Drugs - Real World Outcomes最新文献

{"title":"Disease-Modifying Medications in Patients with Rheumatoid Arthritis in the USA: Trends from 2016 to 2021.","authors":"Samuel K Peasah, Elizabeth C S Swart, Yan Huang, Sandra L Kane-Gill, Amy L Seybert, Urvashi Patel, Chronis Manolis, Chester B Good","doi":"10.1007/s40801-024-00416-3","DOIUrl":"10.1007/s40801-024-00416-3","url":null,"abstract":"<p><strong>Background: </strong>Disease-modifying anti-rheumatic drugs (DMARDs), since their introduction in 1990, have revolutionized the management of rheumatoid arthritis. Newer DMARDs have recently been approved, influencing treatment patterns and clinical guidelines.</p><p><strong>Objective: </strong>To update the current prescribing patterns of DMARDs in the pharmacotherapy of rheumatoid arthritis (RA) to include the pandemic era.</p><p><strong>Methods: </strong>This was a retrospective cross-sectional multi-year study. Using Optum's Clinformatics® Data Mart Database, we summarized trends in the prevalence of DMARD use in the USA from 2016 to 2021 by year for adult patients ≥ 18 years old with at least one medical RA claim and one pharmacy/medical claim of a DMARD medication. Trends included type of DMARD, class of DMARD (conventional (csDMARDs), biologics [tumor necrosis factor (TNFi) and Non-TNFi), and Janus kinase inhibitors (JAKs)], and triple therapy [methotrexate (MTX), hydroxychloroquine (HCQ), sulfasalazine (SUL)] used.</p><p><strong>Results: </strong>The total sample from 2016 to 2021 was 670,679 commercially insured patients. The average age was 63.7 years (SD 13.6), and 76.7% were female and 70% were White. csDMARDs remain the most prescribed (ranging from 77.2 to 79.2%). Although JAKs were the least prescribed DMARD class, their proportion more than doubled from 2016 (1.5%) to 2021 (4%). MTX utilization declined from 40% in 2016 to 34% in 2021. In contrast, HCQ use increased during the pandemic era from < 25% in 2018 to 30% in 2021. Although there is evidence of the therapeutic benefit of triple therapy, its use was very low (~ 1%) compared to biologics only (~ 17%) or biologics+MTX (~ 10%).</p><p><strong>Conclusion: </strong>About half of patients with RA were on DMARDs. As expected, csDMARDs were highly used consistently. The COVID-19 pandemic might have influenced the use of HCQ and infusion DMARDs. Triple therapy use remains low.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"241-249"},"PeriodicalIF":2.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11176124/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139897947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in Anti-Influenza Drug Prescription and Adverse Drug Reaction Reporting After the Lifting of Oseltamivir Prescribing Restrictions in Pediatric Outpatients: An Ecological Study Using the MDV Analyzer^® And the Japanese Adverse Drug Event Report Database.","authors":"Misaki Tokunaga, Daisuke Kikuchi, Aoi Noda, Sachiko Oikawa, Makoto Shiozawa, Hiroaki Hino, Ryosuke Miura, Kensuke Usui, Taku Obara, Kouji Okada","doi":"10.1007/s40801-023-00414-x","DOIUrl":"10.1007/s40801-023-00414-x","url":null,"abstract":"<p><strong>Background: </strong>Abnormal behavior after oseltamivir administration has been reported in the media; in 2007, the package insert for oseltamivir phosphate was revised to restrict its administration to individuals aged over 10 years. However, in 2018, the age limitation specified in the package insert was removed. Here, we evaluated the trends in anti-influenza drug prescription and adverse drug reactions (ADRs) reported in pediatric outpatients after revising the oseltamivir package insert as an ecological study.</p><p><strong>Methods: </strong>Anti-influenza drug prescriptions for pediatric outpatients with influenza aged 0-19 years were downloaded from the acute Diagnosis Procedure Combination hospital databases using the MDV analyzer^®. ADR reports on anti-influenza drug prescription among patients aged 0-20 years in the Japanese Adverse Drug Event Report database were downloaded from the Pharmaceutical and Medical Devices Agency website. Data were collected during the 2016/2017 and 2019/2020 influenza seasons.</p><p><strong>Results: </strong>During the influenza epidemic season (January-March), the percentage of oseltamivir prescriptions for patients with influenza aged 10-19 years tripled after the revision of the oseltamivir package insert (9.3% during the 2016/2017 season and 29.2% during the 2019/2020 season); however, reports of abnormal behavior did not increase (two during the 2016/2017 season and none during the 2019/2020 season).