Drug-induced Adverse Events

Study on risk factors and associated drug related problems in patients with stroke

Fri, 2025-03-21 06:00

BMC Neurol. 2025 Mar 20;25(1):117. doi: 10.1186/s12883-025-04130-7.

ABSTRACT

BACKGROUND: The second most common cause of death and disability worldwide is stroke. Drug-related problems (DRPs) can arise during any step of the medication process, whether it involves prescribing, transcribing, dispensing, or administering drugs. The purpose of this study was to assess risk factors and associated DRPs in patients with stroke.

METHODS: A cross-sectional study was conducted involving patients who had been diagnosed with stroke for 3 months using a purposive sampling technique at Annapurna Hospital. Data on demographics, comorbidities, and medications were collected through patient medical records, medicine Cardex, and nursing notes. DRPs were identified and classified using the Hepler-Strand classification system. Medscape software was used to assess potential drug-drug interactions (pDDIs). Descriptive statistics, chi-square tests, and binary logistic regression were performed.

RESULTS: Among the 111 patients, the mean age was 58.72 ± 15.68 years. The majority of strokes were ischemic (68.5%), with the middle cerebral artery being the most commonly affected (24.3%). Males were more commonly affected (76.6%) than females (23.4%). Hypertension was the most prevalent comorbidity (61.3%), followed by diabetes mellitus (27.0%) and hyperlipidemia (21.6%). Hyperlipidemia was significantly associated with risk factors for ischemic stroke. The study found that 91.9% of stroke patients experienced DRPs, with pDDIs being the most common type (91.09%). The severity of pDDIs was predominantly categorized as "monitor closely" (73.2%). The use of more than 10 medications was a significant predictor for high-severity pDDIs.

CONCLUSION: The study concludes that polypharmacy is a significant predictor for high-severity pDDIs, highlighting the need for careful consideration when adding new medications to a patient's therapy. The high rate of pDDIs (91%) emphasizes the critical role of clinical pharmacists in identifying and mitigating these interactions to prevent further drug-related complications in stroke patients. Further research is needed to explore interventions to reduce DRPs.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:40114139 | DOI:10.1186/s12883-025-04130-7

Categories: Literature Watch

GLP-2 prevents antipsychotics-induced metabolic dysfunction in mice

Fri, 2025-03-21 06:00

Nat Metab. 2025 Mar 20. doi: 10.1038/s42255-025-01252-7. Online ahead of print.

ABSTRACT

Antipsychotic drugs have severe metabolic side effects. Acute use can induce hypothermia, while chronic use often leads to weight gain and associated disorders. However, no treatment is currently available for drug-induced hypothermia, and weight control measures lack evidence for long-term effectiveness. Here we demonstrate that a glucagon-like peptide 2 analogue, teduglutide, effectively prevents olanzapine-induced hypothermia and weight gain, and restores glucose tolerance and insulin sensitivity in mice. Mechanistically, olanzapine suppresses prodynorphin-expressing neurons in the ventromedial hypothalamus (VMHPdyn neurons) via serotonin receptor 2C, while teduglutide activates the same neuron population. Selective ablation of VMHPdyn neurons mimics olanzapine-induced side effects. More importantly, chemogenetic activation of VMHPdyn neurons abolishes olanzapine-induced hypothermia and excessive weight gain, although the psychotropic effects remain intact. Together, our data show that VMHPdyn neurons are the crucial mediator of antipsychotic-induced metabolic dysfunction and glucagon-like peptide 2 receptor agonism may be an effective target to mitigate both acute and chronic side effects.

PMID:40114026 | DOI:10.1038/s42255-025-01252-7

Categories: Literature Watch

Renal triple therapy: treatment strategies for type 2 diabetes mellitus complicated with chronic kidney disease

Thu, 2025-03-20 06:00

Zhonghua Yi Xue Za Zhi. 2025 Mar 25;105(12):867-871. doi: 10.3760/cma.j.cn112137-20241024-02396.

