Raritan, NJ, United States
Raritan, NJ, United States

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Mystakidou K.,National and Kapodistrian University of Athens | Clark A.J.,Pain Management Unit | Fischer J.,Witten/Herdecke University | Lam A.,Johnson and Johnson Pharmaceutical Services | And 2 more authors.
Pain Practice | Year: 2011

Chronic pain affects a substantial part of the population, and conveys a huge economic cost to society. Owing to its prevalence and adverse impact, it is of particular interest to clinicians, patients, and the pharmaceutical industry. Conversely, the effects of pain on sleep, sleep on pain, and opioid analgesics on sleep represent a large gap in our understanding, even though pain and sleep are closely linked, inter-related conditions. Chronic pain is often treated by opioid analgesics, which are often thought to promote restful sleep. Indeed it may be assumed that by relieving pain, sleep quality will improve concomitantly. In fact, the reality is much more complicated. The effects of opioids vary according to their formulation and duration of action, and have diverse effects on sleep processes. Despite the prevalence of this problem, there is a surprising paucity of data on the effects of opioids on sleep. This review attempts to summarize the links between pain and sleep, and to look at the studies with opioid analgesics, particularly those with extended-release formulations, that have investigated the effects of opioid analgesics on sleep. © 2010 Johnson and Johnson Pharmaceutical Services; Pain Practice © 2010 World Institute of Pain.


Deodhar A.,Oregon Health And Science University | Braun J.,Rheumazentrum Ruhrgebiet | Inman R.D.,University of Toronto | Mack M.,Centocor | And 5 more authors.
Arthritis Care and Research | Year: 2010

Objective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS). Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores. Results. Median JSEQ scores at baseline were 9.0 in the placebo group, 10.0 in the 50-mg group, and 11.0 in the 100-mg group, indicating moderate to severe sleep disturbance. Patients who received golimumab showed significantly greater median improvement from baseline in JSEQ scores compared with placebo at week 14 (-3.0 versus 0.0; P < 0.001) and week 24 (-3.0 versus -1.0; P < 0.001). Changes from baseline in JSEQ scores significantly correlated with changes from baseline in Short Form 36 summary scores, Bath AS Functional Index scores, total back pain, night back pain, and Bath AS Disease Activity Index scores. Multiple regression analyses indicated that improvement in the night back pain score was the most consistent predictor of change in JSEQ score or reduction in sleep disturbance. Conclusion. Patients with active AS showed significant sleep disturbance at baseline due to underlying pain associated with AS. Treatment with subcutaneous golimumab every 4 weeks significantly reduced sleep disturbance and improved health-related quality of life. © 2010, American College of Rheumatology.


Wagner L.I.,Northwestern University | Robinson Jr. D.,Johnson and Johnson Pharmaceutical Services | Weiss M.,Marshfield Clinic | Katz M.,International Myeloma Foundation | And 3 more authors.
Journal of Pain and Symptom Management | Year: 2012

Context: Multiple myeloma (MM) is a common hematologic malignancy and is associated with symptom burden and impairments in health-related quality of life (HRQL). Objectives: To develop a disease-specific, patient-reported outcome (PRO) measure for the assessment of HRQL among patients with MM as part of the Functional Assessment of Cancer Therapy (FACT) measurement system. Methods: HRQL concerns and symptoms associated with MM were tabulated based on a literature review, and 52 candidate PRO items were identified. Expert clinicians (n = 13) rated 52 items on relevance to HRQL for MM patients (0-3 scale). Experts added 11 items for comprehensive PRO assessment in MM. A list of 63 candidate items was rated (0-3 scale) by 13 MM patients enrolled through the International Myeloma Foundation website. Qualitative data and quantitative item ratings were reviewed to select FACT-MM scale items. Results: Expert clinicians provided the highest HRQL relevance ratings for bone pain, bodily pain, difficulty walking (2.9), tiring easily (2.6), feeling discouraged (2.5), interference with activities and difficulty with self-care as a result of bone pain (2.5), and fatigue (2.5). Mean age of patients was 57 years; Eastern Cooperative Oncology Group performance status was 0 (38%), 1 (31%), or 2 (31%). Quantitative ratings by patients identified sexual function (1.3), uncertainty about health (1.2), fatigue (1.0), weight gain (1.0), and emotional concerns, such as worry about new symptoms and difficulty planning for the future (1.0) as most relevant to HRQL. Conclusion: The 14-item FACT-MM PRO measure was developed based on expert clinician and patient data, ensuring relevance to HRQL for MM patients. © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.


