scholarly journals Real-life prescribing of SGLT2 inhibitors: How to handle other medications, including glucose-lowering drugs and diuretics

Kidney360 ◽  
2021 ◽  
pp. 10.34067/KID.0000412021
Author(s):  
David Lam ◽  
Aisha Shaikh
Keyword(s):  
Real Life ◽  
Sglt2 Inhibitors ◽  
Glucose Lowering ◽  
Early Access

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scholarly journals Emergence of SGLT2 Inhibitors as Powerful Antioxidants in Human Diseases

Antioxidants ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1166
Author(s):  
Kai-Fan Tsai ◽  
Yung-Lung Chen ◽  
Terry Ting-Yu Chiou ◽  
Tian-Huei Chu ◽  
Lung-Chih Li ◽  
...  
Keyword(s):  
Liver Diseases ◽  
Redox Homeostasis ◽  
Sglt2 Inhibitors ◽  
Human Diseases ◽  
Oral Glucose ◽  
Diabetic Patients ◽  
Protective Effects ◽  
Glucose Lowering ◽  
Therapeutic Benefits ◽  
Neural Disorders

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of oral glucose-lowering agents. Apart from their glucose-lowering effects, large clinical trials assessing certain SGLT2 inhibitors have revealed cardiac and renal protective effects in non-diabetic patients. These excellent outcomes motivated scientists and clinical professionals to revisit their underlying mechanisms. In addition to the heart and kidney, redox homeostasis is crucial in several human diseases, including liver diseases, neural disorders, and cancers, with accumulating preclinical studies demonstrating the therapeutic benefits of SGLT2 inhibitors. In the present review, we aimed to update recent advances in the antioxidant roles of SGLT2 inhibitors in common but debilitating human diseases. We anticipate that this review will guide new research directions and novel therapeutic strategies for diabetes, cardiovascular diseases, nephropathies, liver diseases, neural disorders, and cancers in the era of SGLT2 inhibitors.

scholarly journals Diabetes and Frail Older Patients: Glycemic Control and Prescription Profile in Real Life

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 115
Author(s):  
Anne-Sophie Mangé ◽  
Arnaud Pagès ◽  
Sandrine Sourdet ◽  
Philippe Cestac ◽  
Cécile McCambridge
Keyword(s):  
Glycemic Control ◽  
Older Patients ◽  
Diabetes Management ◽  
Real Life ◽  
Cross Sectional ◽  
Glucose Lowering ◽  
Frailty Status ◽  
Frail Patients ◽  
Patients With Diabetes ◽  
Hba1c Target

(1) Background: The latest recommendations for diabetes management adapt the objectives of glycemic control to the frailty profile in older patients. The purpose of this study was to evaluate the proportion of older patients with diabetes whose treatment deviates from the recommendations. (2) Methods: This cross-sectional observational study was conducted in older adults with known diabetes who underwent an outpatient frailty assessment in 2016. Glycated hemoglobin (HbA1c) target is between 6% and 7% for nonfrail patients and between 7% and 8% for frail patients. Frailty was evaluated using the Fried criteria. Prescriptions of glucose-lowering drugs were analyzed based on explicit and implicit criteria. (3) Results: Of 110 people with diabetes with an average age of 81.7 years, 67.3% were frail. They had a mean HbA1c of 7.11%. Of these patients, 60.9% had at least one drug therapy problem in their diabetes management and 40.9% were potentially overtreated. The HbA1c distribution in relation to the targets varied depending on frailty status (p < 0.002), with overly strict control in frail patients (p < 0.001). (4) Conclusions: Glycemic control does not seem to be routinely adjusted to the health of frail patients. Several factors can lead to overtreatment of these patients.

scholarly journals Lorlatinib in pretreated ALK- or ROS1-positive lung cancer and impact of TP53 co-mutations: results from the German early access program

2021 ◽  
Vol 13 ◽  
pp. 175883592098055 ◽  
Author(s):  
Nikolaj Frost ◽  
Petros Christopoulos ◽  
Diego Kauffmann-Guerrero ◽  
Jan Stratmann ◽  
Richard Riedel ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Survival Rates ◽  
Real Life ◽  
Progression Free Survival ◽  
Leptomeningeal Carcinomatosis ◽  
Resistance Mutations ◽  
Duration Of Treatment ◽  
Tp53 Mutations ◽  
Early Access ◽  
Access Program