ABSTRACT

Type 2 diabetes mellitus and chronic kidney disease (T2DM-CKD) is common in the Chinese population and seriously threatens human health. With the development and application of new drugs, the outcome of T2DM-CKD has been improved in recent years. However, how to combine those drugs effectively and reduce side effects deserves further attention. "Renal triple therapy " (RTT) refers to combined and sequential use of three key medications in treatment of T2DM-CKD, namely renin-angiotensin system inhibitor (RASi), sodium-glucose cotransporter 2 inhibitor (SGLT-2i) and non-steroidal mineralocorticoid receptor antagonist (finerenone), targeting various pathogenic factors in T2DM-CKD. Clinical studies have demonstrated that RTT is superior for protecting the kidney and heart compared with single or dual therapy, and thus improves outcomes of patients with T2DM-CKD. Moreover, RTT can reduce the risk of drug-induced hyperkalemia. Based on research progress at home and abroad and personal clinical experience, this article discusses the origin, theoretical basis, benefits and precautions of RTT in treating T2DM-CKD, aiming to provide a good treatment strategy for primary care physicians and improve the overall level of disease prevention and control.

PMID:40113409 | DOI:10.3760/cma.j.cn112137-20241024-02396

Categories: Literature Watch

Multispecific Antibodies Targeting PD-1/PD-L1 in Cancer

Wed, 2025-03-19 06:00

BioDrugs. 2025 Mar 19. doi: 10.1007/s40259-025-00712-6. Online ahead of print.

ABSTRACT

The development of immune checkpoint inhibitors has revolutionized the treatment of patients with cancer. Targeting the programmed cell death protein 1 (PD-1)/programmed cell death 1 ligand 1(PD-L1) interaction using monoclonal antibodies has emerged as a prominent focus in tumor therapy with rapid advancements. However, the efficacy of anti-PD-1/PD-L1 treatment is hindered by primary or acquired resistance, limiting the effectiveness of single-drug approaches. Moreover, combining PD-1/PD-L1 with other immune drugs, targeted therapies, or chemotherapy significantly enhances response rates while exacerbating adverse reactions. Multispecific antibodies, capable of binding to different epitopes, offer improved antitumor efficacy while reducing drug-related side effects, serving as a promising therapeutic approach in cancer treatment. Several bispecific antibodies (bsAbs) targeting PD-1/PD-L1 have received regulatory approval, and many more are currently in clinical development. Additionally, tri-specific antibodies (TsAbs) and tetra-specific antibodies (TetraMabs) are under development. This review comprehensively explores the fundamental structure, preclinical principles, clinical trial progress, and challenges associated with bsAbs targeting PD-1/PD-L1.

PMID:40106158 | DOI:10.1007/s40259-025-00712-6

Categories: Literature Watch

Severe denosumab-induced hypocalcemia requiring long-term intensified medication in a patient with <em>EGFR</em>-mutant lung cancer and diffuse osteoblastic bone metastases

Wed, 2025-03-19 06:00

Respir Med Case Rep. 2025 Feb 26;54:102183. doi: 10.1016/j.rmcr.2025.102183. eCollection 2025.

ABSTRACT

Lung cancer often causes bone metastasis, and denosumab is administered to bone metastases to prevent bone-related adverse events. One of the important side effects of denosumab is hypocalcemia, but this is generally not a problem, as it is used with calcium supplementation. A 48-year-old non-smoker male was diagnosed with lung adenocarcinoma with EGFR L858R mutation with diffuse bone metastases. Three days after receiving denosumab, the patient developed weakness and numbness in his limbs and was diagnosed with drug-induced hypocalcemia due to denosumab. It takes more than 4 months for treating the hypocalcemia in this case with continuous intravenous infusion of calcium gluconate with oral calcium supplementation for 2 months of hospitalization and subsequent 2 months of outpatient treatment with intermittent intravenous infusion of calcium gluconate three times a week along with oral supplementation. Tartrate-resistant acid phosphatase-5b (TRACP-5b), a marker of bone resorption, was a biomarker for the required amount of calcium in this case. Patients with lung cancer with diffuse osteoblastic bone metastases could develop severe hypocalcemia and require long-term calcium supplementation.

PMID:40104434 | PMC:PMC11915153 | DOI:10.1016/j.rmcr.2025.102183

Categories: Literature Watch

Suspected hypersensitivity probably related to the use of morphine: A case report

Tue, 2025-03-18 06:00

Rev Salud Publica (Bogota). 2023 Mar 1;25(2):103211. doi: 10.15446/rsap.V25n2.103211. eCollection 2023 Apr.

