scholarly journals Greater than the Sum: Applying Daily-Dose Equivalents to Antipsychotic Prescription Claims to Study Real-World Effects

2021 ◽  
Vol 12 ◽  
Author(s):  
Kaleen N. Hayes ◽  
Tara Gomes ◽  
Mina Tadrous

Traditional methods to standardize exposures in pharmacoepidemiologic studies, like defined daily-doses, may be inadequate to capture drug class effects when there are many in-class medications, formulations, and administration routes. Antipsychotic medications are one example of a drug class with these complexities. Direct dose conversion methods are pharmacologically-based but often overlooked, potentially for lack of real-world guidance and examples of their implementation. The purpose of this article is to describe a method to implement dose conversion, using an example study that quantifies antipsychotic use among a cohort of older adults with dementia. We identified 45,442 older adults (aged ≥66 years) with dementia initiating antipsychotic therapy between January 1, 2009 and December 31, 2012 in Ontario, Canada using linked administrative healthcare databases. We developed and applied a data cleaning and dose conversion algorithm to quantify antipsychotic exposure in chlorpromazine dose equivalents at initiation, month 6, and month 12 of therapy. Results were stratified by route of administration. At initiation, 14% of patients received multiple antipsychotic prescriptions simultaneously. Patients initiating regular injectable and multiple administration routes received the highest median chlorpromazine equivalent daily-doses. Data cleaning changed 3, 16, 36, and 42% of total equivalent daily-doses in patients initiating oral, regular injectable, long-acting injectable, and multiple administration routes, respectively. Dose conversion of prescription claims data was a feasible method to quantify and present antipsychotic drug exposures. Dose conversion methods can be considered for drug effects studies of antipsychotic therapies and other medication classes with complex use.

2021 ◽  
pp. 070674372110554
Author(s):  
Ofer Agid ◽  
Gary Remington ◽  
Carmen Fung ◽  
Natalie M. Nightingale ◽  
Marc Duclos ◽  
...  

Objective: The objective of this study was to analyze the real-world prevalence of long-acting injectable (LAI) antipsychotic use and determine when LAIs are being used in sequencing of antipsychotic medications among Canadian patients with schizophrenia. Methods: This was a retrospective, longitudinal cohort study using Canadian pharmacy prescription data between August 2005 and June 2017. Patients with inferred schizophrenia spectrum disorder were indexed on the date of their first antipsychotic prescription and analyzed for minimum 12 months to track lines of antipsychotic therapy and LAI utilization. Results: A total of 16,300 patients were identified for analysis. 48.2% and 46.0% of index antipsychotic prescriptions were prescribed by a general practitioner/family medicine doctor and psychiatrist, respectively. 1,062 (6.5%) patients used an LAI during the study period. Of those patients, 789 used an LAI within two years of index (74.3% of LAI users; 4.8% of all patients). The majority of LAI use (62.0%) occurred in the third line of therapy or later. 65.0% of patients had tried at least two therapy lines, and most patients reported gaps of six months to one year between treatment lines. Conclusion: Despite their potential to reduce relapse in schizophrenia by improving treatment adherence, this study shows LAIs continue to be under-utilized in Canada. When used, LAIs are positioned late in sequencing of antipsychotic medications, often not initiated until years after diagnosis. Continued preference for oral APs with poor adherence may be negatively impacting prognosis and exacerbating burden of schizophrenia. Efforts should be invested to understand barriers to LAI uptake and advocate for earlier, widespread use of LAIs.


2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S534-S535
Author(s):  
Charlotte-Paige M Rolle ◽  
Vu Nguyen ◽  
Kiran Patel ◽  
Dan Cruz ◽  
Federico Hinestrosa ◽  
...  

