-
Association Between First-Time Neurologic Events and Metronidazole Treatment: A Case-Time Control Study Clin. Ther. (IF 3.2) Pub Date : 2024-03-15 Michael Asger Andersen, Rasmus Gregersen, Tonny Studsgaard Petersen, Joanna Nan Wang, Janne Petersen, Espen Jimenez-Solem
[Display omitted]
-
Clinical Impact of Vancomycin MIC on Outcomes in Patients With Coagulase-negative Staphylococcal Bacteremia Clin. Ther. (IF 3.2) Pub Date : 2024-03-15 Wade Wheat PharmD BCIDP AAHIVP, Brenda Simiyu PharmD BCPS BCIDP AAHIVP, Gabriela Andonie PharmD BCIDP AAHIVP, Lillian Bellfi PharmD BCCCP
Coagulase-negative staphylococci (CoNS) are Gram-positive organisms that are a known component of normal skin flora and the most common cause of nosocomial bacteremia. For CoNS species, the vancomycin MIC breakpoint for susceptibility set by the Clinical and Laboratory Standards Institute is ≤4 µg/mL. There has been published reports of vancomycin heteroresistance in CoNS with vancomycin MICs of 2
-
Advanced Model-Based Approach to Evaluate Human Plasma, Cerebrospinal Fluid, and Neuronal mTORC1 Activation Biomarkers After NV-5138 Administration in Healthy Volunteers Clin. Ther. (IF 3.2) Pub Date : 2024-03-13 Azmi Nasser PhD, J. Randall Owen MD, Roberto Gomeni PhD FCP, Alisa R. Kosheleff PhD, Jeanelle Portelli PhD, Lilian W. Adeojo PharmD, Thomas E. Hughes PhD
NV-5138 ([S]-2-amino-5,5-difluoro-4,4-dimethylpentanoic acid) is an orally bioavailable, small-molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) pathway in development for treatment-resistant depression. The authors established a model to describe the relationship between plasma and cerebrospinal fluid (CSF) concentrations of NV-5138 and between CSF concentrations and potential
-
Nirmatrelvir and ritonavir Clin. Ther. (IF 3.2) Pub Date : 2024-03-07 P, a, u, l, , B, e, n, i, n, g, e, r, , M, D, , M, B, A
-
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia Clin. Ther. (IF 3.2) Pub Date : 2024-02-29 Abdulkadir Urgessa Jada, Gashahun Mekonnen Disassa, Belete Habte Melesse, Mohammed Mecha Abafogi, Eyob Girma Abera, Kelil Hussein Jibicho, Kedir Negesso Tukeni
Warfarin is effective therapy to prevent thromboembolic complications of venous thromboembolism, atrial fibrillation, and cardiac thrombus, among valvular heart diseases, including in patients treated with prostheses and/or repair. Its optimum effect is achieved when the international normalized ratio (INR) is in the target therapeutic range, but a subtherapeutic level increases risk of thromboembolism
-
Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study Clin. Ther. (IF 3.2) Pub Date : 2024-02-24 Francelise Bridi Cavassin, Marcello Mihailenko Chaves Magri, Jose Ernesto Vidal, Fabianne Altruda de Moraes Costa Carlesse, Diego Rodrigues Falci, João Luís Baú-Carneiro, Giovanni Luís Breda, Fábio de Araújo Motta, Cássia Silva de Miranda Godoy, Renata de Bastos Ascenço Soares, Carla Sakuma De Oliveira, Ana Verena Almeida Mendes, Hugo Paz Morales, Patrícia Silva Montes, Mariane Taborda, Caroline Martins
Data on the real-life use of amphotericin B lipid complex (ABLC) compared with other available formulations are limited. This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC. This
-
Comparison of Empiric Antibiotic Treatment Regimens for Hospitalized, Non-severe Community-acquired Pneumonia: A Retrospective, Multicenter Cohort Study Clin. Ther. (IF 3.2) Pub Date : 2024-02-24 Sidney D. Reeves, Aaron P. Hartmann, Amanda C. Tedder, Paul A. Juang, Mikaela Hofer, Marin H. Kollef, Scott T. Micek, Kevin D. Betthauser
Consensus guidelines for hospitalized, non-severe community-acquired pneumonia (CAP) recommend empiric macrolide + β-lactam or respiratory fluoroquinolone monotherapy in patients with no risk factors for resistant organisms. In patients with allergies or contraindications, doxycycline + β-lactam is a recommended alternative. The purpose of this study was to compare differences in outcomes among guideline-recommended
-
-
