Current drug safety最新文献

{"title":"Disproportionality Analysis of Reporting Signals for Pericardial Disorders in the FDA Adverse Event Reporting System, 2000 to 2025.","authors":"Kenneth L McCall, Kristin T Bush, Courtney E George, Hailey N Goudy, Dante T Mento, Nicholas C Schwier","doi":"10.2174/0115748863515024261006073915","DOIUrl":"https://doi.org/10.2174/0115748863515024261006073915","url":null,"abstract":"<p><strong>Background/objectives: </strong>Pericardial syndromes cause significant morbidity, decreased quality of life, and rarely mortality. Drug-associated pericardial syndromes are underreported. This study characterized reports of pericardial disorders, described demographic and reporting features, and identified disproportionality signals across suspect drugs and therapeutic classes.</p><p><strong>Methods: </strong>This study analyzed FDA Adverse Event Reporting System reports from January 2000 to March 2025, using predefined preferred terms for pericardial syndromes. Duplicate and pediatric reports (<18 years) were excluded, resulting in 12,106 unique reports. A lower 90% confidence limit of the Empirical Bayes Geometric Mean (EB05)>2 and a lower limit of the 95% credibility interval of the Information Component (IC025)>0 were indicators of signals.</p><p><strong>Results: </strong>Raw counts of reports increased from 133 in 2000 to 939 in 2024. The cohort had a balanced sex distribution and a mean age of 55.5 years. Among females, antineoplastic (e.g., rituximab, EB05 = 13.3, IC025 = 3.7) and immunomodulating agents (e.g., adalimumab, EB05 = 3.1, IC025 = 1.6) were most frequently suspected. Among males, antithrombotic agents (e.g., aspirin, EB05 = 7.1, IC025 = 2.8) predominated. A higher age-adjusted reporting odds of death was observed in females versus males (OR=1.14, 95% CI 1.03-1.25; deaths: females n=1,030, males n=925).</p><p><strong>Discussion: </strong>Raw report counts of pericardial syndromes increased over 25 years, supporting heightened vigilance for drug-induced etiologies. Sex-stratified drug rankings were exploratory and do not demonstrate drug-by-sex interactions. The results extend the existing literature by providing a broad descriptive overview of the reporting landscape for pericardial disorders within a national spontaneous reporting system.</p><p><strong>Conclusions: </strong>Immunomodulating, antineoplastic, and antithrombotic agents generated reporting signals involving pericardial disorders, with sex-based differences and reported drug classes and outcomes. These findings do not establish causality and warrant confirmatory studies.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bilateral Lower Extremity Edema During Donepezil Treatment: A Case Report.","authors":"Kyusik Kang","doi":"10.2174/0115748863527540260928113823","DOIUrl":"https://doi.org/10.2174/0115748863527540260928113823","url":null,"abstract":"<p><p>Introduction/ Background: Acute bilateral lower-extremity edema is uncommon and often results from medication side effects, acute heart failure, nephrotic syndrome, or bilateral deep vein thrombosis. Drugs such as dihydropyridine calcium channel blockers, corticosteroids, thiazolidinediones, and nonsteroidal anti-inflammatory agents are known to cause edema. Donepezil, a widely used acetylcholinesterase inhibitor for Alzheimer's disease, has not been previously linked to leg edema. Recognizing rare adverse reactions is essential for patient safety, as edema may indicate serious conditions. Case Presentation: A 75-year-old woman with Alzheimer's disease developed bilateral pitting lower leg edema six months after starting treatment with donepezil. She had no history of cardiac, renal, hepatic, or venous diseases. Laboratory tests, electrocardiography, chest X-ray, and computed tomography venogram were normal, except for mild anemia and a slightly reduced estimated glomerular filtration rate. The edema resolved three weeks after discontinuation and did not recur after the administration of rivastigmine. Conclusion: The temporal association and resolution upon drug cessation suggest a probable association. Possible mechanisms may include cholinergic-induced vasodilation, which increases capillary permeability.