Jeffrey Scott Andrews

Direct Medical Costs and Medication Compliance among Fibromyalgia Patients: Duloxetine Initiators vs. Pregabalin Initiators

To assess and compare direct medical costs and medication compliance between patients with fibromyalgia who initiated duloxetine and patients with fibromyalgia who initiated pregabalin in 2008.

Real-world treatment patterns and opioid use in chronic low back pain patients initiating duloxetine versus standard of care

To describe the use of pain medications in patients with chronic low back pain (CLBP) after initiating duloxetine or standard of care (SOC [muscle relaxants, gabapentin, pregabalin, venlafaxine, and tricyclic antidepressants]) for pain management, pharmacy and medical claims from Surveillance Data, Inc (SDI) Health were analyzed. Adult patients with CLBP who initiated duloxetine or SOC between November 2010 and April 2011 were identified. Treatment initiation was defined as no pill coverage for duloxetine or SOC in the previous 90 days. Included patients had no opioid use in the 90 days before initiation. Propensity score matching was used to select patients with similar baseline demographic and clinical characteristics for duloxetine and SOC cohorts. Compliance with index medication was assessed via medication possession ratio (MPR) and proportion of days covered (PDC) for 6 months after initiation. The proportion of patients receiving opioids and days on opioids after index date were assessed, and regression models were estimated to compare opioid use between cohorts. A total of 766 patients initiated duloxetine and 6,206 patients initiated SOC. After matching, 743 patients were selected for the duloxetine (mean age 57 years; female 74%) and SOC (mean age 57 years; female 75%) cohorts, respectively. Of the duloxetine cohort, 92% started on or below recommended daily dose (≤60 mg). The duloxetine cohort had significantly higher MPR (0.78 versus [vs] 0.60) and PDC (0.50 vs 0.31), were less likely to use opioids (45% vs 61%), and had fewer days on opioids (median 0 vs 7 days) than the SOC cohort (all P < 0.001). After adjusting for demographic and clinical characteristics, the duloxetine cohort initiated opioids later than the SOC cohort (hazard ratio 0.77, 95% confidence interval 0.66–0.89). CLBP patients initiating duloxetine had better compliance with initiated medication and were less likely to use opioids than those initiating SOC.

Identifying factors of activities of daily living important for cost and caregiver outcomes in Alzheimer's disease.

BACKGROUND We aimed to obtain a better understanding of how different aspects of patient functioning affect key cost and caregiver outcomes in Alzheimers disease (AD). METHODS Baseline data from a prospective observational study of community-living AD patients (GERAS) were used. Functioning was assessed using the Alzheimers Disease Cooperative Study-Activities of Daily Living Scale. Generalized linear models were conducted to analyze the relationship between scores for total activities of daily living (ADL), basic ADL (BADL), instrumental ADL (IADL), ADL subdomains (confirmed through factor analysis) and individual ADL questions, and total societal costs, patient healthcare and social care costs, total and supervision caregiver time, and caregiver burden. RESULTS Four distinct ADL subdomains were confirmed: basic activities, domestic/household activities, communication, and outside activities. Higher total societal costs were associated with impairments in all aspects of ADL, including all subdomains; patient costs were associated with total ADL and BADL, and basic activities subdomain scores. Both total and supervision caregiver hours were associated with total ADL and IADL scores, and domestic/household and outside activities subdomain scores (greater hours associated with greater functional impairments). There was no association between caregiver burden and BADL or basic activities subdomain scores. The relationship between total ADL, IADL, and the outside activities subdomain and outcomes differed between patients with mild and moderate-to-severe AD. CONCLUSIONS Identification of ADL subdomains may lead to a better understanding of the association between patient function and costs and caregiver outcomes at different stages of AD, in particular the outside activities subdomain within mild AD.

Clinical and Economic Characteristics of Milestones Along the Continuum of Alzheimer's Disease: Transforming Functional Scores into Levels of Dependence