Physiologically Based Pharmacokinetic Modeling of Lacosamide in Patients With Hepatic and Renal Impairment and Pediatric Populations to Support Pediatric Dosing Optimization Clin. Ther. (IF 3.2) Pub Date : 2024-02-17 Xinyu Zhu, Lingfeng Guo, Lei Zhang, Yichao Xu
-
Effect of Optimizing the Induction Regimen in Preventing Cough Reactions in Patients Undergoing General Anesthesia: A Prospective Randomized Controlled Study Clin. Ther. (IF 3.2) Pub Date : 2024-02-16 Lei Wang, Xing Lu, Yi Cheng, You-chuan Zhang, De-xiang Zhao, Yan-hong Zhu
During the induction of general anesthesia, opioids and endotracheal intubation may cause coughing. This study aimed to investigate the safety and effectiveness of an optimized drug induction scheme for general anesthesia to prevent coughing in patients. A total of 220 patients aged 18 to 65 years who underwent surgery under general anesthesia with endotracheal intubation were randomly assigned to
-
Therapeutic Effect and Side Effects of Pharmacotherapy in Patients With Parkinson Disease and Myasthenia Gravis: A Systematic Review of Case Reports and Case Series Studies Clin. Ther. (IF 3.2) Pub Date : 2024-02-14 Haoyu Xie, Yadi Liu, Cindy Schmidt, Jung Hung Chien, Chuhuai Wang
The co-existence of Parkinson disease (PD) and myasthenia gravis (MG) in an individual should be exceptionally rare. The purpose of this study was to systematically review the current literature regarding the therapeutic effect and side effects of pharmacotherapy on patients with PD and MG. Five bioscience and engineering databases (MEDLINE via PubMed, Cochrane Library, Scopus, EMBASE, and China National
-
Efficacy of Sevoflurane and Propofol Anesthesia on Perioperative Adverse Cardiovascular Events and Hemodynamics in Elderly Patients With Diabetes Clin. Ther. (IF 3.2) Pub Date : 2024-02-12 Liling Jia, Hongfeng Li, Tuping Li
This study was undertaken to compare the effects of sevoflurane and propofol anesthesia on perioperative hemodynamics and perioperative adverse cardiovascular events (PACE) in elderly patients with diabetes undergoing general anesthesia for noncardiac surgery. According to the random number table (n = 40), 80 patients with diabetes undergoing noncardiac general anesthesia were divided into a control
-
Effect of Household Income on Cardiovascular Diseases, Cardiovascular Biomarkers, and Socioeconomic Factors Clin. Ther. (IF 3.2) Pub Date : 2024-02-12 Mengjin Hu, Boyu Li, Tao Yang, Yuejin Yang, Chunlin Yin
To examine whether household income is causally related to cardiovascular diseases and investigate the potential reasons. Using 2-sample Mendelian randomization analyses, we obtained summary statistics from genome-wide association studies of household income and a range of cardiovascular diseases, biomarkers, and socioeconomic factors. Higher household income was causally associated with lower risks
-
-
-
Use of Dulaglutide, Semaglutide, and Tirzepatide in Diabetes and Weight Management Clin. Ther. (IF 3.2) Pub Date : 2024-02-02 Jason Powell, James Taylor
Glucagon-like peptide 1 receptor agonists (GLP1-RA) are effective therapies in lowering glycosylated hemoglobin (HbA), providing cardioprotective benefits, and lowering weight. The use of GLP1-RA solely for weight-loss has become commonplace in many practices, which in turn has made it difficult in some areas for those with type 2 diabetes (T2DM) to obtain these much-needed medications. Using recent
-
The Safety and Efficacy of Abaloparatide on Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis Clin. Ther. (IF 3.2) Pub Date : 2024-02-02 Fuxin Xu, Yurun Wang, Xinjian Zhu
The aging of the population increases the incidence of postmenopausal osteoporosis, which threatens the health of elderly women. Abaloparatide is a synthetic peptide analogue of the human parathyroid hormone–related protein that has recently been approved for the treatment of postmenopausal osteoporosis. Its efficacy and safety have not been systematically evaluated. Therefore, studies on the efficacy
-
