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Short and medium-term safety and tolerability of Sacubitril-Valsartan and Empaglifozin joint intake
BACKGROUND: Sacubitril-Valsartan has improved the prognosis of patients with heart failure and reduced ejection fraction. Empaglifozin has reduced heart failure incidence in patients with type 2 diabetes. However, data regarding safety and tolerability of joint intake are scarce. PURPOSE: The aim of our study is to describe clinical use of Sacubitril-Valsartan together with Empaglifozin coadministration in real world practice, with special focus on safety and tolerability. METHODS: We performed a single-centre, retrospective evaluation of Sacubitril-Valsartan and Empaglifozin joint prescription from the date of the first drug prescription until the 20th December 2018. Inclusion criteria was any sustained prescription of both drugs by Cardiology and/or General Practitioners. Patients were excluded if no data were available or prescription had an incorrect indication. We collected baseline characteristics of the patients, data of tolerance and information regarding laboratory markers. Statistical analysis was performed using SPSS Software for MAC, 20.0 version. Changes in cuantitative values over time were analyzed using T-Test. RESULTS: From the 3rd of March 2016 to the 20th of December 2018, 41 patients were included in the study. Three patients were excluded from the final analysis (1 due to unavailable data, 2 because of incorrect prescription of Sacubitril-Valsartan with LVEF > 45%). Thirty-eight patients remained, of which 62% were men. Mean age was 68 years old. All the patients were diabetic, 67% hypertensive and 80% received statins. Ischaemic heart disease was the main cause of heart failure (65%). At baseline, 60% of the patients reported NYHA functional class II symptoms. Sacubitril-Valsartan was started first in 14 patients, Empaglifozin in 11 patients, and both drugs were started at the same time in 13 patients, usually after heart failure admission. During a medium follow-up of 432 +/- 202 days, only 4 patients (10,53%) were admitted to the hospital due to acute heart failure. No cardiovascular nor renal deaths were registered. Creatinine (Cr) levels remained stable during follow-up, with a non-significant decrease of Cr values from 1,043mg/dl (SD = 0,33) at baseline to 1,034 mg/dl (SD = 0,29) at the end of the study. Blood test at intermediate time-points showed similar results (Cr = 1,068; 0,987, and 0,997mg/dl at blood test 2, 3 and 4 respectively). Cr increase above 40% of baseline levels was detected only in 3 patients (7,89%) and reversible in all, without any case of severe acute kidney injury. Glycated hemoglobin (HbA1c) showed a mild and also non-significant reduction during the study, from 6,834% (SD = 1,19) at baseline to 6,723% (SD = 0,99) in the last visit. Glycemic values improved shortly after initiating Sacubitril-Valsartan or Empaglifozin (HbA1c 6,410 at blood test 2, p = 0,065). CONCLUSIONS: Combination of Sacubitril-Valsartan and Empaglifozin is frequent, safe, and well tolerated in real world clinical practice.
In line with the ESC mission, newly presented content is made available to all for a limited time (4 months for ESC Congress, 3 months for other events). ESC Professional Members, Association Members (Ivory & above) benefit from year-round access to all the resources from their respective Association, and to all content from previous years. Fellows of the ESC (FESC), and Professionals in training or under 40 years old, who subscribed to a Young Combined Membership package benefit from access to all ESC 365 content from all events, all editions, all year long. Find out more about ESC Memberships here.
ESC 365 is supported by Bayer, Boehringer Ingelheim and Lilly Alliance, Bristol-Myers Squibb and Pfizer Alliance, Novartis Pharma AG and Vifor Pharma in the form of educational grants. The sponsors were not involved in the development of this platform and had no influence on its content.
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