Drugs & Therapy Perspectives

Skalli, Souad

doi: 10.1007/s40267-026-01259-4pmid: N/A

IntroductionFenugreek (Trigonella foenum-graecum) seeds are widely used for their hypoglycemic properties, which are attributed to bioactive compounds that enhance insulin secretion and sensitivity and reduce hepatic glucose production. While these effects may complement conventional antidiabetic therapies, concomitant use may increase the risk of severe hypoglycemia.ObjectiveThis paper investigates incidents of hypoglycemic coma linked to the concurrent use of fenugreek seeds and premixed insulin, based on four case reports from an ethnobotanical study of diabetic patients.MethodsAn ethnobotanical survey was conducted in several healthcare facilities in the Rabat–Salé–Kénitra region of Morocco among diabetic patients reporting fenugreek use. Data regarding the form, mode of administration, dose of fenugreek, and its concomitant use with antidiabetic medications were collected using a semi-structured questionnaire. Plant samples were botanically authenticated, and the causality between fenugreek intake and hypoglycemic events was assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) standardized causality assessment method. All participants provided informed consent.ResultsFour patients receiving insulin therapy developed hypoglycemic coma while concomitantly consuming fenugreek seeds in various traditional forms and doses. The temporal relationship and clinical evolution supported a possible-to-probable causal association, consistent with synergistic glucose-lowering mechanisms, including potentiation of insulin activity, delayed intestinal glucose absorption, and enhanced insulin signaling.ConclusionTo the best of available knowledge, this is the first report documenting such an interaction. These findings highlight that the concomitant use of fenugreek and insulin may precipitate life-threatening hypoglycemia. Healthcare professionals should actively inquire about medicinal plant use, closely monitor glycemic control, and counsel patients regarding potential herb–drug interactions. Strengthened pharmacovigilance, phytovigilance, and patient education are essential to ensure the safe integration of medicinal plants into diabetes management. This work provides clinically relevant evidence supporting safer integrative practices in diabetes care across diverse healthcare settings worldwide today.

Valencia, Eunice; Lavu, Alekhya; Shouman, Walid; Eltonsy, Sherif

doi: 10.1007/s40267-026-01260-xpmid: N/A

BackgroundGabapentin is a newer-generation antiseizure medication (ASM) that is Food and Drug Administration (FDA)-approved for the treatment of postherpetic neuralgia and partial seizures. In addition, it is also widely prescribed off-label for other pain conditions, migraine prophylaxis, and psychiatric disorders. However, there is currently limited safety data for the use of gabapentin in pregnancy. Understanding how gabapentin use in pregnancy has changed over time will facilitate future safety studies. Here, we examine the trends of gabapentin utilization, prescribing patterns, and indications in pregnant people in Manitoba, Canada over a 20-year period.MethodsA population-based cohort study was conducted using administrative health databases in Manitoba, from 1 April 1999 to 31 March 2019. Our data cohort captured all pregnant people living in Manitoba between 1999 and 2019. Pregnancy capture is based on administrative data identifying all pregnancies, including live births, stillbirths, miscarriages, and terminations. Inclusion criteria encompassed all pregnancies in Manitoba between 1999 and 2019 that met data completeness criteria; exclusion criteria were missing gestational age data or invalid records. Gabapentin use was defined as having at least one gabapentin prescription filled during the exposure period. The trends of utilization and indications for gabapentin prescriptions were examined in each pregnancy trimester as well as over the whole pregnancy term. Descriptive statistics were used to assess gabapentin prescriptions by prescriber specialty.ResultsThe main outcome is gabapentin prescription fills during pregnancy. There were 0.30% (95% confidence interval [CI] 0.28–0.32%) of pregnancies exposed to gabapentin between the years 1999 and 2019 in Manitoba. Gabapentin use in pregnancy rose substantially by 38.6-fold, with use predominantly in the first trimester. Trend analysis revealed a significant increase in the 5-year utilization rates in all three trimesters. Pain was the most frequent indication (32.8%), followed by mood and personality disorders (17.4%). Among pain indications, back, joint, and soft tissue disorders (66.7%) were the most common. Among mood and personality disorders, anxiety (70.4%) was the most common. Prescribers were predominantly general practitioners (77.8%).ConclusionsGabapentin use during pregnancy in Manitoba has increased substantially over the past two decades, predominantly in the first trimester, and is largely prescribed by general practitioners for off-label indications, including pain and mood disorders. Given the limited safety data in pregnancy, these findings underscore the need for ongoing pharmacovigilance and future safety studies to inform clinical decision-making for pregnant people and their children.

