Results 201 to 210 of about 748,749 (317)

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

British Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner, Daniela Krepper, Micha Johannes Pilz, Lisa Marie Storz, Maike Thumfart, Johannes Maria Giesinger   +5 more
wiley   +1 more source

Counterintuitive: reducing regression-to-the-mean worsens efficiency in simulated clinical trials. [PDF]

Seizure
Goldenholz DM, Goldenholz SR, Bhansali R, Kaptchuk TJ, Westover MB.   +4 more
europepmc   +1 more source

Blood pressure effects of SGLT2 inhibitors and GLP‐1 receptor agonists: Mechanisms, trial evidence and Real‐world data

British Journal of Clinical Pharmacology, EarlyView.
SGLT2 inhibitors and GLP‐1 receptor agonists modestly lower blood pressure across diverse patient populations, including those without diabetes. These effects appear largely independent of glycaemic control and offer additive value in high‐risk patients with overlapping comorbidities.
Andrej Belančić, Yusuf Ziya Sener, Marijana Vučković, Joseph Edgar Blais, Almir Fajkić, Emina Sher, Mislav Radić, Josipa Radić   +7 more
wiley   +1 more source

Targeting the Disease Response With NlpD and LytM for Effective Nonantibiotic Treatment of Urinary Tract Infections. [PDF]

J Infect Dis
Tran HT, Gomes I, Chaudhuri A, Nazari A, Ahmadi S, Végh H, Carneiro ANBM, Höglund U, Krintel C, Svanborg C, Ambite I.   +10 more
europepmc   +1 more source

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

A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of Linustedastat (OG-6219) in Women with Moderate to Severe Endometriosis-Related Pain. [PDF]

Int J Womens Health
Arbelaez F, Yureneva J, Larsson P, Colaci D, Gordon K, Dupclay L, Wilk K.   +6 more
europepmc   +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

Body Composition and Lifestyle Interventions in Pharmacological Treatment of Acquired Hypothalamic Obesity: A Systematic Review of Randomized Controlled Trials. [PDF]

Obesity (Silver Spring)
Yu H, Wang J, Yin M, Ji L, Guo S, Liu T, Wang R.   +6 more
europepmc   +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

Rethinking placebos [PDF]

Nature Medicine, 2014
openaire   +1 more source