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1. Development of a General Composite Scale (GENCOMS) for Progressive Neurodegenerative Diseases and Implications for the Assessment of Disease-Modifying Therapies

Author

Samuel P. Dickson, Craig H. Mallinckrodt, Basia Rogula, Lauren C. Powell, Michele H. Potashman, Vladimir Coric, Gilbert J. L’Italien, and Suzanne B. Hendrix

Subjects
Composite measure, Neurodegenerative disease, Disease progression, Functional impairment, Partial least squares regression, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Introduction The reliable assessment of treatment outcomes for disease-modifying therapies (DMT) in neurodegenerative disease is challenging. The objective of this paper is to describe a generalized framework for developing composite scales that can be applied in diverse, degenerative conditions, termed “GENCOMS.” Composite scales optimize the sensitivity for detecting clinically meaningful effects that slow disease progression. Methods The GENCOMS method relies on robust natural history data and/or placebo arm data from DMT trials. Validated scales that are core to the disease process have been identified, and item level data obtained to standardize the response outcomes from 0 (best possible score) to 1 (worst possible score). A partial least squares regression analysis was conducted with temporal change as the dependent variable and change scores in standardized items as the explanatory variables. The derived model coefficients constitute a weighted sum of items that most effectively measure disease progression. Results The resultant composite scale was optimized to detect disease progression and can be examined in a range of slow or fast progressing populations. The scale can be used in studies with comparable patient populations as an endpoint optimized to measure disease progression and therefore ideally suited to assess treatment effects in DMTs. Conclusion The methodology presented here provides a generalizable framework for developing composite scales in the assessment of neurodegenerative disease progression and evaluation of DMT effects. By objectively selecting and weighting items from previously validated measures based solely on their sensitivity to disease progression, this methodology allows for the creation of a more responsive measurement of clinical decline. This heightened sensitivity to clinical decline can be utilized to detect modest yet meaningful treatment effects in the early stages of neurogenerative diseases, when it is optimal to begin a DMT.

Published
2024
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2. Video-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis

Author

Gilbert J. L’Italien, Evangelos K. Oikonomou, Rohan Khera, Michele H. Potashman, Melissa W. Beiner, Grant D. H. Maclaine, Jeremy D. Schmahmann, Susan Perlman, and Vladimir Coric

Subjects
Troriluzole, Spinocerebellar ataxia, Kinematic analysis, Video, Artificial intelligence, Pose dispersion index, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Introduction Traditional methods for assessing movement quality rely on subjective standardized scales and clinical expertise. This limitation creates challenges for assessing patients with spinocerebellar ataxia (SCA), in whom changes in mobility can be subtle and varied. We hypothesized that a machine learning analytic system might complement traditional clinician-rated measures of gait. Our objective was to use a video-based assessment of gait dispersion to compare the effects of troriluzole with placebo on gait quality in adults with SCA. Methods Participants with SCA underwent gait assessment in a phase 3, double-blind, placebo-controlled trial of troriluzole (NCT03701399). Videos were processed through a deep learning pose extraction algorithm, followed by the estimation of a novel gait stability measure, the Pose Dispersion Index, quantifying the frame-by-frame symmetry, balance, and stability during natural and tandem walk tasks. The effects of troriluzole treatment were assessed in mixed linear models, participant-level grouping, and treatment group-by-visit week interaction adjusted for age, sex, baseline modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA), and time since diagnosis. Results From 218 randomized participants, 67 and 56 participants had interpretable videos of a tandem and natural walk attempt, respectively. At Week 48, individuals assigned to troriluzole exhibited significant (p = 0.010) improvement in tandem walk Pose Dispersion Index versus placebo {adjusted interaction coefficient: 0.584 [95% confidence interval (CI) 0.137 to 1.031]}. A similar, nonsignificant trend was observed in the natural walk assessment [coefficient: 1.198 (95% CI − 1.067 to 3.462)]. Further, lower baseline Pose Dispersion Index during the natural walk was significantly (p = 0.041) associated with a higher risk of subsequent falls [adjusted Poisson coefficient: − 0.356 [95% CI − 0.697 to − 0.014)]. Conclusion Using this novel approach, troriluzole-treated subjects demonstrated improvement in gait as compared to placebo for the tandem walk. Machine learning applied to video-captured gait parameters can complement clinician-reported motor assessment in adults with SCA. The Pose Dispersion Index may enhance assessment in future research. Trial Registration—ClinicalTrials.gov Identifier NCT03701399.

Published
2024
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3. Health-related quality of life in people with predementia Alzheimer’s disease, mild cognitive impairment or dementia measured with preference-based instruments: a systematic literature review

Author

Filipa Landeiro, Seher Mughal, Katie Walsh, Elsbeth Nye, Jasmine Morton, Harriet Williams, Isaac Ghinai, Yovanna Castro, José Leal, Nia Roberts, Helena Wace, Ron Handels, Pascal Lecomte, Anders Gustavsson, Emilse Roncancio-Diaz, Mark Belger, Gurleen S. Jhuti, Jacoline C. Bouvy, Michele H. Potashman, Antje Tockhorn-Heidenreich, Alastair M. Gray, and on behalf of the ROADMAP consortium

Subjects
Dementia, Alzheimer’s disease, Quality of life, Systematic literature review, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Obtaining reliable estimates of the health-related quality of life (HR-QoL) of people with predementia Alzheimer’s disease [AD] (preclinical or prodromal AD), mild cognitive impairment (MCI) and dementia is essential for economic evaluations of related health interventions. Aims To provide an overview of which quality of life instruments are being used to assess HR-QoL in people with predementia AD, MCI or dementia; and, to summarise their reported HR-QoL levels at each stage of the disease and by type of respondent. Methods We systematically searched for and reviewed eligible studies published between January 1990 and the end of April 2017 which reported HR-QoL for people with predementia AD, MCI or dementia. We only included instruments which are preference-based, allowing index scores/utility values to be attached to each health state they describe based on preferences obtained from population surveys. Summary results were presented by respondent type (self or proxy), type of instrument, geographical location and, where possible, stage of disease. Health state utility values derived using the EuroQoL 5-Dimensions (EQ-5D) were meta-analysed by pooling reported results across all studies by disease severity (MCI, mild, mild to moderate, moderate, severe dementia, not specified) and by respondent (person with dementia, carer, general public, not specified), using a fixed-effects approach. Results We identified 61 studies which reported HR-QoL for people with MCI or dementia using preference-based instruments, of which 48 used the EQ-5D. Thirty-six studies reported HR-QoL for mild and/or moderate disease severities, and 12 studies reported utility values for MCI. We found systematic differences between self-rated and proxy-rated HR-QoL, with proxy-rated utility valued being significantly lower in more severe disease states. Conclusions A substantial literature now exists quantifying the impact of dementia on HR-QoL using preference-based measures, giving researchers and modellers a firmer basis on which to select appropriate utility values when estimating the effectiveness and cost-effectiveness of interventions in this area. Further research is required on HR-QoL of people with preclinical and prodromal AD and MCI, possible differences by type of dementia, the effects of comorbidities, study setting and the informal caregiver’s own HR-QoL, including any effect of that on their proxy-ratings.