</p><p><strong>Conclusions: </strong>The number of oseltamivir-related ADR reports among minors over 10 years of age did not increase although the proportion of oseltamivir prescriptions increased after the revision of the oseltamivir package insert.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"177-184"},"PeriodicalIF":2.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11176281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139485158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Oral Cephalexin-Clavulanic Acid, Cefuroxime, and Amoxicillin-Clavulanic Acid in the Management of Dental Infections: A Real-World, Retrospective, Electronic Medical Record-Based Study in India.","authors":"Kalyan Banerjee, Ajay Kakkar, Kashif Ahmed Shamsi, Deepak Bansal, Priyesh Mathur, Nitin Madan Potode, Pankaj Pagariya, Sha Perveez Azher, Apurva Chaudhari, Ritu Mandal, Archana S Karadkhele, Neeraj Markandeywar, Shruti Dharmadhikari, Chintan Khandhedia, Amey Mane, Suyog Mehta, Sadhna Joglekar","doi":"10.1007/s40801-023-00406-x","DOIUrl":"10.1007/s40801-023-00406-x","url":null,"abstract":"<p><strong>Background: </strong>Despite multiple antibiotics being available to manage dental infections (DI), there is lack of data comparing commonly prescribed antibiotics in India.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate the real-world effectiveness and tolerability of cephalexin-clavulanic acid fixed-dose combination (cephalexin CV FDC) in contrast with amoxicillin-clavulanic acid (co-amoxiclav FDC) and cefuroxime among patients with dental infections (odontogenic) in India.</p><p><strong>Methods: </strong>This retrospective, multi-centric, observational, real-world electronic medical record (EMR)-based study was conducted between January 2022 and December 2022. The EMRs of 355 adults with DI receiving oral cephalexin CV, co-amoxiclav, or cefuroxime were categorized into two distinct groups: Group I (Test Group) with patients prescribed cephalexin extended release 375/750 mg along with clavulanic acid 125 mg; and Group II (Comparator Group) with patients prescribed co-amoxiclav 625 mg (500 mg amoxicillin + 125 mg clavulanic acid) or cefuroxime (250 mg/500 mg).</p><p><strong>Results: </strong>Toothache was the most common complaint, reported by 95.5% of patients, followed by swelling (46.8%), tooth sensitivity (35.5%), pus discharge (33.0%), redness and halitosis (30.4% each). Dental caries was observed in 81.1% of patients. Clinical improvement, defined as improvement/partial resolution of infection-related clinical signs and symptoms (composite measure of pain, swelling, fever, requirement of additional antimicrobial therapy) as per dentists' judgment, was recorded in 98.3% of patients with cephalexin CV, 96.8% of patients with co-amoxiclav, and 98.9% of patients treated with cefuroxime within 10 days. Time (days) to clinical improvement was numerically lesser among patients receiving cephalexin CV (4.6 ± 2.0) compared with cefuroxime (4.9 ± 2.1) and co-amoxiclav (5.0 ± 2.6). All treatments were well tolerated.</p><p><strong>Conclusion: </strong>Cephalexin CV was as effective as co-amoxiclav and cefuroxime, with faster clinical improvement and better resolution of certain symptoms.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"53-68"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138801033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes of a Medication Optimization Virtual Interdisciplinary Geriatric Specialist (MOVING) Program: A Feasibility Study.","authors":"Joanne Man-Wai Ho, Eric To, Rebecca Sammy, Matei Stoian, Jennifer Man-Han Tung, Robert Jack Bodkin, Lindsay Cox, Tony Antoniou, Sophiya Benjamin","doi":"10.1007/s40801-023-00403-0","DOIUrl":"10.1007/s40801-023-00403-0","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug events among older adults result in significant mortality, morbidity and cost. This harm may be mitigated with appropriate prescribing and deprescribing. We sought to understand the prescribing outcomes of an interdisciplinary geriatric virtual consultation service.</p><p><strong>Methods: </strong>We conducted a retrospective, before-and-after feasibility study to measure prescribing outcomes for a medication optimization virtual interdisciplinary geriatric specialist (MOVING) programme comprised of expertise from geriatric clinical pharmacology, pharmacy and psychiatry for older adults (aged ≥ 65 years) between June and December 2018, Ontario, Canada. The primary outcome was the number of distinct prescriptions and the presence of polypharmacy (defined as ≥ 4 medications) before and after the service. Secondary outcomes included the number of as needed and regularly administered prescriptions, number of potentially inappropriate prescriptions as defined by the Beers and STOPP criteria, and number of prescriptions for psychotropics, long-acting opioids and diabetic medications.