ABSTRACT

The case of a 46-year-old male patient is presented. He was admitted to the emergency department with a clinical picture of oppressive chest pain of 10/10 intensity on the pain analog scale, which had been evolving for one hour. After evaluation and based on electrocardiographic and laboratory findings, the patient was diagnosed with acute myocardial infarction with st elevation. Additionally, aortic dissection and hypertensive emergency with end-organ damage to the heart were suspected due to intense precordial pain and blood pressure readings of 230/120 mmHg. As part of the therapeutic approach, 3 mg of intravenous morphine diluted in 10 ml of 0.9 % saline solution were administered. Following administration, the patient exhibited suspected hypersensitivity. Therefore, a suspected adverse event assessment was performed using the Naranjo algorithm, and it was established that the effects of morphine were plausible (category probable).

PMID:40099127 | PMC:PMC11254130 | DOI:10.15446/rsap.V25n2.103211

Categories: Literature Watch

Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season

Tue, 2025-03-18 06:00

Hum Vaccin Immunother. 2025 Dec;21(1):2475616. doi: 10.1080/21645515.2025.2475616. Epub 2025 Mar 18.

ABSTRACT

Enhanced Passive Safety Surveillance was used to detect safety signals before the peak period of immunization with quadrivalent inactivated influenza vaccines (IIV4) in Finland (standard dose [SD]) and Germany (high dose [HD]) in the 2023-24 season. The primary objective was to evaluate adverse drug reactions (ADRs) occurring ≤7 days following IIV4 vaccination. Enrolled participants were vaccinated in routine clinical care settings and encouraged to report ADRs. Exposure data and ADR reports were collected in a near real-time manner using an electronic system. Vaccinee reporting rate (RR) with 95% confidence interval (CI) was calculated as the number of vaccinees reporting ≥ 1 ADR divided by total number of vaccinees. In Finland for SD-IIV4, among 1,003 vaccinees aged ≥ 6 months, 81 reported a total of 192 suspected ADRs occurring ≤ 7 days following vaccination (vaccinee RR 8.08%; 95% CI 6.46, 9.94). In Germany for HD-IIV4, among 1,075 vaccinees aged ≥ 60 years, 15 reported 46 ADRs that occurred in ≤ 7 days of vaccination (vaccinee RR 1.40%; 95% CI 0.78, 2.29). No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4.

PMID:40098448 | DOI:10.1080/21645515.2025.2475616

Categories: Literature Watch

Incidence of Adverse Effects and Misuse of Zolpidem

Mon, 2025-03-17 06:00

J Pharm Technol. 2025 Mar 14:87551225251324856. doi: 10.1177/87551225251324856. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Zolpidem is a widely prescribed medication for treating insomnia due to its effectiveness as a sedative-hypnotic. This study aimed to estimate the incidence of potential adverse effects associated with the use and misuse of zolpidem.

METHODS: Retrospective cohort study. Participants were selected from consumers who had purchased zolpidem in a commercial pharmacy in Brazil and submitted an interviewed. Descriptive analysis was used to present the results. Pearson's chi-square tests were used to compare adverse reactions to zolpidem with categorical variables, and Student's t-tests were used to compare means. The significance level adopted was 5%.

RESULTS: The study involved 65 participants, with a mean age of 52.7 years, 76.9% of whom were women. Of the total sample, 69.2% used zolpidem for the treatment of long-term insomnia, and 77.4% used it continuously. Among the interviewees, 55.4% reported experiencing adverse reactions, with amnesia, insomnia, and sleepwalking being the most reported. A statistically significant association was found between the occurrence of adverse reactions and continuous use (P value = 0.048), as well as among those with lower mean age (P value = 0.042).

CONCLUSION: Despite being a prescription-controlled medication, zolpidem was used excessively and inappropriately in the studied sample. Given the high prevalence of adverse effects identified in this study, the risk/benefit ratio of pharmacological treatments for insomnia warrants careful evaluation during prescription and dispensing. Incidence of adverse effects and misuse of zolpidem.

PMID:40092895 | PMC:PMC11909643 | DOI:10.1177/87551225251324856

Categories: Literature Watch

Recognition, management, and patient perspectives of impulsive-compulsive disorders in Parkinson's disease

Mon, 2025-03-17 06:00

J Parkinsons Dis. 2025 Mar 16:1877718X251323922. doi: 10.1177/1877718X251323922. Online ahead of print.