Published
2020
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4. Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019

Author

Emma Nichols, Jaimie D Steinmetz, Stein Emil Vollset, Kai Fukutaki, Julian Chalek, Foad Abd-Allah, Amir Abdoli, Ahmed Abualhasan, Eman Abu-Gharbieh, Tayyaba Tayyaba Akram, Hanadi Al Hamad, Fares Alahdab, Fahad Mashhour Alanezi, Vahid Alipour, Sami Almustanyir, Hubert Amu, Iman Ansari, Jalal Arabloo, Tahira Ashraf, Thomas Astell-Burt, Getinet Ayano, Jose L Ayuso-Mateos, Atif Amin Baig, Anthony Barnett, Amadou Barrow, Bernhard T Baune, Yannick Béjot, Woldesellassie M Mequanint Bezabhe, Yihienew Mequanint Bezabih, Akshaya Srikanth Bhagavathula, Sonu Bhaskar, Krittika Bhattacharyya, Ali Bijani, Atanu Biswas, Srinivasa Rao Bolla, Archith Boloor, Carol Brayne, Hermann Brenner, Katrin Burkart, Richard A Burns, Luis Alberto Cámera, Chao Cao, Felix Carvalho, Luis F S Castro-de-Araujo, Ferrán Catalá-López, Ester Cerin, Prachi P Chavan, Nicolas Cherbuin, Dinh-Toi Chu, Vera Marisa Costa, Rosa A S Couto, Omid Dadras, Xiaochen Dai, Lalit Dandona, Rakhi Dandona, Vanessa De la Cruz-Góngora, Deepak Dhamnetiya, Diana Dias da Silva, Daniel Diaz, Abdel Douiri, David Edvardsson, Michael Ekholuenetale, Iman El Sayed, Shaimaa I El-Jaafary, Khalil Eskandari, Sharareh Eskandarieh, Saman Esmaeilnejad, Jawad Fares, Andre Faro, Umar Farooque, Valery L Feigin, Xiaoqi Feng, Seyed-Mohammad Fereshtehnejad, Eduarda Fernandes, Pietro Ferrara, Irina Filip, Howard Fillit, Florian Fischer, Shilpa Gaidhane, Lucia Galluzzo, Ahmad Ghashghaee, Nermin Ghith, Alessandro Gialluisi, Syed Amir Gilani, Ionela-Roxana Glavan, Elena V Gnedovskaya, Mahaveer Golechha, Rajeev Gupta, Veer Bala Gupta, Vivek Kumar Gupta, Mohammad Rifat Haider, Brian J Hall, Samer Hamidi, Asif Hanif, Graeme J Hankey, Shafiul Haque, Risky Kusuma Hartono, Ahmed I Hasaballah, M Tasdik Hasan, Amr Hassan, Simon I Hay, Khezar Hayat, Mohamed I Hegazy, Golnaz Heidari, Reza Heidari-Soureshjani, Claudiu Herteliu, Mowafa Househ, Rabia Hussain, Bing-Fang Hwang, Licia Iacoviello, Ivo Iavicoli, Olayinka Stephen Ilesanmi, Irena M Ilic, Milena D Ilic, Seyed Sina Naghibi Irvani, Hiroyasu Iso, Masao Iwagami, Roxana Jabbarinejad, Louis Jacob, Vardhmaan Jain, Sathish Kumar Jayapal, Ranil Jayawardena, Ravi Prakash Jha, Jost B Jonas, Nitin Joseph, Rizwan Kalani, Amit Kandel, Himal Kandel, André Karch, Ayele Semachew Kasa, Gizat M Kassie, Pedram Keshavarz, Moien AB Khan, Mahalaqua Nazli Khatib, Tawfik Ahmed Muthafer Khoja, Jagdish Khubchandani, Min Seo Kim, Yun Jin Kim, Adnan Kisa, Sezer Kisa, Mika Kivimäki, Walter J Koroshetz, Ai Koyanagi, G Anil Kumar, Manasi Kumar, Hassan Mehmood Lak, Matilde Leonardi, Bingyu Li, Stephen S Lim, Xuefeng Liu, Yuewei Liu, Giancarlo Logroscino, Stefan Lorkowski, Giancarlo Lucchetti, Ricardo Lutzky Saute, Francesca Giulia Magnani, Ahmad Azam Malik, João Massano, Man Mohan Mehndiratta, Ritesh G Menezes, Atte Meretoja, Bahram Mohajer, Norlinah Mohamed Ibrahim, Yousef Mohammad, Arif Mohammed, Ali H Mokdad, Stefania Mondello, Mohammad Ali Ali Moni, Md Moniruzzaman, Tilahun Belete Mossie, Gabriele Nagel, Muhammad Naveed, Vinod C Nayak, Sandhya Neupane Kandel, Trang Huyen Nguyen, Bogdan Oancea, Nikita Otstavnov, Stanislav S Otstavnov, Mayowa O Owolabi, Songhomitra Panda-Jonas, Fatemeh Pashazadeh Kan, Maja Pasovic, Urvish K Patel, Mona Pathak, Mario F P Peres, Arokiasamy Perianayagam, Carrie B Peterson, Michael R Phillips, Marina Pinheiro, Michael A Piradov, Constance Dimity Pond, Michele H Potashman, Faheem Hyder Pottoo, Sergio I Prada, Amir Radfar, Alberto Raggi, Fakher Rahim, Mosiur Rahman, Pradhum Ram, Priyanga Ranasinghe, David Laith Rawaf, Salman Rawaf, Nima Rezaei, Aziz Rezapour, Stephen R Robinson, Michele Romoli, Gholamreza Roshandel, Ramesh Sahathevan, Amirhossein Sahebkar, Mohammad Ali Sahraian, Brijesh Sathian, Davide Sattin, Monika Sawhney, Mete Saylan, Silvia Schiavolin, Allen Seylani, Feng Sha, Masood Ali Shaikh, KS Shaji, Mohammed Shannawaz, Jeevan K Shetty, Mika Shigematsu, Jae Il Shin, Rahman Shiri, Diego Augusto Santos Silva, João Pedro Silva, Renata Silva, Jasvinder A Singh, Valentin Yurievich Skryabin, Anna Aleksandrovna Skryabina, Amanda E Smith, Sergey Soshnikov, Emma Elizabeth Spurlock, Dan J Stein, Jing Sun, Rafael Tabarés-Seisdedos, Bhaskar Thakur, Binod Timalsina, Marcos Roberto Tovani-Palone, Bach Xuan Tran, Gebiyaw Wudie Tsegaye, Sahel Valadan Tahbaz, Pascual R Valdez, Narayanaswamy Venketasubramanian, Vasily Vlassov, Giang Thu Vu, Linh Gia Vu, Yuan-Pang Wang, Anders Wimo, Andrea Sylvia Winkler, Lalit Yadav, Seyed Hossein Yahyazadeh Jabbari, Kazumasa Yamagishi, Lin Yang, Yuichiro Yano, Naohiro Yonemoto, Chuanhua Yu, Ismaeel Yunusa, Siddhesh Zadey, Mikhail Sergeevich Zastrozhin, Anasthasia Zastrozhina, Zhi-Jiang Zhang, Christopher J L Murray, and Theo Vos

Subjects
Public aspects of medicine, RA1-1270
Abstract

Summary: Background: Given the projected trends in population ageing and population growth, the number of people with dementia is expected to increase. In addition, strong evidence has emerged supporting the importance of potentially modifiable risk factors for dementia. Characterising the distribution and magnitude of anticipated growth is crucial for public health planning and resource prioritisation. This study aimed to improve on previous forecasts of dementia prevalence by producing country-level estimates and incorporating information on selected risk factors. Methods: We forecasted the prevalence of dementia attributable to the three dementia risk factors included in the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 (high body-mass index, high fasting plasma glucose, and smoking) from 2019 to 2050, using relative risks and forecasted risk factor prevalence to predict GBD risk-attributable prevalence in 2050 globally and by world region and country. Using linear regression models with education included as an additional predictor, we then forecasted the prevalence of dementia not attributable to GBD risks. To assess the relative contribution of future trends in GBD risk factors, education, population growth, and population ageing, we did a decomposition analysis. Findings: We estimated that the number of people with dementia would increase from 57·4 (95% uncertainty interval 50·4–65·1) million cases globally in 2019 to 152·8 (130·8–175·9) million cases in 2050. Despite large increases in the projected number of people living with dementia, age-standardised both-sex prevalence remained stable between 2019 and 2050 (global percentage change of 0·1% [–7·5 to 10·8]). We estimated that there were more women with dementia than men with dementia globally in 2019 (female-to-male ratio of 1·69 [1·64–1·73]), and we expect this pattern to continue to 2050 (female-to-male ratio of 1·67 [1·52–1·85]). There was geographical heterogeneity in the projected increases across countries and regions, with the smallest percentage changes in the number of projected dementia cases in high-income Asia Pacific (53% [41–67]) and western Europe (74% [58–90]), and the largest in north Africa and the Middle East (367% [329–403]) and eastern sub-Saharan Africa (357% [323–395]). Projected increases in cases could largely be attributed to population growth and population ageing, although their relative importance varied by world region, with population growth contributing most to the increases in sub-Saharan Africa and population ageing contributing most to the increases in east Asia. Interpretation: Growth in the number of individuals living with dementia underscores the need for public health planning efforts and policy to address the needs of this group. Country-level estimates can be used to inform national planning efforts and decisions. Multifaceted approaches, including scaling up interventions to address modifiable risk factors and investing in research on biological mechanisms, will be key in addressing the expected increases in the number of individuals affected by dementia. Funding: Bill & Melinda Gates Foundation and Gates Ventures.

