Drugs - Real World Outcomes最新文献

{"title":"Effectiveness of Dapagliflozin as Add-On to Metformin with or without Other Oral Antidiabetic Drugs in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Database Study.","authors":"Bipin Sethi, Rakesh Sahay, Mangesh Tiwaskar, Vijay Negalur, Rajnish Dhediya, Kumar Gaurav, Rahul Rathod, Bhavesh Kotak, Gauri Dhanaki, Snehal Shah","doi":"10.1007/s40801-023-00398-8","DOIUrl":"10.1007/s40801-023-00398-8","url":null,"abstract":"<p><strong>Background: </strong>Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce.</p><p><strong>Methods: </strong>An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed.</p><p><strong>Results: </strong>A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m²). However, the change in BMI in the HbA1c subgroup ≥ 8% was noted to be -1.4 ± 10.4 kg/m², which was not statistically significant (p = 0.08). In the overall study population, significant change in the SBP (-4.5 ± 14.9 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -4.5 ± 15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥ 8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5 ± 8.94 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.4 ± 8.91 mmHg; p < 0.05 for HbA1c subgroup ≥ 8%) was noted.</p><p><strong>Conclusions: </strong>Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"81-90"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66783735","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":"Evaluation of Triple Whammy Prescriptions After the Implementation of a Drug Safety Algorithm.","authors":"Hendrike Dahmke, Jana Schelshorn, Rico Fiumefreddo, Philipp Schuetz, Ali Reza Salili, Francisco Cabrera-Diaz, Carla Meyer-Massetti, Claudia Zaugg","doi":"10.1007/s40801-023-00405-y","DOIUrl":"10.1007/s40801-023-00405-y","url":null,"abstract":"<p><strong>Background and objective: </strong>The term triple whammy (TW) refers to the concomitant use of non-steroidal anti-inflammatory drugs, diuretics, and angiotensin system inhibitors; this combination significantly increases the risk of acute kidney injury (AKI). To prevent this serious complication, we developed an electronic algorithm that detects TW prescriptions in patients with additional risk factors such as old age and impaired kidney function. The algorithm alerts a clinical pharmacist who then evaluates and forwards the alert to the prescribing physician.</p><p><strong>Methods: </strong>We evaluated the performance of this algorithm in a retrospective observational study of clinical data from all adult patients admitted to the Cantonal Hospital of Aarau in Switzerland in 2021. We identified all patients who received a TW prescription, had a TW alert, or developed AKI during TW therapy. Algorithm performance was evaluated by calculating the sensitivity and specificity as a primary endpoint and determining the acceptance rate among clinical pharmacists and physicians as a secondary endpoint.</p><p><strong>Results: </strong>Among 21,332 hospitalized patients, 290 patients had a TW prescription, of which 12 patients experienced AKI. Overall, 216 patients were detected by the alert algorithm, including 11 of 12 patients with AKI; the algorithm sensitivity is 88.3% with a specificity of 99.7%. Physician acceptance was high (77.7%), but clinical pharmacists were reluctant to forward the alerts to prescribers in some cases.</p><p><strong>Conclusion: </strong>The TW algorithm is highly sensitive and specific in identifying patients with TW therapy at risk for AKI. The algorithm may help to prevent AKI in TW patients in the future.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"125-135"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139110871","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":"Association of Antipsychotic Drugs with the Risk of Recurrent Venous Thromboembolism: A Retrospective Study of Data from a Japanese Inpatient Database.","authors":"Hiroyuki Hashimoto, Shinobu Imai, Ryoka Yamashita, Anna Kiyomi, Munetoshi Sugiura","doi":"10.1007/s40801-023-00401-2","DOIUrl":"10.1007/s40801-023-00401-2","url":null,"abstract":"<p><strong>Background: </strong>Approximately a decade has passed since the addition of venous thromboembolism to the list of significant adverse reactions of antipsychotic drugs. However, only a few studies have investigated the relationship between antipsychotic use and venous thromboembolism in the Japanese population.</p><p><strong>Purpose: </strong>We aimed to evaluate the risk of recurrent venous thromboembolism in users of antipsychotic drugs and update the evidence on venous thromboembolism in the Japanese population.</p><p><strong>Methods: </strong>A cross-sectional retrospective analysis of data from a large Japanese claims database, managed by Medical Data Vision Co. Ltd., was conducted. Adult patients who experienced venous thromboembolism between October 2014 and September 2018 in acute care hospitals were identified. The risk of recurrent venous thromboembolism was evaluated with logistic regression using demographic variables. The data of patients using antipsychotic drugs within specific therapeutic classes were also evaluated.