ABSTRACT

BackgroundImpulsive-compulsive disorders (ICDs) are commonly acknowledged as side effects of dopaminergic therapy in Parkinson's disease (PD). While many large-scale studies have focused on prevalences and high-risk treatments, little is known about practical management of ICDs in clinical care and patients' experiences.ObjectiveTo investigate how ICDs are recognized in clinical PD care, clinical features of patients with ICDs, and how patients are impacted by their ICD.MethodsQuestionnaires were sent to all patients who reported ICD symptoms in the Swedish quality register for PD in Skåne County (n = 170) and patients' medical records were screened for mention of ICDs. Core subjects were communication between clinician and patient, course and management of ICDs, and impact on different life domains.ResultsDespite sufficient awareness of the ICD risk during PD treatment, there was limited communication between clinical care staff and patients regarding ICDs. Only 49% of patients had reported their ICD as part of clinical care, and only 14% had been asked about it. Additionally, collaboration with psychiatry was rare (12%). ICD severity increased over time with ongoing PD treatment, and most patients reported a mild to moderate impact of their ICD on close relationships, family, mental and physical health.ConclusionsThis study identified insufficient communication about ICDs as part of clinical care in PD and a very limited involvement of mental health services. Thus, to improve prevention and treatment, ICDs should be recognized, monitored and treated more systematically in routine clinical care, and collaboration with mental health services should be increased.

PMID:40091420 | DOI:10.1177/1877718X251323922

Categories: Literature Watch

Drug-Induced Gingival Enlargement: A Comparative Study on the Effect of Phenytoin, Gabapentin, and Cyclosporin on Gingival Fibroblast Cells

Sat, 2025-03-15 06:00

Mol Biotechnol. 2025 Mar 14. doi: 10.1007/s12033-025-01397-6. Online ahead of print.

ABSTRACT

Drug-induced gingival enlargement (DIGE) is an abnormal overgrowth that may occur as a side effect in some patients when calcium channel blockers, immunosuppressants, or anticonvulsants are taken. The prevalence of DIGE was shown to be 70% for phenytoin (30% for other anticonvulsant medicines) and 50-80% for cyclosporine. The usage of these medications is increasing as new indications emerge. These drugs act through a common mechanism of action at the cellular level by inhibiting intracellular calcium influx. DIGE is characterized by the presence of varied quantities of inflammatory infiltrates, primarily plasma cells, and an excessive build-up of extracellular matrix like-collagen. Fibroblasts, the cells responsible for collagen synthesis, may become hyperactive, leading to the excessive production of collagen fibers. This increased collagen content can result in the enlargement of gingival tissues. As collagen deposits increase, it hinders normal oral care routines, masticatory processes, and esthetics. In this study, we compared the cytotoxicity of phenytoin, gabapentin, and cyclosporine on gingival fibroblast cells using the methyl thiazolyl-tetrazolium assay to understand their effect on gingival fibroblast cells. Phenytoin had the greatest half-maximal inhibitory concentration (IC50) with a value of 305.78 µg/ml, followed by gabapentin with a value of 260.44 µg/ml and cyclosporin with a value of 243.79 µg/ml. Understanding the cytotoxic thresholds of these medications is essential for improving patient outcomes and minimizing the incidence of gingival enlargement in those requiring long-term therapy. According to the study, cytotoxicity increases along with medication concentration. These findings will assist medical professionals in selecting the drug that poses the least risk of adverse effects on gingival health, ultimately guiding more informed prescribing practices.

PMID:40087263 | DOI:10.1007/s12033-025-01397-6

Categories: Literature Watch

A Systematic Review of Mechanisms, Incidence, and Management of Trastuzumab Deruxtecan Induced ILD/Pneumonitis in Solid Tumors

Fri, 2025-03-14 06:00

Drug Des Devel Ther. 2025 Mar 8;19:1655-1668. doi: 10.2147/DDDT.S508773. eCollection 2025.