Published
2022
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5. What outcomes are important to patients with mild cognitive impairment or Alzheimer's disease, their caregivers, and health‐care professionals? A systematic review

Author

Claire Tochel, Michael Smith, Helen Baldwin, Anders Gustavsson, Amanda Ly, Christin Bexelius, Mia Nelson, Christophe Bintener, Enrico Fantoni, Josep Garre‐Olmo, Olin Janssen, Christoph Jindra, Isabella F. Jørgensen, Alex McKeown, Buket Öztürk, Anna Ponjoan, Michele H. Potashman, Catherine Reed, Emilse Roncancio‐Diaz, Stephanie Vos, Cathie Sudlow, and the ROADMAP consortium

Subjects
Alzheimer's Disease, Mild cognitive impairment, Outcomes, Systematic review, Qualitative, Quantitative, Neurology. Diseases of the nervous system, RC346-429, Geriatrics, RC952-954.6
Abstract

Abstract Introduction Clinical trials involving patients with Alzheimer's disease (AD) continue to try to identify disease‐modifying treatments. Although trials are designed to meet regulatory and registration requirements, many do not measure outcomes of the disease most relevant to key stakeholders. Methods A systematic review sought research that elicited information from people with AD, their caregivers, and health‐care professionals on which outcomes of the disease were important. Studies published in any language between 2008 and 2017 were included. Results Participants in 34 studies described 32 outcomes of AD. These included clinical (memory, mental health), practical (ability to undertake activities of daily living, access to health information), and personal (desire for patient autonomy, maintenance of identity) outcomes of the disease. Discussion Evidence elicited directly from the people most affected by AD reveals a range of disease outcomes that are relevant to them but are not commonly captured in clinical trials of new treatments.

Published
2019
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6. Ataxia Rating Scales Reflect Patient Experience: an Examination of the Relationship Between Clinician Assessments of Cerebellar Ataxia and Patient-Reported Outcomes

Author

Michele H. Potashman, Miranda L. Mize, Melissa W. Beiner, Samantha Pierce, Vladimir Coric, and Jeremy D. Schmahmann

Subjects
Neurology, Neurology (clinical)
Abstract

Ataxia rating scales are observer administered clinical outcome assessments (COAs) of the cerebellar motor syndrome. It is not known whether these COAs mirror patient experience of their disease. Here we test the hypothesis that ataxia COAs are related to and reflect patient reported symptoms and impact of illness. A concept library of symptoms and activities impacted by ataxia was created by reviewing (a) concept elicitation data from surveys completed by 147 ataxia patients and 80 family members and (b) cognitive debrief data from focus groups of 17 ataxia patients used to develop the Patient Reported Outcome Measure of Ataxia. These findings were mapped across the items on 4 clinical measures of ataxia (SARA, BARS, ICARS and FARS). Symptoms reported most commonly related to balance, gait or walking, speech, tremor and involuntary movements, and vision impairment. Symptoms reported less frequently related to hand coordination, loss of muscle control, dizziness and vertigo, muscle discomfort or pain, swallowing, and incontinence. There was a mosaic mapping of items in the observer-derived ataxia COAs with the subjective reports by ataxia patients/families of the relevance of these items to their daily lives. Most COA item mapped onto multiple real-life manifestations; and most of the real-life impact of disease mapped onto multiple COA items. The 4 common ataxia COAs reflect patient reported symptoms and impact of illness. These results validate the relevance of the COAs to patients’ lives and underscore the inadvisability of singling out any one COA item to represent the totality of the patient experience.

Published
2022
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7. Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019