</p><p><strong>Results: </strong>We included 8960 patients (mean age, 69 years; 59.2% female). Recurrent venous thromboembolism was observed in 686 patients (7.7%). The risk of recurrent venous thromboembolism was significantly higher in younger patients [< 65 years: reference; 65-74 years: odds ratio (OR) 0.81, 95% confidence interval (CI) 0.66-0.99, p = 0.04; ≥ 75 years: OR 0.77, 95% CI 0.64-0.94, p = 0.01], those with history of surgery (OR 1.39, 95% CI 1.18-1.65, p = 0.01), and anticoagulant users (OR 2.25, 95% CI 1.46-3.48, p = 0.01) and was significantly lower in the presence of comorbidities (OR 0.68, 95% CI 0.58-0.81, p< 0.01) and fractures (OR 0.49, 95% CI 0.26-0.94, p = 0.03). Long-term antipsychotic drug prescriptions (> 14 days) were associated with a higher risk of venous thromboembolism than short-term prescriptions (≤ 14 days) (OR 1.56, 95% CI 1.04-2.34, p = 0.03).</p><p><strong>Conclusions: </strong>In patients with a history of venous thromboembolism, particular attention should be paid to recurrence in younger patients. If antipsychotic drugs are prescribed for > 14 days to patients with a history of venous thromboembolism, they should be administered carefully, guided by reported findings. Further evaluations using different databases or populations are required to generalize the findings of this study.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"109-116"},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138444253","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":"Compliance with Pregnancy Prevention Recommendations for Isotretinoin Following the Amendment of the European Union Pregnancy Prevention Program: A Repeat Study in Estonia.","authors":"Maaja Ivask, Katrin Kurvits, Maia Uusküla, Anne Juppo, Ott Laius, Mia Siven","doi":"10.1007/s40801-023-00381-3","DOIUrl":"10.1007/s40801-023-00381-3","url":null,"abstract":"<p><strong>Background: </strong>Isotretinoin, indicated for severe acne, is a potent teratogen and therefore contraindicated in pregnancy. Thus, the pregnancy prevention program (PPP) for isotretinoin has been introduced.</p><p><strong>Objectives: </strong>The aim of this study was to assess the concomitant use of isotretinoin and effective contraception and the rate of potential isotretinoin-exposed pregnancies in females of childbearing age in 2017-2020 in Estonia. In addition, we aimed to evaluate whether compliance with the PPP has improved compared with the previous study conducted in Estonia covering the period of 2012-2016.</p><p><strong>Methods: </strong>This retrospective, nationwide study using prescription and healthcare claims data included 2575 females aged 15-45 years who started using isotretinoin between 2017 and 2020.</p><p><strong>Results: </strong>For 64.7% of females of childbearing age, no concurrent use of an effective contraceptive was detected while using isotretinoin. A moderately higher contraceptive coverage (35.3%) was observed compared with the previous study (29.7%) (p < 0.001). Complete contraception coverage was highest in females aged 30-39 years with an adjusted OR of 12.8 (p < 0.001) compared with the age group 15-19 years and 2.47 (p < 0.001) compared with the age group 20-29 years. 17 pregnancies coincided with the isotretinoin treatment-related period. The risk for potential isotretinoin-exposed pregnancy was 6.6 (95% CI 3.9-10.5) per 1000 treated females of childbearing age over the 4-year observation period. The risk for potential isotretinoin-exposed pregnancies per 1000 treated females was 1.0 in females aged 15-19 years, 11.6 in females aged 20-29 years, 8.8 in females aged 30-39 years, and 7.4 in females aged 40-45 years (p = 0.009).</p><p><strong>Conclusion: </strong>A slight improvement in complete contraceptive coverage during isotretinoin use has not resulted in a decrease in the risk of isotretinoin-exposed pregnancies. The contraceptive usage and risk for pregnancy vary greatly across age groups, suggesting the need for a more targeted approach to improve the effectiveness of the PPP.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"91-98"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9830586","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":"The Association between Deductibles and Cardiovascular Medication Adherence: A Retrospective Inception Cohort Study.","authors":"Dennis Steenhuis, Xuechun Li, Talitha Feenstra, Eelko Hak, Stijn de Vos","doi":"10.1007/s40801-023-00397-9","DOIUrl":"10.1007/s40801-023-00397-9","url":null,"abstract":"<p><strong>Objective: </strong>Drug non-adherence in primary preventive cardiovascular therapy is one of the most important modifiable drivers of cardiovascular events. The effect of deductibles in healthcare cost-sharing plans (the amount that has to be paid for healthcare services before the insurance company starts to pay) on such non-adherence in a European setting is unknown. Therefore, we estimated the association between deductibles and the adherence to primary preventive antihypertensive and antihyperlipidemic medication.