Jennifer A. Flynn

Health service utilization among Alzheimer's disease patients: Evidence from managed care

The objective of this study was to assess the disease burden of Alzheimers disease (AD) in a commercial managed care setting by comparing direct health care costs and adverse event outcomes between patients with AD and without AD.

Measuring change in quality of life in response to Helicobacter pylori eradication in peptic ulcer disease: the QOLRAD.

This study was designed to determine if a new condition-specific quality of life measure, the Quality Of Life in Reflux And Dyspepsia (QOLRAD), was responsive to clinical change over a four-week period when evaluating peptic ulcer disease patients undergoing Helicobacter pylori (Hp) eradication. A secondary aim was to evaluate QOLRADs psychometric performance. Hp-positive patients with peptic ulcer disease were recruited from primary care and gastroenterology clinics (N = 155). QOLRAD scores improved significantly (P < 0.0001) and mean total score increase was 1.07 points on a 7-point scale among 111 subjects who responded to Hp eradication. Effect sizes were moderate for responders (0.64) and low for nonresponders (0.36). Score changes below 0.60 were associated with the smallest improvement in patient and physician condition rating; scores above 1.2 were associated with the greatest improvement. The QOLRAD demonstrates reliability and validity. Changes in QOLRAD score can be meaningfully related to clinical changes, aiding evaluation of health-related quality of life in peptic ulcer disease.

Validation of a new symptom impact questionnaire for mild to moderate cognitive impairment

BACKGROUND Patient-reported outcomes assessment enhances the understanding of disease impact in a range of disorders. At mild levels of cognitive impairment the patient perspective on functioning, behavior and symptoms can be particularly valuable for syndrome characterization when clinical and neuropsychological findings are limited. We have evaluated the psychometric performance of the 55-item Patient-Reported Outcomes in Cognitive Impairment (PROCOG), a new patient-reported measure, to measure mild to moderate cognitive impairment symptoms and their impact from the perspective of patients with dementia of the Alzheimers type (DAT) and mild cognitive impairment (MCI). METHODS The sample of 75 DAT patients, 78 MCI patients and 33 cognitively intact control subjects (> 64 years) was recruited through medical centers in the U.SA. Validity was assessed through correlation to the Quality of Life--Alzheimers Disease (QOL-AD) and Centers for Epidemiologic Studies--Depression Scale (CES-D) and neuropsychological assessments (WAIS subscales and MMSE). RESULTS PROCOG scores for MCI patients were generally intermediate between DAT and control subjects. Internal consistency and test-retest reliability were acceptable. Correlations with the CES-D and QOL-AD were in the moderate to high range; correlations with the neuropsychological measures were low to moderate. CONCLUSIONS The PROCOG demonstrated good to excellent psychometric properties among a sample of older adults with MCI and DAT as well as cognitively intact older adult control subjects and provides a method for collecting unique information on the patient experience of cognitive impairment. Subscales permit focused evaluation of domains relevant to the patients experience of cognitive impairment.

Systematic review of raloxifene in postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia)

Purpose To systematically review the literature describing the efficacy, effectiveness, and safety of raloxifene for postmenopausal Japanese women with osteoporosis or low bone mass (osteopenia). Materials and methods Medline via PubMed and Embase was systematically searched using prespecified terms. Retrieved publications were screened and included if they described randomized controlled trials or observational studies of postmenopausal Japanese women with osteoporosis or osteopenia treated with raloxifene and reported one or more outcome measures (change in bone mineral density [BMD]; fracture incidence; change in bone-turnover markers, hip structural geometry, or blood–lipid profile; occurrence of adverse events; and change in quality of life or pain). Excluded publications were case studies, editorials, letters to the editor, narrative reviews, or publications from non-peer-reviewed journals; multidrug, multicountry, or multidisease studies with no drug-, country-, or disease-level analysis; or studies of participants on dialysis. Results Of the 292 publications retrieved, 15 publications (seven randomized controlled trials, eight observational studies) were included for review. Overall findings were statistically significant increases in BMD of the lumbar spine (nine publications), but not the hip region (eight publications), a low incidence of vertebral fracture (three publications), decreases in markers of bone turnover (eleven publications), improved hip structural geometry (two publications), improved blood–lipid profiles (five publications), a low incidence of hot flushes, leg cramps, venous thromboembolism, and stroke (12 publications), and improved quality of life and pain relief (one publication). Conclusion Findings support raloxifene for reducing vertebral fracture risk by improving BMD and reducing bone turnover in postmenopausal Japanese women with osteoporosis or osteopenia. Careful consideration of fracture risk and the risk–benefit profile of antiosteoporosis medications is required when managing patients with osteoporosis.