A Physiologically Based Pharmacokinetic Modeling Approach to Assess the Potential for Drug Interactions Between Trofinetide and CYP3A4-Metabolized Drugs Clin. Ther. (IF 3.2) Pub Date : 2024-02-02 Mona Darwish, James M. Youakim, Inger Darling, Viera Lukacova, Joel S. Owen, Heather Bradley
-
Predicting Factors of Long-term Outcome of Gastrointestinal Behçet's Disease: A Chinese Retrospective Study Clin. Ther. (IF 3.2) Pub Date : 2024-01-30 Xiaoman Zu, Shanshan Xiong, Yaming Lu, Ning Zhang, Shu Xu, Rui Feng, Baili Chen, Zhirong Zeng, Minhu Chen, Yao He
Purpose Behçet's disease (BD) is a complex disorder affecting multiple systems and organs, and gastrointestinal BD is poorly understood. We aimed to identify factors influencing the long-term outcomes of patients with gastrointestinal BD. Methods Consecutive patients with gastrointestinal BD were analyzed retrospectively. Data on the following clinical characteristics were collected: sex, age at diagnosis
-
Real-World Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM Clin. Ther. (IF 3.2) Pub Date : 2024-01-25 Thomas C. Kühler, Aritz Ateka, Zeineb Lassoued, François-Xavier Routhier, Souha Mékary-Sawaya
Purpose We studied under which circumstances and to what extent Real-World Data (RWD) and Real-World Evidence (RWE) were used in regulatory decisions when switching products from Prescription-only (Rx) to Over-the-Counter (OTC) status with the aim of extracting learnings that could be applied in future switches. Methods Sanofi commissioned Clarivate Analytics to identify switches from Rx to OTC in
-
Low-Dose Naltrexone Improves post–COVID-19 condition Symptoms Clin. Ther. (IF 3.2) Pub Date : 2024-01-23 Leonardo Tamariz, Elizabeth Bast, Nancy Klimas, Ana Palacio
Purpose Treatments for myalgic encephalomyelitis and chronic fatigue syndrome can be adapted for post–COVID-19 condition. Our aim was to compare treatments in patients from our post–COVID-19 clinic. Methods We conducted a retrospective cohort study and included consecutive patients enrolled in our post–COVID-19 clinic. We included patients who received low-dose naltrexone, amitriptyline, duloxetine
-
Joint Flexibility and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome After Mononucleosis Clin. Ther. (IF 3.2) Pub Date : 2024-01-18 Jeffrey Thomas Poomkudy, Chelsea Torres, Leonard A. Jason, Joseph Fishbein, Ben Z. Katz
Purpose Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic disease characterized by substantial fatigue, postexertional malaise, unrefreshing sleep, and orthostatic intolerance, among other symptoms. Specific risk factors for the development of ME/CFS have not been adequately characterized. It has been suggested that ME/CFS is a connective tissue disorder and that joint hyperflexibility
-
The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance Clin. Ther. (IF 3.2) Pub Date : 2024-01-16 Dawn Cooper, Robert W. Platt, Florence van Hunsel, Miranda Davies, Alison Yeomans, Samantha Lane, Saad Shakir
Purpose In 2019, the International Working Group (IWG), focusing on New Developments in Pharmacovigilance, was established. This group is coordinated by the Drug Safety Research Unit in the United Kingdom, and the mission of the IWG is to progress pharmacovigilance methodologies and promote the safe and effective use of medicines and vaccines, thereby further protecting patients. Novel therapeutics
-
A Future European Scientific Dialogue Regulatory Framework: Connecting the Dots Clin. Ther. (IF 3.2) Pub Date : 2024-01-15 Claudia Hey, Alexa Hunter, Mireille Muller, Nadege Le Roux, Simon Bennett, Kasia Nowok, Laura Oliveira
The regulatory framework of the European Union (EU) offers multiple and valuable options for Scientific Advice (SA). However, at a time of increasing scientific complexity and global competition, navigating the SA landscape may be challenging. Such challenges are related to the technicalities of the framework itself, as well as to fundamental changes in the development of promising therapeutics. This
-