</p><p><strong>Methods: </strong>Using the claims database of Menzis Health Insurer in the Netherlands, we applied ordered beta regression mixed modelling to estimate the association between deductibles and adherence taking several demographic and social-economic factors, repeated measurements and within-patient variation into account.</p><p><strong>Results: </strong>All in all, 106,316 patients starting primary preventive antihypertensive or antihyperlipidemic monotherapy were eligible for analysis. At index date, mean age of the study population was 58 years and 52% were male. Reaching the deductible limit and no need to pay for medication anymore increased the adherence [relative adherence ratio (RAR) 1.03, 95% confidence interval (95% CI): 1.00-1.05] for antihyperlipidemic therapy and 1.02 (95% CI: 1.00-1.04) for antihypertensive therapy. A larger deductible amount decreases the adherence of antihyperlipidemic and antihypertensive therapy (RAR 0.83; 95% CI: 0.69-1.00 and RAR 0.85, 95% CI: 0.74-0.98, respectively).</p><p><strong>Conclusion: </strong>Independent of other risk factors for non-adherence, presence of deductibles in health insurance is associated with a small negative effect on the adherence to both primary preventive antihypertensive as well as antihyperlipidemic therapy. Further study is needed on the potential health-economic consequences.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"99-108"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928036/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71479328","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":"Economic Burden of Parkinson's Disease: A Multinational, Real-World, Cost-of-Illness Study.","authors":"K Ray Chaudhuri, Jean-Philippe Azulay, Per Odin, Susanna Lindvall, Josefa Domingos, Ali Alobaidi, Prasanna L Kandukuri, Vivek S Chaudhari, Juan Carlos Parra, Toru Yamazaki, Julia Oddsdottir, Jack Wright, Pablo Martinez-Martin","doi":"10.1007/s40801-023-00410-1","DOIUrl":"10.1007/s40801-023-00410-1","url":null,"abstract":"<p><strong>Background: </strong>Parkinson's disease is now one of the fastest-growing neurodegenerative disorders in the developed world, with an increasing prevalence and associated socioeconomic costs. Progression of the disease leads to a gradual deterioration in patients' quality of life, despite optimal treatment, and both medical and societal needs increase, often with the assistance of paid and/or unpaid caregivers.</p><p><strong>Objective: </strong>We aimed to quantify the incremental economic burden of Parkinson's disease by disease severity in a real-world setting across differing geographic regions.</p><p><strong>Methods: </strong>Demographics, clinical characteristics, health status, patient quality of life, caregiver burden, and healthcare resource utilization data were drawn from the Adelphi Parkinson's Disease Specific Program™, conducted in the USA, five European countries, and Japan.</p><p><strong>Results: </strong>A total of 563 neurologists provided data for 5299 individuals with Parkinson's disease; 61% were male, with a mean age of 64 years. Approximately 15% of individuals were deemed to have advanced disease, with significantly more comorbidities, and a poorer quality of life, than those with non-advanced disease. Overall, the mean annual healthcare resource utilization increased significantly with advancing disease, and resulted in a three-fold difference in the USA and Europe. The main drivers behind the high economic burden included hospitalizations, prescription medications, and indirect costs.</p><p><strong>Conclusions: </strong>People with Parkinson's disease, and their caregivers, incur a higher economic burden as their disease progresses. Future interventions that can control symptoms or slow disease progression could reduce the burden on people with Parkinson's disease and their caregivers, whilst also substantially impacting societal costs.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"1-11"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139402295","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":"Exploring the Use of Traditional Medicines, Natural Health Products and Conventional Medicines: Development and Testing of the New Zealand 'All-Medicines' Questionnaire.","authors":"E Lyn Lee, Jeff Harrison, Joanne Barnes","doi":"10.1007/s40801-023-00389-9","DOIUrl":"10.1007/s40801-023-00389-9","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Traditional, complementary and alternative medicine (TCAM) are popular healthcare choices among consumers globally. The latest national data on the use of TCAM practitioners in New Zealand (NZ) were collected over a decade ago. Robust data on the use of natural health products (NHPs) and TCAM practices alongside conventional medicines are not yet available in NZ.