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Sex-specific differences in HFrEF patients using ARNI in real-world setting

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Literature - Vicent L, Ayesta A, Esteban-Fernández A, et al. - Cardiology 2019, 142:73–78, doi: 10.1159/000498984

Introduction and methods

Women are underrepresented in clinical trials [1,2]. There are sex differences in pharmacokinetics, and treatment response, or incidence of adverse events can differ between sexes [3,4]. With respect to CVD, men tend to suffer from CVD earlier in life [5]. For some CVD, women have a worse prognosis than men, which may be due to reduced administration of evidence-based therapies in women [5]. When looking at heart failure {HF), women more often have preserved left ventricular ejection fraction and a higher prevalence of hypertension [6-8]. Furthermore, women have increased survival, but are older and a worse functional class [8].

The PARADIGM-HF trial demonstrated that sacubitril/valsartan reduced mortality and HF hospitalization compared to enalapril [9]. In this trial, 21% of patients were women and a similar percentage of women was enrolled in the TITRATION trial [9,10].

This study examined sex differences in efficacy, tolerability and safety of sacubitril/valsartan in a real-world cohort of HFrEF patients. This prospective registry in 10 centers included all patients starting treatment with sacubitril/valsartan as outpatients during 6 months prior. Mean follow-up was 7 months.

Main results

  • Of 427 patients, 126 (29.5%) were women.
  • There was no difference in discontinuation with sacubitril/valsartan between women and men (16 women [12.7%] and 33 men [11.0%]).
  • There were no differences in received dose of sacubitril/valsartan (24/26, 49/51 or 97/103 mg) between women vs. men.
  • A greater proportion of women improved functional class compared to men (104 women [82.5%] vs. 221 men [73.4%], P=0.047).
  • There was no difference in SV-related adverse events (31 women [24.6%] vs. 79 men [26.5%]).
  • Female sex was an independent predictor of functional class improvement (OR 2.33, 95%CI:1.24-4.38, P=0.04).
Sex-specific differences in HFrEF patients using ARNI in real-world setting

Conclusion

In a real-world cohort of HFrEF patients starting sacubitril/valsartan, 29.5% were women. Tolerability and safety were similar in women vs. men. NYHA functional class improvement was greater in women compared with men.

References

1. Liu KA, Mager NA. Women’s involvement in clinical trials: historical perspective and future implications. Pharm Pract (Granada). 2016;14:708.

2. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities

in heart failure clinical trials. Arch Intern Med. 2002;162:1682–8.

3. Parekh A, Fadiran EO, Uhl K, Throckmorton DC. Adverse effects in women: implications for drug development and regulatory policies. Expert Rev Clin Pharmacol. 2011;4:453–66.

4. U.S. Food and Drug Administration. Guideline for the study and evaluation of gender differences

in the clinical evaluation of drugs; notice. Fed Regist. 1993;58: 39406–16.

5. Khamis RY, Ammari T, Mikhail GW. Gender differences in coronary heart disease. Heart. 2016;102: 1142–9.

6. Garcia M, Mulvagh SL, Merz CN, Buring JE, Manson JE. Cardiovascular Disease in Women: clinical Perspectives. Circ Res. 2016;118:1273–93.

7. Martinez-Selles M, Doughty RN, Poppe K, Whalley GA, Earle N, Tribouilloy C, et al.; Meta-Analysis Global Group In Chronic Heart Failure (MAGGIC). Gender and survival in patients with heart failure: interactions with diabetes and aetiology. Results from the MAGGIC individual patient meta-analysis.

Eur J Heart Fail. 2012;14: 473–9.

8. Jessup M, Pina IL. Is it important to examine gender differences in the epidemiology and outcome of severe heart failure? J Thorac Cardiovasc Surg. 2004;127: 1247–52.

9. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al.; PARADIGM- HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371: 993–1004.

10. Senni M, McMurray JJ, Wachter R, McIntyre HF, Reyes A, Majercak I, et al. Initiating sacubitril/valsartan (LCZ696) in heart failure: resultsof TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail. 2016;181193–202.

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