Baser O.,University of Michigan | Baser O.,STATinMED Research Inc. | Supina D.,Johnson and Johnson Pharmaceutical Services | Sengupta N.,Johnson and Johnson Pharmaceutical Services | And 2 more authors.
Current Medical Research and Opinion | Year: 2011

Background: Venous thromboembolism (VTE) occurs most often during hospitalization for major surgery or trauma but may also occur up to several months after surgery. Since the potential for VTE exists in a range of clinical settings, an assessment of its impact on overall outcomes and costs to the patient and to the healthcare system is warranted. Objective: To evaluate the effects of VTE (deep vein thrombosis, pulmonary embolism, or both) occurring within the first 30 days of hospital discharge for total hip replacement (THR) or total knee replacement (TKR) surgery on inpatient costs, mortality, rehospitalization, and major bleeding within 1 year after initial hospitalization for THR or TKR surgery. Methods: The Medicare Provider Analysis and Review (MEDPAR) file for calendar years 20052007 provided hospital discharge abstracts for the fee-for-service, acute-care hospitalizations of all Medicare recipients. All patients included in the analysis underwent THR (n51,108) or TKR (n115,627). VTE events were diagnosed within the first 30 days and within 1 year post discharge. Propensity score matching was used to control for differences in baseline characteristics in patients with and without VTE events. Total cost was measured as Medicare cost plus beneficiary out-of-pocket cost. Results: VTE occurred in 0.74 of patients undergoing THR. For patients with VTE versus no VTE, mortality was higher (2.9 vs 0.4, P<0.001) and rehospitalization within 1 year was more frequent (51.9 vs 22.4, P<0.001), as were complications such as bleeding (11.2 vs 2.7, P<0.001). Risk-adjusted Medicare cost and total healthcare cost, including beneficiary cost share in 1 year, were significantly higher for VTE patients versus patients with no VTE ($18,929 vs $3763, P<0.001). VTE occurred in 0.70 of patients undergoing TKR. For patients with VTE versus no VTE, mortality was higher (2.5 vs 0.15, P<0.001), and rehospitalization within 1 year was more frequent (48.7 vs 20.7, P<0.001), as were complications such as bleeding (13.7 vs 2.1, P<0.001). For TKR surgery, risk-adjusted total healthcare cost, including beneficiary cost share in 1 year, was significantly different for VTE versus no VTE ($17,996 vs $4358, P<0.001). Limitations: Study limitations include a reliance on ICD-9-CM codes, which could be inaccurate, and the inability (1) to control for unmeasured confounders, such as surgeons' skills; (2) to include outpatient medical care costs; and (3) to ensure that all patients were enrolled continuously throughout the study period. Conclusions: VTE after THR or TKR is associated with higher mortality, rehospitalization, and bleeding within 1 year, compared with no VTE. Risk-adjusted total, Medicare, and beneficiary healthcare costs were significantly higher for both THR and TKR patients with VTE (P<0.001). © 2011 Informa UK Ltd All rights reserved.


Itani K.M.F.,Boston University | Merchant S.,Johnson and Johnson Pharmaceutical Services | Lin S.-J.,Hind Hatoum and Company | Lin S.-J.,University of Illinois at Chicago | And 4 more authors.
American Journal of Infection Control | Year: 2011

Background: This study was conducted to determine outcomes and costs of treating complicated skin and skin-structure infections (cSSSIs) due to gram-positive only, gram-negative only, or mixed pathogens (gram-positive and gram-negative), including those with methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa. Methods: Data on length of stay (LOS), mortality, and charges for cSSSIs were compiled from claims in the multihospital Solucient database from 2002 to 2006. Results: Among the 5156 cases with pathogens identified, 59.7% were gram-positive, 21.5% were gram-negative, and 18.8% were mixed. Patients with mixed pathogens incurred significantly higher LOS (17.2 days), mortality (10.2%), and charges ($80,093) than those with cSSSIs due to gram-negative pathogens (10.1 days, 6.5%, and $41,634, respectively) or to gram-positive pathogens (9.5 days, 4.8%, and $40,046, respectively). MRSA was isolated from 21.6% of all cases and from 26.3% of cases involving mixed pathogens. MRSA cases had significantly longer LOS and greater mortality than non-MRSA cases, but similar total charges. P aeruginosa occurred in 13.3% of all cases and in 36.3% of cases involving mixed pathogens. P aeruginosa cases had significantly higher LOS and charges compared with nonP aeruginosa cases. Conclusion: Although gram-positive pathogens were the most common causes of cSSSIs, cases involving mixed and resistant pathogens were associated with longer LOS, greater mortality, and higher total charges. © 2011 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.


