Estimating the Association between Iron Deficiency and Treatment with Ferric Carboxymaltose (FCM) and the Risk of Hospitalization in Chronic Heart Failure Patients: A Retrospective Real World Evidence Study Using a Hospital Registry in Spai ...
Author(s)
Ramirez de Arellano Serna A1, Núñez J2, Arbona C3, Mollar A2, Villaescusa A2, Civera JM2, Núñez E2, Rodriguez D2, Santas E2, De La Espriella E2, Miñana G2, Gavata-Steiger S4, Schulmann T4
1Vifor Pharma Group, Glattbrugg, ZH, Switzerland, 2Hospital Clinico Valencia, INCLIVA, Valencia, Spain, 3Hospital Clinico Valencia, INCLIVA, Valencia, V, Spain, 4Vifor Pharma Group, Glattbrugg, Switzerland
OBJECTIVES A number of randomized placebo-controlled trials with Ferric Carboxymaltose (FCM) have demonstrated a clinical benefit in the correction of iron deficiency (ID) in patients with Chronic Heart Failure (CHF). FCM is associated with significant improvements in functional capacity, symptoms and quality of life. Reduction in the risk of first hospitalization and recurrent hospitalization due to worsening heart failure were also identified. The aim of this study is twofold; firstly, to investigate if ID is associated with an increased risk of hospitalizations. Secondly, if the prescription of FCM could be associated with a reduced risk of subsequent hospital admissions for CHF patients in routine clinical practice. METHODS For this study, 712 patients (3,692 observations) were analyzed from 2014 to 2018. Patients were diagnosed for both absolute iron deficiency (aID) when serum ferritin is <100 µg/L and for functional iron deficiency (fID) when serum ferritin is between 100 y 300 µg/L and TSAT <20%. From the 391 patients (1,782 observations) with data in both variables (ID and FCM), 94.2% of those with aID+fID had treatment with FMC as compared with 5.8% of those with no aID+fID. From the 712 patients under scrutiny, 247 (34.7%) had at least 1 hospital admission over the follow-up. The statistical method used was a frailty-mixture survival model for recurrent event times and stratification on event order. RESULTS The existence of ID as time-varying exposure was significantly associated with any hospital admission (HR: 1.37, 95% CI = 1.01-1.85; p=0.042). In turn, treatment with FCM as time-varying exposure was borderline associated with lower risk of any hospital admission (HR: 0.66, 95% CI = 0.43-1.02; p=0.064). CONCLUSIONS The study shows that ID is associated with an increased risk of hospitalizations and treatment with FCM may be associated with a risk reduction on hospitalizations for patients with ID and CHF in routine clinical practice.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PCV103
Topic
Clinical Outcomes, Economic Evaluation, Health Service Delivery & Process of Care
Topic Subcategory
Clinical Outcomes Assessment, Disease Management
Disease
Cardiovascular Disorders