BACKGROUND Because Alzheimers disease (AD) is characterized by a gradual decline, it can be difficult to identify distinct clinical milestones that signal disease advancement. Adapting a functional scale may be a useful way of staging disease progression that is more informative for healthcare systems. OBJECTIVES To adapt functional scale scores into discrete levels of dependence as a way of staging disease progression that is more informative to care providers and stakeholders who rely on the functional impact of diseases to determine access to supportive services and interventions. DESIGN Analysis of data from the GERAS study. SETTING GERAS is an 18-month prospective, multicenter, naturalistic, observational cohort study reflecting the routine care of patients with AD in France, Germany, and the United Kingdom. PARTICIPANTS Data were from baseline results of 1497 community-living patients, aged ≥55 years, diagnosed with probable AD and their caregivers. MEASUREMENTS We used data from the Alzheimers Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) and mapped items onto established categories of functional dependence, validated using clinical and economic measures. Cognitive function, behavioral symptoms, caregiver burden, and cost were assessed. Based on stages of functional dependence described by the Dependence Scale, individual ADCS-ADL items were used to approximate 6 dependence levels. RESULTS There was a significant relationship between assigned level of dependence derived from the ADCS-ADL score and cognitive severity category. As the assigned level of dependence increased, the associated clinical and economic indicators demonstrated a pattern of greater disease severity. CONCLUSIONS This mapping provides initial support for dependence levels as appropriate interim clinical milestones that characterize the functional deficits associated with AD.

Utilization of duloxetine and celecoxib in osteoarthritis patients

Abstract Objectives: To describe utilization patterns of duloxetine and celecoxib and subsequent opioid use among patients with osteoarthritis. Research design and methods: Pharmacy and medical claims from SDI Health were analyzed for adult osteoarthritis patients (ICD-9-CM: 715.xx) who initiated duloxetine or celecoxib between 11/30/2010 and 4/30/2011. Initiation was defined as no pill coverage in the prior 90 days. Included patients had continuous enrollment for 6 months before and after the initiation and did not use opioid for 90 days before initiation. Propensity score matching was used to select patients with similar demographic and clinical characteristics for duloxetine and celecoxib cohorts. Compliance to index medication was assessed via medication possession ratio (MPR), proportion of days covered (PDC), and proportion discontinued (no access for 60 days). Initiating dose and opioid use after the index date was assessed. A Cox proportional hazard model was estimated to compare time to first opioid use. Results: A total of 1360 patients initiated duloxetine and 1408 patients initiated celecoxib. After matching, 784 patients were selected for the duloxetine (mean age: 66, female: 78%) and celecoxib (mean age: 66; female: 76%) cohorts, respectively. Of the duloxetine cohort 92.5% started on ≤60 mg/day, the recommended dose, and 72.8% of the celecoxib cohort started on ≤200 mg/day. The duloxetine cohort had higher MPR and PDC and a lower proportion of discontinuation than the celecoxib cohort (MPR: 0.81 vs. 0.70; PDC: 0.51 vs. 0.35; discontinuation: 57% vs. 78%; all p < 0.001). A lower proportion of the duloxetine cohort used opioids after the index date (48.6% vs. 68.5%, p < 0.001), and they started on opioids later than the celecoxib cohort (25th percentile: 69.5 vs. 32 days; median: >183 days vs. 117 days, p < 0.001). After controlling for baseline characteristics, the duloxetine cohort initiated opioids later than the celecoxib cohort (hazard ratio: 0.66, 95% confidence interval: 0.58–0.76). Conclusion: Osteoarthritis patients initiating duloxetine had better compliance and a lower likelihood of opioid utilization than those initiating celecoxib. Study limitations included lack of information on reasons for medication initiation and discontinuation, severity of disease symptoms, and use of over-the-counter medications.

Functional limitations and healthcare resource utilization for individuals with cognitive impairment without dementia: Findings from a u.s. population-based survey

Age, mean 72.3 61.8* 72.2 73.2 Gender, % male 33.3% 41.4%* 33.5% 31.3% Years of education, mean 11.6 13.8* 11.6 11.8 Race, % Caucasian 82.7% 92.0%* 83.1% 83.6% Comorbidity profile, % Arthritis or rheumatism 67.2% 48.0%* 67.1% 65.4% Cancer 16.6% 10.6%* 16.7% 17.9% Chronic lung disease 9.4% 6.1%* 9.4% 9.7% Diabetes 21.1% 12.6%* 21.1% 15.5%* Emotional, nervous, or psychiatric problems 18.9% 12.1%* 18.9% 10.3%*

Real-world comparison of health care utilization between duloxetine and pregabalin initiators with fibromyalgia.