Nelson M.,Chelsea and Westminster Hospital | Girard P.-M.,Hopital Saint Antoine | Girard P.-M.,University Pierre and Marie Curie | Girard P.-M.,French Institute of Health and Medical Research | And 5 more authors.
Journal of Antimicrobial Chemotherapy | Year: 2010

Objectives: To examine how treatment adherence differences in ARTEMIS (96 week analysis) affected clinical outcome, and to assess factors impacting adherence. Patients and methods: ARTEMIS is a Phase III trial, in HIV-1-infected treatment-naive patients, comparing efficacy and safety of once-daily darunavir/ritonavir (800/100 mg) versus lopinavir/ritonavir (800/200 mg total daily dose), each with a fixed-dose background tenofovir and emtricitabine regimen. Self-reported treatment adherence was assessed using the Modified Medication Adherence Self-Report Inventory (M-MASRI). In posthoc analyses, mean adherence from weeks 4-96 was used to assess overall adherence for each patient, and transformed into a binary variable (.95%,adherent; ≤95%,suboptimally adherent). Results: Overall adherence was high: 83% of darunavir/ritonavir-treated patients and 78% of lopinavir/ritonavirtreated patients were .95%adherent. The difference in virological response rate for adherent versus suboptimally adherent patients was smaller for darunavir/ritonavir (6%difference: 82%versus 76%, P=0.3312) than for lopinavir/ritonavir (25% difference: 78% versus 53%, P,0.0001). In suboptimally adherent patients, a higher virological response rate was seen with darunavir/ritonavir (76%) versus lopinavir/ritonavir (53%) (P,0.01). Suboptimally adherent patients (both treatment groups) reported more adverse events (AEs), including gastrointestinal AEs, than adherent patients. Darunavir/ritonavir had a lower rate of AEs, including gastrointestinal AEs, than lopinavir/ritonavir, in adherent and suboptimally adherent patients. Conclusions: Suboptimal adherence had no significant effect on the virological response rate with once-daily darunavir/ritonavir treatment. In contrast, the lopinavir/ritonavir response rate was significantly reduced in suboptimally adherent patients compared with adherent patients. Once-daily darunavir/ritonavir resulted in a higher virological response rate in suboptimally adherent patients compared with lopinavir/ritonavir. © The Author 2010.


Mauskopf J.,RTI Health Solutions | Brogan A.,RTI Health Solutions | Martin S.,Johnson and Johnson Pharmaceutical Services | Smets E.,Johnson and Johnson Pharmaceutical Services LLC
PharmacoEconomics | Year: 2010