Kang, Connie

doi: 10.1007/s40267-026-01252-xpmid: N/A

Scabies infestations can present differently in older adults, and may require additional considerations when diagnosing and before initiating treatment. While topical permethrin and benzyl benzoate are typically recommended for initial management, the difficulties involved in topical administration for older adults and a concern around possible treatment resistance may warrant a switch to oral ivermectin. This is especially true for scabies outbreaks in aged care facilities, which are very common, and demand more time and resources to diagnose and treat. To hopefully address these and other concerns, several new treatment options are being explored to treat scabies infestation.

Silwal, Pratikshya; Dilley, Andrew; Adhikari, Saroj; Lusk, Jayson L.; McFadden, Brandon R.

doi: 10.1007/s40267-026-01243-ypmid: N/A

IntroductionRising obesity rates in the US highlight the growing need for effective weight-management options. Glucagon-like peptide-1 (GLP-1) agonists, originally developed for type 2 diabetes mellitus, have become increasingly popular for weight management due to their appetite-reducing and satiety-enhancing effects.ObjectiveTo evaluate self-reported effectiveness, perceptions of safety, and barriers associated with GLP-1 agonists among US adults.MethodsAn online survey was distributed via Prolific in May 2024. A total of 1955 usable observations were categorized into four groups: Currently Taking (n = 495), Previously Taken (n = 468), Planning to Take (n = 492), and Neither Taken nor Planning (n = 500). Interval, binary logistic, and ordered probit models were estimated.ResultsIn the Currently Taking group, self-reported weight loss averaged 16.44 lb at ≤ 6 months, 29.83 lb at 6–12 months, and 36.09 lb at > 1 year; in the Previously Taken group, the corresponding means were 14.93 lb, 24.70 lb, and 31.81 lb. Financial constraints, side effects (notably nausea and gastrointestinal issues), and insufficient insurance coverage were the most commonly reported barriers. Respondents generally perceived GLP-1 agonists as safe for short- and long-term use, with stronger positive perceptions among those with higher education and greater self-reported knowledge of the medications.ConclusionThese self-reported patient experiences suggest that improving affordability and insurance coverage of GLP-1 agonists could support more effective real-world weight management, while reinforcing the need for longitudinal clinical research.

Aiyegbusi, Olalekan Lee; Kamudoni, Paul; Wilson, Roger; Calvert, Melanie J.

doi: 10.1007/s40267-026-01254-9pmid: N/A

BackgroundPatients require adequate and accurate information to make informed decisions about their treatment. Issues such as time constraints may limit the amount of information healthcare professionals (HCPs) can provide during clinical consultations. Patients may seek additional information from other sources including commercial drug websites, drug review sites, and social media platforms. Drug company pharmaceutical websites are an option for both patients and HCPs to access information about patient-reported outcomes (PROs) and benefits of drug therapy. However, there is limited information on how PRO information is provided by pharmaceutical companies on their websites. The aim of this study was to review the use of PRO and preference data in the marketing of oncology products with US Food and Drug Administration (FDA) approvals on publicly available pharmaceutical websites.MethodsA ‘case study’ approach was taken for this study. Oncology products with FDA approvals including PRO data between 2010 and 2020 were identified using an article by Cella et al. as a source document. Two FDA-approved oncology drugs that included tolerability labelling claims assessed by PROs were purposively selected and included in this review as exemplars. Product websites targeting lay audiences and or HCPs for the identified drugs were independently searched for by two researchers using the Google search engine in January and March 2025. The search terms used were combinations of the generic and brand names for each drug. PRO-related information was checked for and extracted. Approaches taken by the websites to providing PRO-specific patient information, including graphical data visualisation and other audio-visual methods of providing information were summarised.ResultsEleven oncology products with PRO or preference data within their FDA approved label were identified. Of these, only six products had PRO or preference data available to support shared decision making on patient and/or HCP websites. Content varied significantly across websites and no standardised format was used. Patient websites for fedratinib (PRO data), pertuzumab/trastuzumab/hyaluronidase-zzfx (preference data) and ruxolitinib (PRO data) provided more information referencing the actual clinical trials with Total Symptom Scores mentioned specifically for fedratinib and ruxolitinib.ConclusionsPRO data provided by pharmaceutical companies need to have sufficient detail to inform patient decisions otherwise there is a probability they may seek information from other sources which may be inaccurate or misleading. Pharmaceutical companies should consider and adopt recommendations for PRO data presentation on their website for effective communications to patients and HCPs.

