Expanding Drug Indications: Strategic Lifecycle Management vs. Evergreening in SGLT2 Inhibitors DOI Creative Commons

Kazuhisa Shimmura

Published: Dec. 24, 2024

In the rapidly evolving pharmaceutical industry, Lifecycle Management (LCM) strategies are critical for maximizing profitability and extending market life of drugs. This study investigates strategic importance expanding indications sodium-glucose cotransporter 2 (SGLT2) inhibitors before expiration their foundational patents. By analyzing these pre-expiration strategies, balance between genuine innovation evergreening is addressed. The analysis covers legal, regulatory, clinical dimensions indication expansions across US, EU, Japan, contrasting with traditional focus on LCM post-patent expiration.

Language: Английский

Efficacy and safety of SGLT2 inhibitors with and without glucagon-like peptide 1 receptor agonists: a SMART-C collaborative meta-analysis of randomised controlled trials DOI
Ellen M. Apperloo, Brendon L. Neuen, Robert A. Fletcher

et al.

The Lancet Diabetes & Endocrinology, Journal Year: 2024, Volume and Issue: 12(8), P. 545 - 557

Published: July 8, 2024

Citations

41

Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials DOI
Sunil V. Badve, Anika Bilal, Matthew M.Y. Lee

et al.

The Lancet Diabetes & Endocrinology, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 1, 2024

Language: Английский

Citations

16

The prevalence of chronic kidney disease in people with severe mental illness: A systematic review protocol DOI Creative Commons
Claire Carswell, Kate Bramham, Joseph Chilcot

et al.

PLoS ONE, Journal Year: 2025, Volume and Issue: 20(1), P. e0310568 - e0310568

Published: Jan. 31, 2025

People with severe mental illness (SMI) are more likely to develop long-term physical health conditions, including type 2 diabetes and cardiovascular disease, compared people without SMI. This contributes an inequality in life expectancy known as the 'mortality gap'. Chronic kidney disease (CKD) is a growing global concern set be 5th leading cause of life-years lost by 2040. However, there limited research exploring relationship between CKD systematic review will aim examine prevalence incidence among We search Medline, Embase, PsycINFO, CINAHL, Scopus Web Science for primary epidemiological reporting or SMI any setting. Retrieved records managed Covidence screened two independent reviewers. Data extracted from included studies using piloted data extraction form, quality evaluated appropriate JBI Critical Appraisal Checklist. The certainty evidence assessed Grading Recommendations, Assessment, Development, Evaluations (GRADE) approach. narratively synthesised. Meta-analyses conducted random effects models There SMI, this proposed first highlight extent problem provide foundation future improve outcomes

Language: Английский

Citations

1

Closing CKD Treatment Gaps: Why Practice Guidelines and Better Drug Coverage Are Not Enough DOI
Anukul Ghimire, Christoph Wanner, Marcello Tonelli

et al.

American Journal of Kidney Diseases, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 1, 2025

Language: Английский

Citations

0

Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: rationale and design of a randomized controlled trial. DOI
Nancy Haff, Daniel M. Horn,

Gauri Bhatkhande

et al.

American Heart Journal, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 1, 2025

Language: Английский

Citations

0

Hypertension in chronic kidney disease and future heart failure DOI

Michel Burnier

Current Opinion in Cardiology, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 11, 2025

Hypertension and chronic kidney diseases (CKDs) are known risk factors for the development or worsening of heart failure. In last years, several new therapeutic approaches management people with diabetic nondiabetic CKD hypertension have been investigated. this brief review, most recent findings regarding ability SGLT-2 inhibitors nonsteroidal mineralocorticoid receptor antagonists (nsMRA) GLP-1 agonists to prevent failure in patients will be discussed. 3 large clinical trials involving very numbers published showing that these significantly reduce events hospitalizations nephropathies as well without nephropathy. Moreover, drugs retard progression towards end-stage disease. These observations already a major impact on CKD. now recommended first-line therapy diabetes, The use nsMRA is increasing could replace spironolactone over time early stages.

Language: Английский

Citations

0

Illnesses associated with ketosis including diabetic ketoacidosis during very low carbohydrate and ketogenic diets DOI Creative Commons
Caroline G. P. Roberts, Shaminie J. Athinarayanan,

Robert E. Ratner

et al.