Author

Nichols, E, D Steinmetz, J, Emil Vollset, S, Fukutaki, K, Chalek, J, Abd-Allah, F, Abdoli, A, Abualhasan, A, Abu-Gharbieh, E, Tayyaba Akram, T, Al Hamad, H, Alahdab, F, Mashhour Alanezi, F, Alipour, V, Almustanyir, S, Amu, H, Ansari, I, Arabloo, J, Ashraf, T, Astell-Burt, T, Ayano, G, L Ayuso-Mateos, J, Amin Baig, A, Barnett, A, Barrow, A, T Baune, B, Béjot, Y, M Mequanint Bezabhe, W, Mequanint Bezabih, Y, Srikanth Bhagavathula, A, Bhaskar, S, Bhattacharyya, K, Bijani, A, Biswas, A, Rao Bolla, S, Boloor, A, Brayne, C, Brenner, H, Burkart, K, A Burns, R, Alberto Cámera, L, Cao, C, Carvalho, F, S Castro-de-Araujo, L, Catalá-López, F, Cerin, E, P Chavan, P, Cherbuin, N, Chu, D, Marisa Costa, V, S Couto, R, Dadras, O, Dai, X, Dandona, L, Dandona, R, De la Cruz-Góngora, V, Dhamnetiya, D, Dias da Silva, D, Diaz, D, Douiri, A, Edvardsson, D, Ekholuenetale, M, El Sayed, I, I El-Jaafary, S, Eskandari, K, Eskandarieh, S, Esmaeilnejad, S, Fares, J, Faro, A, Farooque, U, L Feigin, V, Feng, X, Fereshtehnejad, S, Fernandes, E, Ferrara, P, Filip, I, Fillit, H, Fischer, F, Gaidhane, S, Galluzzo, L, Ghashghaee, A, Ghith, N, Gialluisi, A, Amir Gilani, S, Glăvan, I, V Gnedovskaya, E, Golechha, M, Gupta, R, Bala Gupta, V, Kumar Gupta, V, Rifat Haider, M, J Hall, B, Hamidi, S, Hanif, A, J Hankey, G, Haque, S, Kusuma Hartono, R, I Hasaballah, A, Tasdik Hasan, M, Hassan, A, I Hay, S, Hayat, K, I Hegazy, M, Heidari, G, Heidari-Soureshjani, R, Herteliu, C, Househ, M, Hussain, R, Hwang, B, Iacoviello, L, Iavicoli, I, Stephen Ilesanmi, O, M Ilic, I, D Ilic, M, Sina Naghibi Irvani, S, Iso, H, Iwagami, M, Jabbarinejad, R, Jacob, L, Jain, V, Kumar Jayapal, S, Jayawardena, R, Prakash Jha, R, B Jonas, J, Joseph, N, Kalani, R, Kandel, A, Kandel, H, Karch, A, Semachew Kasa, A, M Kassie, G, Keshavarz, P, B Khan, M, Nazli Khatib, M, Ahmed Muthafer Khoja, T, Khubchandani, J, Seo Kim, M, Jin Kim, Y, Kisa, A, Kisa, S, Kivimäki, M, J Koroshetz, W, Koyanagi, A, Anil Kumar, G, Kumar, M, Mehmood Lak, H, Leonardi, M, Li, B, S Lim, S, Liu, X, Liu, Y, Logroscino, G, Lorkowski, S, Lucchetti, G, Lutzky Saute, R, Giulia Magnani, F, Azam Malik, A, Massano, J, Mohan Mehndiratta, M, G Menezes, R, Meretoja, A, Mohajer, B, Mohamed Ibrahim, N, Mohammad, Y, Mohammed, A, H Mokdad, A, Mondello, S, Ali Moni, M, Moniruzzaman, M, Belete Mossie, T, Nagel, G, Naveed, M, C Nayak, V, Neupane Kandel, S, Huyen Nguyen, T, Oancea, B, Otstavnov, N, S Otstavnov, S, O Owolabi, M, Panda-Jonas, S, Pashazadeh Kan, F, Pasovic, M, K Patel, U, Pathak, M, P Peres, M, Perianayagam, A, B Peterson, C, R Phillips, M, Pinheiro, M, A Piradov, M, Dimity Pond, C, H Potashman, M, Hyder Pottoo, F, I Prada, S, Radfar, A, Raggi, A, Rahim, F, Rahman, M, Ram, P, Ranasinghe, P, Laith Rawaf, D, Rawaf, S, Rezaei, N, Rezapour, A, R Robinson, S, Romoli, M, Roshandel, G, Sahathevan, R, Sahebkar, A, Ali Sahraian, M, Sathian, B, Sattin, D, Sawhney, M, Saylan, M, Schiavolin, S, Seylani, A, Sha, F, Ali Shaikh, M, S Shaji, K, Shannawaz, M, K Shetty, J, Shigematsu, M, Il Shin, J, Shiri, R, Augusto Santos Silva, D, Pedro Silva, J, Silva, R, A Singh, J, Yurievich Skryabin, V, Aleksandrovna Skryabina, A, E Smith, A, Soshnikov, S, Elizabeth Spurlock, E, J Stein, D, Sun, J, Tabarés-Seisdedos, R, Thakur, B, Timalsina, B, Roberto Tovani-Palone, M, Xuan Tran, B, Wudie Tsegaye, G, Valadan Tahbaz, S, R Valdez, P, Venketasubramanian, N, Vlassov, V, Thu Vu, G, Gia Vu, L, Wang, Y, Wimo, A, Sylvia Winkler, A, Yadav, L, Hossein Yahyazadeh Jabbari, S, Yamagishi, K, Yang, L, Yano, Y, Yonemoto, N, Yu, C, Yunusa, I, Zadey, S, Sergeevich Zastrozhin, M, Zastrozhina, A, Zhang, Z, L Murray, C, Vos, T, Emma Nichols, Jaimie D Steinmetz, Stein Emil Vollset, Kai Fukutaki, Julian Chalek, Foad Abd-Allah, Amir Abdoli, Ahmed Abualhasan, Eman Abu-Gharbieh, Tayyaba Tayyaba Akram, Hanadi Al Hamad, Fares Alahdab, Fahad Mashhour Alanezi, Vahid Alipour, Sami Almustanyir, Hubert Amu, Iman Ansari, Jalal Arabloo, Tahira Ashraf, Thomas Astell-Burt, Getinet Ayano, Jose L Ayuso-Mateos, Atif Amin Baig, Anthony Barnett, Amadou Barrow, Bernhard T Baune, Yannick Béjot, Woldesellassie M Mequanint Bezabhe, Yihienew Mequanint Bezabih, Akshaya Srikanth Bhagavathula, Sonu Bhaskar, Krittika Bhattacharyya, Ali Bijani, Atanu Biswas, Srinivasa Rao Bolla, Archith Boloor, Carol Brayne, Hermann Brenner, Katrin Burkart, Richard A Burns, Luis Alberto Cámera, Chao Cao, Felix Carvalho, Luis F S Castro-de-Araujo, Ferrán Catalá-López, Ester Cerin, Prachi P Chavan, Nicolas Cherbuin, Dinh-Toi Chu, Vera Marisa Costa, Rosa A S Couto, Omid Dadras, Xiaochen Dai, Lalit Dandona, Rakhi Dandona, Vanessa De la Cruz-Góngora, Deepak Dhamnetiya, Diana Dias da Silva, Daniel Diaz, Abdel Douiri, David Edvardsson, Michael Ekholuenetale, Iman El Sayed, Shaimaa I El-Jaafary, Khalil Eskandari, Sharareh Eskandarieh, Saman Esmaeilnejad, Jawad Fares, Andre Faro, Umar Farooque, Valery L Feigin, Xiaoqi Feng, Seyed-Mohammad Fereshtehnejad, Eduarda Fernandes, Pietro Ferrara, Irina Filip, Howard Fillit, Florian Fischer, Shilpa Gaidhane, Lucia Galluzzo, Ahmad Ghashghaee, Nermin Ghith, Alessandro Gialluisi, Syed Amir Gilani, Ionela-Roxana Glăvan, Elena V Gnedovskaya, Mahaveer Golechha, Rajeev Gupta, Veer Bala Gupta, Vivek Kumar Gupta, Mohammad Rifat Haider, Brian J Hall, Samer Hamidi, Asif Hanif, Graeme J Hankey, Shafiul Haque, Risky Kusuma Hartono, Ahmed I Hasaballah, M Tasdik Hasan, Amr Hassan, Simon I Hay, Khezar Hayat, Mohamed I Hegazy, Golnaz Heidari, Reza Heidari-Soureshjani, Claudiu Herteliu, Mowafa Househ, Rabia Hussain, Bing-Fang Hwang, Licia Iacoviello, Ivo Iavicoli, Olayinka Stephen Ilesanmi, Irena M Ilic, Milena D Ilic, Seyed Sina Naghibi Irvani, Hiroyasu Iso, Masao Iwagami, Roxana Jabbarinejad, Louis Jacob, Vardhmaan Jain, Sathish Kumar Jayapal, Ranil Jayawardena, Ravi Prakash Jha, Jost B Jonas, Nitin Joseph, Rizwan Kalani, Amit Kandel, Himal Kandel, André Karch, Ayele Semachew Kasa, Gizat M Kassie, Pedram Keshavarz, Moien A B Khan, Mahalaqua Nazli Khatib, Tawfik Ahmed Muthafer Khoja, Jagdish Khubchandani, Min Seo Kim, Yun Jin Kim, Adnan Kisa, Sezer Kisa, Mika Kivimäki, Walter J Koroshetz, Ai Koyanagi, G Anil Kumar, Manasi Kumar, Hassan Mehmood Lak, Matilde Leonardi, Bingyu Li, Stephen S Lim, Xuefeng Liu, Yuewei Liu, Giancarlo Logroscino, Stefan Lorkowski, Giancarlo Lucchetti, Ricardo Lutzky Saute, Francesca Giulia Magnani, Ahmad Azam Malik, João Massano, Man Mohan Mehndiratta, Ritesh G Menezes, Atte Meretoja, Bahram Mohajer, Norlinah Mohamed Ibrahim, Yousef Mohammad, Arif Mohammed, Ali H Mokdad, Stefania Mondello, Mohammad Ali Moni, Md Moniruzzaman, Tilahun Belete Mossie, Gabriele Nagel, Muhammad Naveed, Vinod C Nayak, Sandhya Neupane Kandel, Trang Huyen Nguyen, Bogdan Oancea, Nikita Otstavnov, Stanislav S Otstavnov, Mayowa O Owolabi, Songhomitra Panda-Jonas, Fatemeh Pashazadeh Kan, Maja Pasovic, Urvish K Patel, Mona Pathak, Mario F P Peres, Arokiasamy Perianayagam, Carrie B Peterson, Michael R Phillips, Marina Pinheiro, Michael A Piradov, Constance Dimity Pond, Michele H Potashman, Faheem Hyder Pottoo, Sergio I Prada, Amir Radfar, Alberto Raggi, Fakher Rahim, Mosiur Rahman, Pradhum Ram, Priyanga Ranasinghe, David Laith Rawaf, Salman Rawaf, Nima Rezaei, Aziz Rezapour, Stephen R Robinson, Michele Romoli, Gholamreza Roshandel, Ramesh Sahathevan, Amirhossein Sahebkar, Mohammad Ali Sahraian, Brijesh Sathian, Davide Sattin, Monika Sawhney, Mete Saylan, Silvia Schiavolin, Allen Seylani, Feng Sha, Masood Ali Shaikh, K S Shaji, Mohammed Shannawaz, Jeevan K Shetty, Mika Shigematsu, Jae Il Shin, Rahman Shiri, Diego Augusto Santos Silva, João Pedro Silva, Renata Silva, Jasvinder A Singh, Valentin Yurievich Skryabin, Anna Aleksandrovna Skryabina, Amanda E Smith, Sergey Soshnikov, Emma Elizabeth Spurlock, Dan J Stein, Jing Sun, Rafael Tabarés-Seisdedos, Bhaskar Thakur, Binod Timalsina, Marcos Roberto Tovani-Palone, Bach Xuan Tran, Gebiyaw Wudie Tsegaye, Sahel Valadan Tahbaz, Pascual R Valdez, Narayanaswamy Venketasubramanian, Vasily Vlassov, Giang Thu Vu, Linh Gia Vu, Yuan-Pang Wang, Anders Wimo, Andrea Sylvia Winkler, Lalit Yadav, Seyed Hossein Yahyazadeh Jabbari, Kazumasa Yamagishi, Lin Yang, Yuichiro Yano, Naohiro Yonemoto, Chuanhua Yu, Ismaeel Yunusa, Siddhesh Zadey, Mikhail Sergeevich Zastrozhin, Anasthasia Zastrozhina, Zhi-Jiang Zhang, Christopher J L Murray, Theo