</p><p><strong>Results: </strong>We studied 40 patients with a mean age of 80.6 [standard deviation (SD) 8.8] years who received a MOVING consult. We found no significant change in the mean total number of prescriptions per patient before (12.02, SD 5.83) and after the intervention (11.58, SD 5.28), with a mean difference of -0.45 [95% confidence interval (CI) -0.94 to 0.04; p = 0.07]. We found statistically significant decreases in as needed prescriptions (mean difference - 0.30, 95% CI - 0.45 to - 0.15; p<0.001), and potentially harmful medications as identified by the Beers (mean difference -1.25, 95% CI -2.00 to -0.50; p = 0.002) and STOPP (mean difference -1.65, 95% CI -2.33 to -0.97; p < 0.001) scores. Without including the cost savings from hospital diversion by a MOVING consult, the costs of a MOVING consult were $545.80-$629.80 per person, compared with the costs associated with traditional in-person consults involving similar specialist clinical services ($904.89-$1270.69 per person).</p><p><strong>Conclusion: </strong>A MOVING model of care is associated with decreases in prescriptions for potentially inappropriate medications in older adults. These findings support further evaluation to ascertain health system impacts.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"117-124"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928046/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138440499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis and Treatment Patterns of Chronic Thromboembolic Pulmonary Hypertension in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia: A Registry Study.","authors":"Hürrem Gül Öngen, Bahri Akdeniz, Mehmet Akif Düzenli, Alexander Chernyavsky, Georges Dabar, Majdy Idrees, Elena Khludeeva, Hakan Kültürsay, Vera Lukianchikova, Tamila Martynyuk, Nesrin Moğulkoç, Murat A Mukarov, Bülent Mutlu, Gülfer Okumuş, Anuar Omarov, Zeynep Pinar Önen, Hussam Sakkijha, Nadezhda Shostak, Maria Simakova, Lale Tokgözoğlu, Tatyana Tomskaya, Hüseyin Yildirim, Dmitry Zateyshchikov, Klaus Hechenbichler, Stefanie Kessner, Isabel Schauerte, Nagihan Turgut, Kai Vogtländer, Abdullah Aldalaan","doi":"10.1007/s40801-023-00407-w","DOIUrl":"10.1007/s40801-023-00407-w","url":null,"abstract":"<p><strong>Background: </strong>Patients with chronic thromboembolic pulmonary hypertension (CTEPH) in countries with limited resources have, to date, been poorly represented in registries.</p><p><strong>Objective: </strong>This work assesses the epidemiology, diagnosis, hemodynamic and functional parameters, and treatment of CTEPH in Russia, Kazakhstan, Turkey, Lebanon, and Saudi Arabia.</p><p><strong>Methods: </strong>A prospective, cohort, phase IV, observational registry with 3-year follow-up (n = 212) in patients aged ≥ 18 years diagnosed with CTEPH was created. Clinical, hemodynamic, and functional parameters were obtained at an initial visit, follow-up visits, and a final visit at the end of 3 years' observation or end of follow-up. Data were recorded on electronic case report forms. Parameters evaluated included 6-minute walking distance (6MWD), use of pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), pulmonary hypertension (PH)-targeted therapy, and survival. All statistical analyses were exploratory and descriptive, and were performed in the overall population.</p><p><strong>Results: </strong>The most common symptoms were typical of those expected for CTEPH. Almost 90% of patients underwent right heart catheterization at diagnosis or initial study visit. In total, 66 patients (31%) underwent PEA before the initial visit; 95 patients (45%) were considered operable, 115 (54%) were inoperable, and two (1%) had no operability data. Only 26 patients (12%) had been assessed for BPA at their initial visit. PH-targeted therapy was documented at diagnosis for 77 patients (36%), most commonly a phosphodiesterase type 5 inhibitor (23%). Use of PH-targeted therapy increased to 142 patients (67%) at the initial visit, remaining similar after 3 years. Use of riociguat increased from 6% of patients at diagnosis to 38% at 3 years. Between baseline and end of observation, results for patients with paired data showed an increase in 6MWD. Survival at the end of observation was 88%.