ABSTRACT

Trastuzumab deruxtecan (T-DXd) has been approved to treat various tumors. While most adverse events (AEs) associated with T-DXd are manageable, interstitial lung disease (ILD)/pneumonitis is a notable AE of special concern. This review describes the incidence, severity, and management of T-DXd-induced ILD/pneumonitis across different tumors. We conducted a systematic search of PubMed, Embase, Cochrane Library, and Web of Science for literature published up to 13 September 2024, regarding the use of T-DXd in the treatment of HER2-positive tumors. Studies included were clinical trials involving HER2-positive tumors with reported ILD/pneumonitis cases.The main data extracted from the full-text articles included the incidence and severity of T-DXd-induced ILD. 18 studies involving 3380 patients with various advanced solid malignancies were included in our review. The overall incidence of adjudicated drug-related ILD/pneumonitis was 12.40%. Although most ILD/pneumonitis cases were low-grade, the risk of ILD/pneumonitis-related death should not be overlooked. Given the prolonged exposure to the drug, careful monitoring and management of T-DXd-induced ILD/pneumonitis are critical. Management strategies include dose reduction, treatment interruption, discontinuation, corticosteroids, and supportive care. Further research is needed to clarify the risk factors and mechanisms underlying T-DXd-induced ILD/pneumonitis. This review highlights critical gaps in understanding the risk factors and mechanisms of T-DXd-induced ILD, underscoring the need for further research.

PMID:40083848 | PMC:PMC11904318 | DOI:10.2147/DDDT.S508773

Categories: Literature Watch

Recommendations on how to proceed in case of suspected allergy to penicillin/β-lactam antibiotics: Position paper of the German Society for Allergology and Clinical Immunology (DGAKI) in cooperation with the German Society for Pediatric Allergology ...

Fri, 2025-03-14 06:00

Allergol Select. 2025 Mar 6;9:28-39. doi: 10.5414/ALX02531E. eCollection 2025.

ABSTRACT

β-lactam antibiotics (BLAs) are still the antibiotics of first choice for the treatment of many bacterial infections. Treatment with a BLA is often hindered by a suspected allergy, up to 10% of the population report an allergy to penicillin. After allergological evaluation of the suspected allergic reaction to a BLA, most patients show a low probability of a BLA allergy; only in a minority of cases an allergic reaction to the repeated administration of a BLA appear likely in view of the previous history. In > 90% of cases, the suspected BLA allergy can be ruled out by allergy diagnostics. We recommend a risk-stratified approach in the context of an urgent need for BLA, which should enable most patients to receive a BLA therapy. After acute therapy, allergy diagnostics have to be done to clearly prove or reliably rule out a BLA allergy.

PMID:40083843 | PMC:PMC11905010 | DOI:10.5414/ALX02531E

Categories: Literature Watch

Gabapentinoids and COPD exacerbations

Thu, 2025-03-13 06:00

Drug Ther Bull. 2025 Mar 13:dtb-2025-000010. doi: 10.1136/dtb.2025.000010. Online ahead of print.

NO ABSTRACT

PMID:40081948 | DOI:10.1136/dtb.2025.000010

Categories: Literature Watch

Safety and Efficacy of the Use of pdVWF/FVIII-C in Patients with von Willebrand Disease: A Prospective, Observational, Post-Authorization Study

Thu, 2025-03-13 06:00

Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251327593. doi: 10.1177/10760296251327593. Epub 2025 Mar 13.

ABSTRACT

IntroductionPlasma-derived von Willebrand factor containing FVIII concentrates (pdVWF/FVIII-C) are indicated as replacement therapy for patients with von Willebrand disease (VWD). This study assessed safety and efficacy associated with long-term real-world experience of the pdVWF/FVIII-C, Fanhdi®, in patients with VWD.MethodsThis observational, prospective, post-authorization cohort study was conducted at five centers in Spain. Patients with VWD were treated with the pdVWF/FVIII-C to achieve satisfactory hemostasis for on-demand (bleeding episodes and surgical/invasive procedures) and prophylaxis treatment. Clinical efficacy was evaluated as the response to treatment in both settings. Safety parameters were assessed.ResultsFifteen VWD patients received at least one dose of the pdVWF/FVIII-C and were followed for 12 months. Forty-six bleeding episodes were reported for 9 (60.0%) patients, and 6 surgical/invasive procedures for 5 (33.3%) patients. Most frequently reported bleedings were gastrointestinal (3 [33.0%] patients) and gynecological (3 [33.0%] patients). No complications nor bleeding episodes related to surgical/invasive procedures were reported. Overall clinical efficacy of treatment (including on-demand and prophylaxis) achieved 100% excellent and/or good (n = 15 patients), being excellent for 7 (46.7%) patients. There were 27 treatment-emergent adverse events in 8 (53.3%) patients, 11 serious adverse events in 3 (20.0%) patients, but none of them were drug-related. No clinical signs and symptoms of immunogenicity or thromboembolic events were reported.ConclusionsThis real-world evidence study confirmed the efficacy of the pdVWF/FVIII-C as on-demand and/or prophylaxis treatment in patients with bleeding episodes or surgical procedures in VWD. Fanhdi® was well tolerated without any safety concerns.