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Sequential Combined Immunomodulatory Systemic Therapies Used in the Management of Refractory Cytokine Release Syndrome in Critically Ill Patients with COVID-19.","authors":"Antonio Mastroianni, Luciana Chidichimo, Valeria Vangeli, Giuliana Guadagnino, Lavinia Berardelli, Roberto Manfredi, Antonio Siniscalchi, Sonia Greco","doi":"10.2174/0115748863492031260920211559","DOIUrl":"https://doi.org/10.2174/0115748863492031260920211559","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction/objective: &lt;/strong&gt;Severe Coronavirus Disease 2019 (COVID-19) is characterized by systemic hyperinflammation and cytokine storm, a series of clinical conditions caused by excessive immune reactions. Although numerous studies have been conducted on anti-inflammatory treatments for severe COVID-19, no specific recommendations have been made regarding drugs to use in patients with Refractory Cytokine Release Syndrome (CRS) after the use of first-line anticytokine drugs. The objective of this report was to evaluate the efficacy of sequential immunomodulatory therapies in the management of refractory CRS in COVID-19 patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;From March 2020 to March 2023, 1,025 patients with COVID-19 were admitted to the Infectious and Tropical Diseases ward at the Annunziata Cosenza Hub Hospital in Cosenza, Italy. To determine how many patients with refractory COVID-19-associated CRS were treated with combinedsequential therapy involving tocilizumab, a recombinant humanized anti-Interleukin-6 (IL-6) receptor monoclonal antibody, and baricitinib, a Janus kinase inhibitor, or anakinra, a recombinant human interleukin- 1 receptor antagonist, the electronic medical records of all hospitalized patients with COVID-19 were reviewed. The primary outcome was the incidence of CRS by day 29. Secondary outcomes included in-hospital mortality and 30-day mortality, to assess hospital performance and patient safety. Electronic databases such as MEDLINE, EMBASE, and Cochrane Central were searched through June 30, 2026, for case-series and studies evaluating the efficacy of sequential combined immunomodulatory systemic therapies in the management of refractory CRS in critically ill patients with COVID-19.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;From January 2021 to December 2023, a total of 25 patients received sequential combined immunomodulatory systemic therapies, including tocilizumab and baricitinib or anakinra, in the management of COVID-19-related CRS. After 72 hours from the introduction of the new anti-cytokine therapy, a significant improvement of respiratory parameters, clinical state, inflammatory markers, and blood counts was observed. All patients survived, and those 5 previously mechanically ventilated patients were extubated. Non-infectious or infectious pulmonary or systemic complications were observed in all patients who underwent sequential combined immunomodulatory systemic therapies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The study's findings suggest that tocilizumab used in sequential combination with baricitinib or anakinra, in conjunction with standard of care treatments, was associated with improved outcomes in critically ill patients with COVID-19 disease and early discharge from the hospital.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;There is clear rationale for using combined immunomodulatory systemic therapies in critically ill patients who develop refractory CRS. The results of the experience, supported by a review ","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Duality of Rarity of Chemotherapy-induced Flagellate Erythema among Cancer Patients: A Case Report with 26 Years of Evidence in Oncology.","authors":"Rajesh Krishna, Revathy Nandakumar, Rajesh Raju, Anusha Hegde, Raushan Kumar Chaudhary","doi":"10.2174/0115748863494991260907111941","DOIUrl":"https://doi.org/10.2174/0115748863494991260907111941","url":null,"abstract":"<p><strong>Introduction: </strong>Flagellate Dermatitis (FD) due to anticancer therapy is a rare, unusual Adverse Drug Reaction (ADR) in oncology. The current case describes the impact of financial constraints on the choice of anticancer therapy, the occurrence of FD and poor outcomes among Hodgkin's Lymphoma patients, and 26 years of evidence on FD due to anticancer therapy.</p><p><strong>Case report: </strong>A 25-year-old male presented with fever, cough, night sweats, weight loss, and swelling on the right side of the neck, which was diagnosed as Hodgkin's Lymphoma with a complex diagnostic work-up (PET-CT scan, histopathology/immunohistochemistry reports). The patient was planned for Nivolumab-AVD therapy, but treated with ABVD chemotherapy due to financial constraints. Unfortunately, the patient developed linear streaks on the trunk region of the body after 4 days of 1st dose of ABVD therapy, which was diagnosed as FD triggered by Bleomycin. Thus, Bleomycin was omitted from the polychemotherapy regimen (AVD), and ADR was managed with corticosteroids. Although the PET-CT report initially showed a partial response to ABVD/AVD. Later, the disease was found to be metabolically progressive, for which salvage therapy (GDP, DHAP, and palliative radiotherapy) was given. Further, the patient was suggested Brentuximab and Nivolumab therapy, but the patient declined therapy due to financial constraints, lack of funding, and coverage by the government healthcare scheme. Thus, the patient was discharged against medical advice.