Introduction: Darunavir is a new protease inhibitor (PI) that is co-administered with low-dose ritonavir and has demonstrated substantial efficacy in clinical trials of highly treatment-experienced patients when combined with an optimized background regimen (with or without enfuvirtide). This study estimates the cost effectiveness of darunavir with ritonavir (DRV/r) in this population over 5-year and lifetime time horizons in the USA. Methods: AMarkov model was used to follow a treatment-experienced HIV-1 cohort through six health states, based on CD4 cell count: greater than 500, 351-500, 201-350, 101-200, 51-100 and 0-50 cells/mm 3, and death. The magnitude of the CD4 cell count increase and duration of increasing and stable periodswere derived fromweek 48DRV/r clinical trial results (POWER1 and 2). The treatment pathway assumed one regimen switch following treatment failure on the initial regimen. The use of antiretroviral drugs was based on usage in DRV/r clinical trials. US daily wholesale acquisition costs were calculated using the recommended daily doses. For each CD4 cell count range, utility values, HIV-1-related mortality rates and costs for medical resources (other than antiretroviral drug costs) were obtained from published literature. Non-HIV-1-related mortality rates were calculated by applying a relative risk value to theUS general population age and gender-specific mortality rates. Costs and outcomes were discounted at 3% per year. One-way and probabilistic sensitivity analyses and variability analysis were performed. Results: In a 5-year analysis, patients receivingDRV/r experienced 3.80 qualityadjusted life-years (QALYs) and incurred total medical costs of US$217 288, while those receiving control PIs experienced 3.60QALYs and incurred costs of US$218 962. DRV/r was both more effective and less costly than control PIs. For the lifetime analysis, the QALYs and lifetime medical costs with DRV/r were 10.03 and US$565 358, compared with 8.76 and US$527 287 with control PIs. The incremental cost-effectiveness ratio for DRV/r compared with control PIs was US$30 046. One-way sensitivity analyses for both time horizons indicated that the results were most sensitive to changes in the rate of CD4 cell count change during stable and declining periods (lifetime only), duration of stable period (5-year only) andHIV-1-relatedmortality rates. The results of the variability analysis weremost sensitive to themodel time horizon.Nevertheless, for all ranges and scenarios tested in these analyses, the incremental cost perQALY gained remained below US$50 000. The probabilistic sensitivity analysis showed that there was a 0.921 and 0.950 probability of a cost-effectiveness ratio below US$50000 per QALY for the 5-year and lifetime time horizon, respectively. Conclusions: DRV/r is predicted to be cost effective compared with control PI in highly treatment-experienced patients and is predicted to yield an average of 0.20 additional QALYs per treatment-experienced patient over 5 years and 1.27 additional QALYs over a lifetime in this population. © 2010 Adis Data Information BV. All rights reserved.


Schmitz B.,Stroke Unit and Center for Epilepsy | Montouris G.,Boston University | Caleo S.,Johnson and Johnson Pharmaceutical Services | Schauble B.,Medical Affairs
Epilepsia | Year: 2010

Summary Patients with resistant epilepsy are often coprescribed multiple medications and are more likely to experience drug-drug interactions and adverse events (AEs). A new generation of antiepileptic drugs (AEDs) has been developed with improved safety/tolerability profiles. To evaluate the unmet treatment needs in epilepsy, a comprehensive search of the English-language literature was conducted on Medline and other databases using the terms partial epilepsy and focal seizure, focusing on newer AEDs. Sixty-nine articles were identified. Most patients experienced AEs, which were generally mild-moderate in severity. Drug-drug interactions existed for 6 of 11 AEDs for which data were available. There is evidence for depressive symptoms being associated with zonisamide, and mood-stabilizing effects were shown for lamotrigine and pregabalin. Levetiracetam and eslicarbazepine improved cognitive function. Vigabatrin may increase the risk of developing psychosis. Health-related quality of life (HRQoL) was inversely correlated with seizure frequency. Discontinuation rates were often high, although treatment retention improved with slower dose titration. Adjunctive therapy with newer AEDs has the potential to enhance HRQoL and treatment continuation in patients with partial epilepsy. There remains room for improvement in the management of epilepsy, and better treatments and longer-term trials are needed to meet the special requirements of refractory patients. © 2010 International League Against Epilepsy.


Nicholl D.,Johnson and Johnson Pharmaceutical Services | Akhras K.S.,Johnson and Johnson Pharmaceutical Services | Diels J.,Johnson and Johnson Pharmaceutical Services | Schadrack J.,Johnson and Johnson Pharmaceutical Services
Current Medical Research and Opinion | Year: 2010