Diabetes Obesity and Metabolism, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 25, 2025

Abstract Aims Ketogenic diets are used by individuals with obesity and type 2 diabetes for improved glycaemic control, reduced appetite weight loss. However, the risks associated higher ketone levels, including diabetic ketoacidosis (DKA), in without not well‐documented. Materials Methods We analysed real world data from a single‐centre telemedicine clinic specializing very low carbohydrate ketogenic diet (VLCKD) as lifestyle intervention. Illnesses ketosis (IAK) were defined beta‐hydroxybutyrate (BHB) levels ≥3 mmol/L when patients sought in‐person care. estimated IAK DKA incidence rate diabetes. Results In 72 751 patient‐years of follow‐up, 86 people had (incidence 1.18 per 1000 person‐years). 22 347 follow‐up diabetes, was 0.04 person‐years no cases. 50 404 (PWD), rates 1.69 1.01 person‐years, respectively. 12 763 PWD using SGLT2‐inhibitors, 2.90 patient‐years. Conclusions Very generally safe IAK, DKA, The on VLCKD who also SGLT2‐inhibitors may be manageable through at‐home monitoring BHB levels.

Language: Английский

Citations

0

Impact of hospital-based early detection on management in chronic kidney disease: the CKD Stewardship study (CKD-S) – protocol for a prospective, multicentre, observational cohort study DOI Creative Commons
Lucinda Alix Wynter, Brendan Smyth,

John R. Saunders

et al.

BMJ Open, Journal Year: 2025, Volume and Issue: 15(3), P. e094554 - e094554

Published: March 1, 2025

Chronic kidney disease (CKD) causes significant morbidity and mortality. Medical therapies can reduce the progression of by up to 50%. CKD is undiagnosed in majority people who have it, resulting undertreatment. Stewardship (CKD-S) aims identify hospital inpatients with mid-stage late-stage goal facilitating diagnosis initiating guideline-based therapies. This prospective, multicentre, cohort study compares two models care, CKD-S standard for identification management CKD, across six public hospitals metropolitan Sydney, Australia. entails active case finding using electronic medical record, nephrologist outreach admitting teams nurse provided patient education. Adult an admission estimated glomerular filtration rate (eGFR)<45 mL/min/1.73 m2 not known a will be eligible, excluding those short life expectancy or advanced age (>80 years). Participants enrolled between 1 March 2024 2025. Baseline demographic data collected after discharge from hospital. followed 12 months Pharmaceutical Benefits Schedule data, linked via Australian Institute Health Welfare Hub. We report proportion all adults admitted are already nephrologist, which stage 3b-5 recognised intervention team, compared care. then compare each eGFR urine albumin:creatinine ratio measured, referred prescribed guideline-directed over following The has ethics approval Sydney Local District's Ethics Committee (Concord Hospital Zone). results published peer-reviewed journals presented at academic conferences. ACTRN12624000452594.

Language: Английский

Citations

0

The prevalence of chronic kidney disease in people with severe mental illness: A systematic review protocol DOI Creative Commons
Claire Carswell, Kate Bramham, Joseph Chilcot

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 5, 2024

Abstract Background People with severe mental illness (SMI) are more likely to develop long-term physical health conditions, including type 2 diabetes and cardiovascular disease, compared people without SMI. This contributes an inequality in life expectancy known as the ‘mortality gap’. Chronic kidney disease (CKD) is a growing global concern set be 5th leading cause of life-years lost by 2040. However, there limited research exploring relationship between CKD systematic review will aim examine prevalence incidence among Methods We search Medline, Embase, PsycINFO, CINAHL, Scopus Web Science for primary epidemiological reporting or SMI any setting. Retrieved records managed Covidence screened two independent reviewers. Data extracted from included studies using piloted data extraction form, quality evaluated appropriate JBI Critical Appraisal Checklist. The certainty evidence assessed Grading Recommendations, Assessment, Development, Evaluations (GRADE) approach. narratively synthesised. Meta-analyses conducted random effects models Discussion There SMI, this proposed first highlight extent problem provide foundation future improve outcomes

Language: Английский

Citations

2

Unlocking the potential: boosting SGLT2 inhibitor uptake to prevent the cardiorenal consequences of chronic kidney disease DOI Creative Commons
Julio A. Lamprea‐Montealegre

The Lancet Regional Health - Western Pacific, Journal Year: 2024, Volume and Issue: 43, P. 101004 - 101004

