Table 2

Representation of patients with kidney disease in cardiovascular trials, stratified by study era

VariableContemporary Era (2006–2014), No. (%)Prior Era (1985–2005a), No. (%)P Value
Quantitative thresholds for exclusionb
 Serum Cr >1.5–2.0 mg/dl20 (7)19 (12)0.15
 Serum Cr >−2.1 to 2.9 mg/dl27 (9)24 (16)0.14
 Serum Cr >−3.0 mg/dl23 (8)16 (10)0.72
 eGFR/Cr Cl levels42 (14)3 (2)<0.01
 Nonspecific exclusion31 (10)24 (16)0.34
Nonspecific exclusion criteriab
 Need for HD only10 (3)n/an/a
 Known kidney insufficiency3 (1)n/an/a
 Severity only15 (5)n/an/a
 Contraindication to meds only3 (1)n/an/a
Trials reporting proportion of patients with KD allocated to each arm68 (22)22 (14)<0.05
Trials reporting baseline Cr or eGFR given for each group71 (23)19 (12)<0.01
Trials with subgroup analysis on patients with KD56 (18)10 (7)<0.01
  • P values represent comparisons across groups. P value calculated using number of trials excluding KD not total trials. eGFR calculated either via Modification of Diet in Renal Disease equation or Cockroft–Gault equation. Cr, creatinine; Cr Cl, creatinine clearance; HD, hemodialysis; n/a, not applicable.

  • a Data from the 1985–2005 era were adopted from the study by Coca et al.5

  • b Includes overlaps.