The Safety and Efficacy of Abaloparatide on Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis
Clin Ther. 2024 Feb 1:S0149-2918(24)00004-3. doi: 10.1016/j.clinthera.2023.12.010. Online ahead of print.ABSTRACTPURPOSE: 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 and safety of abaloparatide could be of assistance in the clinical medication of postmenopausal osteopo...
Source: Clinical Therapeutics - February 2, 2024 Category: Drugs & Pharmacology Authors: Fuxin Xu Yurun Wang Xinjian Zhu Source Type: research
Predicting Factors of Long-term Outcome of Gastrointestinal Beh çet's Disease: A Chinese Retrospective Study
Clin Ther. 2024 Jan 30:S0149-2918(24)00005-5. doi: 10.1016/j.clinthera.2023.12.012. Online ahead of print.ABSTRACTPURPOSE: 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, symptoms, endoscopic findings, medical treatments, and surgery. Mucosal healing and surgical rates at 1,...
Source: Clinical Therapeutics - January 31, 2024 Category: Drugs & Pharmacology Authors: Xiaoman Zu Shanshan Xiong Yaming Lu Ning Zhang Shu Xu Rui Feng Baili Chen Zhirong Zeng Minhu Chen Yao He Source Type: research
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. 2024 Jan 25:S0149-2918(24)00007-9. doi: 10.1016/j.clinthera.2023.12.013. Online ahead of print.ABSTRACTPURPOSE: 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 the European Union (centrally by the European Medicines Agency [EMA] and in Germany by the Bundesinstitut für Arz...
Source: Clinical Therapeutics - January 26, 2024 Category: Drugs & Pharmacology Authors: Thomas C K ühler Aritz Ateka Zeineb Lassoued Fran çois-Xavier Routhier Souha M ékary-Sawaya Source Type: research
Low-Dose Naltrexone Improves post-COVID-19 condition Symptoms
Clin Ther. 2024 Jan 23:S0149-2918(24)00003-1. doi: 10.1016/j.clinthera.2023.12.009. Online ahead of print.ABSTRACTPURPOSE: 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, and physical therapy, and evaluated improvements in fatigue, pain, dyspnea, and brain fog recorded in the electr...
Source: Clinical Therapeutics - January 24, 2024 Category: Drugs & Pharmacology Authors: Leonardo Tamariz Elizabeth Bast Nancy Klimas Ana Palacio Source Type: research
Joint Flexibility and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome After Mononucleosis
This study was part of a prospective cohort study. College students were studied for the development of IM and were followed up for the development of ME/CFS 6 months later. Participants in the cohort for the present study included 53 students who met criteria for ME/CFS 6 months after IM and 66 recovered control subjects who had modified Beighton scores (a measure of joint hyperflexibility) available.FINDINGS: No connection was found between joint hyperflexibility and the development of ME/CFS after IM. Differences in joint hyperflexibility (as measured by using the modified Beighton score) in the ME/CFS group and the con...
Source: Clinical Therapeutics - January 19, 2024 Category: Drugs & Pharmacology Authors: Jeffrey Thomas Poomkudy Chelsea Torres Leonard A Jason Joseph Fishbein Ben Z Katz Source Type: research
The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance
Clin Ther. 2024 Jan 16:S0149-2918(24)00002-X. doi: 10.1016/j.clinthera.2023.12.008. Online ahead of print.ABSTRACTPURPOSE: 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 are continuously being developed to alleviate medical conditions, but with advancing technologies, innovative pha...
Source: Clinical Therapeutics - January 17, 2024 Category: Drugs & Pharmacology Authors: Dawn Cooper Robert W Platt Florence van Hunsel Miranda Davies Alison Yeomans Samantha Lane Saad Shakir Source Type: research
A Future European Scientific Dialogue Regulatory Framework: Connecting the Dots
This article provides an overview of these challenges and reflects on the ways in which the already available SA options could be consolidated and optimized for building an integrated, easy-to-navigate process. The key elements of the proposal are improved orientation and navigation support, a simplified process of managing parallel interactions with multiple bodies, competitive SA timelines, consistency and harmonization across stakeholders, a strengthened horizon scanning to increase network preparedness, and a mechanism for building an institutional memory. The article builds on ongoing dialogues driven by the European ...
