Article
Endocrinology & Metabolism
Sang-Jun Cho, In-Sun Oh, Han Eol Jeong, Young Min Cho, Yul Hwangbo, Oriana Hoi Yun Yu, Ju-Young Shin
Summary: This study compared the treatment patterns and clinical outcomes of single-pill fixed-dose combination (FDC) therapy and two-pill combination (TPC) therapy in patients with type 2 diabetes using real-world data from South Korea. The results showed that FDC therapy had better medication adherence and was associated with a reduced risk of cardiovascular events, particularly stroke, and hospitalization.
DIABETES OBESITY & METABOLISM
(2022)
Article
Pharmacology & Pharmacy
Claudia Veloso, Romeu A. Videira, Paula B. Andrade, Catarina Cardoso, Carla Vitorino
Summary: The combination of multiple active pharmaceutical ingredients in a fixed-dose combination product for topical administration shows potential in treating various pathologies, including pain. This study presents information on accepted in vitro tests for assessing the safety of topical products and the commonly used methods for evaluating anti-inflammatory activity. Additionally, a new approach for selecting fixed-dose combination products to enhance therapeutic effects is rationalized.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Health Policy & Services
Laila Carolina Abu Esba, Consuela Yousef, Sherine Ismail, Murtada Halim, Hind Almodaimegh, Hana Abdullah Al-Abdulkarim, Mansour Alhowimel
Summary: Determining whether a fixed-dose combination (FDC) is beneficial to a healthcare organization requires a comprehensive consideration of evidence, practicality, and cost.
HEALTH POLICY AND TECHNOLOGY
(2021)
Article
Chemistry, Medicinal
Claudia Veloso, Catarina Cardoso, Carla Vitorino
Summary: Pain is a severe public health problem, and combining active pharmaceutical ingredients with multiple mechanisms of action may be more effective than traditional monotherapy. Topical drug delivery has advantages such as high efficacy, better safety profile, and good patient compliance. Fixed-dose combinations for topical administration could be a promising therapeutic option for pain management.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Pharmacology & Pharmacy
Jin-Woo Park, Jong-Min Kim, Ji Hyeon Noh, Kyoung-Ah Kim, Hyewon Chung, EunJi Kim, Minja Kang, Ji-Young Park
Summary: This study investigated the pharmacokinetic equivalence between different formulations of dapagliflozin and linagliptin, and found that the pharmacokinetic characteristics were similar and the combined use was safe and tolerable.
Article
Pharmacology & Pharmacy
Agata Gorniak, Adrianna Zlocinska, Mateusz Trojan, Adrianna Pecak, Bozena Karolewicz
Summary: The simvastatin-ezetimibe solid dispersion prepared using the co-grinding method showed improved dissolution of ezetimibe regardless of simvastatin content. The study also confirmed a simple eutectic phase equilibrium diagram between simvastatin and ezetimibe.
Article
Chemistry, Medicinal
Eunsol Yang, Hyounggyoon Yoo, In-Jin Jang, Kyung-Sang Yu, SeungHwan Lee
Summary: The study aimed to compare the pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/rosuvastatin 50/20 mg in a bilayer tablet with that in a monolayer tablet. Results showed that the bilayer tablet demonstrated equivalent PK and PD properties, suggesting it could be a viable alternative to the monolayer tablet for healthy subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Pharmacology & Pharmacy
Olufunke Esan Olorundare, Adejuwon Adewale Adeneye, Akinyele Olubiyi Akinsola, Abayomi Mayowa Ajayi, Olalekan Ayodele Agede, Sunday Sokunle Soyemi, Alban Ikenna Mgbehoma, Ikechukwu Innocent Okoye, Ralph M. Albrecht, James Mukasa Ntambi, Peter Anthony Crooks
Summary: This study unveiled the promising therapeutic potentials of amlodipine, lisinopril, valsartan, and their fixed-dose combinations in the management of TZM cardiotoxicity, majorly mediated via antiapoptotic and oxidative stress inhibition mechanisms.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Pharmacology & Pharmacy
Claudia Veloso, Romeu A. Videira, Paula B. Andrade, Catarina Cardoso, Carla Vitorino
Summary: This article discusses the application of fixed-dose combination products in pain management and emphasizes the role of animal models in evaluating the efficacy and safety of these formulations.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Ophthalmology
Nilima A. Kshirsagar, Renuka Munshi, Sandeep B. Bavdekar, Rohit Saxena
Summary: This paper discusses the ingredients of some Fixed Dose Combinations (FDCs) marketed for Dry Eye Syndrome (DES), emphasizing the need for careful evaluation of their ingredients and efficacy and safety data, and prescribing them only if necessary.