PMID:40079811 | DOI:10.1177/10760296251327593

Categories: Literature Watch

Treat-And-Extend Versus Pro Re Nata Regimen of Intravitreal Conbercept Injection for Neovascular Age-Related Macular Degeneration: Results from COCOA, a Prospective, Open-Label, Multicenter, Randomized Phase IV Clinical Trial

Thu, 2025-03-13 06:00

Semin Ophthalmol. 2025 Mar 13:1-7. doi: 10.1080/08820538.2025.2467853. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate and contrast the effectiveness and safety of two conbercept treatment protocols-a three-dose treat-and-extend (3+T&E) regimen and a three-dose pro re nata (3+PRN) regimen-in Chinese patients diagnosed with neovascular age-related macular degeneration (nAMD).

METHODS: Eligible patients, who had not undergone anti-VEGF intraocular injections within 3 months prior to enrollment, were randomly assigned to either the 3+T&E or 3+PRN regimen. The 3+T&E group received at least three monthly injections, with subsequent visit intervals extended based on disease activity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to week 48, using a predefined noninferiority threshold.

RESULTS: Among 501 participants (249 in 3+T&E, 252 in 3+PRN), approximately half had prior anti-VEGF treatment. At 48 weeks, both regimens showed significant BCVA improvements (+9.9 for 3+PRN, +8.6 for 3+T&E; p = .208), with comparable rates of ≥15-letter gains (32.12% for 3+PRN, 30.77% for 3+T&E; p = .827). The 3+PRN group received fewer injections (mean 6.4 vs. 6.9 in 3+T&E; p = .028) but had shorter intervals between injections (6.93 weeks vs. 7.46 weeks in 3+T&E; p = .010). Drug-related adverse events occurred in 5% of patients, with ocular events evenly distributed and minimal cardiovascular events reported.

CONCLUSION: Both 3+T&E and 3+PRN conbercept regimens effectively improved visual and anatomical outcomes in Chinese nAMD patients. The 3+T&E regimen was noninferior to 3+PRN in improving BCVA from baseline to week 48. The 3+T&E regimen enabled longer injection intervals while 3+PRN regimen with less injections is more cost-effective while maintaining a comparable safety profile. Treatment plan tailored to an individual patient's situation appears necessary.

PMID:40079155 | DOI:10.1080/08820538.2025.2467853

Categories: Literature Watch

Comparison of Transforaminal Magnesium Sulfate with Steroid Injection in the Management of ‎Radicular Back Pain: A Randomized Double-Blinded Clinical Trial Study

Thu, 2025-03-13 06:00

Anesth Pain Med. 2024 Sep 8;14(4):e148739. doi: 10.5812/aapm-148739. eCollection 2024 Aug.

ABSTRACT

BACKGROUND: This study compares the effects of transforaminal magnesium sulfate injection versus other methods for managing radicular back pain, highlighting its potential for improved pain relief and functional outcomes.

METHODS: This randomized, double-blind clinical trial involved 30 patients with radicular back pain who were randomly assigned to receive either transforaminal magnesium sulfate or triamcinolone injection. Primary outcomes were pain intensity and functional disability, assessed using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI), respectively. These were evaluated at five time points: Before the injection, 2 weeks, 1 month, 3 months, and 6 months after the injection. Secondary outcomes included drug-related adverse events within the six-month follow-up period.

RESULTS: Baseline characteristics were not significantly different between the two study groups. Compared to pre-injection measures, post-injection pain intensity and functional disability were significantly reduced in both groups at all time points (P < 0.001). At all postoperative evaluations, pain intensity and functional disability were lower in the magnesium sulfate group compared to the steroid group (P < 0.001). No drug-related side effects were recorded in either group.

CONCLUSIONS: For patients with radicular back pain, transforaminal magnesium sulfate injection appears to be an effective and safe alternative to transforaminal steroid injection.

