Thymosin beta-4 in atherosclerotic cardiovascular disease and cardiovascular risk reduction — evidence extract
The Institute's graded assessment of Thymosin beta-4 for atherosclerotic cardiovascular disease and cardiovascular risk reduction, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Atherosclerotic cardiovascular disease and cardiovascular risk reduction
§1.1Question and anchor outcome
- Population
- Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
- Intervention
- Thymosin beta-4, intravenous, subcutaneous or topical in clinical studies
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Three-point major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Additional outcomes the Institute extracts for this indication: Cardiovascular death; All-cause death; Hospitalisation for heart failure.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Thymosin beta-4 in atherosclerotic cardiovascular disease and cardiovascular risk reduction.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| TB4-PH1-CARDIAC | 1 | Phase 1 ascending dose | — | Single and multiple dose | 2012 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Very serious | The evidence base is small, recent and wholly sponsor-generated. |
| Overall rating: Very low certainty. The Institute has very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate. In this series a very low rating most often reflects an absence of controlled human evidence rather than conflicting evidence. | ||
§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.
- Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opinion on Biological Therapy 2012;12(1):37–51. doi:10.1517/14712598.2012.634793 · PMID 22074294
- 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
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
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.