Underrepresentation of Patients with CKD in CVD Medication Trials: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On March 8, 2024, we reported on findings from a study published in JAMA Network Open that examined the representation of patients with chronic kidney disease (CKD) in cardiovascular randomized clinical trials.

The study

Researchers searched databases including ClinicalTrials.gov MEDLINE, and Embase, from 2000 to 2021 for clinical trials that evaluated the effectiveness of antiplatelet agents, anticoagulants, antihypertensives, and antihyperglycemic and antihyperlipidemia agents in adults with CVD or CV risk factors. All trials included cohorts of more than 100 participants.

The final group of trials numbered 1194 and comprised 2 207 677 participants (mean age, 63 years, 64% men).

Proportions of the trials investigating the treatment classes of interest were:

• Antihyperglycemics 46% (552)

• Antiplatelets and anticoagulants 19% (229)

• Antihypertensive agents 19% (221)

• Combination of these interventions 3% (30)

Outcomes of interest were the frequency of excluding patients with CKD, defined as the exclusion of patients meeting kidney-related eligibility criteria, and reporting results for patients with CKD through subgroup analyses or restriction of the study population. Investigators evaluated the frequency of excluding patients with CKD for different periods, medications, and dose recommendations.

The findings

The researchers found that since 2000, the percentage of CV RCTs excluding patients with CKD has increased from 66% to 79%. They also reported that 38% of all trials included in the study and 52% that excluded participants with CKD excluded those with CKD stages 1-3. Of significant note, during the 20-year period examined the exclusion of those with CKD 1-3 has remained stable while exclusion of participants with CKD stages 4-5 has increased.

Authors' comment

"While excluding patients with CKD from RCTs due to safety concerns can be justifiable, the substantially more stringent kidney exclusion criteria compared with prescription thresholds in clinical practice suggest there were additional reasons for excluding patients with CKD."

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