PMID:40078471 | PMC:PMC11895787 | DOI:10.5812/aapm-148739

Categories: Literature Watch

Efficacy and safety of pharmacological and non-pharmacological therapies in Lennox-Gastaut syndrome: a systematic review and network meta-analysis

Thu, 2025-03-13 06:00

Front Pharmacol. 2025 Feb 26;16:1522543. doi: 10.3389/fphar.2025.1522543. eCollection 2025.

ABSTRACT

OBJECTIVE: This study aimed to evaluate the efficacy and safety of antiepileptic drugs and non-pharmacological treatments in patients with Lennox-Gastaut syndrome (LGS).

METHODS: We conducted a systematic search of the PubMed, Embase, Cochrane, and Web of Science databases for randomized controlled trials (RCTs) evaluating both pharmacological and non-pharmacological interventions for LGS. The treatments assessed included cannabidiol, fenfluramine, clobazam, rufinamide, felbamate, lamotrigine, topiramate, deep brain stimulation, and anterior corpus callosotomy. The primary efficacy outcome was defined as a reduction of at least 50% in the frequency of drop seizures during treatment compared to baseline levels. The secondary efficacy outcome was measured as the median percentage reduction in monthly drop seizure frequency throughout the treatment period. Safety assessments were based on the incidence of adverse events and serious adverse events. All outcomes were ranked according to their surface under the cumulative ranking curve (SUCRA).

RESULT: This network meta-analysis encompassed 12 RCTs involving a total of 1,445 patients. The SUCRA indicated that clobazam 1 mg/kg/day, anterior corpus callosotomy, and rufinamide were the three most effective interventions for achieving a reduction of at least 50% in drop seizures. In terms of median percentage reduction in drop seizure frequency, clobazam 1 mg/kg/day ranked highest, followed by clobazam 0.5 mg/kg/day and rufinamide. Regarding safety profiles, SUCRA analysis revealed that cannabidiol 20 mg/kg/day had the highest likelihood of inducing adverse events, followed closely by fenfluramine 0.7 mg/kg/day. Lamotrigine was found to be most likely to cause serious adverse reactions, with cannabidiol 10 mg/kg/day following closely behind.

CONCLUSION: Clobazam 1 mg/kg/day, anterior corpus callosotomy, and rufinamide manifested the most optimal efficacy in seizure control among LGS patients. Caution should be exercised when administering cannabidiol, lamotrigine, and fenfluramine 0.7 mg/kg/day in clinical practice to mitigate safety concerns associated with drug-related side effects.

PMID:40078280 | PMC:PMC11898213 | DOI:10.3389/fphar.2025.1522543

Categories: Literature Watch

Efficacy of anlotinib and chemotherapy combination as neoadjuvant therapy in the treatment of pulmonary artery intimal sarcoma: a case report

Thu, 2025-03-13 06:00

Front Oncol. 2025 Feb 26;15:1507281. doi: 10.3389/fonc.2025.1507281. eCollection 2025.

ABSTRACT

Pulmonary arterial intimal sarcoma (PAIS) is a rare malignant mesenchymal tumor often associated with an unfavorable prognosis and lacks a standardized treatment approach to date. This report presents a notable case of PAIS treated with neoadjuvant therapy involving anlotinib concomitantly administered with chemotherapy of ifosfamide and pirarubicin, which resulted in a favorable outcome. A 38-year-old man was admitted to our hospital with chest tightness, cough, and dyspnea, all of which had persisted for more than a week. Initial evaluation via chest computed tomography (CT) revealed a sizable posterior mediastinal tumor measuring 11.9 × 7.6 cm. A CT-guided biopsy was performed, and pathological findings confirmed the diagnosis of PAIS. Efficacy evaluation showed slow progress after one cycle of chemotherapy with ifosfamide and pirarubicin. To enhance treatment outcomes, we incorporated anlotinib as a neoadjuvant therapy alongside ifosfamide and pirarubicin. Subsequent CT imaging demonstrated a significant reduction in tumor size, and the patient experienced notable alleviation of symptoms. The patient then underwent surgery, radiation, and subsequently, maintenance treatment with anlotinib for one year. No severe drug-related side effects were observed. The patient achieved progression-free survival of 25 months following administration of anlotinib. Thus, the combination of anlotinib with ifosfamide and pirarubicin demonstrated significant efficacy and safety. This approach holds promise as an effective therapeutic strategy for managing unresectable, locally advanced, or advanced PAIS. However, further clinical studies are necessary to validate these findings.