Vos, Nichols, E, D Steinmetz, J, Emil Vollset, S, Fukutaki, K, Chalek, J, Abd-Allah, F, Abdoli, A, Abualhasan, A, Abu-Gharbieh, E, Tayyaba Akram, T, Al Hamad, H, Alahdab, F, Mashhour Alanezi, F, Alipour, V, Almustanyir, S, Amu, H, Ansari, I, Arabloo, J, Ashraf, T, Astell-Burt, T, Ayano, G, L Ayuso-Mateos, J, Amin Baig, A, Barnett, A, Barrow, A, T Baune, B, Béjot, Y, M Mequanint Bezabhe, W, Mequanint Bezabih, Y, Srikanth Bhagavathula, A, Bhaskar, S, Bhattacharyya, K, Bijani, A, Biswas, A, Rao Bolla, S, Boloor, A, Brayne, C, Brenner, H, Burkart, K, A Burns, R, Alberto Cámera, L, Cao, C, Carvalho, F, S Castro-de-Araujo, L, Catalá-López, F, Cerin, E, P Chavan, P, Cherbuin, N, Chu, D, Marisa Costa, V, S Couto, R, Dadras, O, Dai, X, Dandona, L, Dandona, R, De la Cruz-Góngora, V, Dhamnetiya, D, Dias da Silva, D, Diaz, D, Douiri, A, Edvardsson, D, Ekholuenetale, M, El Sayed, I, I El-Jaafary, S, Eskandari, K, Eskandarieh, S, Esmaeilnejad, S, Fares, J, Faro, A, Farooque, U, L Feigin, V, Feng, X, Fereshtehnejad, S, Fernandes, E, Ferrara, P, Filip, I, Fillit, H, Fischer, F, Gaidhane, S, Galluzzo, L, Ghashghaee, A, Ghith, N, Gialluisi, A, Amir Gilani, S, Glăvan, I, V Gnedovskaya, E, Golechha, M, Gupta, R, Bala Gupta, V, Kumar Gupta, V, Rifat Haider, M, J Hall, B, Hamidi, S, Hanif, A, J Hankey, G, Haque, S, Kusuma Hartono, R, I Hasaballah, A, Tasdik Hasan, M, Hassan, A, I Hay, S, Hayat, K, I Hegazy, M, Heidari, G, Heidari-Soureshjani, R, Herteliu, C, Househ, M, Hussain, R, Hwang, B, Iacoviello, L, Iavicoli, I, Stephen Ilesanmi, O, M Ilic, I, D Ilic, M, Sina Naghibi Irvani, S, Iso, H, Iwagami, M, Jabbarinejad, R, Jacob, L, Jain, V, Kumar Jayapal, S, Jayawardena, R, Prakash Jha, R, B Jonas, J, Joseph, N, Kalani, R, Kandel, A, Kandel, H, Karch, A, Semachew Kasa, A, M Kassie, G, Keshavarz, P, B Khan, M, Nazli Khatib, M, Ahmed Muthafer Khoja, T, Khubchandani, J, Seo Kim, M, Jin Kim, Y, Kisa, A, Kisa, S, Kivimäki, M, J Koroshetz, W, Koyanagi, A, Anil Kumar, G, Kumar, M, Mehmood Lak, H, Leonardi, M, Li, B, S Lim, S, Liu, X, Liu, Y, Logroscino, G, Lorkowski, S, Lucchetti, G, Lutzky Saute, R, Giulia Magnani, F, Azam Malik, A, Massano, J, Mohan Mehndiratta, M, G Menezes, R, Meretoja, A, Mohajer, B, Mohamed Ibrahim, N, Mohammad, Y, Mohammed, A, H Mokdad, A, Mondello, S, Ali Moni, M, Moniruzzaman, M, Belete Mossie, T, Nagel, G, Naveed, M, C Nayak, V, Neupane Kandel, S, Huyen Nguyen, T, Oancea, B, Otstavnov, N, S Otstavnov, S, O Owolabi, M, Panda-Jonas, S, Pashazadeh Kan, F, Pasovic, M, K Patel, U, Pathak, M, P Peres, M, Perianayagam, A, B Peterson, C, R Phillips, M, Pinheiro, M, A Piradov, M, Dimity Pond, C, H Potashman, M, Hyder Pottoo, F, I Prada, S, Radfar, A, Raggi, A, Rahim, F, Rahman, M, Ram, P, Ranasinghe, P, Laith Rawaf, D, Rawaf, S, Rezaei, N, Rezapour, A, R Robinson, S, Romoli, M, Roshandel, G, Sahathevan, R, Sahebkar, A, Ali Sahraian, M, Sathian, B, Sattin, D, Sawhney, M, Saylan, M, Schiavolin, S, Seylani, A, Sha, F, Ali Shaikh, M, S Shaji, K, Shannawaz, M, K Shetty, J, Shigematsu, M, Il Shin, J, Shiri, R, Augusto Santos Silva, D, Pedro Silva, J, Silva, R, A Singh, J, Yurievich Skryabin, V, Aleksandrovna Skryabina, A, E Smith, A, Soshnikov, S, Elizabeth Spurlock, E, J Stein, D, Sun, J, Tabarés-Seisdedos, R, Thakur, B, Timalsina, B, Roberto Tovani-Palone, M, Xuan Tran, B, Wudie Tsegaye, G, Valadan Tahbaz, S, R Valdez, P, Venketasubramanian, N, Vlassov, V, Thu Vu, G, Gia Vu, L, Wang, Y, Wimo, A, Sylvia Winkler, A, Yadav, L, Hossein Yahyazadeh Jabbari, S, Yamagishi, K, Yang, L, Yano, Y, Yonemoto, N, Yu, C, Yunusa, I, Zadey, S, Sergeevich Zastrozhin, M, Zastrozhina, A, Zhang, Z, L Murray, C, Vos, T, Emma Nichols, Jaimie D Steinmetz, Stein Emil Vollset, Kai Fukutaki, Julian Chalek, Foad Abd-Allah, Amir Abdoli, Ahmed Abualhasan, Eman Abu-Gharbieh, Tayyaba Tayyaba Akram, Hanadi Al Hamad, Fares Alahdab, Fahad Mashhour Alanezi, Vahid Alipour, Sami Almustanyir, Hubert Amu, Iman Ansari, Jalal Arabloo, Tahira Ashraf, Thomas Astell-Burt, Getinet Ayano, Jose L Ayuso-Mateos, Atif Amin Baig, Anthony Barnett, Amadou Barrow, Bernhard T Baune, Yannick Béjot, Woldesellassie M Mequanint Bezabhe, Yihienew Mequanint Bezabih, Akshaya Srikanth Bhagavathula, Sonu Bhaskar, Krittika Bhattacharyya, Ali Bijani, Atanu Biswas, Srinivasa Rao Bolla, Archith Boloor, Carol Brayne, Hermann Brenner, Katrin Burkart, Richard A Burns, Luis Alberto Cámera, Chao Cao, Felix Carvalho, Luis F S Castro-de-Araujo, Ferrán Catalá-López, Ester Cerin, Prachi P Chavan, Nicolas Cherbuin, Dinh-Toi Chu, Vera Marisa Costa, Rosa A S Couto, Omid Dadras, Xiaochen Dai, Lalit Dandona, Rakhi Dandona, Vanessa De la Cruz-Góngora, Deepak Dhamnetiya, Diana Dias da Silva, Daniel Diaz, Abdel Douiri, David Edvardsson, Michael Ekholuenetale, Iman El Sayed, Shaimaa I El-Jaafary, Khalil Eskandari, Sharareh Eskandarieh, Saman Esmaeilnejad, Jawad Fares, Andre Faro, Umar Farooque, Valery L Feigin, Xiaoqi Feng, Seyed-Mohammad Fereshtehnejad, Eduarda Fernandes, Pietro Ferrara, Irina Filip, Howard Fillit, Florian Fischer, Shilpa Gaidhane, Lucia Galluzzo, Ahmad Ghashghaee, Nermin Ghith, Alessandro Gialluisi, Syed Amir Gilani, Ionela-Roxana Glăvan, Elena V Gnedovskaya, Mahaveer Golechha, Rajeev Gupta, Veer Bala Gupta, Vivek Kumar Gupta, Mohammad Rifat Haider, Brian J Hall, Samer Hamidi, Asif Hanif, Graeme J Hankey, Shafiul Haque, Risky Kusuma Hartono, Ahmed I Hasaballah, M Tasdik Hasan, Amr Hassan, Simon I Hay, Khezar Hayat, Mohamed I Hegazy, Golnaz Heidari, Reza Heidari-Soureshjani, Claudiu Herteliu, Mowafa Househ, Rabia Hussain, Bing-Fang Hwang, Licia Iacoviello, Ivo Iavicoli, Olayinka Stephen Ilesanmi, Irena M Ilic, Milena D Ilic, Seyed Sina Naghibi Irvani, Hiroyasu Iso, Masao Iwagami, Roxana Jabbarinejad, Louis Jacob, Vardhmaan Jain, Sathish Kumar Jayapal, Ranil Jayawardena, Ravi Prakash Jha, Jost B Jonas, Nitin Joseph, Rizwan Kalani, Amit Kandel, Himal Kandel, André Karch, Ayele Semachew Kasa, Gizat M Kassie, Pedram Keshavarz, Moien A B Khan, Mahalaqua Nazli Khatib, Tawfik Ahmed Muthafer Khoja, Jagdish Khubchandani, Min Seo Kim, Yun Jin Kim, Adnan Kisa, Sezer Kisa, Mika Kivimäki, Walter J Koroshetz, Ai Koyanagi, G Anil Kumar, Manasi Kumar, Hassan Mehmood Lak, Matilde Leonardi, Bingyu Li, Stephen S Lim, Xuefeng Liu, Yuewei Liu, Giancarlo Logroscino, Stefan Lorkowski, Giancarlo Lucchetti, Ricardo Lutzky Saute, Francesca Giulia Magnani, Ahmad Azam Malik, João Massano, Man Mohan Mehndiratta, Ritesh G Menezes, Atte Meretoja, Bahram Mohajer, Norlinah Mohamed Ibrahim, Yousef Mohammad, Arif Mohammed, Ali H Mokdad, Stefania Mondello, Mohammad Ali Moni, Md Moniruzzaman, Tilahun Belete Mossie, Gabriele Nagel, Muhammad Naveed, Vinod C Nayak, Sandhya Neupane Kandel, Trang Huyen Nguyen, Bogdan Oancea, Nikita Otstavnov, Stanislav S Otstavnov, Mayowa O Owolabi, Songhomitra Panda-Jonas, Fatemeh Pashazadeh Kan, Maja Pasovic, Urvish K Patel, Mona Pathak, Mario F P Peres, Arokiasamy Perianayagam, Carrie B Peterson, Michael R Phillips, Marina Pinheiro, Michael A Piradov, Constance Dimity Pond, Michele H Potashman, Faheem Hyder Pottoo, Sergio I Prada, Amir Radfar, Alberto Raggi, Fakher Rahim, Mosiur Rahman, Pradhum Ram, Priyanga Ranasinghe, David Laith Rawaf, Salman Rawaf, Nima Rezaei, Aziz Rezapour, Stephen R Robinson, Michele Romoli, Gholamreza Roshandel, Ramesh Sahathevan, Amirhossein Sahebkar, Mohammad Ali Sahraian, Brijesh Sathian, Davide Sattin, Monika Sawhney, Mete Saylan, Silvia Schiavolin, Allen Seylani, Feng Sha, Masood Ali Shaikh, K S Shaji, Mohammed Shannawaz, Jeevan K Shetty, Mika Shigematsu, Jae Il Shin, Rahman Shiri, Diego Augusto Santos Silva, João Pedro Silva, Renata Silva, Jasvinder A Singh, Valentin Yurievich Skryabin, Anna Aleksandrovna Skryabina, Amanda E Smith, Sergey Soshnikov, Emma Elizabeth Spurlock, Dan J Stein, Jing Sun, Rafael Tabarés-Seisdedos, Bhaskar Thakur, Binod Timalsina, Marcos Roberto Tovani-Palone, Bach Xuan Tran, Gebiyaw Wudie Tsegaye, Sahel Valadan Tahbaz, Pascual R Valdez, Narayanaswamy Venketasubramanian, Vasily Vlassov, Giang Thu Vu, Linh Gia Vu, Yuan-Pang Wang, Anders Wimo, Andrea Sylvia Winkler, Lalit Yadav, Seyed Hossein Yahyazadeh Jabbari, Kazumasa Yamagishi, Lin Yang, Yuichiro Yano, Naohiro Yonemoto, Chuanhua Yu, Ismaeel Yunusa, Siddhesh Zadey, Mikhail Sergeevich Zastrozhin, Anasthasia Zastrozhina, Zhi-Jiang Zhang, Christopher J L Murray, and Theo Vos

