scholarly journals Prospective Monitoring of Newly Marketed Drugs in Frail Older Adults Using Real-World Databases

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 209-209
Author(s):  
Dae Kim ◽  
Elisabetta Patorno
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Older Adults ◽  
Real World ◽  
New Drugs ◽  
Frail Older Adults ◽  
Drug Benefits ◽  
Monitoring Framework ◽  
Prospective Monitoring

Abstract In recent years several new drugs have been approved for treatment of heart failure and type 2 diabetes. Despite their life-prolonging benefits, uptake of new drugs is often slow among older patients with frailty due to under-representation of frail older adults in pivotal clinical trials and concerns for adverse events. To optimize pharmacotherapy, timely evaluation of the drug benefits and risks is urgently needed. We propose a novel drug monitoring framework that prospectively evaluates the effectiveness and safety of newly marketed drugs for frail and non-frail patients in real-world databases. This framework utilizes a validated claims-based frailty index (CFI) (range: 0-1; frail if ≥0.20) to find early signals for effectiveness and safety of new drugs by updating the analysis at regular intervals as new data become available. In this symposium, we present early results of this prospective monitoring framework for 2 new drug classes using Medicare claims data from the approval date until the end of 2017: 1) angiotensin receptor-neprilysin inhibitor (ARNI) (approved in July 2015) for heart failure with reduced ejection fraction (HFrEF) and 2) sodium-glucose cotransporter-2 inhibitors (SGLT2i) (approved in March 2013) for type 2 diabetes. We first show the uptake of ARNI and SGLT2i over time among the eligible Medicare beneficiaries by clinical characteristics, including frailty. Subsequently we present the results of sequential cohort analysis for the effectiveness and safety results of ARNI and SGLT2i. After these presentations, the panel will discuss the strengths, limitations, and challenges of implementing our monitoring framework in real-world databases.

scholarly journals Heart failure among people with Type 2 diabetes mellitus: real‐world data of 289 954 people from a diabetes database

2019 ◽  
Vol 37 (8) ◽  
pp. 1291-1298
Author(s):  
D. Stoyanova ◽  
B. Stratmann ◽  
A. Schwandt ◽  
N. Heise ◽  
S. Mühldorfer ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Real World ◽  
Real World Data ◽  
World Data

194-OR: Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL (Gla-300) in Older Adults (≥70 Years) with Type 2 Diabetes (T2DM): A Subgroup Analysis of the ATOS Study

Diabetes ◽  
2021 ◽  
Vol 70 (Supplement 1) ◽  
pp. 194-OR
Author(s):  
GAGIK R. GALSTYAN ◽  
AMIR TIROSH ◽  
HERNANDO VARGAS-URICOECHEA ◽  
MARIA AILEEN N. MABUNAY ◽  
MATHIEU COUDERT ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Insulin Glargine ◽  
Real World ◽  
Subgroup Analysis

scholarly journals Treatment of Patients with Heart failure and Type 2 Diabetes: a review of the literature

2019 ◽  
Vol 13 (4) ◽  
pp. 205-224
Author(s):  
Elisa Fabbri ◽  
Maurizio Nizzoli
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Sglt2 Inhibitors ◽  
New Drugs ◽  
Review Of The Literature ◽  
Glucose Lowering ◽  
Promising Tool ◽  
Patients With Heart Failure ◽  
Underlying Mechanisms

Heart failure (HF) and type 2 diabetes (T2D) often coexist and having both the diseases compared to having one alone is associated with greater challenges in their management/treatment and worse outcomes. The present review of the literature is aimed at providing a comprehensive synopsis of the main evidences about the treatment of the two coexisting conditions. In particular, the recent introduction of new glucose-lowering drugs has been deeply changing the therapeutic approach to T2D. Big randomized controlled trails (RCTs) developed to test the cardiovascular safety of these new drugs consistently highlighted a reduction of the risk of hospitalization for HF in patients with T2D treated with sodium-glucose co-transporter 2 (SGLT2) inhibitors, suggesting a potential and revolutionary class effect probably related to their diuretic effect. Moreover, a renal protective effect of this drug class has also been emerging and the beneficial effect of SGLT2 inhibitors on the risk of HF hospitalization seems to be even greater in patients with worse renal function. In conclusion, although the underlying mechanisms are not fully understood, SGLT2 inhibitors appear to be a promising tool to treat HF and T2D. Ongoing RCTs specifically enrolling patients with HF treated with SGLT2 inhibitors will provide more insights and further information.

scholarly journals Sodium-glucose cotransporter-2 inhibitors and risk for genitourinary infections in older adults with type 2 diabetes

2021 ◽  
Vol 12 ◽  
pp. 204209862199770
Author(s):  
Navya Varshney ◽  
Sarah J. Billups ◽  
Joseph J. Saseen ◽  
Cy W. Fixen
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Urinary Tract ◽  
Real World ◽  
Fungal Infections ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
Significant Difference ◽  
Tract Infections