</p><p><strong>Conclusions: </strong>These data highlight the current diagnosis and management of CTEPH in the participating countries. They show that early CTEPH diagnosis remains challenging, and use of off-label PH-targeted therapy is common.</p><p><strong>Clinicaltrials: </strong>gov: NCT02637050; registered December 2015.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"149-165"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139912307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and Demographic Characteristics of Patients with Coexistent Hypertension, Type 2 Diabetes Mellitus, and Dyslipidemia: A Retrospective Study from India.","authors":"Jamshed Dalal, Praveen Chandra, Rajeev Chawla, Viveka Kumar, Jabir Abdullakutty, Vidhya Natarajan, Syed Mujtaba Hussain Naqvi, Kumar Gaurav, Rahul Rathod, Gauri Dhanaki, Bhavesh Kotak, Snehal Shah","doi":"10.1007/s40801-023-00400-3","DOIUrl":"10.1007/s40801-023-00400-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Coexisting hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia (triple disease) can lead to greater risk of cardiovascular morbidity and mortality. The present study sought to comprehend the prevalence, demographic traits, clinical traits, and treatment patterns in Indian patients with these coexisting conditions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An electronic medical record (EMR)-based, retrospective, multicenter, cross-sectional study was conducted, and data were collected for patients who were diagnosed with coexistent hypertension, T2DM, and dyslipidemia. Baseline patient variables evaluated were the percentage of patients with triple comorbidity, demographic characteristics, diagnostic laboratory parameters, and treatment pattern details.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data from 4793 centers (clinics) were included, with a total of 6,722,173 patients. Of these, 427,835 (6.36%) patients were found to have coexistent hypertension, T2DM, and dyslipidemia. Most of the patients belonged to the 40-64 year age group (62.10%) and were males (57.00%), while 27.40% patients had a body mass index (BMI) within normal limits, 43.30% patients were pre-obese, and 20.90% patients were class 1 obese. Further, 3402 patients (0.80%) had a recorded history of smoking. Mean glycated hemoglobin (HbA1c) for the patients included in the study was 8.35 ± 1.96 g%. Mean systolic blood pressure (SBP) was 138.81 ± 19.59 mm Hg, while mean diastolic blood pressure (DBP) was 82.17 ± 10.35 mm Hg; 27.60% cases had SBP &lt; 130 mm Hg, while 28.37% cases had DBP &lt; 80 mm Hg. The mean low-density lipoprotein (LDL), total cholesterol, and high-density lipoprotein (HDL) in mg/dl were 98.38 ± 40.39, 174.75 ± 46.73, and 44.5 ± 10.05, respectively. Of the enrolled cases, 55.64% had serum LDL below 100 mg/dl, 72.03% cases had serum cholesterol below 200 mg/dl, and 44.15% males and 71.77% females had serum HDL below the normal prescribed range. The most common monotherapy used for managing hypertension was angiotensin receptor blockers (ARB) (24.80%), followed by beta-blockers (24.30%). The most common combinations administered for management of hypertension were antihypertensives with diuretics (14.30%), followed by ARB plus calcium channel blockers (CCB) (13.30%). For dyslipidemia, the majority of patients (56.60%) received lipid-lowering medication in combination with drugs for other comorbidities. The most common antidiabetic agents prescribed were biguanides (74.60%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Coexistence of triple disease is not uncommon in the Indian population, with middle-aged patients diagnosed as pre-obese and obese being affected more commonly and receiving treatment for the same. The present study highlights that, though there are medications against the three chronic conditions, the rate of uncontrolled cases of hypertension, T2DM, and dyslipidemia remains high. Coexistence of triple disease increases the risk of cardiova","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"167-176"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928019/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138458576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post Hospitalization Clinical Quality Outcomes Among US Patients with Schizophrenia Treated with a Long-Acting Injectable or Switched to a New Oral Antipsychotic: A Retrospective Cohort Study.","authors":"Charmi Patel, Seth Emont, Zhun Cao, Manu Tyagi, Carmela Benson","doi":"10.1007/s40801-023-00408-9","DOIUrl":"10.1007/s40801-023-00408-9","url":null,"abstract":"<p><strong>Background: </strong> Adherence to antipsychotic medication and care discontinuity remain a challenge to healthcare practitioners providing care to patients with schizophrenia.