Introduction: We report on the results of the German early access program (EAP) with the third-generation ALK- and ROS1-inhibitor lorlatinib. Patients and Methods: Patients with documented treatment failure of all approved ALK/ROS1-specific therapies or with resistance mutations not covered by approved inhibitors or leptomeningeal carcinomatosis were enrolled and analyzed. Results: In total, 52 patients were included [median age 57 years (range 32–81), 54% female, 62% never smokers, 98% adenocarcinoma]; 71% and 29% were ALK- and ROS1-positive, respectively. G1202R and G2032R resistance mutations prior to treatment with lorlatinib were observed in 10 of 26 evaluable patients (39%), 11 of 39 patients showed TP53 mutations (28%). Thirty-six patients (69%) had active brain metastases (BM) and nine (17%) leptomeningeal carcinomatosis when entering the EAP. Median number of prior specific TKIs was 3 (range 1–4). Median duration of treatment, progression-free survival (PFS), response rate and time to treatment failure were 10.4 months, 8.0 months, 54% and 13.0 months. Calculated 12-, 18- and 24-months survival rates were 65, 54 and 47%, overall survival since primary diagnosis (OS2) reached 79.6 months. TP53 mutations were associated with a substantially reduced PFS (3.7 versus 10.8 month, HR 3.3, p = 0.003) and were also identified as a strong prognostic biomarker (HR for OS2 3.0 p = 0.02). Neither prior treatments with second-generation TKIs nor BM had a significant influence on PFS and OS. Conclusions: Our data from real-life practice demonstrate the efficacy of lorlatinib in mostly heavily pretreated patients, providing a clinically meaningful option for patients with resistance mutations not covered by other targeted therapies and those with BM or leptomeningeal carcinomatosis.

Abstract 81: Early Access to Cardiac Catheterization Laboratory for Patients Resuscitated from Cardiac Arrest Due to a Shockable Rhythm: The Minnesota Resuscitation Consortium Twin Cities Unified Protocol Two-Year Report

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Demetris Yannopoulos ◽  
Santiago Garcia ◽  
Brian Mahoney ◽  
Ralph J Frascone ◽  
Greg Helmer ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Cardiac Catheterization ◽  
Real Life ◽  
Inclusion Criteria ◽  
Catheterization Laboratory ◽  
Cardiac Catheterization Laboratory ◽  
Early Access ◽  
Shockable Rhythm ◽  
Surface Ecg ◽  
Gain Access

Background: Cardiac arrest patients that have been successfully resuscitated from shockable rhythms have a high prevalence of thrombotic and/or flow limiting coronary occlusion regardless of the presence of STEMI on the ECG. In 2012, the Minnesota Resuscitation Consortium (MRC) developed an organized approach for all those patients to gain early access to the cardiac catheterization laboratory (CCL). We report the two-year outcomes. Methods: Eleven metropolitan hospitals with 24/7 PCI capabilities agreed to provide early (within 2 hours of arrival to the emergency department) access to the CCL for all patients that were successfully resuscitated from VF/VT arrest regardless of the presence or absence of STEMI on the surface ECG. Inclusion criteria were: witnessed or un-witnessed, age >18 and <70, cardiac arrest of presumed cardiac etiology, comatose or conscious patients. Patients with PEA or asystole, known DNR/DNI, non-cardiac etiology, significant bleeding of any cause, terminal disease were excluded. Patient outcomes were recorded in the state database Cardiac Arrest Registry to Enhance Survival. Results: A total of 370 patients were resuscitated and met the inclusion criteria. Of those, 313 (85%) patients were taken to the CCL per protocol. The mean age was 55.5 years, 77% were men and 79% had witnessed arrest. Only 57 patients (15%) did not gain access to the CCL. Of the 313 patients that had early coronary angiography a total of 47% received primary angioplasty and had at least one vessel disease and 5% received coronary artery bypass. All comatose patients received therapeutic hypothermia and 35% received and implantable cardiac defibrillator. A total of 235/313 (75%) were discharged alive and of those 222/235 (94.5%) were discharged neurologically intact with a CPC of 1. Of the patients that did not gain access to the CCL, 46% (26/57) were discharged alive and of those 73% (19/26) had CPC of 1 [OR: 3.63; 2.03-6.5, p< 0.001]. Conclusions: Over the first two years of implementation, the MRC protocol for early access to the CCL in resuscitated patients from shockable rhythm was associated with 75% survival to hospital discharge and excellent neurological outcomes in a large metropolitan area and real-life clinical practice.

