Drugs - Real World Outcomes最新文献

{"title":"Correction to: Omeprazole and Risk of Hypertension: Analysis of Existing Literature and the WHO Global Pharmacovigilance Database.","authors":"Merhawi Bahta, Natnael Russom, Amon Solomon Ghebrenegus, Yohana Tecleab Okubamichael, Mulugeta Russom","doi":"10.1007/s40801-024-00448-9","DOIUrl":"10.1007/s40801-024-00448-9","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"745"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046458","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":"Early Clinical Outcomes of Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma: A Real-World Comparison with First-Line or Later-Line Treatment.","authors":"Yudai Fujiwara, Hidekatsu Kuroda, Tamami Abe, Keisuke Kakisaka, Ippeki Nakaya, Asami Ito, Takuya Watanabe, Kenji Yusa, Tomoaki Nagasawa, Hiroki Sato, Akiko Suzuki, Kei Endo, Yuichi Yoshida, Takayoshi Oikawa, Kei Sawara, Akio Miyasaka, Takayuki Matsumoto","doi":"10.1007/s40801-024-00458-7","DOIUrl":"10.1007/s40801-024-00458-7","url":null,"abstract":"<p><strong>Background and objective: </strong>Durvalumab plus tremelimumab (Durva/Treme) has recently been approved as a first-line or later-line treatment for patients with unresectable hepatocellular carcinoma (u-HCC) in Japan. We assessed the real-world outcomes of Durva/Treme for u-HCC, with a focus on treatment efficacy and safety.</p><p><strong>Methods: </strong>We retrospectively evaluated 22 patients with u-HCC treated with Durva/Treme at Iwate Medical University during the period from 2023 to 2024, with a comparison of the clinical outcomes between patients who received Durva/Treme as first-line and later-line treatments. We further evaluated changes in the modified albumin-bilirubin (mALBI) grade during treatment.</p><p><strong>Results: </strong>There were 10 patients in the first-line group and 12 patients in the later-line treatment group. During the follow-up with a median duration of 7.6 months, the median progression-free survival (first-line versus later-line: 4.7 months versus 2.9 months, p = 0.85), the objective response rate (0.0% versus 16.7%, p = 0.48), the disease control rate (60.0% versus 58.4%, p = 1.00), and the incidence of any adverse event (50.0% versus 75.0%, p = 0.38) were not statistically different between the two groups. The changes in the mALBI scores were not statistically significant (p = 0.75).</p><p><strong>Conclusions: </strong>Durva/Treme may be effective and safe for patients with u-HCC, even in patients who receive Durva/Treme as a later-line treatment.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"701-710"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388850","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":"Residual Depressive Symptoms in Treatment-Resistant Bipolar Depression Following Short-Term Ketamine Administration.","authors":"Michał Pastuszak, Wiesław Jerzy Cubała, Aleksander Kwaśny","doi":"10.1007/s40801-024-00453-y","DOIUrl":"10.1007/s40801-024-00453-y","url":null,"abstract":"<p><strong>Background: </strong>Residual symptoms are frequently observed in a significant number of patients with depression, indicating an unmet need for effective management strategies to achieve functional recovery.</p><p><strong>Objective: </strong>This observational study aimed to evaluate the impact of ketamine infusions on depressive symptoms in patients with bipolar disorder who continued their baseline psychotropic and chronic somatic treatments.</p><p><strong>Methods: </strong>Datasets of the two consecutive real-world registries (NCT04226963 for 2019-2022; NCT05565352 from 2023 onward) for the tertiary reference center for psychiatry at the Medical University of Gdańsk (Poland) for the safety and tolerability of ketamine use in mood and anxiety disorders were retrospectively analyzed. Depressive symptoms were assessed using the Inventory of Depressive Symptomatology Self-Report 30 (IDS-SR30). Residual symptoms were identified in patients who achieved a treatment response, defined as a 50% or greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to the seventh infusion.</p><p><strong>Results: </strong>Overall, 14 out of 22 patients met the criteria for response. The most commonly persistent depressive symptoms included sad mood (85.7%), view of my future (78.6%), difficulty falling asleep, and leaden paralysis/physical energy (both 71.4%), with the most severe being difficulty falling asleep (64.3%) and sad mood (42.9%).