INDIAN JOURNAL OF OPHTHALMOLOGY
(2022)
Article
Thermodynamics
Agata Gorniak, Hanna Czapor-Irzabek, Adrianna Zlocinska, Bozena Karolewicz
Summary: The study demonstrated that the solid dispersions of ezetimibe and aspirin prepared in this work can release the drugs more quickly, proving the effectiveness of this formulation in enhancing drug dissolution.
JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY
(2021)
Article
Pharmacology & Pharmacy
Abdulmajeed A. Althobaiti, Eman A. Ashour, Ahmed Almotairy, Mashan Almutairi, Mohammed AlYahya, Michael A. Repka
Summary: This study aimed to design and develop different dosage forms of nifedipine/indomethacin fixed-dose combination (FDC) to provide delayed-extended and immediate release profiles. The developed FDC dosage forms showed significant improvement in drug release profiles and remained stable during the stability study. These designed dosage forms could enhance patient compliance and improve the quality of life.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2023)
Article
Infectious Diseases
Pooja Anand, Navjot Kaur, Veena Verma, Nusrat Shafiq, Samir Malhotra
Summary: India is one of the largest consumers of antibiotics and the easy availability and growing sales of Fixed Dose Combinations (FDCs) of antibiotics can worsen Antimicrobial Resistance (AMR). A study found that over 90% of existing FDCs were irrational, with two thirds of them being unapproved or banned from use in the country. Despite regulatory awareness, there is an urgent need to reassess these FDCs in order to promote prudent antibiotic use.
EXPERT REVIEW OF ANTI-INFECTIVE THERAPY
(2022)
Article
Medicine, Research & Experimental
Yujing Di, Zhaojun Wang, Chuandong Jia, Xin Xie, Shanshan Yang, Wenhua Wang, Xiaochuan Xie, Qian Wang, Chanyan Hu, Fang Xie, Mohamed Abdel-Moneim, Lionel Hovsepian, Yanzhen Wu, Na Yang, Jie Hou
Summary: This study evaluated the bioequivalence of ezetimibe/rosuvastatin fixed dose combination compared to the concomitant administration of individual formulations in healthy Chinese subjects under fasting conditions. The results showed that the fixed dose combination achieved bioequivalence with reference to commercial tablets.
ADVANCES IN THERAPY
(2023)
Review
Pharmacology & Pharmacy
Qiran Wei, Jiting Zhou, Hongchao Li, Luying Wang, Yao Wu, Aixia Ma, Xin Guan
Summary: This study conducted a large-scale meta-analysis and subgroup analysis to compare the effect of fixed-dose combination (FDC) therapy with that of free-equivalent combination (FEC) therapy on medication adherence. The results showed that FDC significantly improved medication compliance compared to FEC. Subgroup analyses also revealed differences in the impact of FDC on different disease types, evaluation periods, and compliance indicators.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Deepak L. Bhatt, Michael Szarek, Bertram Pitt, Christopher P. Cannon, Lawrence A. Leiter, Darren K. McGuire, Julia B. Lewis, Matthew C. Riddle, Silvio E. Inzucchi, Mikhail N. Kosiborod, David Z. I. Cherney, Jamie P. Dwyer, Benjamin M. Scirica, Clifford J. Bailey, Rafael Diaz, Kausik K. Ray, Jacob A. Udell, Renato D. Lopes, Pablo Lapuerta, P. Gabriel Steg
Summary: The trial involving 10,584 patients with diabetes and chronic kidney disease showed that sotagliflozin resulted in fewer deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure compared to placebo. However, there were adverse events such as diarrhea, mycotic infections, and diabetic ketoacidosis associated with sotagliflozin.