</p><p><strong>Conclusion: </strong>Healthcare professionals should be aware of and vigilant for this whip-like dermatological manifestation (FD) when choosing Bleomycin-based therapy. A patient-centric approach to cessation or rechallenge with the culprit drug, along with antihistamines and topical/ oral corticosteroids, is the mainstay for the management of FD.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance Knowledge, Attitudes, and ADR Reporting Behaviour Among Physicians and Pharmacists in a Tertiary Hospital.","authors":"Zühal Kaltuş, Ezgi Eroğlu, Sinem Gürcü, Serkan Ceyhan","doi":"10.2174/0115748863492008260909072146","DOIUrl":"https://doi.org/10.2174/0115748863492008260909072146","url":null,"abstract":"<p><strong>Introduction: </strong>Adverse Drug Reactions (ADRs) remain a major challenge in pharmacovigilance due to persistent underreporting. Healthcare professionals' knowledge, attitudes, and reporting practices play an important role in effective ADR monitoring. This study aimed to assess pharmacovigilance knowledge, attitudes, and ADR reporting behaviour among physicians and pharmacists and to identify factors associated with ADR reporting.</p><p><strong>Methods: </strong>This cross-sectional study was conducted among physicians and pharmacists in a tertiary hospital in Türkiye between August 2024 and September 2025. A structured questionnaire was used to assess pharmacovigilance knowledge, attitudes, and ADR reporting behaviour. ADR reports from the institutional system over the past five years were also reviewed. Knowledge scores were calculated as the proportion of correct answers. Associations between variables were analyzed using independent-samples t-test and chi-square test. Statistical significance was set at p < 0.05.</p><p><strong>Results: </strong>A total of 224 healthcare professionals participated (196 physicians, 28 pharmacists). Pharmacists had significantly higher knowledge scores than physicians (p < 0.001). However, previous ADR reporting was uncommon in both groups, with similar reporting rates among physicians (22/196, 11.2%) and pharmacists (3/28, 10.7%). Previous pharmacovigilance training was significantly associated with previous ADR reporting in bivariate analysis, whereas professional experience was not. In multivariable logistic regression, pharmacovigilance knowledge score was independently associated with previous ADR reporting.</p><p><strong>Discussion: </strong>Pharmacists demonstrated higher pharmacovigilance knowledge than physicians; however, this advantage did not translate into ADR reporting rates. The findings indicate that improving knowledge alone may not be sufficient, and institutional support and targeted training strategies are required to enhance reporting behaviour.</p><p><strong>Conclusion: </strong>Knowledge gaps and limited awareness remain important challenges in ADR reporting. Although pharmacists had higher pharmacovigilance knowledge, reporting rates were similar between groups. Targeted training programs may contribute to improving ADR reporting practices.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149036692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Possible Interaction of the Gut-selective Antibiotic Rifaximin with Carvedilol Associated with Transient Indirect Hyperbilirubinemia: A Case Report.","authors":"Dawesh Prakash Yadav, Aakanksha Jaiswal, Siddhartha Vats, Sankha Shubhra Chakrabarti, Upinder Kaur","doi":"10.2174/0115748863499430260827111726","DOIUrl":"https://doi.org/10.2174/0115748863499430260827111726","url":null,"abstract":"<p><strong>Introduction: </strong>Rifaximin is a gut-selective antimicrobial with poor bioavailability. One potential indication of rifaximin use is hepatic encephalopathy. The adverse effects are limited to the gastrointestinal system, and systemic disturbances are rare. We report a case of hyperbilirubinemia possibly associated with rifaximin-carvedilol co-administration.</p><p><strong>Case presentation: </strong>A 58-year-old male with chronic liver disease (Child Pugh class B) of probable autoimmune etiology and associated chronic kidney disease developed transient indirect hyperbilirubinemia temporally associated with rifaximin-carvedilol co-administration. The hyperbilirubinemia improved with the discontinuation of both drugs.</p><p><strong>Conclusion: </strong>This appears to be the first report of new-onset indirect hyperbilirubinemia with rifaximin in the presence of carvedilol in a patient with chronic liver disease of autoimmune etiology. Carvedilol-mediated P-glycoprotein inhibition represents a biologically plausible but unproven mechanism for overexposure to rifaximin. Clinical studies are warranted to assess the potential consequences of P-glycoprotein-mediated modulation of rifaximin pharmacokinetics in patients with chronic liver and renal disease.