Osteoporosis and treatments in Japan: management for preventing subsequent fractures

Prevalent fractures are major contributors to an increased risk of subsequent fractures, particularly in people with osteoporosis. While many studies have been conducted to assess the incidence of fracture in Japanese people with osteoporosis, far fewer have been conducted to assess the risk of subsequent fractures. This article reviews the morbidity, mortality, and risk of fracture in patients who are at high risk of subsequent fracture in Japan and the current treatment options available for these patients. Osteoporotic fractures in Japan are associated with high morbidity and mortality that result in significant financial and social costs. The rise in the proportion of elderly women in the Japanese population is contributing to a greater proportion of people with osteoporotic fractures and the high cost of osteoporosis. Although hip fractures have a significant effect on costs, a greater proportion of the Japanese population experience vertebral fractures. An increase in the incidence of vertebral fractures is concerning because preexisting vertebral fractures in older patients are associated with an increased risk of subsequent fractures. Hence, there is a clear rationale for pharmacological treatment of patients with prevalent vertebral fractures, or for those who are hospitalized or undergo surgery for osteoporotic fractures. Several pharmacological therapies are now available in Japan for the treatment of patients with osteoporosis. Understanding the consequences of subsequent fractures and the treatment options available for patients at high risk of subsequent fractures may contribute to clinical decision-making and improved outcomes for patients with osteoporosis.

Burden of illness among commercially insured patients with Alzheimer's disease.

The purpose of this study was to examine the direct costs of care for patients newly diagnosed with Alzheimers disease (AD) by using retrospective healthcare claims data.

Adherence and Persistence with Once-Daily Teriparatide in Japan: A Retrospective, Prescription Database, Cohort Study

Adherence and persistence with osteoporosis treatments are essential for reducing fracture risk. Once-daily teriparatide is available in Japan for treating osteoporosis in patients with a high risk of fracture. The study objective was to describe real-world adherence and persistence with once-daily teriparatide 20 μg during the first year of treatment for patients who started treatment during the first eight months of availability in Japan. This prescription database study involved patients with an index date (first claim) between October 2010 and May 2011, a preindex period ≥6 months, and a postindex period ≥12 months and who were aged >45 years. Adherence (medication possession ratio (MPR)) and persistence (time from the start of treatment to discontinuation; a 60-day gap in supply) were calculated. A total of 287 patients started treatment during the specified time period; 123 (42.9%) were eligible for inclusion. Overall mean (standard deviation) adherence was 0.702 (0.366), with 61.0% of patients having high adherence (MPR > 0.8). The percentage of patients remaining on treatment was 65.9% at 180 days and 61.0% at 365 days. Our findings suggest that real-world adherence and persistence with once-daily teriparatide in Japan are similar to that with once-daily teriparatide in other countries and with other osteoporosis medications.

Treatment for Osteoporosis among Women in Japan: Associations with Patient Characteristics and Patient-Reported Outcomes in the 2008–2011 Japan National Health and Wellness Surveys

This study was conducted to identify characteristics associated with treatment for osteoporosis among women aged 50 years and older in Japan and to explore differences among patients according to treatment regimen. Data were provided by a large annual survey representative of Japanese aged 18 and older; all measures were by self-report. Women aged 50 and older who reported diagnosed osteoporosis (N = 900) were compared based on current treatment status using bivariate statistics and logistic regression. Approximately 1 in 3 women in this study reporting diagnosed osteoporosis were currently untreated. Factors associated with current treatment for osteoporosis included having ≥1 physician visit in the prior 6 months (OR = 5.4, P < 0.001), self-rated moderate or severe osteoporosis (OR = 2.8, P < 0.001), completion of menopause (OR = 1.6, P < 0.05), and family history of osteoporosis (OR = 1.5, P < 0.05), while longer duration of osteoporosis diagnosis (OR = 0.9, P < 0.05) and arthritis (OR = 0.7, P < 0.05) were associated with lower odds of treatment. These findings suggest that diagnosed patients are not being actively managed in the longer term, and efforts need to be made to ensure that patients stay engaged with their healthcare providers.