Source: Clinical Therapeutics - January 16, 2024 Category: Drugs & Pharmacology Authors: Claudia Hey Alexa Hunter Mireille Muller Nadege Le Roux Simon Bennett Kasia Nowok Laura Oliveira Source Type: research
First Report of Inclisiran Utilization for Hypercholesterolemia Treatment in Real-World Clinical Settings in a Middle East Population
This study is the first from the Middle East and North Africa region that reported the real-world efficacy and safety profile of inclisiran in a mixed-risk population of patients with heterozygous familial hypercholesterolemia and other non-familial hypercholesterolemia indications. Clinically meaningful and sustained reductions in pro-atherogenic lipids with good tolerability were observed after inclisiran initiation. Fewer AEs were reported in this predominantly Arabic population, consistent with previous safety reports for inclisiran. It is important to note that no patient stopped inclisiran treatment due to AEs. Stren...
Source: Clinical Therapeutics - January 14, 2024 Category: Drugs & Pharmacology Authors: Sajid Iqbal Hani Mohamed Sabbour Tanveer Ashraf Raul D Santos Adam Buckley Source Type: research
Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials
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 criteria were the following: (1) age 45-64 years, (2) distance-corrected near visual acuity (DCNVA) at 40 cm ≥0.40 and ≤0.90 logarithm of the minimum angle of resolution (logMAR, approximately 20/50-20/160 Snellen) in at least 1 ...
Source: Clinical Therapeutics - January 12, 2024 Category: Drugs & Pharmacology Authors: Edward Holland Paul Karpecki Murray Fingeret Jack Schaeffer Preeya Gupta Nicole Fram Gerard Smits Teresa Ignacio Richard Lindstrom Source Type: research
Safety and Pharmacokinetics Following Oral or Intravenous Lefamulin in Adults With Cystic Fibrosis
Clin Ther. 2024 Jan 8:S0149-2918(23)00475-7. doi: 10.1016/j.clinthera.2023.12.002. Online ahead of print.ABSTRACTPURPOSE: 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 study assessed the safety and pharmacokinetic profile of oral and intravenous (IV) lefamulin in adults with C...
Source: Clinical Therapeutics - January 9, 2024 Category: Drugs & Pharmacology Authors: Gregory S Sawicki Wolfgang W Wicha Tara S Hiley Nicole C Close Steven P Gelone Christine J Guico-Pabia Source Type: research
Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes
Clin Ther. 2024 Jan;46(1):e7-e11. doi: 10.1016/j.clinthera.2023.10.005. Epub 2023 Oct 28.ABSTRACTPURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost.METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM di...
Source: Clinical Therapeutics - January 2, 2024 Category: Drugs & Pharmacology Authors: Jason Powell Shaunak R Mulani Source Type: research
Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes
Clin Ther. 2024 Jan;46(1):e7-e11. doi: 10.1016/j.clinthera.2023.10.005. Epub 2023 Oct 28.ABSTRACTPURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost.METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM di...
Source: Clinical Therapeutics - January 2, 2024 Category: Drugs & Pharmacology Authors: Jason Powell Shaunak R Mulani Source Type: research
Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes
Clin Ther. 2024 Jan;46(1):e7-e11. doi: 10.1016/j.clinthera.2023.10.005. Epub 2023 Oct 28.ABSTRACTPURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost.METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM di...
Source: Clinical Therapeutics - January 2, 2024 Category: Drugs & Pharmacology Authors: Jason Powell Shaunak R Mulani Source Type: research
Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes
Clin Ther. 2024 Jan;46(1):e7-e11. doi: 10.1016/j.clinthera.2023.10.005. Epub 2023 Oct 28.ABSTRACTPURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost.METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM di...
Source: Clinical Therapeutics - January 2, 2024 Category: Drugs & Pharmacology Authors: Jason Powell Shaunak R Mulani Source Type: research
Partnering for Better Health: Using Continuous Glucose Monitoring and Clinical Pharmacist Collaboration to Improve Glycemic Control in Underserved Patients With Type 2 Diabetes
Clin Ther. 2024 Jan;46(1):e7-e11. doi: 10.1016/j.clinthera.2023.10.005. Epub 2023 Oct 28.ABSTRACTPURPOSE: The purpose of this study was to examine the effect of initiating use of a continuous glucose monitor (CGM) in patients being treated for type 2 diabetes mellitus, specifically those who face barriers to obtaining this device because of its cost.METHODS: This retrospective medical record review compared diabetes control of patients before and after use of a CGM device within a single primary care office. Patient medical records were reviewed 18 months after initial CGM was provided, and only those who received a CGM di...
Source: Clinical Therapeutics - January 2, 2024 Category: Drugs & Pharmacology Authors: Jason Powell Shaunak R Mulani Source Type: research