Published: Jan. 15, 2024

Chronic kidney disease (CKD) is projected to become the fifth leading cause of death worldwide by 2030.1Foreman K.J. Marquez N. Dolgert A. et al.Forecasting life expectancy, years lost, and all-cause cause-specific mortality for 250 causes death: reference alternative scenarios 2016-40 195 countries territories.Lancet. 2018; 392: 2052-2090Summary Full Text PDF PubMed Scopus (1102) Google Scholar Considering its severe health consequences, including renal cardiovascular complications, it imperative adopt measures that mitigate these risks from both clinical public perspectives. The advent SGLT2 inhibitors marks a significant advancement in therapeutic options prevent cardiorenal consequences CKD. With robust evidence supporting their efficacy, time now intensify implementation efforts ensure life-saving drugs reach patients who need them most. As class, have consistently demonstrated protective effects. Meta-analyses randomized trials involving with CKD shown reductions progression, end-stage disease, acute injury, heart failure hospitalizations, mortality.2Nuffield Department Population Health Renal Studies GroupSGLT2 inhibitor Meta-Analysis Cardio-Renal Trialists' ConsortiumImpact diabetes on effects sodium glucose co-transporter-2 outcomes: collaborative meta-analysis large placebo-controlled trials.Lancet. 2022; 400: 1788-1801Summary (182) These been observed across spectrum are evident irrespective presence diabetes. However, despite compelling protection, data potential impact medications broader population still relatively scarce. In Lancet Regional Health—Western Pacific,3Neuen B.L. Jun M. Wick J. al.Estimating population-level impacts improved uptake chronic disease: cross-sectional observational study using routinely collected Australian primary care data.Lancet Reg Western Pac. 2024; 43100988https://doi.org/10.1016/j.lanwpc.2023.100988Summary Neuen colleagues report comprehensive analysis conducted MedicineInsight, nationally representative individual-level dataset encompassing 392 practices Australia. aimed quantify absolute number cardio-renal events potentially preventable through optimal usage– defined as 75% among adult population. authors utilized MedicineInsight identify an eGFR < 60 ml/min/1.73 m2 and/or urinary albumin creatinine ratio >3.4 mg/mmol. individuals were then matched inclusion criteria three pivotal CKD: CREDENCE, DAPA-CKD, EMPA-KIDNEY. Subsequently, they extrapolated age- sex-stratified prevalence (using different UACR definitions) national census data. This allowed estimate Australia, drawing effectiveness trials. Overall, during 2020–2021, 147,119 (12.1%) adults found > 3.5 Nearly half (44%) met EMPA-KIDNEY, 17% 7% CREDENCE.4Perkovic V. Jardine M.J. Neal B. al.Canagliflozin outcomes type 2 nephropathy.N Engl J Med. 2019; 380: 2295-2306Crossref (3459) Scholar, 5Heerspink H.J.L. Stefánsson B.V. Correa-Rotter R. al.Dapagliflozin disease.N 2020; 383: 1436-1446Crossref (2191) 6Herrington W.G. Staplin Wanner C. al.The EMPA-KIDNEY Collaborative Group. Empagliflozin 2023; 388: 117-127Crossref (0) Compared trials, was older, had higher eGFR, less likely established disease. Notably, renin angiotensin system (RAS) blockade usage substantially lower compared where virtually all participants background RAS inhibition. Baseline use very low ranging 4.1% eligible 14.4% CREDENCE patients. Using strict (eGFR 3.4 mgl/L at least occasions, 90 days apart), yielded numbers needed treat (NNT) one event 14 25, 15 27 avert over years. estimates translated into more than 3500 1000 could be prevented annually this therapy. findings remained various definitions, thresholds "optimal use," or absence provides valuable glimpse tangible real-world setting. It underscores key points: portion benefit inhibitors; current disappointingly low, only 15% high-risk (eligible CREDENCE) treatment; and, implementations yield benefits, far outweighing adverse study's limitation reliance rather directly inhibitors, trial Discrepancies often exist between demographic characteristics Additionally, medication adherence real world may not levels reducing expected benefits. Therefore, future studies should measure adherence, side effects, discontinuation rates accurately assess general Despite benefits society, remains strikingly low. Structural barriers care, such inadequate testing albuminuria treatment paradox those albuminuria—and consequently risk—are receive preventive treatments,7Chu C.D. Xia F. Du Y. al.Estimated US risk disease.JAMA Netw Open. 6e2326230Crossref (1) Scholar,8Lamprea-Montealegre J.A. Madden E. Tummalapalli S.L. al.Prescription patterns cardiovascular- kidney-protective therapies disease.Diabetes Care. 45: 2900-2906Crossref exacerbated SGLT2-specific challenges. include high costs, racial ethnic disparities prescriptions, lack knowledge about indications, effects.9Tummalapalli Montealegre J.L. Warnock Green Ibrahim S.A. Estrella M.M. Coverage, formulary restrictions, affordability sodium-glucose cotransporter insurance plan types.JAMA Forum. 2021; 2e214205Crossref (9) Scholar,10Lamprea-Montealegre al.Association race ethnicity prescription GLP1 receptor agonists veterans administration system.JAMA. 328: 861-871Crossref (20) To address barriers, coordinate multi-disciplinary critically needed. substantial advantages can realized proper warrant immediate concerted action. JALM supported funding National Heart, Lung, Blood Institute (1K99HL157721-01A1) related topic. Estimating dataImproved Australia has experiencing progression dying due Identifying strategies increase critical realising drug class. Full-Text Open Access

Language: Английский

Citations

1