</p><p><strong>Conclusions: </strong>This observational post hoc analysis indicates that the most frequently observed residual depressive symptoms were low mood, altered view of future, sleep disturbances, and low energy levels. This study should be treated with caution as causality does not apply, however, it reports on a real-world population of subjects with treatment-resistant bipolar depression. Establishing standardized definitions for residual symptoms could enhance the quality and comparability of future research in this area.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"565-571"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589017/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282012","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 Significance of Prior Ramucirumab Use on the Effectiveness of Nivolumab as the Third-Line Regimen in Gastric Cancer: A Multicenter Retrospective Study.","authors":"Yuka Obayashi, Shoichiro Hirata, Yoshiyasu Kono, Makoto Abe, Koji Miyahara, Masahiro Nakagawa, Michihiro Ishida, Yasuhiro Choda, Kenta Hamada, Masaya Iwamuro, Seiji Kawano, Yoshiro Kawahara, Motoyuki Otsuka","doi":"10.1007/s40801-024-00460-z","DOIUrl":"10.1007/s40801-024-00460-z","url":null,"abstract":"<p><strong>Background and objective: </strong>Because vascular endothelial growth factor inhibition has been suggested to improve immune cell function in the cancer microenvironment, we examined whether using ramucirumab (RAM) before nivolumab usage is more effective in advanced gastric cancer.</p><p><strong>Methods: </strong>This was a multicenter retrospective observational study. We analyzed patients who received nivolumab monotherapy as the third-line regimen for unresectable advanced or recurrent gastric cancer between October 2017 and December 2022. They were divided into the RAM (RAM-treated) group and the non-RAM (non-treated) group according to the RAM usage in the second-line regimen. The primary outcome was to compare the overall survival after nivolumab administration in the third-line regimen between the RAM and non-RAM groups.</p><p><strong>Results: </strong>Fifty-two patients were included in the present study: 42 patients in the RAM group and ten patients in the non-RAM group. The median overall survival was significantly longer in the RAM group than in the non-RAM group (8.5 months vs 6.9 months, p < 0.05). In the RAM group, patients without peritoneal metastasis had significantly better median overall survival than those with peritoneal metastasis (23.8 months vs 7.7 months, p = 0.0033). Multivariate Cox-proportional hazards analyses showed that the presence of peritoneal metastasis (hazard ratio, 2.4; 95% confidence interval 1.0-5.7) alone was significantly associated with overall survival in the RAM group.</p><p><strong>Conclusions: </strong>The use of RAM prior to nivolumab monotherapy may contribute to prolonged survival in patients with gastric cancer, especially those without peritoneal metastasis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"557-564"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460337","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":"Prescription Patterns of Inducers and Inhibitors of Cytochrome P450 and Their Potential Drug Interactions in the Real World: A Cross-Sectional Study.","authors":"Luis Fernando Valladales-Restrepo, Juan Alberto Ospina-Cano, Brayan Stiven Aristizábal-Carmona, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-024-00450-1","DOIUrl":"10.1007/s40801-024-00450-1","url":null,"abstract":"<p><strong>Introduction: </strong>Both the induction and inhibition of cytochrome P450 are associated with multiple pharmacological interactions, which can lead to loss of efficacy or increase the risk of adverse drug reactions.</p><p><strong>Objective: </strong>The aim was to determine the prescription patterns of cytochrome P450-inducing and -inhibiting drugs and their contraindicated and major pharmacological interactions in a group of patients from Colombia.</p><p><strong>Methods: </strong>This cross-sectional observational study included patients who received drugs that induce or inhibit metabolism and examined their contraindicated and major pharmacological interactions. The patients were identified from a population-based database of drug dispensing. Patients were included between December 1 and December 31, 2021. Inhibitors and inducers of cytochrome P450 were classified based on FDA (Food and Drug Administration) guidelines. Drug interactions were identified using the Micromedex® database. Descriptive, bivariate and multivariable analysis was performed.