Exclusion of chronic kidney disease patients from cardiovascular trials leaves significant evidence gaps medrxivpreprint UniUtrecht chronickidneydisease CKD CVD cardiovasculardisease trials clinicaltrials evidencegaps
By Dr. Liji Thomas, MDJul 24 2023Reviewed by Lily Ramsey, LLM The higher risk of cardiovascular disease among patients with chronic kidney disease is not reflected in their poor level of inclusion in cardiovascular trials.
*Important notice: medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Interestingly, trials that do not specifically exclude such patients still often fail to have them in representative numbers or to analyze treatment effects in this subgroup.
Related StoriesThe researchers found that almost 80% of cardiovascular RCTs conducted from the year 2000 onwards did not include CKD patients, up from 66% earlier. CKD stages 1-3 were excluded in half of all RCTs that excluded CKD, and about 40% of all included RCTs.In three out of four RCTs, a higher-than-expected number of patients was excluded pleading safety.
Reporting endpoints also remained nonspecific, covering composite outcomes rather than individual cardiovascular endpoints or other separate reports for CKD patients. Thus, there were large gaps in the evidence for various CVRM measures, especially for those in stage 4 or 5 CKD. Some trials have compared the efficacy of older and novel glucose-lowering agents in CKD patients with eGFR less than 30 ml/min/1.73m2.
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