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This study aimed to develop and test a bespoke questionnaire (All-MedsNZ) that included comprehensive data collection elements exploring NHPs' and conventional medicines' use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This was a questionnaire design study involving expert panel feedback, and engagement with TCAM users, in the development process. This work comprised questionnaire development (stage 1) followed by a questionnaire-testing study (stage 2). The questionnaire was developed on the basis of literature review findings and the research team's expertise. The questionnaire content was then validated by an expert panel comprising practitioners in TCAM and conventional medicine. Then, a two-phase study was utilised to test the questionnaire. Phase 1 involved participants (NHP users) completing the web-based questionnaire and providing feedback by answering probing questions added throughout the questionnaire to evaluate users' comprehension of the questions and to identify issues with the questionnaire. In phase 2, selected participants were interviewed online to gain in-depth insights into issues identified in phase one. Based on these findings, the questionnaire was revised.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The expert panel (n = 9) confirmed the questionnaire had high face and content validity; most original questions were retained. In the questionnaire-testing study, 95 and 27 participants completed the phase 1 and 2 studies, respectively. Most questions achieved a high response rate of ≥ 90%, and participants had no major issues understanding and answering the questionnaire. Problematic questions were those relating to providing product barcodes and photographs, and information on product costs. Most of the NHPs data entered by participants included the brand/generic name, manufacturer/company name, main ingredient(s) and dose form. Generally, these NHP-related data were of acceptable quality. However, information on the main ingredient(s) of products entered by participants was less satisfactory: approximately one-third of the 143 NHPs recorded in the study had the main ingredient(s) missing or incorrectly stated. Interviews with participants reiterated the issues identified in the phase 1 study. The low response rates for some of the questions were partly due to participants' unpreparedness (i.e. not having NHPs/medicines on hand) to complete the questionnaire. In addition, a lack of clarity for the term 'natural health practitioner' led to confusion among some participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Overall, no","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"13-32"},"PeriodicalIF":2.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10928020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71479327","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":"Efficacy of Three Teriparatide Preparations and Romosozumab, Osteogenesis Promoters, in the Treatment of Fresh Vertebral Fractures: A Retrospective Observational Study.","authors":"Kouken Hayashi","doi":"10.1007/s40801-023-00385-z","DOIUrl":"10.1007/s40801-023-00385-z","url":null,"abstract":"<p><strong>Background: </strong>In Japan, daily, twice weekly, and weekly formulations of teriparatide (TPD) and monthly formulations of romosozumab (ROMO) are available as osteogenesis promoters for the treatment of osteoporosis with a high risk for fracture.</p><p><strong>Objective: </strong>To compare the effects of three TPD preparations and ROMO on fracture healing and low back pain after a fresh vertebral fracture.</p><p><strong>Methods: </strong>This was a retrospective observational study. Patients presenting with fresh osteoporotic vertebral fractures were treated subcutaneously with TPD daily (DTPD), twice weekly (2/WTPD), weekly (WTPD), or with ROMO monthly. Bone union, vertebral height changes, and low back pain in the injured vertebra were compared after 6 months of treatment.</p><p><strong>Results: </strong>Bone union and pain improvement were more frequent among those who received daily and twice weekly administration of TPD compared with those who received WTPD and ROMO administration. A comparison for multiplicity between the groups using the Steel-Dwass test showed significant differences between the DTPD and ROMO groups (p = 0.0029) and WTPD and ROMO groups (p = 0.0490), suggesting superior bone fusion in the DTPD and WTPD groups. Similarly, significant differences were noted between the DTPD and ROMO groups (p = 0.0001), WTPD and ROMO groups (p = 0.0341), and 2/WTPD and ROMO groups (p = 0.0009), indicating a higher degree of pain improvement in the DTPD, WTPD, and 2/WTPD groups compared with that in the ROMO group.</p><p><strong>Conclusions: </strong>Daily, weekly, and twice-weekly administration of TPD may be superior to ROMO for promoting fresh vertebral fracture healing.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"631-637"},"PeriodicalIF":2.