Abstract Background Approximately 50% of people living with HIV (PLWH) in the United States are ≥50 years old. Efforts are ongoing to identify antiretrovirals associated with fewer drug-drug interactions (DDIs) and long-term side effects in this group. Clinical trials of B/F/TAF demonstrated favorable efficacy and safety in older adults, however, data from real-word settings are needed to validate these results. Methods This retrospective analysis evaluated records from PLWH aged ≥ 50 years at the Orlando Immunology Center who were switched to B/F/TAF between 2/7/2018 and 5/31/2019. Eligible patients had baseline HIV-1 RNA< 50 copies/mL and were followed for 48 weeks post-switch. The primary endpoint was maintenance of HIV-1 RNA< 50 copies/mL at week 48. The impact of switching to B/F/TAF on DDIs, adverse events (AEs) and safety parameters were analyzed throughout the study. Results 306 patients met inclusion criteria. 62 (20%) were female, 126 (41%) were non-white, median age was 58 years (range [r] 50-81), median duration of HIV infection was 19.5 years (r 2-40), median number of chronic co-morbid conditions was 5 (r 0-20), and median number of baseline concomitant medications was 4 (r 0-23). 159 (52%) patients were switched from regimens containing ritonavir or cobicistat. The most commonly documented reason for switch was simplification (Table 1). At Week 48, 287 (94%) patients maintained an HIV-1 RNA< 50 copies/ml and 19 (6%) had an HIV-1 RNA between 50-200 copies/mL (Figure 1). 1 patient discontinued due to lack of efficacy. A total of 123 potential DDIs were identified in 104 (34%) patients taking a boosting agent or rilpivirine at baseline (Table 2). At Week 48, there was a significant median decline in total cholesterol (15.5 mg/dL, 95% confidence interval [CI]: 9.5; 21.5), LDL cholesterol (9.5 mg/dL, 95% CI: 4; 15.5) and triglycerides (20 mg/dL, 95% CI: 9.5; 32.5), and median weight increased by 2.5 pounds (95% CI: 1.5; 3.5). Treatment-related AEs occurred in 33 (11%) patients (all Grade 1-2) and led to 7 (2%) discontinuations. Table 1-Baseline demographic and clinical characteristics Table 2-Avoidance of Drug-Drug Interactions (DDIs) following switch to B/F/TAF Figure 1-Subgroup analysis of virologic outcomes at Week 48 Conclusion In this real-world cohort, switching to B/F/TAF was associated with maintenance of virologic control, improvement in lipid parameters, and avoidance of DDIs in a large proportion of patients. These data support use of B/F/TAF as a treatment option in older PLWH. Disclosures Charlotte-Paige M. Rolle, MD MPH, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Speaker’s Bureau)Janssen Infectious Disease (Grant/Research Support)ViiV Healthcare (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Kiran Patel, PharmD, Gilead Sciences (Employee) Federico Hinestrosa, MD, AbbVie (Speaker’s Bureau)Gilead Sciences (Speaker’s Bureau)Merck (Speaker’s Bureau)Theratechnologies (Speaker’s Bureau) Edwin DeJesus, MD, Gilead Sciences (Advisor or Review Panel member)


CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 154-154
Author(s):  
Heather M. Fitzgerald ◽  
Jason Shepherd ◽  
Hollie Bailey ◽  
Mia Berry ◽  
Jack Wright ◽  
...  

AbstractBackgroundPatient preferences in schizophrenia (SCZ), including identification of key goals and outcomes for treatment and relative importance of certain treatment goals to patients, have been assessed by several studies. However, there continues to be a lack of sufficient evidence on US patient attitudes and perceptions towards treatment goals and pharmacotherapy options in SCZ, especially taking into context long-acting injectable antipsychotics (LAIs) in this disease area. This lack of evidence is further pronounced in caregivers of individuals with SCZ. The objective of this analysis was to characterize patients with SCZ on LAIs vs patients on oral antipsychotics (OAPs) and evaluate the treatment goals of patients in each group.MethodsThis was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old with a diagnosis of SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology, which has been previously published. Psychiatrists (n=120) completed detailed record forms for next 8 consecutive outpatients and 2 inpatients matching inclusion criteria, including non-interventional clinical and subjective assessments. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.ResultsOf 1135 patients on treatment where the physician provided survey data; 251 were on an LAI, and 884 were on an OAP. Mean (SD) time to SCZ diagnosis for those on an LAI was 10.3 (12.0) years vs 7.8 (10.5) years for those on OAPs. More patients in the LAI vs OAP group were being treated as an inpatient (27.1% vs 15.7%, respectively; p<0.0001). Patients on an LAI reported being on their current medication regimen for less time (mean 1.7 years) vs those on OAPs (mean 2.5 years) (p=0.0093). More patients on LAIs were unemployed due to disability vs those on OAPs (56.1% vs 39.5%, respectively), and less patients on LAIs were able to work part-time or full-time (21.1% or 4.1%) vs those on OAPs (23.2% or 11.4%). More patients on an LAI had a caregiver vs those on OAPs (37.3% vs 26.1%, respectively; p=0.0011). Regarding the most important treatment goals reported by patients, both groups reported similar preferences for decrease in disease symptoms (62% on LAI vs 65% on OAPs) and thinking more clearly (53% on LAI vs 46% on OAPs); however, a numerically higher proportion of LAI patients reported that the current medication helped decrease hospitalizations due to relapse vs those on OAPs (38% vs 32%, respectively).DiscussionGiven the characteristics of patients participating in this real-world survey, those on LAIs exhibited qualities which indicate a higher severity of illness vs those on OAPs. Results suggest that treatment with LAIs is still mainly being provided to patients later in the disease course and/or who have adherence problems, despite a growing body of evidence of utility in younger patients earlier in the course of illness.FundingOtsuka Pharmaceutical Development & Commercialization, Inc. and Lundbeck LLC


Author(s):  
Michal Kafri ◽  
Patrice L. Weiss ◽  
Gabriel Zeilig ◽  
Moshe Bondi ◽  
Ilanit Baum-Cohen ◽  
...  

