provided by the clinical trials and the investigators using those drugs initially. The study showed that subspecialists may have a better understanding of this and therefore should have a greater responsibility when treating patients with newer modalities of intervention. Clinicians must use greater caution in extrapolating data from clinical trials. Nuances that may seem irrelevant frequently have great clinical impact and will affect outcomes. Clearly in this regard, further investigation would be helpful to optimize outcomes.
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