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10730485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41107589","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":"Cabozantinib for Advanced Hepatocellular Carcinoma in the Latest Real-World Practice: A Multicenter Retrospective Analysis.","authors":"Hiroaki Kanzaki, Sadahisa Ogasawara, Tomomi Okubo, Norio Itokawa, Ryohei Yoshino, Kentaro Fujimoto, Tadayoshi Kogure, Sae Yumita, Takamasa Ishino, Keita Ogawa, Terunao Iwanaga, Miyuki Nakagawa, Kisako Fujiwara, Ryuta Kojima, Keisuke Koroki, Masanori Inoue, Kazufumi Kobayashi, Naoya Kanogawa, Soichiro Kiyono, Masato Nakamura, Takayuki Kondo, Ryo Nakagawa, Shingo Nakamoto, Ryosuke Muroyama, Ei Itobayashi, Masanori Atsukawa, Jun Kato, Naoya Kato","doi":"10.1007/s40801-023-00379-x","DOIUrl":"10.1007/s40801-023-00379-x","url":null,"abstract":"<p><strong>Background: </strong>Cabozantinib was found to be effective as a second- or third-line treatment after sorafenib in patients with advanced hepatocellular carcinoma (HCC) in the phase 3 CELESTIAL trial. So far, as immunotherapy has substituted molecular target agents as the primary systemic therapy for advanced HCC, cabozantinib is extensively used in the latest real-world clinical practice in a greatly different position than that shown by the CELESTIAL trial. In the current analysis, we examined the safety and effectiveness of cabozantinib administration in real-life settings for patients with advanced HCC.</p><p><strong>Methods: </strong>We retrospectively obtained data from patients with advanced HCC who received cabozantinib in three institutions in Japan between 14 September 2018 and 30 November 2021.</p><p><strong>Results: </strong>During the study period, 23 patients with advanced HCC received cabozantinib. Our cohort included 21.7% of patients with Child-Pugh class B, and 52.2% of patients in fourth line or later. The median progression-free survival of patients given cabozantinib was 3.7 months. Regarding patients with Child-Pugh class B or administration in fourth line or later, the discontinuation rate due to adverse events in patients who initialized at 40 or 20 mg was lower than those who initialized at 60 mg (42.9% versus 75.0%). Patients who were able to continue treatment with cabozantinib for more than 3 months were more likely to undergo dose reduction than those who did not (85.7% versus 25.0%).</p><p><strong>Conclusions: </strong>Cabozantinib has recently been administered to a diverse range of patients, including those who were not enrolled in the CELESTIAL trial. Deliberate dose reduction could potentially offer clinical benefits to patients with impaired liver function. Furthermore, managing adverse events by reducing the dose could play a crucial role in extending the duration of treatment with cabozantinib. The preprint version of this work is available on https://www.researchsquare.com/article/rs-2655181/v1 .</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"513-520"},"PeriodicalIF":1.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10730490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10208918","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 Characteristics and Treatment of Irritable Bowel Syndrome in a Colombian Population: A Cross-Sectional Study.","authors":"Daniel Andrés Hernández-Velásquez, Esteban Rodríguez-Martínez, Jhonathan David Montoya-Meneses, Juan Sebastián González-Ceballos, Katherin Mosquera-Pérez, Laura Patiño-Mazuera, Melissa González-Montoya, Andrés Gaviria-Mendoza, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-023-00395-x","DOIUrl":"10.1007/s40801-023-00395-x","url":null,"abstract":"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a functional disorder that leads to abdominal pain; its diagnosis is based on Rome IV criteria (recurrent abdominal pain at least 1 day per week in the last 3 months with more than two of the following: related to defecation, associated with a change in stool frequency and/or with a change in stool appearance).</p><p><strong>Objective: </strong>To characterize an outpatient population diagnosed with IBS in Colombia during 2017-2018.</p><p><strong>Methods: </strong>A cross-sectional study based on a review of clinical records of patients with a primary diagnosis of IBS. A representative sample of 380 individuals was recruited from a population of 38,182 people with a new diagnosis of IBS from a drug-claim database. Sociodemographic, clinical (symptoms, type of IBS, alarm features, etc.), treatment (pharmacological or not), and follow-up variables (for those with additional medical care at 3-12 months) were analyzed. The diagnosis and treatment used in the consultation were compared with clinical guidelines.</p><p><strong>Results: </strong>Most of the 380 patients were women (n = 238; 62.6%), and the mean age was 40.1 ± 15.0 years. None of the physicians recorded the Rome IV criteria in the medical records. Unclassified IBS was the most prevalent subtype (n = 311; 81.8%), and the main symptom was abdominal pain (n = 327; 86.1%). Only 73 patients (19.2%) had follow-up data. The most frequently used drugs were aluminum hydroxide (n = 203; 53.4%) and hyoscine N-butyl bromide (n = 200; 52.6%). Regarding drugs included in the clinical practice guidelines, 19 people received loperamide (5.0%), 3 received trimebutine (0.8%), and 1 received sertraline (0.3%).</p><p><strong>Conclusions: </strong>The patients were diagnosed without clearly established criteria, and they were treated symptomatically with little follow-up.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"651-658"},"PeriodicalIF":2.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10730489/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134648605","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}