Results 131 to 140 of about 3,973 (220)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Comparative efficacy of GLP‐1 RA, tirzepatide and SGLT‐2 inhibitors in metabolic liver disease: A network meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aim Metabolic liver disease, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, is a major cause of chronic liver dysfunction worldwide, creating an urgent need for effective treatments. This systematic literature review (SLR) and network meta‐analysis (NMA) systematically reviews and compares the efficacy and safety ...
Andrej Belančić, Christina Antza, Anastasios Poutachidis, Smaro Palaska, Elvira Meni Maria Gkrinia, Andrea Katrin Faour, Yusuf Ziya Sener, Seher Sener, Rehena Sultana   +8 more
wiley   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Psychotropic medication use among community dwellers with and without Parkinson's disease – A nationwide cohort study

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims We studied the prevalence of psychotropic use and psychotropic polypharmacy in persons with Parkinson's disease (PD) during a 10‐year follow‐up, because longitudinal studies on this topic are scarce although non‐motor symptoms of PD are often treated with psychotropics.
Noora Nieminen, Anna‐Maija Tolppanen, Valtteri Kaasinen, Marjaana Koponen, Sirpa Hartikainen   +4 more
wiley   +1 more source

Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

British Journal of Clinical Pharmacology, EarlyView.
Abstract Introduction Active surveillance of adverse events using healthcare data is emerging as complementary to the monitoring of spontaneous reports and stand‐alone pharmacoepidemiologic studies. The risk of urinary tract infections (UTIs) was listed as a special warning for sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) when marketed in Europe
Haoxin Le, Dilsad Simay Peker, Lukas Frederic Westphal, Nikolai Brun, Christine Erikstrup Hallgreen, Morten Andersen   +5 more
wiley   +1 more source

Placebo mechanisms in aging: A randomized controlled trial comparing deceptive and open-label placebos on psychological, cognitive, and physical functioning in older adults. [PDF]

Int J Clin Health Psychol
Barbiani D, Antonietti A, Pagnini F.
europepmc   +1 more source

Exploring new avenues: Psychedelic‐assisted therapy for young people

British Journal of Clinical Pharmacology, EarlyView.
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou, Dasha Nicholls, David J. Nutt, Martina Di Simplicio   +3 more
wiley   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Patients on statins with elevated transaminases: Frequency of follow‐up creatine kinase testing and gastroenterology referral

British Journal of Clinical Pharmacology, EarlyView.
Abstract Purpose To quantify how often creatine kinase (CK) is measured after newly elevated aminotransferases in statin users, and whether absent CK data are associated with gastroenterology (GI) referrals. Methods Retrospective chart review of adult outpatients on statins with a first alanine/aspartate aminotransferase (ALT/AST) elevation during a 5 ...
Faris Shweikeh, Anas Kartoumah, Rajshri Joshi, Anjali Nadihaan, Mohammed Mouchli, Inderprit Singh   +5 more
wiley   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source