Table 3. Summary of findings of roxadustat for renal anemia and AEs of chronic kidney disease (CKD) patients (patient or population: patients with anemia in CKD patients; settings: hospital; intervention: roxadustat).
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk (control) | Corresponding risk (roxadustat) | |||||
| ΔHb | The mean ΔHb in the intervention groups was 1.22 higher (0.95 to 1.49 higher) | 260 (3 studies) | ⊕⊕⊝⊝ low1,2 | WMD 1.22 (0.95 to 1.49). Roxadustat may slightly increase Hb of CKD patients compared with the placebo | ||
| Hb response | Study population | OR 27.74 (10.18 to 75.62) | 294 (3 studies) | ⊕⊕⊝⊝ low1,2 | Roxadustat may slightly increase the occurrence of Hb response of CKD patients compared with the placebo | |
| 175 per 1,000 | 855 per 1,000 (683 to 941) | |||||
| Medium risk population | ||||||
| 148 per 1,000 | 828 per 1,000 (639 to 929) | |||||
| ΔHepcidin | The mean Δhepcidin in the intervention groups was 3.31 SD lower (5.82 to 0.81 lower) | 294 (3 studies) | ⊕⊕⊝⊝ low1,2 | SMD −3.31 (−5.82 to −0.81). Roxadustat may slightly decrease hepcidin of CKD patients compared with the placebo | ||
| ΔTIBC | The mean ΔTIBC in the intervention groups was 1.59 SD higher (1.17 to 2.01 higher) | 294 (3 studies) | ⊕⊕⊝⊝ low1,2 | SMD 1.59 (1.17 to 2.01). Roxadustat may slightly improve TIBC of CKD patients compared with the placebo | ||
| ΔFerritin | The mean Δferritin in the intervention groups was 51.31 lower (72.91 to 29.71 lower) | 294 (3 studies) | ⊕⊝⊝⊝ very low1,2,3 | We are uncertain about the effect of roxadustat on ferritin of CKD patients compared with the placebo | ||
| ΔTAST | The mean ΔTAST in the intervention groups was 6.55 lower (8.82 to 4.29 lower) | 294 (3 studies) | ⊕⊕⊝⊝ low1,2 | Roxadustat may slightly decrease TAST of CKD patients compared with the placebo | ||
| AE | Study population | OR 1.31 (0.76 to 2.27) | 314 (3 studies) | ⊕⊝⊝⊝ very low1,2,4 | We are uncertain about the occurrence of AE caused by roxadustat of CKD patients compared with the placebo | |
| 424 per 1,000 | 491 per 1,000 (359 to 626) | |||||
| Medium risk population | ||||||
| 464 per 1,000 | 531 per 1,000 (397 to 663) | |||||
| SAE | Study population | OR 1.25 (0.29 to 5.35) | 314 (3 studies) | ⊕⊝⊝⊝ very low1,2,5 | We are uncertain about the occurrence of SAE caused by roxadustat of CKD patients compared with placebo | |
| 24 per 1,000 | 30 per 1,000 (7 to 116) | |||||
| Medium risk population | ||||||
| 33 per 1,000 | 41 per 1,000 (10 to 154) | |||||
| Diarrhea | Study population | OR 1.54 (0.49 to 4.79) | 314 (3 studies) | ⊕⊝⊝⊝ very low1,2,6 | We are uncertain about the occurrence of diarrhea caused by roxadustat of CKD patients compared with placebo | |
| 47 per 1,000 | 71 per 1,000 (24 to 191) | |||||
| Medium risk population | ||||||
| 37 per 1,000 | 56 per 1,000 (18 to 155) | |||||
GRADE Working Group grades of evidence high quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. *, the basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). 1, imprecise due to the small sample size (less than 300) in all researches. Thus, the evidence quality was downgraded as one level; 2, some concerns with selected trials conducted by pharmaceuticals companies, thus the evidence quality was downgraded by one level; 3, one study was inconsistent with the other two in ferritin, thus the quality of evidence was downgraded by one level; 4, one study was inconsistent with the other two in AEs, thus the quality of evidence was downgraded by one level; 5, one study was inconsistent with the other two in SAEs, thus the quality of evidence was downgraded by one level; 6, one study was inconsistent with the other two in diarrhea, thus the quality of evidence was downgraded by one level. CI, confidence interval; AE, adverse event; CKD, chronic kidney disease; Hb, hemoglobin; OR, odds ration; SAE, severe adverse event; SD, standard deviation; SMD, standard mean difference; TIBC, total iron binding capacity; TAST, transferring saturation; WMD, weighted mean difference.