Oh, what a breath of fresh air it is to be reading (scientific) literature again. That doesn’t necessarily mean I’m satisfied with what I read though 😛
“In this study, there was an increased risk of hyperkalemia. In contrast, there was a decreased risk of hypokalemia”…… isnt that obvious??
Every time I see an article from JAMA or NEJM studying the effects of a drug, they always list how the doctor is paid/sponsored for the project. Most of the time, the doctor is endorsed by the pharmaceutical company making the drug. I can’t help feeling uneasy every time I read that–it makes it seem as if the doctor did the trial only under insistence of the pharmaceutical company and not because of interest in improving the care of patients. Which I mean, of course if a drug is promising then it makes sense to test it in patients, and there needs to be some funding for the trial, but…pharm companies are still companies. I guess if the data presented is empirical enough, there is trust that the doctor acted purely objectively and presented correct data, not biased data.
Additionally, it is super frustrating every time I see data that improved the outcomes of patients by <50% . I know, I know…if standards of improvement had to be that rigorous, medicine would probably be at a standstill, and pharm companies would never make any new drugs. But for end stage life care, is it really worth it to spend thousands, even millions developing (and using) a drug that will improve your life by 10%, compared to doing nothing?
We evaluated the effect of adding eplerenone to recommended treatment for systolic heart failure in patients with mild symptoms (NYHA functional class II symptoms). The rate of the primary outcome, a composite of death from cardiovascular causes or hospitalization for heart failure, was 18.3% in the eplerenone group versus 25.9% in the placebo group. This effect of eplerenone was consistent across all prespecified subgroups. With eplerenone, there was also a reduction in both the rate of death from any cause and the rate of hospitalization for any reason. In conclusion, our study showed that, as compared with placebo, eplerenone added to recommended therapy for systolic heart failure in patients with mild symptoms was associated with a reduction in the rate of death from a cardiovascular cause or hospitalization for heart failure. Similar reductions were seen in rates of death from any cause, death from cardiovascular causes, hospitalization for any reason, and hospitalization for heart failure.
I guess the purpose of publishing articles like the one I read is more to highlight the SMALL effectiveness of the tested treatment, emphasize the need for more research, and show that there is more going on out there than known. After all, data is data, and anything it helps to rule out possibilities and prevents redundancy. My main peeve about this article is that they claimed the drug was associated with a reduction. To me, reduction seems too strong of a word; MILD reduction is more like it.
To give the authors credit, 25.9 – 18.3 = 7.6 and 7.6/25.9 = about 30% less risk compared to the control. But thats like saying, taking this $$$ drug will give you a 30% chance of improving your outcome, and a 70% of making things no different. -__-‘
If the purpose of the study is to use the drug to REPLACE a preexisting drug, then I guess it is fair to say a better drug will at least improve the outcomes of all subsequent patients. Meh…I still feel there should be a bigger difference in order for the drug to completely replace the other one…
Ah, medical ethics. I’ll be kicking myself for being too idealistic later, but for now I’ll indulge myself and complain 😛
original article: http://www.nejm.org/doi/full/10.1056/NEJMoa1009492?query=OF&#t=article
edit: Ah, the editorial alleviated some concerns, but also expressed similar sentiments:
“The EMPHASIS-HF investigators have added real value to the management of heart failure. Since spironolactone is available for pennies a day, one might reasonably ask whether the greater cost of eplerenone is warranted or whether it is reasonable to simply assume that the current findings also apply to spironolactone and reserve the newer, more expensive therapy for those few patients in whom the side effects of spironolactone are disabling. I believe this would be a reasonable tactic.”
-Paul W. Armstrong (from http://www.nejm.org/doi/full/10.1056/NEJMe1012547?query=OF)