Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
2022 · paper · Clinical trials
A randomized trial of dapagliflozin versus placebo in 6263 patients with heart failure and mildly reduced or preserved ejection fraction. Worsening heart failure or cardiovascular death occurred in 16.4% versus 19.5%, with similar adverse event rates.
1 finding
Reference or label In the Discussion, the sentence describing EMPEROR-Preserved ('assessed the effects of empagliflozin in patients with a left ventricular ejection fraction of more than 40%.10') cites reference 10. Reference 10 is Hicks et al., '2017 Cardiovascular and stroke endpoint definitions for clinical trials'. The trial report is reference 7 (Anker et al.).
- p. 7 Discussion, paragraph 2
with a left ventricular ejection fraction of more than 40%.10
- p. 10 References, entry 10
Hicks KA, Mahaffey KW, Mehran R, et al. 2017 Cardiovascular and stroke end-point definitions for clinical trials.
- p. 7 Discussion, second paragraph
assessed the effects of empagliflozin in patients with a left ventricular ejection fraction of more than 40%.10
- p. 10 References, entry 7
Anker SD, Butler J, Filippatos G, et al. Empagliflozin in heart failure with a preserved ejection fraction.
Judge's note: On page 7 the superscript clearly reads 10. On the page 10 reference list, entry 10 is Hicks KA et al., Circulation 2018, on endpoint definitions; the Methods cite it correctly for the adjudication criteria ('adjudicated according to prespecified criteria10'). Entry 7 is Anker SD et al., 'Empagliflozin in heart failure with a preserved ejection fraction', N Engl J Med 2021, which the Introduction cites for the same finding. Ref 10 does not support a statement about the EMPEROR-Preserved results, so it should be 7.
Second check: another model agreed
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1 minor (typos and the like; most checked by the judge only)
Wording Table 2 footnote * says the rate ratio applies to 'the total number of hospitalizations for heart failure and cardiovascular deaths', but the row it explains is 'Total no. of worsening heart failure events and cardiovascular deaths‡'. Footnote ‡ defines those events as hospitalization or an urgent visit for heart failure.
- p. 5 Table 2, footnote *
except for the total number of hospitalizations for heart failure and cardiovascular deaths, which is reported as a rate ratio
- p. 5 Table 2, Secondary outcomes row
Total no. of worsening heart failure events and cardiovascular deaths‡
- p. 5 Table 2 footnote *
except for the total number of hospitalizations for heart failure and cardiovascular deaths
- p. 5 Table 2 row
Total no. of worsening heart failure events and cardiovascular deaths
Judge's note: I checked this on the upright page 5 image. The only rate-ratio row is 'Total no. of worsening heart failure events and cardiovascular deaths‡' (815 vs 1057; 0.77 [0.67–0.89]). Footnote ‡ includes urgent visits in worsening heart failure events. Footnote * names hospitalizations only, which is a narrower outcome than the row. There is only one rate-ratio row, so the footnote is most likely loose shorthand, but its wording does not match the row label.
Second check: another model agreed