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148966869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Patient Safety: Patterns of Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Eastern India: A Record-based Retrospective Study.","authors":"Prasanjit Das, Alapan Das, Bisweswar Ojha, Deepasree Sukumaran, Soumitra Mandal","doi":"10.2174/0115748863471075260724094945","DOIUrl":"https://doi.org/10.2174/0115748863471075260724094945","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are a significant cause of increased morbidity and mortality, prolonged hospitalisation, and financial burden on patients. Regular ADR monitoring helps formulate strategies for the safe and effective use of medicines in healthcare settings. This study was conducted to assess the trends in ADR reporting along with their various aspects.</p><p><strong>Methods: </strong>This record-based observational study was conducted at the ADR Monitoring Centre of our healthcare facility. ADRs reported from April to September 2023 were analysed. The WHO-UMC scale, Modified Hartwig Severity Assessment Scale and Modified Schumock and Thornton Scale were used to assess the causality, severity, and preventability of ADRs, respectively. Descriptive statistics were used for the analyses.</p><p><strong>Results: </strong>A total of 146 adverse drug reactions (ADRs) were reported during the study period. Of these, 68.49% of the ADRs were reported from the Department of Psychiatry. Female patients accounted for 53.42% of reported ADRs. Neurological system involvement was observed in 32.9% of the ADRs. Escitalopram was the most frequently implicated drug. Causality assessment revealed that 63.01% of ADRs were possible. Meanwhile, 83% of the ADRs were mild in severity, and a total of five ADRs were found to be serious in this study, none of which were fatal. Furthermore, 39.73% of the ADRs were classified as probably preventable.</p><p><strong>Discussion: </strong>The predominance of neuropsychiatric ADRs observed in this study may reflect both prescribing patterns and improved recognition of CNS-related adverse effects in psychiatric practice. These findings also highlight the importance of strengthening ADR reporting practices across all departments.</p><p><strong>Conclusion: </strong>The ADR reporting pattern observed in this newly established tertiary healthcare facility in eastern India may help increase physicians' awareness of the importance of timely ADR reporting and support their clinical decision-making process.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dapsone-Induced Photosensitivity: A Rare and Overlooked Clinical Dilemma.","authors":"Akshay Sankar Peethambaran","doi":"10.2174/0115748863490734260714102047","DOIUrl":"https://doi.org/10.2174/0115748863490734260714102047","url":null,"abstract":"<p><strong>Introduction: </strong>Dapsone (4,4'- diamino diphenyl sulfone, DDS) is an antimicrobial sulfonamide used for non-dermatological and dermatological disorders. Dapsone has been associated with a wide range of cutaneous adverse effects, with photosensitivity being an unusual side effect.</p><p><strong>Case presentation: </strong>A case of dapsone-induced photosensitivity was reported in a patient with lepromatous leprosy. A 46-year-old male patient complained of redness and scaling, with itching over his face, nape, the flexural aspect of his neck, and bilateral upper and lower limbs, during the second month of multidrug multibacillary therapy. Examining the face, neck, and upper and lower limbs revealed erythematous scaly plaques with crusting and fissuring. Dapsone-induced photosensitivity was suspected, and the drug was stopped immediately. The patient was started on 0.5 mg/kg of prednisolone, antihistamines, and sunscreen. After improving symptomatically, the patient was discharged from the hospital and started on multidrug multibacillary therapy without dapsone.</p><p><strong>Conclusion: </strong>Although it is uncommon, dapsone-induced photosensitivity should be taken into account when patients exhibit photodermatoses while receiving treatment. Morbidity and unnecessary regimen discontinuation can be avoided with early detection followed by prompt care. This case emphasizes how crucial it is for physicians to be aware of this unusual side effect.