</p><p><strong>Results: </strong>A total of 63,433 patients were analyzed. Antiseizure medications (35.9%) and antifungals (27.6%) were the most used inducers and inhibitors. A total of 30.1% of patients had potential contraindicated or greater interactions. The following factors were associated with a higher probability of presenting a potential pharmacological interaction: being male (OR 1.14; 95% CI 1.10-1.19), aged 18-39 years (OR 1.77; 95% CI 1.67-1.89) or 40-64 years (OR 1.64; 95% CI 1.56-1.72), having neurological diseases (OR 1.28; 95% CI 1.21-1.35), having psychiatric diseases (OR 3.84; 95% CI 3.58-4.13), having rheumatologic diseases (OR 1.32; 95% CI 1.23-1.41), receiving comedications with statins (OR 1.14; 95% CI 1.08-1.19), receiving comedications with analgesics (OR 1.33; 95% CI 1.27-1.38), receiving comedications with antiparasitics (OR 2.88; 95% CI 2.66-3.11) and an increase in the number of medications (OR 1.24; 95% CI 1.23-1.25).</p><p><strong>Conclusion: </strong>Among the users of cytochrome P450 inhibitors and inducers, potential contraindications and greater interactions are very common, especially in men under 65 years of age with comorbidities and polypharmacy.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"617-626"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145386","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":"Older Adults' Use of Cannabis and Attitudes Around Disclosing Medical Cannabis Use to Their Healthcare Providers in California: A Mixed Methods Study.","authors":"Dania Abu Baker, Paola N Cruz Rivera, Rekha Narasimhan, Nhi Nguyen, Lize Tibiriçá, Wayne E Kepner, Pearse O'Malley, Annie L Nguyen, Alison A Moore","doi":"10.1007/s40801-024-00451-0","DOIUrl":"10.1007/s40801-024-00451-0","url":null,"abstract":"<p><strong>Background: </strong>The rapidly changing policy climate related to cannabis legalization has led to drastic changes in cannabis use in the United States (US). Medical cannabis use is increasing overall, but at a faster rate among older adults compared to other age groups.</p><p><strong>Objective: </strong>The aim was to investigate older adults' cannabis use behaviors and attitudes around disclosing medical cannabis use to their primary healthcare providers (HCPs).</p><p><strong>Methods: </strong>Nineteen older adults (ages 65+ years) with self-reported medical cannabis use were recruited from flyers posted in ambulatory clinics in San Diego, CA. Surveys and semi-structured interviews on cannabis use were completed. A multi-methods approach was used to analyze data.</p><p><strong>Results: </strong>Participants' mean age was 75.3 years; 52.6% identified as women, and 89.5% as White. Cannabis was used by all participants to treat pain and by 75% for insomnia, with 25-33% reductions in use of prescription medications to treat these symptoms. Approximately 89% reported their primary HCPs were aware of their cannabis use, and 84.2% felt very comfortable/comfortable talking to HCPs about cannabis. Common themes from interviews included participants (1) being motivated to disclose cannabis use to their HCPs to seek medical advice on dosing, side effects, and benefits of cannabis, (2) feeling comfortable disclosing cannabis use as legalization has eased the stigma around cannabis use, and (3) perceiving mostly neutral attitudes from HCPs on their cannabis use.</p><p><strong>Conclusion: </strong>The study emphasizes the pivotal role of HCPs as educators in addressing patient inquiries about cannabis, underlining the need for equipping healthcare professionals with evidence-based knowledge through education and training initiatives.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"647-658"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282011","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":"Psychotropic Drug Use and Associated Factors Among Acutely Admitted Older People: A Cross-Sectional Study of a Clinical Sample.","authors":"Ema Gasi, Maria Gustafsson, Jonas Kindstedt","doi":"10.1007/s40801-024-00455-w","DOIUrl":"10.1007/s40801-024-00455-w","url":null,"abstract":"<p><strong>Introduction: </strong>Older people are on average more susceptible to the adverse effects of psychotropic drugs, but addressing older people as a homogenous group based on age alone can be misleading when exploring psychotropic drug use. This study aimed to describe psychotropic drug use and associated factors among community-dwelling older people who had been acutely admitted to hospital.