SS-31 (elamipretide) in heart failure with preserved ejection fraction and obesity — evidence extract
The Institute's graded assessment of SS-31 (elamipretide) for heart failure with preserved ejection fraction and obesity, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Heart failure with preserved ejection fraction and obesity
§1.1Question and anchor outcome
- Population
- Symptomatic heart failure with a left ventricular ejection fraction of 50 % or above, occurring with obesity as a dominant phenotypic driver.
- Intervention
- SS-31 (elamipretide), subcutaneous or intravenous in clinical studies
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in Kansas City Cardiomyopathy Questionnaire clinical summary score
Additional outcomes the Institute extracts for this indication: Change in six-minute walk distance; Composite of cardiovascular death and worsening heart-failure events; Change in NT-proBNP.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of SS-31 (elamipretide) in heart failure with preserved ejection fraction and obesity.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| ELAM-PH2-HFPEF | 2 | Randomised, double-blind, placebo-controlled | 71 | 4 weeks | 2019 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Very serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
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
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, Devereaux PJ, Montori VM, Freyschuss B, Vist G, Jaeschke R, Williams JW, Murad MH, Sinclair D, Falck-Ytter Y, Meerpohl J, Whittington C, Thorlund K, Andrews J, Schünemann HJ. GRADE guidelines: 6. Rating the quality of evidence — imprecision. Journal of Clinical Epidemiology 2011;64(12):1283–1293. doi:10.1016/j.jclinepi.2011.01.012 · PMID 21839614
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.