Efficacy And Safety Of Levosimendan In Elderly Patients With Chronical Congestive Heart Failure

Objective:To evaluate the efficacy and safety of levosimendan in elderlypatients with chronical congestive heart failure.Methods: Total of50patients with chronical congestive heart failurewere enrolled into this study from the fifth cardiology department of TheSecond Hospital of Hebei Medical University from September2012toDecember2013. Among them,27cases of male,23cases of female, wereselected between the ages of65-80years old patients. They were randomlydivided into two groups,24patients in levosimendan group and others in thecontrol group. The inclusion criteria were as follows:(1) elderly patientsbetween the ages of65-80were permitted (2) Patients were on admission forchronic systolic heart failure and New York Heart Association (NYHA) Classwas Ⅲ-Ⅳ (3)Echocardiography showed left ventricular ejection fraction(LVEF)≤40%.4.The old Patients who ever had accepted standard treatment-angiotensin-converting enzyme inhibitors (ACEI)/angiotensin II receptorantagonists (ARB), aldosterone receptor antagonists (MRA) and β-blockersgot ineffective results. Exclusion criteria:(1) Patients with cardiac shock,hypotension (systolic blood pressure≤85mmHg) or hypovolemia (2) Patientswith severe liver dysfunction, severe renal insufficiency or electrolytedisturbance.(3) Patients with certificated malignant diseases, autoimmunediseases, chronic obstructive pulmonary diseases, severe thyroid disease orrecent surgery and cerebrovascular Accident(≤6months)(4) Patients withsevere valvular heart disease, pericardial involved disease or acute myocardialinfarction(5)Severe arrhythmia includes Non-sustained ventricular tachycardia,paroxysmal atrial fibrillation and etc (6) For levosimendan and other heartfailure drug allergies.(7) pregnant, lactating women8. Patients themselvesrefused to participate in this study and is automatically out. In the control group, patients were treated only with routine drugs, such as Diuretics, ACEI/ARB, vasodilators, β-blockers and digitalis for full anti-infection, primarydisease controlling, limitting the intake of salt and fluid. In the levosimendangroup, based on the treatment of control group, we add(Yue Wen,specification:5ml,125mg/support, Qilu Pharmaceutical), an initialloading dose of12μg/kg10min intravenous injection, followed by acontinuous infusion of0.1μg/kg/min for1h, then up to0.2μg/(kg·min)continuous for23h,5days later, used the same method for a secondmedication. As patients were found dizziness, headaches, vomiting or otheradverse reactions,reductions should be considered for ensuring SBP≥85mmHg, mean pressure≥65mmHg, heart rate≤120beats/min.We Observe the following:1. efficacy indicators: B-type natriureticpeptide (BNP) before and10days after administration;2. Cardiac ultrasoundexamination for LVEF, stroke volume (SV) before and10days afteradministration;3.NYHA class before and10days after administration.4.6min walk test before and10days after administration.5. Breathing difficultiesand systemic conditions before and10days after administration.6.Readmission and mortality rates of patients within3months.Safty indicators:1. Respiratory rate (R), Heart rate (HR), Blood pressure(BP)30min before and1,12,24hours after administration;2. measurement0fblood parameters of two groups: hemoglobin (HGB), renal function,creatinine (Scr), electrolyte and potassium values (K) changes before and24hours,10days after administration;3.Observe reactions of dizziness,gastrointestinal reactions, the incidence of low blood pressure, heart rate andthe incidence of major adverse cardiac events (MACE),etc.Results:1Contrast between the control group and the levosimendan group before test:There were no statistical differences in age, gender, weight, smoking,drinking and incidences of diabetes mellitus and hypertension. According toprimary disease, coronary heart disease, classification of dilated cardiomyo-pathy and previous conventional drug treatment had no significant difference. We also didn’t find any statistical differences in safety indicators, suchas HR, R, SBP, DBP and blood parameters, like serum creatinine (Scr),hemoglobin (HGB), electrolytes (K+). Echocardiographic indices LVEF, SV,BNP,6min walk test of two groups of patients before treatment, Clinicalsymptoms, for example Breathing difficulties and systemic conditions, NYHAclass were no statistical differences.2Comparison of two groups2.1Effectiveness2.1.1Comparison of B-type natriuretic peptide (BNP) value in the twogroup10days after treatment, comparing of two groups patients,, BNP valuesof levosimendan group decreased more significantly.2.1.2The comparison between LVEF and SV-the echocardiographic indicatorsAfter10days treatment, The baseline values of LVEF, SVincrease.levosimendan group was significantly higher in comparison with thecontrol group after treatment.2.1.3The Comparison between the two groups of patients in NYHA classthere were no significant difference in NYHA class with the two groupsbefore treatment,10days after treatment, the difference between the twogroups was significant.2.1.4Comparison in clinical symptoms (dyspnea, and general condition) intwo groups10days after treatment compared with the ones before treatment,Levosimendan group and the control group both have significant improvementin aspects of breathing difficulty and body condition, both of two groupscan alleviate the symptoms of respiratory difficulties and improve the generalcondition of patients, and Levosimendan group more effective than the controlgroup.2.1.5Comparison of6min walk test in two groupsTreatment after10days, compared over the ones before treatment,walking distance increased significantly, after treatment, levosimendan group, walking distance increases more significantly than the control group.2.1.6The comparison between two groups of patients in the mortality rate andrehospitalization rate within3monthsWithin3months, there have been three cases dead in the control group,so the mortality rate was11.54%. there have been two cases dead forlevosimendan group and the mortality rate was8.33%. There were nostatistically significance between two groups.6patients relapse in the controlgroup, recurrence rate was23.08%; in the levosimendan group, two cases ofrecurrence, recurrence rate was8.33%. there was a significant differencebetween the two groups, indicating that levosimendan had a better effect onthe prognosis in patients with heart failure.2.2Comparison in SecurityAfter treatment, two groups of patients,HR and RR were decreased andthe levosimendan group decreased more significantly, no significant changesin BP. creatinine (Scr), hemoglobin (HGB) did not change significantly in24hours after treatment,10days after treatment,comparion with the ones beforetreatment. Levosimendan group and the control group, respectively, comparedwith before treatment, there was no significant difference.24hours aftertreatment, serum potassium of the Levosimendan group decreased.Comparison in Adverse reactions:three cases of adverse reactions occurin the levosimendan group. one case is hypotension,and BP recovered whenslowed the rate of infusion of levosimendan,the other two cases mainly aslow blood potassium, both recovered after gave potassium.1cases of adversereactions in the Control group,1case of hypotension recovered his BP aftergiving dopamine treatment.Conclusion：1Levosimendan injection has exact efficacy in the treatment of chroniccongestive heart failure in elderly patients, and improve NYHA class ofelderly patients with chronic heart failure. Levosimendan injection alsoincreases left ventricular ejection fraction and may reduce readmission rates.2Levosimendan Injection is safe in treatment of elderly patients with chronic congestive heart failure, and has little effect on renal function, butgains the trend of hypotension and low potassium.