</p><p><strong>Objective: </strong>This study used real-world data from a US hospital-based, all-payer database to examine clinical quality measures among patients with schizophrenia initiated on a long-acting injectable (LAI) or switched to a new oral antipsychotic medication (OAP) following a hospitalization.</p><p><strong>Methods: </strong>A retrospective cohort study using the PINC AI™ Healthcare Database compared two cohorts of patients with schizophrenia on post-index hospitalization clinical quality and care continuity endpoints. Patients initiated on an LAI (n = 7292) or switched to a new OAP (n = 31,956) during an index hospitalization between April 2017 and April 2020 were included. Propensity score weighting addressed differences in patient, hospital, and clinical characteristics between the two cohorts.</p><p><strong>Results: </strong>Patients who initiated an LAI experienced significantly greater adjusted 30-day antipsychotic medication continuation to index therapy, higher rate of 30-day outpatient follow-up care, longer mean time to discontinuation of index therapy, and lower risk of discontinuing their index treatment compared to patients who switched to a new OAP (all p values < 0.001). Probability of 30-day antipsychotic medication continuation was significantly higher for LAI initiators than for patients who switched to a new OAP, even after controlling for patient, clinical, and hospital characteristics (adjusted odds ratio = 1.2, 95% CI 1.1-1.3, p < 0.001).</p><p><strong>Conclusion: </strong>Patients who initiated an LAI in a hospital setting experienced better clinical quality and care continuity outcomes compared to patients who were switched to a new OAP. These findings may be useful in identifying solutions to help improve the quality of medication management post-hospital discharge among patients with schizophrenia.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"69-79"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immune Checkpoint Inhibitors and Scleroderma: Data from the European Pharmacovigilance Database.","authors":"Maria Maddalena Nicoletti, Erminia Crisci, Vincenzo Cosenza, Consiglia Riccardi, Maria Rosaria Campitiello, Donatella Ruggiero, Pasquale Maria Berrino, Giovanni Docimo, Cristina Scavone","doi":"10.1007/s40801-023-00399-7","DOIUrl":"10.1007/s40801-023-00399-7","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) can be commonly associated with the occurrence of immune-related adverse drug reactions (irADRs), which can involve any tissue and organ. ICI-induced skin toxicities are common irADRs and they can be a consequence of a rheumatologic ADR, such as in the case of scleroderma. A recent literature review reported that scleroderma and scleroderma mimics represent a group of disorders with significant morbidity that have been described during ICIs' use.</p><p><strong>Objective and methods: </strong>Considering the clinical significance of scleroderma cases, the present study aimed to analyze the occurrence of these events in patients receiving ICIs by describing data from individual case safety reports (ICSRs) retrieved from the European spontaneous reporting system, EudraVigilance (EV).</p><p><strong>Results: </strong>Until February 2023, 70 ICSRs with at least one ICI as the suspected drug and at least one preferred term (PT) related to scleroderma cases were retrieved from the EV. Pembrolizumab was reported as suspected in 41 ICSRs, nivolumab in 25 ICSRs, ipilimumab in 8 ICSRs and atezolizumab in 3 ICSRs. Patients who experienced scleroderma cases were adults, and no differences were found in terms of sex distribution. Scleroderma cases were mainly classified as serious, while the outcome was mainly reported as favorable. The most reported PTs were scleroderma and morphea.</p><p><strong>Conclusions: </strong>Considering the seriousness of ICI-induced scleroderma cases and the recent marketing authorization of some ICIs, we believe that further high-quality clinical studies should be conducted on this topic to better estimate the impact of these events in patients with cancer.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"33-41"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71421600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective Real-World Study of Bacillus clausii Evaluating Use, Treatment Habits and Patient Satisfaction in Italian Community Pharmacies: The PEGASO Study.","authors":"Corrado Giua, Flora Romano, Enrico Keber, Paolo Pellegrino, Marcos Perez, Maria Chiara Uboldi","doi":"10.1007/s40801-023-00402-1","DOIUrl":"10.1007/s40801-023-00402-1","url":null,"abstract":"<p><strong>Background: </strong>Ailments such as diarrhoea and antibiotic-associated gut symptoms are generally self-managed using probiotics. Real-world data on reasons behind self-medication with over-the-counter (OTC) products and patient-reported outcomes can be investigated strategically by the pharmacists.