Abstract

POST-MARKETING SURVEILLANCE OBSERVATIONAL STUDY ON SAFETY, EFFICACY AND QUALITY OF LIFE IN PATIENTS TAKING SACUBITRIL + VALSARTAN COMBINATION IN CHRONIC HEART FAILURE PATIENTS

P. Madhavi*, M. Sri Vidya Reddy, M. Sravya Reddy, M. Swathi, Dr. Bharat Vijay Purohit and Dr. A. Srinivasa Rao

ABSTRACT

This study was contrived with the aim to evaluate the safety, efficacy and quality of life of patients taking Sacubitril + Valsartan combination in chronic heart failure patients. A total population of 56 patients were evaluated for this study from Continental Hospital, Gachibowli, Hyderabad, to assess the efficacy, various side effects (both known and unknown) and how Sacubitril + Valsartan improving the QoL of the patients after taking the drug. The specially designed data collection forms was used to fetch the data and analyzed by the help of Microsoft Excel 2007. Out of 56 patients 32 (57.14%) men and 24 (42.86%) women completed the questionnaire. The study involves patients with chronic heart failure with reduced ejection fraction. Along with CHF, patients were also having other co-morbid conditions like: Dilated /Ischemic cardiomyopathy-11, Cardiogenic shock-1, Cardiorenal syndrome(AKI)-1, CAG Normal coronary artery-2, Hypertension-22, Diabetes mellitus-6, CAD-12, Cardiomegaly-4, Osteoarthritis-1, Hypothyroidism-2, Unstable angina-1, Dyslipidemia-1, Rheumatoid arthritis-1, Hyperthyroidism-2, pulmonary edema-2, chronic liver disease-1. It has been found that, the drug is improving the symptoms like swelling, SOB and also the QoL of the patients was improved after using the drug. The reduction in re-hospitalization due to heart failure has been decreased due to administration of Sacubitril + Valsartan combination [37 (66.07%) outpatients and 19 (33.93%) inpatients]. The major side effects that were observed in the patients were dry cough (36), fatigue (40), dizziness (28), numbness/tingling sensation (17), palpitations (19), muscle/bone pain (27), drowsy (26) but the occurrence of these side effects had not led to the discontinuation of the treatment with Sacubitril + Valsartan combination. Conclusion: Angiotensin receptor–neprilysin inhibition with Sacubitril + Valsartan was superior in reducing the risks of hospitalization or re-hospitalization for heart failure. And this combination was showing better efficacy, safety and improving the QoL of the patients who were suffering from chronic heart failure with reduced ejection fraction.

Keywords: Sacubitril, Valsartan, ejection fraction, neprilysin, chronic heart failure, cardiomyopathy, Cardiogenic shock, Cardiomegaly.