Table 5.

Comparative efficacy and safety data on dabigatran versus warfarin in patients with kidney disease and atrial fibrillation (3641)

Study PopulationSample Size of CKD SubgroupFindingsAdjusted Risk Ratio (95% Confidence Interval)
Dabigatran in patients with CKD
 Lauffenburger   et al. (37)Patients having commercial or Medicare supplemental insurance6727Reduced risk of S/SE0.74 (0.57 to 0.96)a
Increased risk of the composite of major GI bleeding, hemorrhagic stroke, ICH, or other bleeding1.52 (1.27 to 1.81)a
 Hernandez   et al. (38)5% Random sample of Medicare  beneficiaries2964Increased risk of any bleeding1.11 (1.02 to 1.21)a
Increased risk of major bleeding1.55 (1.32 to 1.82)a
 Majeed et al. (39)Pooled analyses of five phase 3 RCTs1034 with any bleeding event, no mention of percentage with CKD30-d Mortality after the first bleeding event was lower for all of those who experienced any bleeding event in the five RCTs (no separate CKD subgroup analysis reported)0.66 (0.44 to 1.00)b
 Graham   et al. (40)Medicare beneficiaries13% of 134,414 had CKDNo CKD subgroup analysis, results reported for the overall cohort
Reduced risk of ischemic stroke0.80 (0.67 to 0.96)a
Reduced risk of ICH0.34 (0.26 to 0.46)a
Increased risk of major GI bleeding1.28 (1.14 to 1.44)a
Reduced risk of all-cause mortality0.86 (0.77 to 0.96)a
 Romanelli   et al. (36)Meta-analysis348,750 Patients and no CKD subgroup analysisNo CKD subgroup analysis, results reported for the overall cohort
Reduced risk of S/SE0.92 (0.84 to 1.01)a
Reduced risk of ICH0.44 (0.34 to 0.59)a
Increased risk of major GI bleeding1.23 (1.01 to 1.50)a
Dabigatran in patients on hemodialysis
 Chan et al. (41)Fresenius Medical Care of North American database of patients on hemodialysis8345Increased risk of hospitalization or death from bleeding1.48 (1.21 to 1.81)c
Increased risk of hemorrhagic death1.78 (1.18 to 2.68)c
  • S/SE, stroke or systemic embolism; GI, gastrointestinal; ICH, intracranial hemorrhage; RCT, randomized, controlled trial.

  • a Adjusted hazard ratio.

  • b Adjusted odds ratio.

  • c Adjusted rate ratio.