Antipsychotic monotherapy among outpatients with schizophrenia treated with olanzapine or risperidone in Japan: a health care database analysis

Purpose Antipsychotic monotherapy is often recommended over antipsychotic polypharmacy because of fewer adverse events, reduced treatment complexity, and lower medication cost. This study compared the rate and the duration of antipsychotic monotherapy following initiation of olanzapine or risperidone in the treatment of outpatients with schizophrenia in Japan. Methods Outpatients diagnosed with schizophrenia in the Japan Medical Data Center database were identified using International Statistical Classification of Diseases and Related Health Problems, 10th Revision, diagnosis codes. Patients were between 20 and 65 years old, initiated on olanzapine or risperidone therapy between August 2003 and July 2008, and continuously enrolled during the 6 months prior to and the 12 months following the initiation date. Antipsychotic polypharmacy was defined as concurrent use of two or more antipsychotics. The probability of monotherapy during the 12-month follow-up period was assessed using a propensity score-adjusted generalized estimating equation model. Duration of monotherapy was contrasted using a propensity score-adjusted bootstrapping model. Results After applying all inclusion and exclusion criteria, the final analytic sample consisted of 332 olanzapine- and 496 risperidone-treated outpatients. At treatment initiation, 61.5% of the olanzapine-treated patients and 45.6% of the risperidone-treated patients received antipsychotic monotherapy (P < 0.001). After correcting for background differences, monotherapy was more common among olanzapine-treated patients (P = 0.001). In addition, olanzapine was used as monotherapy for a longer duration (P = 0.006). Conclusion Consistent with prior global research, this retrospective naturalistic study of schizophrenia outpatients in Japan found that olanzapine is more likely to be used as monotherapy and to be used as monotherapy for a longer duration than risperidone.

Predictors of antipsychotic monotherapy with olanzapine during a 1-year naturalistic study of schizophrenia patients in Japan

Purpose Although expert guidelines for the treatment of schizophrenia recommend antipsychotic monotherapy, the use of antipsychotic polypharmacy is common. This study identified characteristics that differentiate patients with schizophrenia who are treated with olanzapine monotherapy versus polypharmacy in usual care in Japan. Patients and methods In a large (N = 1850) prospective, observational study, Japanese patients with schizophrenia who initiated treatment with olanzapine were followed for 1 year. Consistent with past research, antipsychotic polypharmacy was defined as the concurrent use of olanzapine and another antipsychotic for at least 60 days. Switching was defined as discontinuing a prior antipsychotic therapy rather than augmenting the medication regimen. Predictors of antipsychotic monotherapy were based on information available at the time of olanzapine initiation. Baseline characteristics were compared using t-tests and χ2 tests. Stepwise logistic regression was used to identify independent predictors of monotherapy. Results Patients treated with olanzapine monotherapy (43.2%) differed from those treated with antipsychotic polypharmacy (56.8%) on demographics, treatment history, baseline symptom levels, functional levels, and treatment-emergent adverse events. Stepwise logistic regression identified multiple variables that significantly predicted monotherapy: older age, shorter duration of schizophrenia, outpatient status, comorbid medical conditions, lower body mass index, no prior anticholinergic use, no prior mood stabilizer use, and switching from a previous antipsychotic (typical or atypical). Conclusion Consistent with prior research in Japan, antipsychotic polypharmacy appears to be common in the treatment of schizophrenia. Patients treated with monotherapy could be differentiated from those treated with antipsychotic polypharmacy based on a specific set of demographic and baseline clinical characteristics.