First Report of Inclisiran Utilization for Hypercholesterolemia Treatment in Real-World Clinical Settings in a Middle East Population Clin. Ther. (IF 3.2) Pub Date : 2024-01-14 Sajid Iqbal, Hani Mohamed Sabbour, Tanveer Ashraf, Raul D. Santos, Adam Buckley
Purpose Inclisiran is the first small interfering RNA–based treatment approved for reducing pro-atherogenic lipoproteins in patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol (LDL-C). We report the first evaluation of the effects of inclisiran in a Middle East population
-
Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials Clin. Ther. (IF 3.2) Pub Date : 2024-01-11 Edward Holland, Paul Karpecki, Murray Fingeret, Jack Schaeffer, Preeya Gupta, Nicole Fram, Gerard Smits, Teresa Ignacio, Richard Lindstrom
Purpose This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. Methods Two Phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trials were conducted in 35 private ophthalmology clinics in the United States from October 2020 to February 2022. Key inclusion
-
Safety and Pharmacokinetics Following Oral or Intravenous Lefamulin in Adults With Cystic Fibrosis Clin. Ther. (IF 3.2) Pub Date : 2024-01-08 Gregory S. Sawicki, Wolfgang W. Wicha, Tara S. Hiley, Nicole C. Close, Steven P. Gelone, Christine J. Guico-Pabia
Purpose Methicillin-resistant Staphylococcus aureus infections are increasing in prevalence in patients with cystic fibrosis (CF) and are associated with worsening lung function and increased mortality. Lefamulin is a pleuromutilin antimicrobial approved to treat community-acquired bacterial pneumonia based on potent in vitro activity and clinical efficacy. This Phase I, open-label, randomized crossover
-
-
Growth Hormone Treatment to Final Height in Turner Syndrome: Systematic Review Clin. Ther. (IF 3.2) Pub Date : 2023-12-26 Tommaso Aversa, Alessandra Li Pomi, Giorgia Pepe, Domenico Corica, Maria Francesca Messina, Roberto Coco, Fabio Sippelli, Chiara Ferraloro, Giovanni Luppino, Mariella Valenzise, Malgorzata Gabriela Wasniewska
-
Switching Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide Fumarate (TAF) in Hepatitis B/HIV Co-Infection: A Feasibility Study Clin. Ther. (IF 3.2) Pub Date : 2023-12-23 James Lok, Maria Fernanda Guerra Veloz, Ruth Byrne, Ivana Carey, Kate Childs, Kosh Agarwal, Mark Nelson
Purpose Tenofovir alafenamide (TAF) delivers the active metabolite more efficiently to target cells compared with tenofovir disoproxil fumarate (TDF). Recent studies suggest that TAF is efficacious in treatment naïve individuals who are co-infected with HBV/HIV and may have superior effects on HBV e antigen (HBeAg) seroconversion in this setting. The primary objective of this study was to explore the
-
2024 at Clinical Therapeutics: Looking Back . . . Looking Ahead Clin. Ther. (IF 3.2) Pub Date : 2023-12-22 Paul Beninger, Jill L. Maron
Abstract not available
-
Incidence and Predictors of Major Adverse Drug Reactions Among Human Immunodeficiency Virus–Infected Children on Antiretroviral Treatment in West Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-up Study Clin. Ther. (IF 3.2) Pub Date : 2023-12-16 Alemu Birara Zemariam, Degefaye Zelalem Anlay, Addis Wondmagegn Alamaw, Gebremeskel Kibret Abebe, Masresha Asmare Techane
Purpose Major adverse drug reactions (ADRs) are the leading causes of poor adherence, switching of drugs, morbidity, and mortality. A limited studies was conducted to investigate major ADR in developing countries including Ethiopia, and the purpose of this study was to assess the incidence and predictors of major ADRs among HIV-infected children receiving antiretroviral therapy (ART) in West Amhara
-
The Effects of L-Carnitine Supplementation on Blood Pressure in Adults: A Systematic Review and Dose-Response Meta-Analysis Clin. Ther. (IF 3.2) Pub Date : 2023-12-14 Shiva Rahimipour Anaraki, Yasaman Aali, Mahlagha Nikbaf-Shandiz, Niloufar Rasaei, Alireza Khadem, Hossein Bahari, Zeinab Khalse, Samira Rastgoo, Farideh Shiraseb, Omid Asbaghi
