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A Systematic Review and Meta-analysis

Fiona M. Clement, PhD; Scott Klarenbach, MD, MSc; Marcello Tonelli, MD, SM; Jeffrey A. Johnson, PhD; Braden J. Manns, MD, MSc

Arch Intern Med. 2009;169(12):1104-1112.

Background  Treatment of anemia in chronic kidney disease (CKD) with erythropoietin-stimulating agents (ESAs) is commonplace. The optimal hemoglobin treatment target has not been established. A clearer understanding of the health-related quality of life (HQOL) impact of hemoglobin target levels is needed. We systematically reviewed the randomized controlled trial (RCT) data on HQOL for patients treated with low to intermediate (9.0-12.0 g/dL) and high hemoglobin target levels (>12.0 g/dL) and performed a meta-analysis of all available 36-item short-form (SF-36) RCT data.

Methods  We conducted a search to identify all RCTs of ESA therapy in patients with anemia associated with CKD (1966–December 2006). Inclusion criteria were (1) 30 or more participants, (2) anemic adults with CKD, (3) epoetin (alfa and beta) or darbepoetin used, (4) a control arm, and (5) reported HQOL using a validated measure. All available SF-36 data underwent meta-analysis using the weighted mean difference.

Results  Of 231 full texts screened, 11 eligible studies were identified. The SF-36 was used in 9 trials. Reporting of these data was generally incomplete. Data from each domain of the SF-36 were summarized. Statistically significant changes were noted in the physical function (weighted mean difference [WMD], 2.9; 95% confidence interval [CI], 1.3 to 4.5), general health (WMD, 2.7; 95% CI, 1.3 to 4.2), social function (WMD, 1.3; 95% CI, –0.8 to 3.4), and mental health (WMD, 0.4; 95% CI, 0.1 to 0.8) domains. None of the changes would be considered clinically significant.

Conclusions  Our study suggests that targeting hemoglobin levels in excess of 12.0 g/dL leads to small and not clinically meaningful improvements in HQOL. This, in addition to significant safety concerns, suggests that targeting treatment to hemoglobin levels that are in the range of 9.0 to 12.0 g/dL is preferred.

Author Affiliations: Departments of Community Health Sciences and Medicine and Centre for Health and Policy Studies, University of Calgary, Calgary, Alberta, Canada (Drs Clement and Manns); Department of Medicine, Division of Nephrology, University of Alberta, Edmonton (Drs Klarenbach and Tonelli); and Institute for Health Economics, Edmonton, Alberta (Dr Johnson).

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