Abstract

BACKGROUND: Given the projected trends in population ageing and population growth, the number of people with dementia is expected to increase. In addition, strong evidence has emerged supporting the importance of potentially modifiable risk factors for dementia. Characterising the distribution and magnitude of anticipated growth is crucial for public health planning and resource prioritisation. This study aimed to improve on previous forecasts of dementia prevalence by producing country-level estimates and incorporating information on selected risk factors. METHODS: We forecasted the prevalence of dementia attributable to the three dementia risk factors included in the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 (high body-mass index, high fasting plasma glucose, and smoking) from 2019 to 2050, using relative risks and forecasted risk factor prevalence to predict GBD risk-attributable prevalence in 2050 globally and by world region and country. Using linear regression models with education included as an additional predictor, we then forecasted the prevalence of dementia not attributable to GBD risks. To assess the relative contribution of future trends in GBD risk factors, education, population growth, and population ageing, we did a decomposition analysis. FINDINGS: We estimated that the number of people with dementia would increase from 57·4 (95% uncertainty interval 50·4-65·1) million cases globally in 2019 to 152·8 (130·8-175·9) million cases in 2050. Despite large increases in the projected number of people living with dementia, age-standardised both-sex prevalence remained stable between 2019 and 2050 (global percentage change of 0·1% [-7·5 to 10·8]). We estimated that there were more women with dementia than men with dementia globally in 2019 (female-to-male ratio of 1·69 [1·64-1·73]), and we expect this pattern to continue to 2050 (female-to-male ratio of 1·67 [1·52-1·85]). There was geographical heterogeneity in the projected inc

Published
2022

8. Economic Impact of Alvimopan Considering Varying Definitions of Postoperative Ileus

Author

Michele H Potashman, Cassandra Pauyo, Cheryl McDade, Teresa L. Kauf, Anthony J. Senagore, Emily S. Reese, and Stephanie R. Earnshaw

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Ileus, medicine.medical_treatment, Cystectomy, Young Adult, Postoperative Complications, Gastrointestinal Agents, Piperidines, medicine, Alvimopan, Humans, Hospital Costs, Adverse effect, Digestive System Surgical Procedures, Aged, Aged, 80 and over, Postoperative Care, Gastrointestinal agent, Models, Statistical, business.industry, Decision Trees, Bowel resection, Length of Stay, Middle Aged, medicine.disease, Combined Modality Therapy, United States, Surgery, Clinical trial, Anesthesia, Female, business, Abdominal surgery, medicine.drug
Abstract