Purpose Hypertension stands as a prominent risk factor for cardiovascular disease, making it of utmost importance to address. Studies have shown that L-carnitine supplementation may lower blood pressure (BP) parameters in different populations. Therefore, we have conducted a systematic review and dose-response meta-analysis of published Randomized Controlled Trials (RCTs), including the most recent
-
Cardiovascular Adverse Events Associated With Second-Generation Bruton Tyrosine Kinase Inhibitor Therapy: A Systematic Review and Meta-Analysis Clin. Ther. (IF 3.2) Pub Date : 2023-12-14 Ekaterina Proskuriakova, Dhan Bahadur Shrestha, Ranjit Jasaraj, Vijay Ketan Reddy, Jurgen Shtembari, Anuradha Raut, Suman Gaire, Paramjeet Khosla, Dinesh Kadariya
Purpose Cardiovascular adverse events (CVAEs) are common adverse effects of first-generation Bruton tyrosine kinase inhibitors (BTKis) and limit their use considerably. This led to the development of second-generation BTKis—acalabrutinib and zanubrutinib—which are more selective, potent, and presumed to have better safety profiles than the previous group of medications. However, there have been sporadic
-
Impact Assessment of Divergence on Post-Approval Changes Classifications of Latin America Region With Europe and the United States, and Propositions to Harmonize Classification Based on Risk as a Path to Build the Trust Between National Regulatory Agencies Clin. Ther. (IF 3.2) Pub Date : 2023-12-12 Maria Lucia De Lucia, Christian Comesaña, Heraclio Rodriguez, Agnes Dangy-Caye
The lack of harmonization in the post-approval changes (PACs) classifications for pharmaceutical products may have an impact on the efficient implementation of PACs and in the supply of medicine, jeopardizing the continuity of therapies, especially in the case of chronic diseases. The percentage of similarity between the PACs classifications existing between countries of Latin America (Mexico, Brazil
-
The Effect of Fecal Microbiota Transplantation on Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis Clin. Ther. (IF 3.2) Pub Date : 2023-12-11 Azin Pakmehr, Seyed Mohammad Mousavi, Hanieh-Sadat Ejtahed, Zahra Hoseini-Tavassol, Seyed Davar Siadat, Shirin Hasani-Ranjbar, Bagher Larijani
Purpose Cardiometabolic disease (CMD) is increasing along with its predisposing factors and adverse consequences. As gut microbiota dysbiosis is established in these patients, fecal microbiota transplantation (FMT), which alters the bacterial composition of the intestine, supposedly can help improve cardiometabolic disturbances. We conducted a systematic review and meta-analysis evaluating the impact
-
-
-
Addicted to Addictions: Why Recovering from One Deleterious Habit May Lead to the Next Clin. Ther. (IF 3.2) Pub Date : 2023-12-11 Jill L. Maron
Abstract not available
-
Bayesian Analysis of the ICAT·COVID Randomized Clinical Trial Clin. Ther. (IF 3.2) Pub Date : 2023-12-10 Pierre Malchair, Jesús Villoria, Jordi Giol, Javier Jacob, Thiago Carnaval, Sebastián Videla
Abstract not available
-
De-escalation of Antiplatelet Therapy After Percutaneous Coronary Intervention in East Asian Patients With Acute Coronary Syndrome Clin. Ther. (IF 3.2) Pub Date : 2023-12-09 Wenhui Li, Shuang Zhou, Hanxu Zhang, Zhe Wang, Guangyan Mu, Qiufen Xie, Zhiyan Liu, Manqi Hua, Yimin Cui, Qian Xiang
Purpose East Asian individuals have a lower risk of thromboembolic events while potentially carrying a higher risk of bleeding events compared with non-Asian individuals. The aim of the present analysis was to investigate the effectiveness and safety of the de-escalation of antiplatelet therapy compared with standard dual antiplatelet therapy (DAPT) in East Asian patients undergoing percutaneous coronary
-
Remimazolam: A Retrospective Study of Initial Safety and Recovery Data in Diverse Procedural Sedation Clin. Ther. (IF 3.2) Pub Date : 2023-12-08 Kelsey L. Johnson, Jennifer S. Meyers, Genna N. Mortensen, Jenna R. Steege, Kristin C. Mara, Nathan J. Brinkman