</p><p><strong>Objective: </strong>This study evaluates the use of Bacillus clausii (Enterogermina^®) at the Italian community pharmacies among self-medicating patients, their treatment habits and perceived benefits.</p><p><strong>Design: </strong>This is a multicentre, prospective, non-interventional study which included two visits [at screening (T0) and end of the study (T1) when symptoms had subsided, ≤ 30 days from T0]. Patients who were already inclined to buy B. clausii were enrolled and instructed to complete a questionnaire at T0 and T1. The primary objective was to evaluate the reasons for taking B. clausii. Secondary objectives assessed treatment duration, perceived effectiveness, quality of life (QoL), treatment satisfaction and safety outcomes.</p><p><strong>Results: </strong>Overall, 268 patients were enrolled; 99.6% of them were evaluated at T0 and 97.4% at T1, and safety was evaluated in 97.8% who had ≥ 1 dose of B. clausii. At T0, mean age was 50.7 years and majority were females (62.2%). In the interview, main reason stated for using B. clausii at T0 was diarrhoea (56.93%), followed by other gastrointestinal symptoms. Treatment duration was shorter in those with diarrhoea or abdominal pain versus those with constipation or abdominal tension. More than 90% perceived their symptoms to have improved or improved very much. Overall QoL improved in all the aspects measured. Treatment satisfaction was reported by nearly 90% of patients as satisfied, very satisfied or extremely satisfied. No adverse events were reported.</p><p><strong>Conclusion: </strong>This is the first pharmacy-based study in Italy that evaluated the real-world usage of an OTC probiotic containing B. clausii among self-medicating adults. Diarrhoea was the most common reason for use, with high-level of perceived effectiveness and patient satisfaction with B. clausii.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"137-147"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138477025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Clinical Efficacy of Antifibrotic Agents for Idiopathic Pulmonary Fibrosis: A Single-Center Retrospective Study in Japan.","authors":"Kotaro Iwasaki, Hiroki Wakabayashi, Atsuhito Saiki, Hajime Ueshiba, Yu Murakami, Yasuo Matsuzawa","doi":"10.1007/s40801-023-00396-w","DOIUrl":"10.1007/s40801-023-00396-w","url":null,"abstract":"<p><strong>Background: </strong>The antifibrotic drugs, nintedanib and pirfenidone, inhibit the decline in forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF). Nintedanib also inhibits the onset of acute exacerbation and reduces the risk of all-cause mortality. However, their effectiveness in real-world practice remains unclear. Our study aimed to investigate the changes in forced vital capacity, survival period, causes of death, and risk factors for mortality in patients with IPF receiving antifibrotic drugs.</p><p><strong>Methods: </strong>This retrospective study enrolled Japanese patients who visited Toho University Sakura Medical Center who were diagnosed with IPF and received antifibrotic drugs.</p><p><strong>Results: </strong>We included 102 patients [mean age ± standard deviation (SD): 71.8 ± 7.5 years], of whom 76 were males. The decline in forced vital capacity (mean ± SD) during the antifibrotic therapy period was - 154 ± 259 mL/year, which was significantly lower than before the antifibrotic therapy period (- 484 ± 589 mL/year; n = 80, p = 0.003). Altogether, 52 deaths were confirmed, and the median survival time from antifibrotic therapy initiation was 38.0 months (95% confidence interval: 25.9-50.1 months). Acute exacerbation accounted for 9.6% of all deaths (95% confidence interval: 1.6-17.6). The decline in forced vital capacity during antifibrotic therapy was a risk factor for mortality.</p><p><strong>Conclusions: </strong>In actual clinical practice in Japan, antifibrotic drugs suppressed the gradual decline in forced vital capacity, which is a risk factor for mortality. However, the median survival period remained poor at 38 months.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"43-52"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50161110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}