PMID:40078190 | PMC:PMC11897571 | DOI:10.3389/fonc.2025.1507281

Categories: Literature Watch

HF-Ultrasonography to Quantify Skin Atrophy in Patients with Inflammatory Rheumatic Diseases Treated with Courses of Glucocorticoids

Thu, 2025-03-13 06:00

Diagnostics (Basel). 2025 Mar 4;15(5):619. doi: 10.3390/diagnostics15050619.

ABSTRACT

Background: Prolonged courses of glucocorticoids (GCs) for patients suffering from inflammatory rheumatic diseases (IRDs) are associated with adverse effects. High-frequency ultrasonography (HFUS) has been utilized to quantify skin changes during short-term topical GC treatment. We aimed to quantify skin atrophy in IRD patients treated systemically with prolonged courses of GCs. Methods: We performed a cross-sectional study comparing patients with IRDs and GC treatment who presented with clinically evident skin atrophy to a matched cohort (1:1) without IRDs and GC treatment. Skinfold measurements, utilizing a standardized caliper, and B-mode HFUS images, utilizing an 18 MHz linear sonography probe, were acquired at back-of-hand, cubital, and dorsal midfoot regions and then compared between both groups. Results: A total of 53 GC-treated IRD patients (33 (62%) women, mean age 66.4 (±10.0) years, GC treatment median 8.0 (1.0-47.0) years) were compared to 53 subjects without IRDs and GC treatment (32 (60%) women, 65.9 (±11.3) years). Skinfold thickness measured at the back of hands [1.7 (±0.4) vs. 2.1 (±0.5) mm, p < 0.001], but not at the cubital [6.7 (±2.7) vs. 7.1 (±3.0) mm] or dorsal midfoot [3.6 (±3.7) vs. 4.1 (±3.4) mm] areas, showed a significant difference between the groups. In comparison, all areas displayed statistically significant different cutaneous thickness in the evaluation by HFUS: hand 0.66 (±0.12) vs. 0.82 (±0.18), p < 0.001; cubital 0.86 (±0.15) vs. 1.00 (±0.21), p < 0.001; and midfoot 0.76 (±0.16) vs. 0.94 (±0.18), p < 0.001. Conclusions: This study revealed significantly lower values in the measured cutaneous thickness by HFUS for GC-treated patients with IRDs compared to persons without IRD and GC treatment.

PMID:40075866 | DOI:10.3390/diagnostics15050619

Categories: Literature Watch

Mycophenolic acid trough level assessment in patients with lupus nephritis; does it make a difference?

Thu, 2025-03-13 06:00

Pediatr Rheumatol Online J. 2025 Mar 12;23(1):26. doi: 10.1186/s12969-025-01074-7.

ABSTRACT

INTRODUCTION: Mycophenolate Mofetil (MMF) has become one of the cornerstone treatments of lupus nephritis (LN). It is converted into mycophenolic acid (MPA), an active metabolite, that displays high inter- and intra-individual pharmacokinetic variability. However, the routine monitoring of MPA trough level is still debatable.

OBJECTIVES: The present study aims to evaluate the relationship between MPA trough levels and both clinical outcomes and drug-related adverse effects during the maintenance phase of LN in Egyptian patients.

METHODS: We included thirty-five adults and twenty-nine children with biopsy-proven class III and IV LN, who had been maintained on steroid and MMF as maintenance therapy for more than six months. Clinical and laboratory markers of lupus activity as well as MMF adverse events were reported. MPA trough levels were measured by High-Performance Liquid Chromatography (HPLC).

RESULTS: There was a significant association between low MPA trough levels and both flares and SLEDAI scores in the adult group (P = 0.027 and 0.019, respectively). Moreover, high MPA trough levels were associated with higher risk of gastritis in the same age group (P = 0.007). There was no significant association with any of the parameters studied in the pediatric group. Gastritis was the most frequent side effect in both age groups.

CONCLUSION: MPA trough levels correlated with disease activity and gastritis in adult LN patients, and this may help to optimize MMF dosage in these patients. However, MPA concentration-effect relationships were not observed in pediatric patients.

PMID:40075510 | DOI:10.1186/s12969-025-01074-7

Categories: Literature Watch

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