Abstract Background Virtual reality (VR) enables objective and accurate measurement of behavior in ecologically valid and safe environments, while controlling the delivery of stimuli and maintaining standardized measurement protocols. Despite this potential, studies that compare virtual and real-world performance of complex daily activities are scarce. This study aimed to compare cognitive strategies and gait characteristics of young and older healthy adults as they engaged in a complex task while navigating in a real shopping mall and a high-fidelity virtual replica of the mall. Methods Seventeen older adults (mean (SD) age = 71.2 (5.6) years, 64% males) and 17 young adults (26.7 (3.7) years, 35% males) participated. In two separate sessions they performed the Multiple Errands Test (MET) in a real-world mall or the Virtual MET (VMET) in the virtual environment. The real-world environment was a small shopping area and the virtual environment was created within the CAREN™ (Computer Assisted Rehabilitation Environment) Integrated Reality System. The performance of the task was assessed using motor and physiological measures (gait parameters and heart rate), MET or VMET time and score, and navigation efficiency (cognitive performance and strategy). Between (age groups) and within (environment) differences were analyzed with ANOVA repeated measures. Results There were no significant age effects for any of the gait parameters but there were significant environment effects such that both age groups walked faster (F(1,32) = 154.96, p < 0.0001) with higher step lengths (F(1,32) = 86.36, p < 0.0001), had lower spatial and temporal gait variability (F(1,32) = 95.71–36.06, p < 0.0001) and lower heart rate (F(1,32) = 13.40, p < 0.01) in the real-world. There were significant age effects for MET/VMET scores (F(1,32) = 19.77, p < 0.0001) and total time (F(1,32) = 11.74, p < 0.05) indicating better performance of the younger group, and a significant environment effect for navigation efficiency (F(1,32) = 7.6, p < 0.01) that was more efficient in the virtual environment. Conclusions This comprehensive, ecological approach in the measurement of performance during tasks reminiscent of complex life situations showed the strengths of using virtual environments in assessing cognitive aspects and limitations of assessing motor aspects of performance. Difficulties by older adults were apparent mainly in the cognitive aspects indicating a need to evaluate them during complex task performance.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 645-645
Author(s):  
Anne Ordway

Abstract Aging and disability are normative processes that extend across the lifespan. However, ageism and ableism are incorporated into many of our practices, programs, and policies—devaluing the lives of older adults and people aging with disabilities and ultimately preventing their full participation in society. Ageism and ableism are closely connected. For example, both systems identify impairment as an individual and social liability. As recent studies have demonstrated, this has real world implications for the quantity and quality of health care requested, delivered, and received by both older adults and people with disabilities. In this session, we discuss the connections between these two forms of oppression and present recent work by researchers in both fields and the FrameWorks Institute that shows how to transform our cultural ideas of aging and disability and development more inclusive policies and services. Part of a symposium sponsored by the Lifelong Disabilities Interest Group.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 662-662
Author(s):  
Karen Fortuna ◽  
George Mois ◽  
Jessica Brooks ◽  
Amanda Myers ◽  
Cynthia Bianco

Abstract PeerTECH is a peer-delivered and technology-support integrated medical and psychiatric self-management intervention developed by peers. A pre/post trial by our group has shown PeerTECH is associated with statistically significant improvements in self-efficacy for managing chronic disease and psychiatric self-management skills. This presentation will discuss the feasibility and potential effectiveness of using ecological momentary assessments (EMA) with older adults with mental health conditions to allow us to recognize early signs of loneliness and intervene as early as possible in real-world settings. EMA involves repeated sampling of an individual’s behaviors and experiences in real time, real-world environments on the smartphone application. Then, we will discuss the main and interactive effects of loneliness and factors linked to mortality. In conclusion, we will discuss potential effectiveness of PeerTECH with older adults with SMI.


Author(s):  
Christopher Reynolds ◽  
Sara J. Czaja ◽  
Joseph Sharit

The objectives of this study were to determine if older adults encounter difficulty using real-world telephone menu system applications and to gather data on the usability features of these systems. Six real-world telephone menu systems, which varied in complexity and function, were examined. The sample included 32 community dwelling adults ranging in age from 18–80 years. Participants interacted with the menu systems to perform a sample set of tasks. They were also asked to rate the usability features of the system in terms of their goodness and their relative importance. The data indicated that in addition to taking longer, the older adults tended to have more difficulty performing the tasks. The findings also indicated that memorability was an important usability feature, and that the ratings of overall usability and overall satisfaction were significantly worse for the older adults.


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