Purpose The new ultra-short-acting benzodiazepine, remimazolam, offers a pharmacokinetic and pharmacodynamic advantage over commonly used procedural sedation medication. This retrospective study explored the real-world utilization of remimazolam during procedural sedation to support the development of a nurse sedation protocol. The primary outcome was to identify associations between recovery time
-
Integrating Cognitive Testing as an Outcome in Carotid Revascularization Trials Clin. Ther. (IF 3.2) Pub Date : 2023-12-07 Brajesh Lal, Ronald M. Lazar, Lloyd J. Edwards, Thomas G. Brott, James F. Meschia
Abstract not available
-
Magnitude and Determinants of Long-term Use of Proton Pump Inhibitors Among Portuguese Older Adults in Primary Health Care Clin. Ther. (IF 3.2) Pub Date : 2023-12-06 Daniela A. Rodrigues, Maria Teresa Herdeiro, Ramona Mateos-Campos, Adolfo Figueiras, Fátima Roque
Purpose Proton Pump Inhibitors (PPIs) have been associated with several adverse effects of particular concern in older populations. Their use for a period longer than 8 weeks is not recommended for older adults. Strategies to discontinue PPIs have been offered; however, their use remains high. This study aims to characterize PPI use in Portuguese older people and to identify the factors associated
-
The effect of different types of oral or intravenous corticosteroids on capillary blood glucose levels in hospitalized inpatients with and without diabetes Clin. Ther. (IF 3.2) Pub Date : 2023-12-06 Vaishali Limbachia, Ian Nunney, Daniel J. Page, Hannah A. Barton, Leena K. Patel, Georgia N. Thomason, Stephan L. Green, Kieran F.J. Lewis, Ketan Dhatariya
Purpose This study investigated: (1) the type of corticosteroid associated with the greatest degree of hyperglycemia, assessed using bedside capillary blood glucose monitoring, in hospitalized patients; and (2) the pattern of hyperglycemia throughout the day with the use of each type of corticosteroid. Methods This single-center, retrospective study used data from 964 adult inpatients receiving oral
-
Sulbactam/Durlobactam Clin. Ther. (IF 3.2) Pub Date : 2023-12-07 Paul Beninger
Abstract not available
-
Stepwise Introduction of Elexacaftor-Tezacaftor-Ivacaftor in Patients With Cystic Fibrosis and Liver Cirrhosis Child-Pugh A or B Using Clinical and Therapeutic Drug Monitoring: A Case Series Clin. Ther. (IF 3.2) Pub Date : 2023-12-01 Steffie E.M. Vonk, Rianne Lub, Els J.M. Weersink, Ulrich Beuers, Ron A.A. Mathôt, E. Marleen Kemper, Josje Altenburg
Purpose Cystic fibrosis (CF) is a monogenetic disease caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein and affecting multiple organs, including the lungs and liver. Almost 90% of people affected carry at least 1 Phe508del CFTR mutation. Medical treatment with the CFTR-modulating drug elexacaftor-tezacaftor-ivacaftor (ETI) has been proven
-
Closing the Care Gap: Management of Alcohol Use Disorder in Patients with Alcohol-associated Liver Disease Clin. Ther. (IF 3.2) Pub Date : 2023-12-04 Ellen W. Green, Isabelle S. Byers, Sasha Deutsch-Link
Alcohol-associated liver disease (ALD)-related morbidity and mortality are rising in the United States. Although effective medications and behavioral interventions are available for the treatment of patients with alcohol use disorder (AUD), patients with ALD are profoundly undertreated for AUD. This article reviews the management of AUD in patients with ALD, with a focus on appropriate screening and
-
-
Estimating Changes in Weight and Metabolic Parameters Before and After Treatment With Cariprazine: A Retrospective Study of Electronic Health Records Clin. Ther. (IF 3.2) Pub Date : 2023-11-30 Prakash S. Masand, Roger S. McIntyre, Andrew J. Cutler, Michael L. Ganz, Andrea L. Lorden, Kiren Patel, Ken Kramer, Amanda Harrington, Huy-Binh Nguyen
Purpose Weight gain and associated negative cardiometabolic effects can occur as a result of mental illness or treatment with second-generation antipsychotics (SGAs), leading to increased rates of morbidity and mortality. In this analysis, we evaluated the effect of the SGA cariprazine on weight and metabolic parameters in a real-world, retrospective, observational dataset. Methods Electronic health
