https://gimi-drug.tistory.com/537
당뇨병과 관계없이 박출률 보존 및 경도 감소 심부전에서의 dapagliflozin의 치료 효과에 대한 연구이다.
Dapagliflozin; 포시가 정 10 MG
Background
SGLT2 inhibitor는 EF(ejection fraction) < 40%인 만성 심부전 환자에서 심혈관 사망 및 입원 위험성을 감소시키지만 EF가 높은 환자에서 효과적인지는 확실하지 않다.
Methods
심부전 환자 6,263명을 대상으로 EF > 40% 환자군에서 dapagliflozin(10 mg 1일 1회) or placebo 투여(with usual therapy)하였다.
Primary outcome: 악화되는 심부전 or 심혈관계 사망 composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis.
Results
| dapagliflozin group | placebo group | hazard ratio | confidence interval [CI], P | |
| the primary outcome | 512 of 3131 patients (16.4%) | 610 of 3132 patients (19.5%) | 0.82 | 0.73 to 0.92; P<0.001 |
| worsening heart failure | 368 patients (11.8%) | 455 patients (14.5%) | 0.79 | 0.69 to 0.91 |
| cardiovascular death | 231 patients (7.4%) | 261 patients (8.3%) | 0.88 | 0.74 to 1.05 |
Conclusions
Dapagliflozin은 HFpEF & HFmrEF 환자군에서 심부전 악화와 심혈관계 사망 위험을 감소시켰다.
The DELIVER trial was designed with broader inclusion criteria than those used in previous trials involving similar populations in that we enrolled patients who were hospitalized or recently hospitalized, for whom evidence-based therapy is limited, as well as those with heart failure and a left ventricular ejection fraction that had improved to more than 40% at the time of enrollment. Our data suggest that these understudied groups also benefit from dapagliflozin.
The results of the DELIVER trial extend those of the DAPA-HF trial to patients with heart failure and a left ventricular ejection fraction of more than 40% and are consistent with the overall results of the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction), which assessed the effects of empagliflozin in patients with a left ventricular ejection fraction of more than 40%.
이러한 데이터는 제2형 당뇨병 유무 또는 EF의 정도에 관계없이 심부전 환자의 필수 치료제로 SGLT2 억제제의 사용을 뒷받침하는 추가 증거를 제공한다.
reference:
1) 약학정보원
2) Solomon, Scott D., et al. "Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction." New England Journal of Medicine (2022).
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