Treatments for anemia in chronic kidney disease: effectiveness and value : final evidence report
- Collection:
- Health Policy and Services Research
- Author(s):
- Mustafa, Reem A., author Fox, Grace, (Of Institute for Clinical and Economic Review), author Campbell, Jonathan D., author Agboola, Foluso, author Pearson, Steven D., author Rind, David M., author Bloudek, Lisa, author Carlson, Josh J., author
- Contributor(s):
- Institute for Clinical and Economic Review, issuing body.
- Publication:
- [Boston, Massachusetts] : Institute for Clinical and Economic Review, March 5, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Glycine -- analogs & derivatives Hematinics -- therapeutic use Isoquinolines -- therapeutic use Hypoxia-Inducible Factor-Proline Dioxygenases -- antagonists & inhibitors Anemia, Iron-Deficiency -- drug therapy Renal Insufficiency, Chronic -- complications Renal Insufficiency, Chronic -- drug therapy Treatment Outcome United States
- Genre(s):
- Technical Report
- Abstract:
- In the dialysis-independent chronic kidney disease (DI-CKD) population, we identified three key published Phase III randomized controlled trials (RCTs) of roxadustat and one key unpublished Phase III RCT of roxadustat. A pooled analysis of the placebo-controlled trials reported no statistically significant difference in all-cause mortality with roxadustat (hazard ratio [HR]: 1.06; 95% confidence interval [CI]: 0.91 to 1.23), however this included many patients no longer on treatment, which could bias toward no effect. A meta-analysis of relative risks (RRs) suggested a possible increase in mortality with roxadustat (RR: 1.15, 95% CI: 1.00 to 1.33), however discontinuations could have biased this result toward overestimating any such risk. In support of this possibility, the HR for mortality on treatment was published for one trial and was 0.96, compared with a RR of 1.17 from that same trial. In the trial comparing roxadustat with an erythropoiesis-stimulating agent (E(SA), there were no statistically significant differences in the risk of major adverse cardiovascular events (MACE) (HR: 0.81, CI: 0.52 to 1.25), MACE+ (HR: 0.90, CI: 0.61 to 1.32), or all-cause mortality (HR: 0.83, CI: 0.50 to 1.38). In the DD-CKD population, we also identified four key unpublished Phase III RCTs comparing roxadustat with ESAs. A pooled analysis of three of these trials reported that roxadustat was not different from ESAs in the risk of first MACE (HR: 0.96, CI: 0.82 to 1.13) and all-cause mortality (HR: 0.96, CI: 0.79 to 1.17), however roxadustat reduced the risk of MACE+ (HR: 0.85, CI: 0.74 to 0.98). We used available data from all four trials to perform a meta-analysis of all-cause mortality and found no statistically significant difference (risk ratio [RR]: 1.05, CI: 0.88 to 1.26). The need for IV iron supplementation was reduced with roxadustat across all trials. In summary, in the DI-CKD population, roxadustat reduces the need for transfusions compared to usual care, but we have substantial uncertainty about the effects of roxadustat on all-cause mortality and have rated the evidence insufficient ("I") for this comparison. Compared with ESAs, the confidence intervals around MACE and MACE+ include the possibilities of clinically important harms and benefits and, as such, we have rated the evidence insufficient (I) for this comparison as well. For similar reasons, in the dialysis-dependent chronic kidney disease population, we have insufficient evidence (I) for the comparison between roxadustat and ESAs.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (vi, ES3, 210 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918680387206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918680387206676