-
Alcohol in 2023: Addressing Unmet Needs Through Pharmacotherapy and Integrated Care Clin. Ther. (IF 3.2) Pub Date : 2023-11-30 Alfred Sidney Barritt
Abstract not available
-
The Effect of Berberine Supplementation on Glycemic Control and Inflammatory Biomarkers in Metabolic Disorders: An Umbrella Meta-Analysis of Randomized Controlled Trials Clin. Ther. (IF 3.2) Pub Date : 2023-11-27 Ahmad Nazari, Zahra Rostami Ghotbabadi, Kimia Sadat Kazemi, Yalda Metghalchi, Reza Tavakoli, Razieh Ziaei Rahimabadi, Mohammad Ghaheri
Purpose Several meta-analyses reported berberine (BBR) supplementation improves glycemic parameters and inflammatory marker, but findings remain inconsistent. Therefore, this study was conducted. Methods We systematically searched PubMed, Embase, Web of Science, Scopus, and Google Scholar to identify the relevant meta-analyses up to April 2023. Findings BBR supplementation was effective in reducing
-
-
Past, Present, and Future Therapies for Alcohol-associated Hepatitis Clin. Ther. (IF 3.2) Pub Date : 2023-11-18 Sally Condon, Loretta L. Jophlin
Purpose Alcohol-associated hepatitis (AH) is a unique presentation of cholestatic steatohepatitis with liver dysfunction and malaise preceded by heavy alcohol intake. Although AH exists on a spectrum, in its most severe form, 28-day mortality approaches 50%. Clinical trials of therapeutic interventions over the last 50 years have yielded few durable therapies, none of which convey benefit beyond the
-
Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis Clin. Ther. (IF 3.2) Pub Date : 2023-11-18 Diane Ito, Chaoling Feng, Christine Fu, Chong Kim, James Wu, David Dalton, Josh Epstein, Julia T. Snider, Adam S. DuVall
Purpose Although immunotherapies such as blinatumomab and inotuzumab have led to improved outcomes, financial burden and health resource utilization (HRU) have increased for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). This study assessed real-world HRU and costs of care among adult patients with R/R B-ALL by line of therapy (LoT) in the United States
-
Statin Use, Lipids, and 3-Hydroxy-3-Methyl-Glutaryl Coenzyme A Reductase Inhibition on Risk of Idiopathic Pulmonary Fibrosis Clin. Ther. (IF 3.2) Pub Date : 2023-11-17 Sizheng Steven Zhao, Philip Alton, Kira Rogers, David M. Hughes
Abstract not available
-
-
Combination Therapy Use and Associated Events in Clinical Practice Following Dissemination of Trial Findings: A De-Implementation Study Using Interrupted Time Series Analysis Clin. Ther. (IF 3.2) Pub Date : 2023-11-11 Heather M. Campbell, Allison E. Murata, Adam M. Henrie, Todd A. Conner
-
Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis Clin. Ther. (IF 3.2) Pub Date : 2023-11-11 Hidetoshi Shimizu, Yukiko Nishimura, Youichi Shiide, Makoto Akimoto, Makiko Yashiro, Masaki Ueda, Manabu Hirai, Hiide Yoshino, Tomohiko Mizutani, Kazuaki Kanai, Osamu Kano, Hideki Kimura, Hisakuni Sekino, Kimiko Ito
Purpose Edaravone is a neuroprotective agent approved as an intravenous treatment for amyotrophic lateral sclerosis (ALS). The intravenous administration of edaravone places a burden on patients and there is a clinical need for oral agents for the treatment of ALS. This report aimed to assess the pharmacokinetics and safety of an edaravone oral suspension in patients with ALS after oral and percutaneous
-
Crushing the Contents of Valbenazine Capsules for Potential Addition to Soft Foods or Administration via Gastrostomy Tube Clin. Ther. (IF 3.2) Pub Date : 2023-11-10 Martha Sajatovic, Amita Patel, Mello Hebert, Alexander Mar, Richard Moore, Ali Bristow, Khody Farahmand, Scott Siegert
Purpose One-capsule, once-daily valbenazine is approved for tardive dyskinesia and under evaluation for chorea associated with Huntington's disease, conditions in which patients often experience dysphagia. In vitro studies were conducted to assess the suitability of crushing the contents of valbenazine capsules (40 and 80 mg) for mixing with soft foods or liquids or administration via a gastrostomy