05 Dec Kidney Disease Patients Unrepresented In Cardiovascular Trials
Dr. Nakharni
MedicalResearch.com Interview with:
Girish N. Nadkarni, MD, MPH
Division of Nephrology, Department of Medicine
Icahn School of Medicine at Mount Sinai
New York, New York
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Nadkarni: Cardiovascular disease is one of the major causes of morbidity and mortality in patients with kidney disease. Moreover, there is a lack of good quality evidence in kidney disease patients. In addition, previous studies have shown that cardiovascular trials exclude patients with kidney disease. We wanted to analyze all of the clinical trials on acute myocardial infarctions and heart failure in the last decade and see if they continued excluding patients with kidney disease. We discovered that in 371 trials including close to six hundred thousand patients, the majority (57%) excluded patients with kidney disease. A large proportion of the trials excluded patients for non-specific reasons, rather than a prespecified threshold of kidney function and did not report kidney function at baseline. Finally, in trials that did include kidney patients and reported outcomes by kidney function, only 13% showed an interaction or suggestion of harm.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Nadkarni: We found continued underrepresentation of kidney disease patients with despite previously highlighted underrepresentation in cardiovascular disease trials. This is troubling since kidney and cardiovascular diseases are independent risk factors for each other. In addition, if kidney disease patients are excluded due to concerns for harm with medications/procedures, those might be overstated.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Nadkarni: Researchers who conduct clinical trials should include patients with kidney disease in future cardiovascular disease trials as well as report and analyze outcomes by kidney function, in order to improve the understanding of risks/benefits of interventions in this vulnerable population.
Citation:
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Girish N. Nadkarni, MD, MPH (2015). Kidney Disease Patients Unrepresented In Cardiovascular Trials
Last Updated on December 5, 2015 by Marie Benz MD FAAD