pregabalin (pregabalin, YuHan / YHD 1119 / YHD1119)

Cross national pharmacovigilance analysis of drug-induced delirium: a comparative study using the US FAERS, Japanese JADER, and canadian CVAR datasets.

Jiao Jinghua J, Liu Shunming S, Fang Ying Y, Song Xin X et al.

Drug-induced delirium is a clinically important and potentially preventable adverse event, especially in older adults, yet large-scale cross-national pharmacovigilance evidence remains limited. We conducted a retrospective analysis using three major spontaneous reporting systems: the FDA Adverse Event Reporting System (FAERS, 2004-Q3 2025), the Japanese Adverse Drug Event Report (JADER, 2004-Q2 2025), and the Canada Vigilance Adverse Reaction database (CVAR, 2004-Q3 2025). Delirium cases were identified using five pre-specified Preferred Terms (PTs) selected from the narrow scope of the Standardised MedDRA Query (SMQ) Noninfectious encephalopathy/delirium. Disproportionality analyses were performed using reporting odds ratio, proportional reporting ratio, and empirical Bayes geometric mean, with signal strength defined by lower confidence bounds. Time-to-onset (TTO) was summarized using medians, IQRs, and early-onset proportions. A total of 263,327 reports were identified (FAERS: 243,572; JADER: 7,512; CVAR: 12,243). Delirium was more frequently reported in females (49%-57%) and individuals aged ≥60 years (55%-70%). Strong and consistent signals were observed for nervous system drugs, particularly psycholeptics, analgesics, and psychoanaleptics. Duloxetine, lamotrigine, pregabalin, quetiapine fumarate, and zolpidem demonstrated consistent signals across databases. Additional signals involved antipsychotics, benzodiazepines, opioids, and selected anti-infective agents. Time-to-onset analysis demonstrated early-onset clustering, suggesting an acute temporal pattern. Cross-database consistency in drug class signals and early-onset temporal patterns highlights the need for medication review and risk mitigation in high-risk populations.

The Role of the Antidepressants in Managing Chemotherapy-Induced Neuropathic Pain: A Systematic Review.

Caminiti Rosamaria R, Mazza Valeria V, Nucera Saverio S, Oppedisano Francesca F et al.

Chemotherapy-induced peripheral neuropathy (CIPN) is a prevalent and debilitating complication of cancer treatment, characterized by neuropathic pain, sensory disturbances, and functional impairment that can substantially reduce quality of life. Neurotoxicity induced by chemotherapeutic agents affects peripheral nerves, dorsal root ganglia, and supporting structures, contributing to persistent pain and neurological dysfunction. This systematic review evaluated the efficacy and safety of antidepressants, particularly duloxetine and amitriptyline, in the management of CIPN-related pain. Following PRISMA guidelines and registration in PROSPERO (CRD42024608551), a systematic search of PubMed, Scopus, and Web of Science was conducted for studies published between November 2019 and October 2025. This time frame was selected to capture contemporary evidence and recent developments in multimodal treatment strategies, while acknowledging that foundational studies establishing the efficacy of duloxetine predate this period. Clinical and observational studies involving adult patients with CIPN were included. Of 892 records identified, 11 studies met the eligibility criteria. Duloxetine demonstrated clinically meaningful reductions in neuropathic pain, as assessed by VAS, NRS, and CTCAE measures. Topical amitriptyline also showed promising analgesic effects, although the available evidence remains limited. Combination therapies involving duloxetine and agents such as tapentadol, pregabalin, mirogabalin, or amitriptyline were associated with additional reductions in pain intensity; however, current evidence remains insufficient to establish additive or synergistic effects. Overall, antidepressant therapy was generally well tolerated, with predominantly mild and manageable adverse events. Current evidence supports antidepressants, particularly duloxetine, associated with reductions in pain intensity in heterogeneous studies, whereas evidence for CIPN prevention remains inconclusive. These findings support their continued use in clinical practice and highlight the need for larger, well-designed randomized controlled trials to optimize treatment strategies and further define the role of combination therapies in CIPN management.

Multicentre, 2×2 factorial, randomised, open-label trial of neuromodulators and cough control therapy for refractory or unexplained chronic cough: the FORTITUDE trial protocol.

Kum Elena E, Hassan Wafa W, Beaudin Sue S, Strong Geoff G et al.

While clinicians commonly prescribe neuromodulators for the treatment of refractory or unexplained chronic cough, no trials have directly compared these treatments. Furthermore, although guidelines recommend non-pharmacological management involving physiotherapy and speech-language therapy, few trials have evaluated its effectiveness. FORTITUDE (FactOrial Randomized TrIal To evalUate neuromoDulators and cough control thErapy) is a 6-week, 2×2 factorial, randomised, open-label trial with an observational extension up to 1 year. The trial will include Canadian hospital sites enrolling 124 patients. Patients ≥18 years old with either refractory or unexplained chronic cough will undergo independent 1:1 randomisation to pharmacotherapy-either low-dose morphine (up to 5 mg two times per day) or pregabalin (up to 150 mg two times per day)-and concurrent cough control therapy (CCT) or no CCT. The CCT will consist of five virtual sessions delivered over 6 weeks by a trained physiotherapist or speech-language pathologist. Change from baseline in 24-hour cough frequency at 6 weeks represents the primary outcome. Secondary outcomes include change from baseline in awake, sleep and cough bout frequencies; cough severity on the McMaster Cough Severity Questionnaire and the 100-mm Visual Analogue Scale; and cough quality of life on the Leicester Cough Questionnaire at 6 weeks. We will analyse safety and tolerability at 6 weeks and explore potential interactions between neuromodulators and CCT. Follow-up in an observational extension of up to 12 months post-randomisation will assess long-term treatment patterns, adherence and safety in a real-world setting. Health Canada's Pharmaceutical Drugs Directorate has provided approval to conduct this study. We have approval from the Hamilton Integrated Research Ethics Board of the Main Coordinating Site, with ethics pending at other participating sites. Results of the main trial and the observational extension will be published as manuscripts in peer-reviewed journals. NCT07288528.

Pregabalin Modified-Release Formulations: Clinical Differences Beyond Adherence.

Alcántara Montero Antonio A