SS-31 (elamipretide) in primary mitochondrial myopathy and bioenergetic disorders: tolerability and… — included and excluded studies
The included-studies table with extracted data, the exclusions with reasons, and the risk-of-bias judgements.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§3Included and excluded studies
Every study contributing to this review is listed below with the data extracted from it. The extraction table is published at the level of the individual outcome and study so that the synthesis can be checked without the reader having to retrieve each source.
§3.1Included studies
Table 4. Included studies with the characteristics extracted from each.
| Study | Design | Randomised | Duration | Anchor outcome as reported | Year |
|---|---|---|---|---|---|
| MMPOWER-3SS-31 (elamipretide) | Randomised, double-blind, placebo-controlled | 218 | 24 weeks | Neither primary endpoint was met. The Institute records MMPOWER-3 as a negative phase 3 result and treats it as informative evidence rather than as an absence… | 2022 |
| MMPOWER-2SS-31 (elamipretide) | Randomised crossover | 30 | 4 weeks per period | An increase in six-minute walk distance in a crossover design with a small sample | 2018 |
| 2 included studies. Each links to its structured abstract, which carries a field-by-field provenance table distinguishing extracted figures from Institute reconstructions. | |||||
Contributing participants across studies reporting a randomised total: 248. Studies for which the Institute does not hold a randomised total contribute to the qualitative synthesis and not to any pooled figure.
§3.2Excluded at full text, with reasons
Table 5. Reports excluded at full text, by reason. A review that reports an exclusion count without reasons cannot be checked against its own protocol.
| Reason for exclusion | Reports |
|---|---|
| Not a randomised comparison | 9 |
| Population outside the review question | 9 |
| Intervention outside the review question | 9 |
| Comparator not eligible | 8 |
| No eligible outcome reported | 7 |
| Duplicate report of an included study | 6 |
| Conference abstract without extractable data | 5 |
| Retracted or subject to an expression of concern | 5 |
| 35 reports excluded at full text in total. | |
§3.3Risk of bias across included studies
Table 6. Risk-of-bias judgement recorded for each included study on the review's anchor outcome.
| Study | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias |
|---|---|---|---|---|---|
| MMPOWER-3 | Some | Low | Low | Low | Low |
| MMPOWER-2 | Some | Low | Low | Low | Low |
| Judgements are the Institute's own and are recorded per outcome. A study may carry a different judgement in a different review that assesses a different outcome from it. | |||||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. British Journal of Pharmacology 2014;171(8):2029–2050. doi:10.1111/bph.12461 · PMID 24117165
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.