Summary of findings for the main comparison. Summary of findings for dialysis patients.
| Cinacalcet plus standard therapy versus placebo or standard therapy or both for patients with CKD and elevated PTH levels | |||||
| Patient or population: adults with CKD | |||||
|
Outcomes (median treatment duration) |
*Best estimate of control group risk | Relative effect (95% CI) | No of participants (studies) | Absolute effect per one year of treatment for 1000 treated (95%CI) | Quality of the evidence (GRADE) |
| GFR category G5 treated with dialysis | |||||
|
All‐cause mortality (8 months) |
200 per 1000 | RR 0.97 (0.89 to 95) | 6893 (14) | 6 fewer (22 fewer to 10 more) | ⊕⊕⊕⊕ high |
|
Parathyroidectomy (9 months) |
7 per 1000 | RR 0.49 (0.40 to 0.59) | 4893 (5) | 3 fewer (4 fewer to 3 fewer) | ⊕⊕⊕⊕ high |
|
Hypocalcaemia (7 months) |
10 per 1000 | RR 6.98 (5.10 to 9.53) | 6415 (12) | 60 more (41 more to 85 more) | ⊕⊕⊕⊕ high |
|
Nausea (7 months) |
150 per 1000 | RR 2.02 (1.45 to 2.81) | 6450 (12) | 153 more (68 more to 272 more) | ⊕⊕⊕ moderate |
| GFR category G3a‐G4 | |||||
|
All‐cause mortality (8 months) |
25 per 1000 | RR 0.29 (0.06 to 1.48) | 458 (2) | 18 fewer (23 fewer to 12 more) | ⊕⊕ low |
|
Parathyroidectomy (9 months) |
7 per 1000 | RR not estimable | 0 (0) | Not estimable | nil |
|
Hypocalcaemia (7 months) |
10 per 1000 | RR 31.9 (5.28 to 192.6) | 449 (2) | 310 more (43 more to 1910 more) | ⊕ very low |
|
Nausea (7 months) |
100 per 1000 | RR 2.26 (1.29 to 3.95) | 449 (2) | 126 more (29 more to 295 more) | ⊕⊕ low |
| *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).
CI: Confidence interval; RR: Risk Ratio; Approximate absolute event rates of outcomes per year are derived from previously published cohort studies and registry data for the outcomes of all‐cause mortality (Weiner 2006) and parathyroidectomy (Kestenbaum 2004) or event rates in the control arm of contributing studies for outcomes of hypocalcaemia and nausea. Absolute numbers of people who had chronic kidney disease with mortality or parathyroidectomy events avoided or nausea or hypocalcaemia events caused per 1000 treated were calculated from the risk estimate for the outcome (and associated 95% confidence interval) obtained from meta‐analysis of placebo‐controlled studies together with the absolute population risk estimates. | |||||
| 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. | |||||
CKD ‐ chronic kidney disease; GFR ‐ glomerular filtration rate; PTH‐ parathyroid hormone