NEW ENGLAND JOURNAL OF MEDICINE
(2021)
Review
Cell & Tissue Engineering
Hilary E. Murray, Ali Zafar, Khalid M. Qureshi, Michelle B. Paget, Clifford J. Bailey, Richard Downing
Summary: Pancreatic islet cell transplantation is effective for treating type 1 diabetes, but is limited by donor organ availability and transplant procedure factors. Human amniotic epithelial cells show potential for improving outcomes by protecting islet function.
JOURNAL OF TISSUE ENGINEERING AND REGENERATIVE MEDICINE
(2021)
Article
Endocrinology & Metabolism
Michelle B. Paget, Hilary E. Murray, Clifford J. Bailey, Richard Downing
Summary: The journey towards islet transplantation as a treatment for type 1 diabetes began with Paul Langerhans' discovery of tissue islands in the pancreas in 1869. Advances in biosciences, surgery, gene therapy, and clinical research have led to the development of surrogate insulin-secreting cells from pluripotent stem cells and non-beta cells within the pancreas. Additionally, xenotransplants such as porcine islets are being reconsidered as potential alternatives to overcome safety concerns and immune rejection.
DIABETES OBESITY & METABOLISM
(2022)
Article
Endocrinology & Metabolism
James R. Gavin, Clifford J. Bailey
Summary: This review examines recent real-world evidence (RWE) on the benefits of continuous glucose monitoring (CGM) in improving clinical outcomes, such as avoiding severe hypoglycemic and hyperglycemic crises, and enhancing measures of psychological health and quality of life. Additionally, it explores the role of CGM in optimizing health care resource utilization, including predicting T1D and applications in gestational diabetes, chronic kidney disease, and surgical monitoring.
DIABETES TECHNOLOGY & THERAPEUTICS
(2021)
Review
Endocrinology & Metabolism
Srikanth Bellary, Ioannis Kyrou, James E. Brown, Clifford J. Bailey
Summary: The prevalence of type 2 diabetes mellitus (T2DM) is increasing among the aging population, presenting challenges in management due to patient heterogeneity, comorbidities, susceptibility to hypoglycemia, increased dependence on care, and frailty. This review focuses on the pathophysiological mechanisms of T2DM in older individuals, new evidence on frailty and sarcopenia, clinical difficulties related to age-associated comorbidities, and implications for guidelines and therapeutic options, highlighting the impact of T2DM on an aging society.
NATURE REVIEWS ENDOCRINOLOGY
(2021)
Review
Endocrinology & Metabolism
Clifford J. Bailey, Caroline Day, Srikanth Bellary
Summary: This review evaluates the nephroprotective effects of sodium-glucose co-transporter-2 (SGLT2) inhibitors in people with type 2 diabetes, highlighting their ability to slow down the decline in glomerular filtration rate, reduce microalbuminuria, and slow or reverse proteinuria. These effects are not limited to diabetes patients and extend to non-diabetic, lean, and normotensive individuals as well. The mechanisms behind these effects include tubuloglomerular feedback, improved tubular oxygenation and metabolism, and reduced inflammation and fibrosis. The use of SGLT2 inhibitors has not shown increased risk of urinary tract infections or acute kidney injury.
CURRENT DIABETES REPORTS
(2022)
Article
Biochemistry & Molecular Biology
Isaac Ampong, O. John Ikwuobe, James E. P. Brown, Clifford J. Bailey, Dan Gao, Jorge Gutierrez-Merino, Helen R. Griffiths
Summary: High dietary fat intake reduces the levels of odd chain saturated fatty acids, affects gut microbiota and liver lipid metabolism, and is associated with increased risk of metabolic diseases.