Zovi, Andrea; Langella, Roberto; Martellone, Lorenzo; Sopo, Gerardo Miceli; Polito, Giacomo; Vitiello, Antonio

doi: 10.1007/s40267-026-01246-9pmid: N/A

Myasthenia gravis (MG) is a rare acquired autoimmune disease affecting the neuromuscular junction, characterized by fluctuating muscle weakness that worsens with activity and improves with rest. The disease predominantly affects ocular, bulbar, neck, and limb muscles, with a prevalence of 1/5000 and incidence of 1/250,000–1/33,000 in Europe. Pathogenesis involves autoantibodies targeting post-synaptic membrane antigens, primarily acetylcholine receptors (AChR-Ab+, 80–90% of cases) or muscle-specific tyrosine kinase (MuSK-Ab+, 5–6% of cases). Current therapeutic approaches include symptomatic treatment with acetylcholinesterase inhibitors, immunosuppressive therapy with corticosteroids and non-steroidal immunosuppressants, and rescue therapies such as plasmapheresis for myasthenic crises. Approximately 5% of patients develop refractory MG, requiring targeted biological therapies including complement inhibitors (eculizumab, ravulizumab, zilucoplan) and neonatal Fc receptor (FcRn) inhibitors (efgartigimod alfa, rozanolixizumab). Recent clinical trials have demonstrated the efficacy of nipocalimab, a novel FcRn inhibitor, which recently received Food and Drug Administration (FDA) approval. Emerging chimeric antigen receptor (CAR)-T cell therapies targeting CD19-positive B cells represent an innovative approach inspired by oncological applications, with ongoing phase I/II studies (RESET-MG, KYSA-6) showing promising preliminary results in refractory cases. This review provides a comprehensive analysis of current therapeutic strategies, novel biological agents, and innovative cell-based therapies, highlighting the evolving therapeutic landscape of MG management.

Hoy, Sheridan M.

doi: 10.1007/s40267-026-01253-wpmid: N/A

Lower urinary tract symptoms (LUTS; i.e. storage, voiding and post-micturition symptoms) are a frequent complaint in adult men and strongly associated with aging. A common cause is benign prostatic obstruction, which typically results from benign prostatic hyperplasia (BPH) progressing through benign prostatic enlargement. Treatment of BPH-associated LUTS can be conservative, pharmacological or surgical, and aims to reduce the obstruction and alleviate LUTS. A personalized approach (considering, among other factors, symptom severity, prostate size, comorbidities and patient preference) is recommended. In patients with mixed symptom profiles or those who have insufficiently responded to pharmacological monotherapy, the use of pharmacological combination therapy (e.g. α1-adrenoceptor antagonist plus 5-alpha reductase inhibitor) may be warranted. Tolerability data for most pharmacological combination therapies are limited.

Burgess, Thomas B.; Kang, Connie

doi: 10.1007/s40267-026-01251-ypmid: N/A

Chronic non-cancer pain is a major health concern for older adults (aged ≥ 65 years). If non-pharmacological interventions and non-opioid analgesics are ineffective, opioids may be considered for pain management. Dosage reductions, longer dosing intervals and enhanced monitoring should be considered when prescribing opioids for older adults. Concerns over adverse events and opioid misuse in older adults have led to increased impetus for opioid deprescribing. An individualised approach to opioid deprescribing should be taken, with further research required to determine optimal deprescribing interventions.

Prajapati, Arpitkumar; Dyapa, Dayaker Reddy; Zamruth, Shabhana Chittoor; Dadke, Disha

doi: 10.1007/s40267-026-01245-wpmid: N/A

BackgroundBP14 refers to a recently approved biosimilar of the reference product Neulasta®. This study was conducted to assess the pharmacokinetic and pharmacodynamic similarity between BP14 and Neulasta®.MethodsThis randomized, double-blind, two-period crossover study was conducted in healthy male participants. Each participant received a single dose of 6 mg on day 1 on each treatment period and followed up for pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity assessments. Primary PK endpoints were Cmax and AUC0–t while absolute neutrophil count (ANC) AUC0–t and ANC Emax were PD endpoints. The total study duration was approximately 16 weeks including 4 weeks of screening period.ResultsA total of 184 participants were randomized, with 92 participants in each treatment sequence. Baseline characteristics were well balanced between two groups. For primary PK endpoints, the ratio of geometric means (GMR; 90% confidence interval (CI)) for the ratio of BP14:Neulasta® for Cmax and AUC0–t was 106.55 (98.92, 114.78) and 109.27 (100.92, 118.31), respectively, demonstrating bioequivalence between BP14 and Neulasta®. Similarly, for PD endpoints, the GMR (95% CI) for the ratio of BP14:Neulasta® for ANC Emax and ANC AUC0–t was 100.32 (98.53, 102.15) and 101.06 (99.35, 102.80), respectively, demonstrating PD similarity with the acceptable criteria of 90–111%. No significant differences in terms of safety and immunogenicity were observed.ConclusionOverall, BP14 was found to be clinically similar to reference product Neulasta® for PK and PD profiles in healthy participants. In addition, BP14 was found to be comparable to Neulasta® in terms of safety and immunogenicity profile.Trial RegistrationCTRI/2023/06/054223.