Objectives To compare health care utilization of duloxetine initiators and pregabalin initiators among fibromyalgia patients in a real-world setting. Methods A retrospective cohort study was conducted based on a US national commercial health claims database (2006–2009). Fibromyalgia patients who initiated duloxetine or pregabalin in 2008, aged 18–64 years, and who maintained continuous health insurance coverage 1 year before and 1 year after initiation were assigned to duloxetine or pregabalin cohorts on the basis of their initiated agent. Patients who had pill coverage of the agents over the course of 90 days preceding the initiation were excluded. The two comparative cohorts were constructed using propensity score greedy match methods. Descriptive analysis and paired t-test were performed to compare health care utilization rates in the postinitiation year and the changes of these rates from the preinitiation year to the postinitiation year. Results Both matched cohorts (n=1,265 pairs) had a similar mean initiation age (49–50 years), percentage of women (87%–88%), and prevalence of baseline comorbid conditions (neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, hypertension, headache or migraine, and osteoarthritis). In the preinitiation year, both cohorts had similar inpatient, outpatient, and medication utilization rates (inpatient, 15.7%–16.1%; outpatient, 100.0%; medication, 97.9%–98.7%). The utilization rates diverged in the postinitiation year, with the pregabalin cohort using more fibromyalgia-related inpatient care (3.2% versus 2.2%; P<0.05), any inpatient care (19.3% versus 16.8%; P<0.05), and fibromyalgia-related outpatient care (62.1% versus 51.8%; P<0.05). From the preinitiation period to the postinitiation period, the duloxetine cohort experienced decreases in certain utilization rates, whereas the pregabalin cohort had increases (percentage of patients with a fibromyalgia-related admission, −1.2% versus 0.4% [P<0.01]; number of fibromyalgia-related outpatient claims, −1.7 versus 4.7 [P<0.01]). Conclusion Fibromyalgia patients initiating pregabalin tended to consume more fibromyalgia-related inpatient and outpatient care in the first postinitiation year, whereas fibromyalgia patients initiating duloxetine tended to have lower utilization rates of fibromyalgia-related inpatient care in the postinitiation year than in the preinitiation year.

PATTERNS OF CHANGE IN DEPENDENCE LEVELS FOR COMMUNITY-DWELLING ALZHEIMER’S PATIENTS: 36-MONTH RESULTS FROM THE GERAS OBSERVATIONAL STUDY

b1⁄41,000 s/mm with 5-mm section thickness. The emotional stress was scored by the Holmes and Rahe Stress Scale. Results: TGA lesions were detected 12 patients (14.0 %). The patients with TGA lesion showed more frequent history of the emotional stress. Moreover, The Holmes and Rahe Stress Scale score were higher in patients with TGA lesion compared with negatives. Conclusions: DWI hyperintensities in patients with TGA correlates with the emotional stress. However, recently studies with modified DWI protocol (b1⁄42,000 s/mm, 3-mm or less thickness) showed higher sensitivity for detecting TGA lesions. Further studies are needed using modified image protocols as well as the evaluation of the mechanism between TGA lesion and emotional stress.

BASELINE FINDINGS FROM GERAS-US: A LONGITUDINAL COHORT STUDY OF RESOURCE USE AND COSTS OF MILD COGNITIVE IMPAIRMENT AND MILD DEMENTIA DUE TO ALZHEIMER’S DISEASE (AD) IN THE UNITED STATES

and spatial memory were assessed using the Novel Object Recognition (NOR) and Novel Location Recognition (NLR) testing paradigms, respectively, both preand end-study. Levels of sirtuin 1 and soluble amyloid precursor protein alpha (sAPPa) were determined in hippocampi and frontal cortices of all mice using custom AlphaLISAs (Perkin-Elmer), and amyloid-beta (Ab) 1-40 and 1-42 were determined by ELISA (Thermo). Results:A03 was found to be orally available and brain-penetrant, and 56-day oral treatment significantly increased SirT1 in the hippocampi of E4FAD mice as compared to vehicle-treated E4FAD mice. A03 treatment of E4FAD mice also improved working object memory in NOR (novelty preference) significantly as compared to E4FAD vehicle-treated controls. Conclusions: A03 is the first small molecule compound found to increase SirT1 in hippocampi of mice wherein huApoE4 and mutated huAPP and huPS1 are expressed. Furthermore, the SirT1 increase was associated with improved cognitive performance. Enhancement of neuroprotective SirT1 in subjects expressing ApoE4 may provide a new therapeutic approach to preventing the onset or slowing/arresting progression of Mild Cognitive Impairment (MCI) or AD in those at high risk for development of these neurodegenerative conditions.

DO THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE ESTIMATES FOR CLINICAL OUTCOME ASSESSMENTS FOR ALZHEIMER'S DISEASE DIFFER BY DISEASE SEVERITY?

(Animals) verbal fluency scores were stable in half the patients. Phonemic verbal fluency (Letters) was stable in 3 of 5 patients. All patients remained living in the community. Conclusions: We have for the first time demonstrated stabilization of cognition function in MCI and Dementia for up to 15 years of therapy. Combined therapy is a viable treatment option for medically ill people with dementia until new effective medications become available.