Background and aims: Although landmark clinical trials have demonstrated an increased risk for genitourinary infection (GUI) after initiation of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy that led to an FDA label warning, real world findings have been inconsistent and evidence specifically in older adults is lacking. The objective of the study was to examine the incidence of GUI in patients aged 65 years or older initiated on SGLT2i compared with glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy at a large academic health system. Methods: A retrospective population-based cohort study was conducted using electronic health records of patients aged 65 years and older with a diagnosis of type 2 diabetes mellitus. Patients newly initiated on SGLT2i or GLP1-RA therapy with estimated glomerular filtration rate (eGFR) ⩾30 mL/min per 1.73 m² and active within the health system for at least 1 year prior to initiation were included. We compared the incidence of inpatient, emergency room, or outpatient diagnosis of GUI (bacterial and mycotic) within 6 months of SGLT2i or GLP1-RA initiation. A chi-square or Fisher’s exact test were used to analyze between-group differences for categorical variables, while a t-test was used for continuous variables. A Cox proportional hazards model was used to estimate the impact of confounding variables on the primary outcome. Results: One hundred and thirty-three patients were initiated on SGLT2i therapy and 341 patients newly initiated on GLP1-RA therapy. After adjusting for differences in age, A1c, body mass index, eGFR, race and sex, there was no statistically significant difference in GUI incidence within 6 months of SGLT2i versus GLP1-RA initiation (3.8% versus 6.5%, adjusted hazard ratio: 0.784, 95% confidence interval 0.260–2.367). Conclusion: We found no increased risk of composite GUI within 6 months of initiating SGLT2i compared with GLP1-RA therapy. These real-world data in older adults add to previous findings, which suggest no increased risk of urinary tract infection with SGLT2i initiation. Plain language summary A class of antidiabetic medications and risk for genitourinary infections in older adults with type 2 diabetes Older adults with type 2 diabetes often benefit from a class of antidiabetic medications known as sodium-glucose cotransporter-2 inhibitors (SGLT2is) which help to lower blood glucose, decrease risk for cardiovascular disease and prevent kidney disease progression. However, there is concern that these medications may increase risk for urinary tract infections and/or genital fungal infections in older adults based on clinical trial evidence. Our study evaluated the real-world occurrence of these safety events in patients aged 65 years or older who were newly started on these medications. We compared these patients with a group of patients newly started on an alternative class of antidiabetic agents which are not expected to increase risk for infections, known as glucagon-like peptide-1 receptor agonists (GLP1-RA). In our study, we included 133 patients who started an SGLT2i and 341 patients who started a GLP1-RA at a large teaching hospital. We evaluated the occurrence of infection up to 6 months after initiation of these mediations. We found no significant difference in infection rate between these two groups. We conclude in the study that the use of SGLT2i in older adults was not associated with increased risk for urinary tract infections or genital fungal infections when compared with GLP1-RA use.

scholarly journals Sociodemographic and clinical functional factors in pre-frail and frail older adults with type 2 Diabetes Mellitus in relation to low levels of physical activity

2020 ◽  
Vol 23 (1) ◽  
Author(s):  
Ana Clara Teixeira Fernandes ◽  
Bartolomeu Fagundes de Lima Filho ◽  
Íkaro Felipe da Silva Patrício ◽  
Vanessa da Nóbrega Dias ◽  
Fabrícia Azevêdo da Costa Cavalcanti ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Older Adults ◽  
Type 2 Diabetes Mellitus ◽  
Frail Older Adults ◽  
Functional Factors ◽  
Low Levels ◽  
Years Of Schooling

Abstract Objective: To determine the sociodemographic and clinical-functional factors related to low levels of physical activity in pre-frail and frail older adults with type 2 diabetes mellitus (DM2). Method: an observational, analytical, cross-sectional study was performed. The sample consisted of older adults aged 60 years or over with a clinical diagnosis of DM2 who were treated at the Onofre Lopes University Hospital (or HUOL). Sociodemographic and clinical-functional data were evaluated with the following instruments: the Timed Up and Go (TUG) test, the Mini Mental State Examination (MMSE), the 15-item Geriatric Depression Scale (GDS), the International Physical Activity Questionnaire (IPAQ) and the frailty phenotype. The Chi-square and Mann Whitney tests were used for data analysis. Results: the study sample consisted of 113 individuals classified as pre-frail (52.2%) and frail (47.8%). Low levels of physical activity were verified in 79.6% of the sample. The most closely related variables that showed a statistically significant difference with low levels of physical activity were: years of schooling (p=0.02), social participation (p=0.005), insulin therapy (p=0.02), pain in the lower limbs (p=0.03) and depressive symptoms (p=0.04). Also, significant differences were found between low levels of physical activity and age (p=0.04) and years of schooling (p=0.05). Conclusions: Low levels of physical activity are associated with certain sociodemographic and clinical-functional factors, some of which are modifiable. Identifying these is important for the development of appropriate health interventions for the prevention and treatment of both DM2 and the Frailty Syndrome (FS).

Sign in / Sign up

Export Citation Format

Share Document