Background: Inpatient care to manage relapse of patients with schizophrenia contributes greatly to the overall financial burden of treatment. The present study explores to what extent this is influenced by duration of illness. Methods: Medical and pharmaceutical claims data for patients diagnosed with schizophrenia (ICD-9 295.xx) were obtained from the PharMetrics Integrated Database, a large, regionally representative US insurance claims database, for the period 19982007. Recently diagnosed (n970) and chronic patients (n2996) were distinguished based on ICD-9 295.xx classification, age and claims history relative to the first year (recently diagnosed) and the third year onwards (chronic) after the first index schizophrenia event. Results: The medical resource use and costs during the year following the index schizophrenia event differed significantly between cohorts. A higher proportion of recently diagnosed patients were hospitalised compared with chronic patients (22.3 vs 12.4; p<0.0001), spending a greater mean number of days in hospital (5.1 days vs 3.0 days; p0.0065) as well as making more frequent use of emergency room (ER) resources during this time. The mean annual healthcare costs of recently diagnosed patients were also greater ($20,654 vs $15,489; p<0.0001) with inpatient costs making up a higher proportion of total costs (62.9) compared with chronic patients (38.5). Conclusions: There is a considerably higher overall economic burden in the year following their first schizophrenia event in the treatment of recently diagnosed schizophrenia patients compared with chronic patients. Since hospitalisations and ER visits are the most significant components contributing to this finding, efforts that focus on measures to reduce the risk of relapse, particularly amongst recently diagnosed patients, such as improved adherence programs, may lead to better clinical and economic outcomes in the management of schizophrenia. Limitations: Only commercially insured patients and direct medical costs were included, therefore, results may underestimate the economic burden of schizophrenia. © 2010 Informa UK Ltd All rights reserved.


Patrick D.L.,University of Washington | Burns T.,University of Oxford | Morosini P.,Scientific Clinical and Research Institute | Gagnon D.D.,Johnson and Johnson Pharmaceutical Services | And 2 more authors.
Clinical Therapeutics | Year: 2010

Background: The safety and efficacy of paliperidone extended-release tablets (paliperidone ER) in patients with acute symptoms of schizophrenia have been described in 3 randomized, double-blind, 6-week, placebo-controlled, fixed-dose, Phase III clinical trials. The validity and reliability of the Personal and Social Performance (PSP) scale, both in patients with acute symptoms of schizophrenia and those with stabilized symptoms, have also been reported. Objective: The aim of this work was to estimate the treatment benefit of paliperidone ER compared with placebo in terms of improvements in personal and social functioning as measured by the PSP scale in 3 controlled clinical trials. Methods: Data were derived from 3 paliperidone ER multicenter Phase III pivotal studies of patients with acute symptoms of schizophrenia. Each study included a randomized, double-blind, placebo- and active-controlled, parallel-group, 6-week treatment period with an open-label extension of paliperidone ER treatment. Patients were randomized to receive paliperidone ER, olanzapine 10 mg, or placebo once daily. Paliperidone ER doses were 3, 9, and 15 mg/d in 1 study; 6, 9, and 12 mg/d in another; and 6 and 12 mg/d in the third. Collectively, 1306 intent-to-treat patients received placebo or paliperidone ER in these 3 trials. Most (61.7%) were white; 21.6% were black, 8.8% were Asian, and 7.9% were of another race. The mean age ranged from 36.3 to 39.4 years across treatment groups. Multiple analyses were applied to PSP data (for which higher scores indicate better personal and social functioning) from these paliperidone ER studies: between-group minimum important difference (MID) estimates; responder analyses; between-group cumulative frequency comparisons of PSP change from baseline to end point; and number-needed-to-treat (NNT) estimates. Results: Standardized differences and effect sizes between paliperidone ER and placebo in PSP mean change from baseline to end point ranged from 0.52 to 0.85 for all paliperidone ER doses. Observed between-group differences (paliperidone ER minus placebo) in PSP mean change from baseline to end point exceeded the between-group MID of 7 points at all paliperidone ER doses. The percentage of patients achieving at least one 10-point category improvement in the PSP was higher with all paliperidone ER doses (range, 49.6%-63.6%) than placebo (33.1%) (P < 0.005). Across the distribution of all possible PSP scores, the percentage of patients achieving any level of change appeared to be greater for paliperidone ER than for placebo at all doses. Derived NNTs for improved personal and social functioning based on paliperidone ER trials ranged from 3.3 to 6.1. The improvement in personal and social functioning achieved by patients receiving paliperidone ER during the double-blind studies was maintained throughout the 52-week, open-label extension studies, as assessed using multiple definitions of response; subjects in the placebo arm during doubleblind treatment appeared to achieve and maintain improved functioning when switched to paliperidone ER for the extension studies. Conclusion: These results suggest that paliperidone ER had a meaningful treatment benefit with respect to improving personal and social functioning in these patients with acute symptoms of schizophrenia. © 2010.

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