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating the Therapeutic Potential of a Polyherbal Formulation in Progesterone-induced Obesity: Insights from Preclinical Studies.","authors":"Devendra Shriram Shirode, Aishwarya Sambhaji Patil, Deepak S Khobragade, Sunil Kumar Kadiri, Prashant Tiwari","doi":"10.2174/0115748863396631251005190202","DOIUrl":"https://doi.org/10.2174/0115748863396631251005190202","url":null,"abstract":"<p><strong>Introduction: </strong>Metabolic disorders have grown more common, with obesity representing a significant chronic illness that leads to various severe health complications. The Obesity Atlas 2022 predicts one billion obese people by 2030. Contributors to obesity encompass heightened oxidative stress, hyperlipidemia, hunger enhancement, fat accumulation, insulin resistance, and diminished caloric expenditure. Numerous synthetic interventions for obesity are accessible today ; nonetheless, they frequently entail detrimental side effects. This research aimed to investigate the formulation of a prospective anti-obesity drug derived from plant origins.</p><p><strong>Methods: </strong>The anti-obesity effectiveness of a polyherbal formulation, derived from the ethanolic extract of both Hugonia mystax and Blumea lacera in a 1:1 ratio, was assessed in female mice with progesterone-induced obesity.</p><p><strong>Results: </strong>The preliminary phytochemical screening of the formulation specifies the presence of phenolic acids, flavonoids, and tannins. In accordance to OECD recommendations, 200 mg/kg and 400 mg/kg were designated after performing acute oral toxicity assessment as a low dose and high dose. During the study, body weight, BMI, abdomen circumference, glucose levels, lipid profile, SGOT, SGPT, atherogenic index, lipid peroxidation (LPO), and glutathione (GSH) levels were evaluated in all groups. The treatment markedly corrected the abnormal levels of these parameters and dramatically restored GSH levels.</p><p><strong>Discussion: </strong>Metabolic disorders, especially obesity, are increasing globally. Synthetic therapies have negative consequences; therefore, exploration of plant substitutes is encouraged A polyherbal extract of Hugonia mystax and Blumea lacera has shown significant anti-obesity properties in mice. It restored biochemical parameters, likely due to phytochemicals such as polyphenols. Histological examination validated its therapeutic efficacy.</p><p><strong>Conclusion: </strong>The formulation's efficacy in addressing obesity is likely attributable to the presence of polyphenols, saponins, and terpenoids. Histopathological examination of hepatic and adipose tissues further corroborated the anti-obesity efficacy of the polyherbal formulation. Future research will focus on isolating and identifying the active chemicals in both plants to better understand their composition.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Experience with Quintuple Non-Insulin Drug Therapy in Suboptimally Controlled Type 2 Diabetes.","authors":"Georgios S Papaetis, Costas A Christophi, Andriana M Till, Anastasia Papapostolou, Michalis K Picolos","doi":"10.2174/0115748863485481260722093116","DOIUrl":"https://doi.org/10.2174/0115748863485481260722093116","url":null,"abstract":"<p><strong>Introduction: </strong>Current evidence for individuals experiencing Type 2 Diabetes (T2D), who refuse insulin treatment and are given five non-insulin antidiabetic drug combinations, is scarce.</p><p><strong>Methods: </strong>We conducted a retrospective observational study to investigate the prevalence of quintuple non-insulin drug regimens during a 12-month period, in patients with suboptimally controlled T2D who refuse insulin therapy.</p><p><strong>Results: </strong>1463 individuals with T2D were assessed during the course of the investigation. Forty patients (2.7%) satisfied the eligibility criteria and were included. The mean therapeutic period was 35.5 ± 29.2 months, and the mean A1C was 7.5± 1.0%. The majority of patients received pioglitazone as the fifth choice to background quadruple regimens (70%). The mean decrease in A1C levels was 0.82 ± 0.99% compared to baseline indices without notable side effects and safety concerns (p < 0.001). Fear of starting insulin was the major reason for rejecting insulin therapy.</p><p><strong>Discussion: </strong>Despite the limitations inherent to its retrospective design, this study shows that five non-insulin drug combinations can be considered a possible therapeutic option for this difficultto-treat group of patients, at least until they are convinced to start and maintain insulin therapy.</p><p><strong>Conclusion: </strong>The prevalence of individuals with T2D treated with quintuple non-insulin drug regimens was 2.7% without any notable side effects or safety concerns. In patients who refuse insulin therapy, these combinations can be taken into consideration according to the characteristics of every individual and carefully evaluated for their safety and effectiveness.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}