</p><p><strong>Methods: </strong>This cross-sectional study was based on a sample of 300 community-dwelling people 75 years or older who had been admitted to the acute medical ward at Umeå University Hospital at any time from September 2018 to October 2021. Data on medication use were obtained from electronic medical charts, and psychotropic drug use was presented as user proportions, both in terms of individual substances and drug classes. Associations between psychotropic drug use and factors comprising sex, age, cohabitation, comorbidities and multi-dose dispensing (MDD) of medicines were analysed through logistic regression.</p><p><strong>Results: </strong>Approximately 50% of the individuals used at least one psychotropic drug, and 18% used two or more such medicines. Zopiclone displayed the highest user proportion of all psychotropics (18.3%), followed by mirtazapine (11.3%) and zolpidem (9.7%). Of note, zolpidem was more prevalent among the females than among the males (p = 0.006). Regarding other sex differences, 55 and 38% of the females and males, respectively, used at least one psychotropic drug (p = 0.004). A similar pattern was observed regarding sedatives and hypnotic drugs exclusively (p = 0.048). In the regression analysis, female sex (adjusted odds ratio [OR] 2.05 [95% confidence interval {CI} 1.22-3.42]) and MDD (adjusted OR 2.20 [95% CI 1.23-3.93]) were positively associated with psychotropic drug use.</p><p><strong>Conclusion: </strong>The most common psychotropic drugs used by community-dwelling older people admitted to the acute medical ward were hypnotic drugs and antidepressants. Regarding patient factors, female sex and MDD system were positively associated with psychotropic drug use. Further studies concerning those two factors in relation to potential overprescribing could provide a better picture on how to optimize psychotropic drug use among acutely admitted vulnerable older people.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"627-633"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11589078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307296","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":"Acknowledgement to Referees.","authors":"","doi":"10.1007/s40801-024-00466-7","DOIUrl":"https://doi.org/10.1007/s40801-024-00466-7","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638258","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":"Prescribing Cascades of Loop Diuretics and Anti-vertigo Drugs Following Treatment with Gabapentinoids and Benzodiazepines: Prescription Sequence Symmetry Analysis of a Large-Scale Claims Database Including Japanese Older Adults.","authors":"Rina Omata, Akane Asami, Azusa Hara, Hisashi Urushihara","doi":"10.1007/s40801-024-00446-x","DOIUrl":"10.1007/s40801-024-00446-x","url":null,"abstract":"<p><strong>Background: </strong>Gabapentinoids (GBP) and benzodiazepines (BZ) are commonly prescribed in older adults and their package inserts list edema and vertigo as adverse drug reactions. These adverse drug reactions may be treated with symptomatic drug therapies without discontinuing the culprit drugs or decreasing their dose, thereby initiating a prescribing cascade and often resulting in polypharmacy. Whether prescribing cascades occur in the treatment of edema and dizziness among Japanese patients treated with GBP and BZ has not been investigated, including treatment with mirogabalin, a class drug of GBP marketed in Japan.</p><p><strong>Objective: </strong>We aimed to investigate prescribing cascades with GBP-induced and BZ-induced edema and dizziness treated with loop diuretics (LD) and anti-vertigo drugs (AVD), respectively, among older adults.</p><p><strong>Methods: </strong>A prescription sequence symmetry analysis design was used to detect signals of prescribing cascades associated with edema and dizziness induced by GBP and BZ (exposure drugs). Loop diuretics and AVD were the outcome drugs used to identify prescribing cascades following the initiation of exposure drugs. The study population consisted of enrollees of a large-scale health claims database provided by DeSC Healthcare, Inc., between April 2014 and March 2021. Subjects eligible for a prescription sequence symmetry analysis were patients aged ≥ 65 years prescribed an outcome drug within 90 days before and after exposure drug initiation. A signal of a prescribing cascade was detected if secular trend-adjusted sequence ratios were statistically significant on comparison of the frequencies of outcome drug initiation before and after exposure drug initiation.