Prolonged postoperative ileus (POI) is the predominant cause of extended hospitalization after bowel resection surgery. Alvimopan accelerates gastrointestinal recovery, potentially reducing health care costs. We examined the value of alvimopan in reducing prolonged POI and length of stay for patients undergoing abdominal surgery using different definitions of POI.We developed a decision analytic model to examine costs and outcomes associated with postoperative treatment with either an accelerated care pathway (ACP) only or alvimopan+ACP. To represent an overall perspective for alvimopan, data from four phase 3 bowel resection trials and one phase 4 radical cystectomy trial were used to populate the model with 3 different definitions of POI. The period analyzed included start of surgery to 7 days post discharge. Costs were obtained from standard US costing sources and are reported in 2015 US dollars. Due to variations in published definitions of POI, alternative definitions based on adverse event reports, NG tube insertion, and time to food toleration were examined.The combined clinical trial data included 1,003 ACP and 1,013 alvimopan+ACP patients. When POI was reported as an adverse event, the incidence of POI was significantly lower with alvimopan+ACP (n = 70 [7%]) vs ACP alone (n = 148 [15%]; p0.0001). Time to discharge order written was shorter for patients with POI who were treated with alvimopan+ACP than with ACP (202 ± 115 hours vs 266 ± 138 hours; p0.0001). As a result, costs were $731 lower with alvimopan+ACP ($17,835) vs ACP ($18,566). Alternative definitions of POI produced similar results.The addition of alvimopan to existing treatment pathways for patients undergoing abdominal surgery can reduce overall hospital costs.

Published
2015
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9. Administration costs of intravenous chemotherapy in treating peripheral T-cell lymphoma

Author

Michele H. Potashman, Bruce Wong, Gregory B. Kruse, and Spyros Stavrakas

Subjects
Adult, medicine.medical_specialty, Databases, Factual, Total cost, medicine.medical_treatment, Cancer therapy, Antineoplastic Agents, Insurance Claim Review, Young Adult, Internal medicine, Ambulatory Care, Humans, Medicine, Intensive care medicine, health care economics and organizations, Aged, Retrospective Studies, Chemotherapy, Insurance, Health, business.industry, Health Policy, Lymphoma, T-Cell, Peripheral, Cancer, Intravenous chemotherapy, Retrospective cohort study, Middle Aged, medicine.disease, United States, Peripheral T-cell lymphoma, Costs and Cost Analysis, Administration, Intravenous, business, Administration (government)
Abstract

This retrospective cohort analysis was conducted to examine the cost components of administering IV chemotherapy to peripheral T-cell lymphoma (PTCL) patients in the US to inform decision makers.Patients diagnosed with PTCL (ICD-9 code 202.7X) between 1 October 2007 and 30 September 2012 were identified from a US administrative claims database. Costs for patients receiving at least one NCCN recommended IV chemotherapy were assessed using the allowed payment from claim line items, categorized into cost components (study drug costs, IV administration costs and other visit-related services).The mean costs to the payer for IV cancer therapy administration in a PTCL patient population averaged about $5735 per visit and $9356 per member per month (PMPM). Across all therapies, mean IV administration costs accounted for $127-$794 per visit and $594-$1808 PMPM, contributing an additional 2-32% to the total costs of the drug alone. Mean other visit-related services costs for treating PTCL accounted for $70-$2487 per visit and $444-$3094 PMPM, contributing an additional 2-74% to the total costs. Combined, these additional costs represent an additional mean cost of $220-$3150 per visit and $1193-$4609 PMPM to the base price of the drug alone.This study used a convenience sample to identify PTCL patients and only included visits where at least one NCCN recommended IV chemotherapy was administered.The costs of IV administration and other visit-related services add measurable costs to the total cost of IV therapy for treating PTCL. When considering the cost of the drug, these additional costs can represent a substantial proportion of the overall costs and must be considered when evaluating the costs of IV treatment options for PTCL.

Published
2014
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10. Discovery and optimization of potent and selective triazolopyridazine series of c-Met inhibitors

Author

Alessandro A, Boezio, Loren, Berry, Brian K, Albrecht, David, Bauer, Steven F, Bellon, Christiane, Bode, April, Chen, Deborah, Choquette, Isabelle, Dussault, Mei, Fang, Satoko, Hirai, Paula, Kaplan-Lefko, Jay F, Larrow, Min-Hwa Jasmine, Lin, Julia, Lohman, Michele H, Potashman, Yusheng, Qu, Karen, Rex, Michael, Santostefano, Kavita, Shah, Roman, Shimanovich, Stephanie K, Springer, Yohannes, Teffera, Yajing, Yang, Yihong, Zhang, and Jean-Christophe, Harmange

Subjects
C-Met, Cell Survival, Clinical Biochemistry, Mice, Nude, Neovascularization, Physiologic, Pharmaceutical Science, Angiogenesis Inhibitors, Apoptosis, Biochemistry, Receptor tyrosine kinase, Mice, chemistry.chemical_compound, Drug Discovery, Animals, Humans, Phosphorylation, Kinase activity, Protein Kinase Inhibitors, Molecular Biology, biology, Chemistry, Drug discovery, Organic Chemistry, Proto-Oncogene Proteins c-met, Xenograft Model Antitumor Assays, Small molecule, biology.protein, Molecular Medicine, Signal transduction, Tyrosine kinase
Abstract

Deregulation of the receptor tyrosine kinase c-Met has been implicated in several human cancers and is an attractive target for small molecule drug discovery. We previously showed that O-linked triazolopyridazines can be potent inhibitors of c-Met. Herein, we report the discovery of a related series of N-linked triazolopyridazines which demonstrate nanomolar inhibition of c-Met kinase activity and display improved pharmacodynamic profiles. Specifically, the potent time-dependent inhibition of cytochrome P450 associated with the O-linked triazolopyridazines has been eliminated within this novel series of inhibitors. N-linked triazolopyridazine 24 exhibited favorable pharmacokinetics and displayed potent inhibition of HGF-mediated c-Met phosphorylation in a mouse liver PD model. Once-daily oral administration of 24 for 22days showed significant tumor growth inhibition in an NIH-3T3/TPR-Met xenograft mouse efficacy model.

Published
2009
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11. Examination of hospital length of stay in Canada among patients with acute bacterial skin and skin structure infection caused by methicillin-resistant Staphylococcus aureus

Author

Michele H Potashman, Robin Lawrence, Michael Stokes, Jieruo Liu, and Linda Harris

Subjects
0301 basic medicine, Pathology, medicine.medical_specialty, 030106 microbiology, Length of hospitalization, MRSA, Disease, Skin infection, medicine.disease_cause, 03 medical and health sciences, Canadian provinces, Internal medicine, Medicine, Pharmacology (medical), Original Research, time trends, Pharmacology, LOS, integumentary system, business.industry, Skin and skin structure infection, ABSSSI, medicine.disease, Methicillin-resistant Staphylococcus aureus, hospital outcomes, Infectious Diseases, Staphylococcus aureus, Infection and Drug Resistance, Skin structure, Geographic regions, business
Abstract