scholarly journals The expanding role of SGLT2 inhibitors beyond glucose-lowering to cardiorenal protection

2020 ◽  
pp. 1-32
Author(s):  
Emily Brown ◽  
John PH Wilding ◽  
Uazman Alam ◽  
Thomas M Barber ◽  
Janaka Karalliedde ◽  
...  
Keyword(s):  
Sglt2 Inhibitors ◽  
Glucose Lowering

Real-life experience with mepolizumab in the French early access program for severe eosinophilic asthma

2019 ◽  
Author(s):  
Alina Gruber ◽  
Camille Taillé ◽  
Pascal Chanez ◽  
Gilles Devouassoux ◽  
Alain Didier ◽  
...  
Keyword(s):  
Life Experience ◽  
Real Life ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Early Access ◽  
Access Program

Real-world data of cabozantinib in patients with VEGF-refractory metastatic renal cell carcinoma (mRCC): Results from the French Early Access Program (CABOREAL).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 683-683
Author(s):  
Marine Gross-Goupil ◽  
Aude Flechon ◽  
Christine Chevreau ◽  
Delphine Topart ◽  
Gwenaelle Gravis ◽  
...  
Keyword(s):  
Real World ◽  
Kinase Inhibitors ◽  
Day Treatment ◽  
Real Life ◽  
Treatment Interruption ◽  
Clinical Decision ◽  
Real World Data ◽  
Dose Modification ◽  
Early Access ◽  
Access Program

683 Background: Cabozantinib (Cabo) is approved in Europe for the treatment of mRCC in first line and after failure of tyrosine kinase inhibitors (TKI). We report the results from real-world use of Cabo in the French Early Access Program (EAP) (CABOREAL [NCT03744585]). Methods: Data were retrospectively collected from 26 centers. Patients (pts) were treated with Cabo during the Temporary Authorization for Use (ATU) period from Sep 12, 2016 to licensing in Feb 19, 2018. Pts were eligible after 2 prior VEGFR TKI unless clinical decision for 2nd line (L). The aim was to evaluate the use and activity of Cabo in real-life conditions. Overall survival (OS) was calculated from initiation of Cabo. Results: Overall, 410 pts were included. Median age was 63 years, 85% had clear-cell histology, 41% and 32% were intermediate/poor IMDC risk, respectively. Pts were mostly ECOG 1 (42%) or 2 (30%); 229 (56%) pts had bone metastasis (mets). Median follow-up was 14.4 months (m). Cabo was used as 2L, 3L and 4L or beyond for 101 (25%), 137 (33%) and 172 (41%) pts respectively; 204 pts (50%) were pretreated with nivolumab (Nivo). Activity results and dose reduction are summarized in the table. Starting dose was 60 mg (290 pts, 71%), 40 mg (109 pts, 27%) and 20 mg (8 pts, 2%). Treatment interruption occurred for 267 pts (65%), dose modification for 240 pts (59%) and schedule change for 64 pts (16%). Median daily dose was 40 mg/day. Treatment discontinuation occurred for 348 (85%) pts, with 86 (25%) due to adverse events. Notably, 184 (54%) pts received a subsequent systemic therapy. Conclusions: We report the largest real-world study of Cabo in mRCC to date. CABOREAL demonstrates that using dose modification, median Cabo duration was 7.6 m in a heavily pretreated population, with the longest treatment duration in patients with prior Nivo exposure. Clinical trial information: NCT03744585. [Table: see text]

scholarly journals Network Meta-Analysis of Novel Glucose-Lowering Drugs on Risk of Acute Kidney Injury

2020 ◽  
Vol 16 (1) ◽  
pp. 70-78 ◽  
Author(s):  
Min Zhao ◽  
Shusen Sun ◽  
Zhenguang Huang ◽  
Tiansheng Wang ◽  
Huilin Tang
Keyword(s):  
Type 2 Diabetes ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Lower Risk ◽  
Meta Analysis ◽  
Secondary Analysis ◽  
Sglt2 Inhibitors ◽  
Glucose Lowering ◽  
Event Driven