</p><p><strong>Results: </strong>We identified 2671 patients with prescriptions of a GBP-LD combination, 4009 with a GBP-AVD combination, 8675 with a BZ-LD combination, and 9462 with a BZ-AVD combination. The adjusted sequence ratios for GBP-LD and BZ-LD cascades were significantly larger than one (adjusted sequence ratio [95% confidence interval], 1.69 [1.56-1.83]; 1.35 [1.29-1.41], respectively), indicating positive signals of prescribing cascades. No signal was detected for the GBP-AVD or BZ-AVD cascade (0.89 [0.83-0.94]; 0.90 [0.87-0.94], respectively). The adjusted sequence ratio for the mirogabalin cascade was higher than that for pregabalin (2.23 [1.84-2.71] vs 1.59 [1.46-1.73]).</p><p><strong>Conclusions: </strong>Our study provides good evidence that LD-prescribing cascades associated with edema would be a class effect of GBP and BZ. Edema emerging around 1 month after GBP initiation should be carefully differentiated from pathological edema, and undue LD prescription as a prescribing cascade should be avoided.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"529-540"},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901282","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":"Falls and Fractures among Nursing Home Residents Treated with Pimavanserin versus Other Atypical Antipsychotics: Analysis of Medicare Beneficiaries with Parkinson's Disease Psychosis.","authors":"Krithika Rajagopalan, Nazia Rashid, Daksha Gopal, Dilesh Doshi","doi":"10.1007/s40801-024-00433-2","DOIUrl":"10.1007/s40801-024-00433-2","url":null,"abstract":"<p><strong>Background: </strong>Reducing falls and fractures remains an important clinical goal in managing older residents with Parkinson's disease psychosis (PDP) in long-term care/nursing home (LTC/NH) settings.</p><p><strong>Objectives: </strong>This analysis examined risk of all-cause falls or fractures among PDP residents on continuous monotherapy with pimavanserin (PIM) versus (i) other atypical antipsychotics (AAPs) [quetiapine (QUE), risperidone (RIS), olanzapine (OLA), aripiprazole (ARI)] and (ii) QUE.</p><p><strong>Methods: </strong>A retrospective analysis of parts A, B, and D claims from a 100% Medicare sample (2013-2019) in LTC/NH settings was conducted. LTC/NH residents in the USA initiating continuous monotherapy (PIM versus other AAPs; PIM versus QUE) for ≥ 6 months between 01 January 2014 and 31 December 2018 were 1:1 propensity score matched (PSM) on 31 variables (age, sex, race, region, and 27 Elixhauser comorbidities). Outcomes included three measures: risks of falls only, fractures only, and falls/fractures during 6-months follow-up. Demographic characteristics were described using chi-square and t-tests. Generalized linear models were used to assess difference in risks of falls/fractures.</p><p><strong>Results: </strong>Of 7187 residents, 47.59% (n = 3420) were female and mean age was 78.8 (± 7.75) years. In total, 14% (n = 1005) were on PIM and 86% (n = 6182) were on other AAPs. After PSM, falls only among PIM residents (n = 1005) was 4.58% (n = 46) versus 7.66% (n = 77) for other AAPs (n = 1005) [relative risk (RR) = 0.63 (0.46, 0.86), p < 0.05] and 8.26% (n = 83) for QUE (n = 1005) residents (p < 0.05). Fractures only among PIM residents was 1.39% (n = 14) compared with 2.09% (n = 21) for other AAPs (p = 0.31) and 1.89% (n = 19) for QUE (p = 0.49), respectively. Taken together, falls/fractures among PIM residents were 5.67% (n = 57) versus 9.05% (n = 91) for other AAPs [RR = 0.63 (0.46, 0.86), p < 0.05] and 9.55% (n = 96) for QUE (p < 0.05), respectively.</p><p><strong>Conclusions: </strong>In this analysis of LTC/NH residents with PDP, PIM had a 37% and 41% lower risk of all-cause falls/fractures versus other AAPs and versus QUE, respectively.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"441-449"},"PeriodicalIF":1.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11365880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445831","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}