Tirzepatide in heart failure with preserved ejection fraction and obesity — evidence extract
The Institute's graded assessment of Tirzepatide 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
- Tirzepatide, subcutaneous once weekly
- 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 Tirzepatide in heart failure with preserved ejection fraction and obesity.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| SUMMIT | 3 | Randomised, double-blind, placebo-controlled | 731 | Median 104 weeks | 2024 |
§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 | 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 | Serious | Too few contributing studies for a formal assessment; the risk cannot be excluded. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in 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.
- Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine 2022;387(3):205–216. doi:10.1056/NEJMoa2206038 · PMID 35658024
- Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet 2023;402(10402):613–626. doi:10.1016/S0140-6736(23)01200-X · PMID 37385275
- Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nature Medicine 2023;29(11):2909–2918. doi:10.1038/s41591-023-02597-w · PMID 37840095
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.