Background and objectivesLittle is known about the comparative effects of dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1RAs), or sodium glucose cotransporter-2 (SGLT2) inhibitors on risk of AKI. This study aimed to compare the effects of these three novel classes of glucose-lowering drugs on AKI risk in patients with or without type 2 diabetes, by network meta-analysis of event-driven cardiovascular or kidney outcome trials.Design, setting, participants, & measurementsWe systematically searched electronic databases up to September 2020, and included 20 event-driven cardiovascular or kidney outcome trials (18 trials included patients with type 2 diabetes only, and two trials included patients with or without type 2 diabetes). A network meta-analysis using a frequentist approach was performed to compare the effects of DPP-4 inhibitors, GLP-1RAs, or SGLT2 inhibitors on risk of AKI, and estimate the probability for each intervention as the safest one. The primary analysis included 18 trials with type 2 diabetes only, and a secondary analysis included 20 trials.ResultsIn the 18 trials with a total of 2051 AKI events (range: 1–300) among 156,690 patients with type 2 diabetes only, our network meta-analysis showed that SGLT2 inhibitors were associated with a lower risk of AKI compared with placebo (odds ratio, 0.76; 95% confidence interval, 0.66 to 0.88), whereas both DPP-4 inhibitors and GLP-1RAs had neutral effects on risk of AKI. Moreover, SGLT2 inhibitors were significantly associated with a lower risk in AKI than both GLP-1RAs (odds ratio, 0.79; 95% confidence interval, 0.65 to 0.97) and DPP-4 inhibitors (odds ratio, 0.68; 95% confidence interval, 0.54 to 0.86). SGLT2 inhibitors have the highest probability of being the safest intervention (84%). The results were similar in the secondary analysis.ConclusionsCurrent evidence indicates that SGLT2 inhibitors have a lower risk of AKI than both DPP-4 inhibitors and GLP-1RAs.

scholarly journals Pharmacoeconomic evaluation of ipragliflozin in combination with metformin in comparison with other regimens of therapy for type 2 diabetes mellitus

2021 ◽  
pp. 50-63
Author(s):  
A. S. Kolbin ◽  
A. A. Kurylev ◽  
Yu. E. Balykina ◽  
M. A. Proskurin
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Weighted Average ◽  
Sglt2 Inhibitors ◽  
Cost Effectiveness Ratio ◽  
Glucose Lowering ◽  
Lowering Therapy ◽  
Sodium Glucose Cotransporter ◽  
Glucose Lowering Therapy

Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduce plasma glucose concentrations by inhibiting glucose reabsorption by the kidney through inhibiting SGLT2 sodium-glucose cotransporter and induce glycosuria. SGLT2 inhibitors are a new class of glucose lowering drugs most recently approved for treatment of type 2 diabetes mellitus (T2DM). Unlike other antidiabetic agents, SGLT2 inhibitors improve glycemic control (by HbA1c) and provide multiple additional benefits, including decreased body weight, blood pressure, and other multiple pleiotropic effects. The completed clinical trials and real world data have provided evidence that including of SGLT2 inhibitors in the treatment of T2DM has benefits of reduction of cardiovascular and renal outcomes. Goal. The aim of the study was to conduct a clinical and economic examination of ipragliflozin in comparison with other regimens of glucose-lowering therapy with other SGLT2 inhibitors. Methods. In carrying out the pharmacoeconomic analysis itself, a cost-effectiveness analysis (CEA) was applied with the calculation of the corresponding cost-effectiveness ratio (CER), incremental cost-effectiveness ratio (ICER) according to the formula, as well as an a «budget impact analysis». Multiple one-way sensitivity analysis, check the robustness of the results of the main scenario results to changes in key parameters such as the cost of drugs and complications of diabetes. The time horizon for analyzing the dynamics of economic consequences when using ipragliflozin as a glucose-lowering therapy for T2DM was 5 years. Results. The weighted average cost per patient per year when using the ipragliflozin treatment strategy is 31,182 rubles. The costs of the empagliflozin strategy are 61,291 rubles per patient. In the case of using dapagliflozin, the weighted average costs are 30,032 rubles per patient per year, the total direct medical costs for the current drug therapy option, calculated on the initial number of target practice in 72,143 patients with type 2 diabetes, amounted to 3,068,642,442 rubles. Analysis of the trend of changes in weighted average costs showed that the broader use of ipragliflozin for the treatment of T2DM in the target population leads to reducing in diabetes related direct medical costs by 6.7 %, while the total economic effect of ipragliflozin introduction over five years will be 501,539,327 rubles. Conclusions. Use of ipragliflozin + metformin in T2DM treatment is a cost-effective strategy compared to empagliflozin + metformin. The combination of ipragliflozin with metformin versus dapagliflozin + metformin is economically feasible in terms of cost-effectiveness.

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