Michele H Potashman,1 Michael Stokes,2 Jieruo Liu,2 Robin Lawrence,1 Linda Harris1 1Global Health Outcomes, Merck & Co, Inc., Kenilworth, NJ, USA; 2Evidera, Lexington, MA, USA Purpose: Skin infections, particularly those caused by resistant pathogens, represent a clinical burden. Hospitalization associated with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA) is a major contributor to the economic burden of the disease. This study was conducted to provide current, real-world data on hospitalization patterns for patients with ABSSSI caused by MRSA across multiple geographic regions in Canada. Patients and methods: This retrospective cohort study evaluated length of stay (LOS) for hospitalized patients with ABSSSI due to MRSA diagnosis across four Canadian geographic regions using the Discharge Abstract Database. Patients with ICD-10-CA diagnosis consistent with ABSSSI caused by MRSA between January 2008 and December 2014 were selected and assigned a primary or secondary diagnosis based on a prespecified ICD-10-CA code algorithm. Results: Among 6,719 patients, 3,273 (48.7%) and 3,446 (51.3%) had a primary and secondary diagnosis, respectively. Among patients with a primary or secondary diagnosis, the cellulitis/erysipelas subtype was most common. The majority of patients presented with 0 or 1 comorbid condition; the most common comorbidity was diabetes. The mean LOS over the study period varied by geographic region and year; in 2014 (the most recent year analyzed), LOS ranged from 7.7 days in Ontario to 13.4 days in the Canadian Prairie for a primary diagnosis and from 18.2 days in Ontario to 25.2 days in Atlantic Canada for a secondary diagnosis. A secondary diagnosis was associated with higher rates of continuing care compared with a primary diagnosis (10.6%–24.2% vs 4.6%–12.1%). Conclusion: This study demonstrated that the mean LOS associated with ABSSSI due to MRSA in Canada was minimally 7 days. Clinical management strategies, including medication management, which might facilitate hospital discharge, have the potential to reduce hospital LOS and related economic burden associated with ABSSSI caused by MRSA. Keywords: ABSSSI, MRSA, Canadian provinces, LOS, hospital outcomes, time trends

Published
2016

12. Comment on: Efficacy and safety of daptomycin for the treatment of infectious disease: a meta-analysis based on randomized controlled trials

Author

Danielle N. Formella, Michele H. Potashman, John F. Mohr, and Kamal Hamed

Subjects
Pharmacology, Microbiology (medical), Male, medicine.medical_specialty, business.industry, Communicable Diseases, Surgery, law.invention, Anti-Bacterial Agents, Infectious Diseases, Randomized controlled trial, Daptomycin, law, Infectious disease (medical specialty), Internal medicine, Meta-analysis, Medicine, Humans, Pharmacology (medical), Female, business, medicine.drug
Published
2015

13. Clinical and Economic Burden Of Peripheral T-Cell Lymphoma In The United States

Author

Yanyan Zhu, Chakkarin Burudpakdee, Weiying Wang, Kenneth R. Carson, and Michele H. Potashman

Subjects
Pediatrics, medicine.medical_specialty, Blood transfusion, business.industry, medicine.medical_treatment, Immunology, Advanced stage, Pharmacy, Cell Biology, Hematology, medicine.disease, Biochemistry, Peripheral T-cell lymphoma, Charlson comorbidity index, Medicine, Diagnosis code, Disease management (health), Medical prescription, business
Abstract

Background Peripheral T-cell lymphoma (PTCL) is an aggressive and heterogeneous subtype of non-Hodgkin lymphoma (NHL). PTCL has a poor prognosis due to advanced stage at presentation, and generally poor response to standard chemotherapy. According to recent SEER estimates, PTCL accounts for about 4% of all NHL cases in the United States each year. To date, few studies have assessed the clinical and economic burden of PTCL. Methods MarketScan data for commercially insured and Medicare supplemental patients were used to retrospectively identify unique PTCL patients. Patients were identified by ICD-9-CM diagnosis codes between October 1, 2007 and June 30, 2011. The time of first PTCL diagnosis code served as the index date, and a second PTCL diagnosis date was used for confirmation. All patients were required to have at least 6 months of continuous enrollment before and 12 months of continuous enrollment after their index date. Patients were excluded if aged Results Of 2820 patients with ≥1 PTCL diagnosis, 1000 patients were identified that met all inclusion criteria (mean age 56 years, 58% male), and were matched to the control group. On an average annual basis, PTCL patients were hospitalized more often (0.9 vs 0.1 hospitalizations), and experienced a longer length of stay (6.4 vs 4 days) compared with matched controls. In addition, PTCL patients had a higher utilization of office visits (16.2 vs 4.1 visits), pharmacy services (34.2 vs 11.6 prescriptions), emergency room visits (0.8 vs 0.2 visits), and hospice care (0.6 vs 0.1 stays). PTCL patients also experienced higher comorbidities (mean Charlson Comorbidity Index of 1.72 vs 0.39, as determined at index date). Overall, PTCL patients incurred much higher average annual costs compared with matched patients ($75,934.08 vs $4660.64; Table), driven mainly by hospitalizations (32.2% of overall costs) and pharmacy services (19.6% of overall costs). Conclusions PTCL is associated with high resource utilization rates and high overall costs. The development of efficacious treatments for PTCL may offer better disease management and may reduce the clinical and economic burden of PTCL. Disclosures: Potashman: Millennium: The Takeda Oncology Company: Employment. Burudpakdee:Millennium: The Takeda Oncology Company: Consulting researcher Other. Wang:Millennium: The Takeda Oncology Company: Consulting researcher Other, Research Funding. Zhu:Millennium: The Takeda Oncology Company: Employment. Carson:Millennium: The Takeda Oncology Company: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity’s Board of Directors or advisory committees; Spectrum, Inc.: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Kyowa Hakko Kirin Pharma, Inc.: Research Funding.

Published
2013
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15. Discovery and Optimization of Triazolopyridazines as Potent and Selective Inhibitors of the c-Met Kinase.

Author

Brian K. Albrecht, Jean-Christophe Harmange, David Bauer, Loren Berry, Christiane Bode, Alessandro A. Boezio, April Chen, Deborah Choquette, Isabelle Dussault, Cary Fridrich, Satoko Hirai, Doug Hoffman, Jay F. Larrow, Paula Kaplan-Lefko, Jasmine Lin, Julia Lohman, Alexander M. Long, Jodi Moriguchi, Anne O’Connor, and Michele H. Potashman

Published
2008
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16. Design, Synthesis, and Evaluation of Orally Active Benzimidazoles and Benzoxazoles as Vascular Endothelial Growth Factor-2 Receptor Tyrosine Kinase Inhibitors.

Author

Michele H. Potashman, James Bready, Angela Coxon, Thomas M. DeMelfi Jr., Lucian DiPietro, Nicholas Doerr, Daniel Elbaum, Juan Estrada, Paul Gallant, Julie Germain, Yan Gu, Jean-Christophe Harmange, Stephen A. Kaufman, Rick Kendall, Joseph L. Kim, Gondi N. Kumar, Alexander M. Long, Seshadri Neervannan, Vinod F. Patel, and Anthony Polverino

Subjects
*BENZIMIDAZOLES, *CANCER treatment, *VASCULAR endothelial growth factors, *PROTEIN-tyrosine kinase inhibitors
Abstract

Inhibition of the VEGF signaling pathway has become a valuable approach in the treatment of cancers. Guided by X-ray crystallography and molecular modeling, a series of 2-aminobenzimidazoles and 2-aminobenzoxazoles were identified as potent inhibitors of VEGFR-2 (KDR) in both enzymatic and HUVEC cellular proliferation assays. In this report we describe the synthesis and structure−activity relationship of a series of 2-aminobenzimidazoles and benzoxazoles, culminating in the identification of benzoxazole 22as a potent and selective VEGFR-2 inhibitor displaying a good pharmacokinetic profile. Compound 22demonstrated efficacy in both the murine matrigel model for vascular permeability (79% inhibition observed at 100 mg/kg) and the rat corneal angiogenesis model (ED5016.3 mg/kg). [ABSTRACT FROM AUTHOR]

Published
2007
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17. Design, Synthesis, and Evaluation of Orally Active Benzimidazoles and Benzoxazoles as Vascular Endothelial Growth Factor-2 Receptor Tyrosine Kinase Inhibitors.

Author

Michele H. Potashman, James Bready, Angela Coxon, Thomas M. DeMelfi Jr., Lucian DiPietro, Nicholas Doerr, Daniel Elbaum, Juan Estrada, Paul Gallant, Julie Germain, Yan Gu, Jean-Christophe Harmange, Stephen A. Kaufman, Rick Kendall, Joseph L. Kim, Gondi N. Kumar, Alexander M. Long, Seshadri Neervannan, Vinod F. Patel, and Anthony Polverino

Published
2008
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