0
selected
-
1.
Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice.
Desai, NR, Navaneethan, SD, Nicholas, SB, Pantalone, KM, Wanner, C, Hamacher, S, Gay, A, Wheeler, DC
Journal of diabetes and its complications. 2023;(4):108411
Abstract
AIMS: Contemporary patterns of care of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and the adoption of finerenone are not known. The FINE-REAL study (NCT05348733) is a prospective observational study in patients with CKD and T2D to provide insights into the use of the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone in clinical practice. METHODS FINE-REAL is an international, prospective, multicenter, single-arm study enrolling approximately 5500 adults with CKD and T2D in an estimated 200 sites across 22 countries. The study is anticipated to be ongoing until 2027. RESULTS The primary objective is to describe treatment patterns in patients with CKD and T2D treated with finerenone in routine clinical practice. Secondary objectives include assessment of safety with finerenone. Other endpoints include characterization of healthcare resource utilization and occurrence of newly diagnosed diabetic retinopathy or its progression from baseline in patients with existing disease. A biobank is being organized for future explorative analyses with inclusion of participants from the United States. CONCLUSIONS FINE-REAL is the first prospective observational study with a nonsteroidal MRA in a population with CKD and T2D and is expected to provide meaningful insights into the treatment of CKD associated with T2D. FINE-REAL will inform decision-making with respect to initiation of finerenone in patients with CKD and T2D.
-
2.
Reducing Cardiovascular Risk in the Medicare Million Hearts Risk Reduction Model: Insights From the National Cardiovascular Data Registry PINNACLE Registry.
Borden, WB, Wang, J, Jones, P, Tang, Y, Contreras, J, Daugherty, SL, Desai, NR, Virani, SS, Wasfy, JH, Maddox, TM
Circulation. Cardiovascular quality and outcomes. 2022;(4):e007908
-
-
Free full text
-
Abstract
BACKGROUND The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk. METHODS This study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model. RESULTS The final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction. CONCLUSIONS In cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.
-
3.
The impact of heart failure on patients and caregivers: A qualitative study.
McHorney, CA, Mansukhani, SG, Anatchkova, M, Taylor, N, Wirtz, HS, Abbasi, S, Battle, L, Desai, NR, Globe, G
PloS one. 2021;(3):e0248240
Abstract
BACKGROUND Heart failure is rising in prevalence but relatively little is known about the experiences and journey of patients and their caregivers. The goal of this paper is to present the symptom and symptom impact experiences of patients with heart failure and their caregivers. METHODS This was a United States-based study wherein in-person focus groups were conducted. Groups were audio recorded, transcribed and a content-analysis approach was used to analyze the data. RESULTS Ninety participants (64 patients and 26 caregivers) were included in the study. Most patients were female (52.0%) with mean age 59.3 ± 8 years; 55.6% were New York Heart Association Class II. The most commonly reported symptoms were shortness of breath (81.3%), fatigue/tiredness (76.6%), swelling of legs and ankles (57.8%), and trouble sleeping (50.0%). Patients reported reductions in social/family interactions (67.2%), dietary changes (64.1%), and difficulty walking and climbing stairs (56.3%) as the most common adverse disease impacts. Mental-health sequelae were noted as depression and sadness (43.8%), fear of dying (32.8%), and anxiety (32.8%). Caregivers (mean age 55.5 ± 11.2 years and 52.0% female) discussed 33 daily heart failure impacts, with the top three being reductions in social/family interactions (50.0%); being stressed, worried, and fearful (46.2%); and having to monitor their "patience" level (42.3%). CONCLUSIONS There are serious unmet needs in HF for both patients and caregivers. More research is needed to better characterize these needs and the impacts of HF along with the development and evaluation of disease management toolkits that can support patients and their caregivers.
-
4.
Hyperkalemia treatment modalities: A descriptive observational study focused on medication and healthcare resource utilization.
Desai, NR, Rowan, CG, Alvarez, PJ, Fogli, J, Toto, RD
PloS one. 2020;(1):e0226844
Abstract
Renin-angiotensin-aldosterone system inhibitor (RAASi) therapy has been shown to improve outcomes among patients with congestive heart failure, diabetes, or renal dysfunction. These patients are also at risk for the development of hyperkalemia (HK), often leading to down-titration and/or discontinuation of RAASi therapy. Patiromer is the first sodium-free, non-absorbed potassium (K+) binder approved for the treatment of hyperkalemia (HK) in over 50 years. We described the association between use of K+ binders (Patiromer and sodium polystyrene sulfonate [SPS]) and renin-angiotensin-aldosterone system inhibitor (RAASi), on healthcare resource utilization (HRU). The study population consisted of Medicare Advantage patients with HK (K+ ≥ 5.0 mmol/L) in Optum's Clinformatics® Data Mart between 1/1/2016-12/31/2017. Patiromer and (SPS) initiators, and HK patients not exposed to a K+ binder (NoKb) were included. The index date was the date of the first K+ binder dispensing or HK diagnosis. Outcomes assessed at 6 months post-index were: (1) K+ binder utilization, (2) RAASi continuation, and (3) HRU (pre- vs post-index). HRU change was analyzed using McNemar's statistical test. Study cohorts included 610 (patiromer), 5556 (SPS), and 21,282 (NoKb) patients. Overall baseline patient characteristics were: mean age 75 years; female 49%, low-income subsidy 29%, chronic kidney disease 48% (63% for patiromer cohort), and congestive heart failure 29%. At 6 months post-index, 28% (patiromer) and 2% (SPS) remained continuously exposed to the index K+ binder. RAASi continued for 78% (patiromer), 57% (SPS), and 57% (NoKb). The difference (pre- vs post-index) in hospitalized patients was: -9.4% (patiromer; P<0.05), -7.2% (SPS), and +16.8% (NoKb; P<0.001). Disparate K+ binder utilization patterns were observed. The majority of patiromer patients continued RAASi therapy while the percentage of SPS patients that continued RAASi therapy was lower, overlapping CIs were observed. Following continuous patiromer exposure, statistically significant reductions in hospital admissions and emergency department visits were observed, continuous SPS exposure observed no statistically significant reductions in either hospitalizations or ED visits, while NoKb patients with continuous exposure had statistically significant increases in both. Further research, with a larger sample size using comparative analytic methods, is warranted.