Don’t let the negative studies get you down!


Enough time has now passed to process the implications of studies presented at the 2013 annual scientific sessions of the American College of Cardiology. If you were in attendance at the "late breakers" session – or if you have been diligently reading articles from those sessions – you may find yourself saying this was the year of the negative study.

With the exception of the findings from some subgroup analyses, there were (as usual) many negative studies in heart failure: RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure Trial), RELAX (Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure), ASTRONAUT (Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure), as well as in other disciplines; HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) and TERISA (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina).

Dr. Paul Hauptman

So much for so-called bias against negative study findings!

Maybe as a result of a bumper crop of negative trials in recent years, the obsession with the late-breaker session has become muted of late. There are also fewer real potential blockbuster trials underway that have the potential to demonstrably change practice.

Yet downturns and disappointments affect many fields of endeavor. The stock market might trade sideways for extended periods of time. Sport teams may hover around the .500 mark for multiple seasons. Broadway might feature mostly revivals for a few years. But rest assured, change is underway and the appearance of stasis is just that – appearance. In fact, I think we tend to learn almost as much if not more when a study’s results disappoint.

Why didn’t sildenafil perform better in RELAX? Was it an issue of how the study was statistically powered?

Why is anemia a poor prognostic sign in heart failure, yet correction of anemia yields a big fat zero in affecting outcomes?

Yes, we can argue about the design of some these studies and maybe even the lack of perspective that might have led the sponsors astray. Rest assured, however, that we have moved forward in a slow if albeit inexorable way.

Cardiovascular medicine took a step forward at this year’s annual ACC meeting. Just don’t expect anything radical like a big leap in treatment advances right now. Don’t forget, for a time we were spoiled: Whether it was GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) or SAVE (Survival and Ventricular Enlargement) or 4S (Scandinavian Simvastatin Survival Study), everything seemed to hit for a while. But, on the other hand, we also had CAST (Cardiac Arrhythmia Suppression Trial) and BEST (Beta-blocker Evaluation of Survival Trial) and VEST (the Vesnarinone Trial).

It wasn’t as easy as we would like to think, but we learned a lot.

So the bottom line is: See you in Dallas at the scientific sessions of the American Health Association in the fall!

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