INTERNATIONAL JOURNAL OF BIOCHEMISTRY & CELL BIOLOGY
(2022)
Editorial Material
Biochemistry & Molecular Biology
J. Michael Conlon, Peter R. Flatt, Clifford J. Bailey
Editorial Material
Endocrinology & Metabolism
Clifford Bailey
LANCET DIABETES & ENDOCRINOLOGY
(2021)
Review
Endocrinology & Metabolism
Guntram Schernthaner, Kerstin Brand, Clifford J. Bailey
Summary: Metformin, a drug used for treating type 2 diabetes, has been replaced to some extent by newer antidiabetic medications. However, research on its potential cardiovascular benefits continues.
METABOLISM-CLINICAL AND EXPERIMENTAL
(2022)
Review
Pharmacology & Pharmacy
Clifford J. Bailey, Mike Gwilt
Summary: The clinical literature review shows that metformin treatment in Covid-19 patients with diabetes can improve clinical outcomes, reduce admission into intensive care, and decrease mortality. The pleiotropic actions of metformin, such as reducing insulin resistance and inflammation, may play a role in these effects. Modulation of the ACE2 protein via the AMP kinase pathway could also be involved. However, caution should be exercised in patients with severe Covid-19, as metformin withdrawal may be necessary to avoid acidosis and lactic acidosis.
FRONTIERS IN PHARMACOLOGY
(2022)
Review
Endocrinology & Metabolism
Christophe De Block, Clifford Bailey, Carol Wysham, Andrea Hemmingway, Sheryl Elaine Allen, Jennifer Peleshok
Summary: Tirzepatide is a novel drug that improves glycemic control and aids weight loss in patients with type 2 diabetes. It also shows potential for treatment of other conditions. Clinical trials have demonstrated that Tirzepatide has better effects on reducing glycated hemoglobin and body weight compared to GLP-1 receptor agonists, with a lower risk of hypoglycemia.
DIABETES OBESITY & METABOLISM
(2023)
Article
Endocrinology & Metabolism
James R. R. Gavin III, Clifford J. Bailey
Summary: Randomized controlled trials show the benefits of continuous glucose monitoring (CGM) in intensive insulin regimens for diabetes patients. Other studies have investigated CGM's impact on nonintensive therapies, leading to changes in payer coverage and expanding use. This article reviews recent real-world studies, highlights key lessons, and discusses increasing access to CGM for all diabetes patients.
DIABETES TECHNOLOGY & THERAPEUTICS
(2023)
Review
Pharmacology & Pharmacy
Keith G. Thomas, Natalie J. Klempel, Peter R. Flatt, Clifford J. Bailey, R. Charlotte Moffett
Summary: This short review examines the early studies performed with Syn A in animals and diabetic patients, finding that excess glucagon secretion from pancreatic alpha-cells is a problem in both type 1 and type 2 diabetes. Therefore, therapeutic strategies aimed at limiting the number or function of alpha-cells might be worthy of reconsideration.
JOURNAL OF PHARMACY AND PHARMACOLOGY
(2023)
Article
Biochemistry & Molecular Biology
Clifford J. Bailey, Peter R. Flatt, J. Michael Conlon
Summary: Long-acting analogues of GLP-1 and GLP-1R/GIP-R dual agonists have shown high efficacy in lowering glucose levels and promoting weight loss. These peptide-based therapies provide a promising approach for treating T2D and obesity. Semaglutide, an GLP-1R agonist, has shown particularly high efficacy and is available in oral and injectable formulations. Other pharmacological approaches, such as monoclonal antibodies and agonists targeting different receptors, are also being explored for chronic weight management. However, the high demand for GLP-1R agonists as anti-obesity agents has caused a shortage, leading to their prioritized use in T2D therapy.