United BioSource Corporation Research Articles

Use of Herpes Zoster Prophylaxis in Myeloma Patients Treated with Proteasome Inhibitors

BackgroundMultiple myeloma patients on proteasome inhibitors (PIs) have an increased risk for herpes zoster infections. As a result, the U.S. National Comprehensive Cancer Network guidelines recommend antiviral prophylaxis. We examined the use of, and adherence to, antiviral agents in myeloma patients who are on PIs.MethodsWe performed a retrospective cohort analysis in the Truven MarketScan Database, from January 2009 to December 2013. Patients with myeloma continuously receiving PIs (bortezomib or carfilzomib) for ≥3 months were selected. Use of herpes zoster prophylaxis was determined by having one or more pharmacy claims for acyclovir and valacyclovir. Adherence was defined as having a medication possession ratio (MPR; ratio of the sum of all days supplied by the pharmacy divided by the number of days between the first and last prescription) ≥80% over 3 months in patients who filled ≥2 prescriptions for an antiviral agent. Rates of herpes infections were determined in users, users who were adherent, users who were non-adherent, and non-users. Covariates examined included age, calendar year, geographic location, living in a metropolitan area, employment status, health plan, type of pharmacy, prior herpes infection, antiviral use prior to initiation of PI, and Charlson comorbidity score. Patients were followed until end of continuous PI use, end of enrollment from MarketScan, or December 31, 2013, whichever occurred earliest. Multivariable logistic regression analyses were used to examine factors associated with both use and adherence. Cox proportional hazards model was used to examine time to claim for herpes infection.ResultsAmongst a total of 70,786 patients with a diagnosis of myeloma between 2009-2013, we identified 6,934 patients who received PI. Of these, 3,632 (52%) filled a prescription for an antiviral agent at least once during the follow-up period. Acyclovir was more commonly used than valacyclovir (74% vs 26%). Factors associated with antiviral use included more recent calendar year (odds ratio [OR] 2.27 for 2013 versus 2009; 95%CI 1.91-2.71) and being on more chemotherapy agents concurrently (OR 1.82 for 3 agents compared to 1; 95%CI 1.56-2.12). Amongst users who received an antiviral agent more than once (N=2,803), adherence to zoster prophylaxis was 84% over 3 months. Factors associated with adherence included retiree status (OR 1.70; 95%CI 1.20-2.42), and use of mail order pharmacies (OR 2.22; 95%CI 1.19-4.61). Patients on antiviral agents were less likely to develop zoster (hazard ratio 0.40; 95%CI 0.30-0.52).ConclusionsAlthough use of antiviral therapy was associated with a decreased risk of herpes infections, we found that half of myeloma patients in the U.S. did not receive this guideline-recommended care. More efforts are needed to prevent this important complication in myeloma patients on PIs. DisclosuresLentzsch:Caelum Biosciences: Other: leadership position and stock; Amgen: Consultancy; BMS: Consultancy. Neugut:Eisai Pharmaceuticals: Consultancy; Pfizer: Consultancy; Teva Pharmaceuticals: Consultancy; Otsuka Pharmaceuticals: Consultancy; United Biosource Corporation: Consultancy; EHE, Intl: Employment.

68Ga-FAPI-04 PET/CT for Molecular Assessment of Fibroblast Activation and Risk Stratification in Systemic Sclerosis-Related Interstitial Lung Disease

Background: Interstitial lung disease (ILD) is the most common cause of death in systemic sclerosis (SSc). However, the course of ILD in this population is highly variable. Effective diagnostic tools to assess activity and to predict the individual course of the disease are lacking. Here, we tested the hypothesis that in vivo quantification of fibroblast activation may correlate with ILD activity and improve risk stratification in SSc patients. Methods: Fibroblast activation was visualized by positron emission tomography/computed tomography (PET/CT) using the 68Gallium-labeled selective inhibitor of fibroblast activation protein (68Ga-FAPI-04). We correlated 68Ga-FAPI-04 uptake with changes in lung function parameters, high resolution CT scan (HRCT) and patient reported outcomes. 68Ga-FAPI-04 PET/CTs, HRCTs and lung function tests were evaluated in a blinded manner. Findings: In this single center study, we enrolled 21 patients with SSc-ILD, five patients with dermatomyositis-associated-ILD, ten non-SSc/non-ILD control patients and ten non-diseased control individuals. 68Ga-FAPI-04 accumulated in fibrotic areas of the lungs in SSc-ILD with significantly higher wlSUVmean (p 1.0 or a wlTL-FAPI > 500 cm3 demonstrated radiologic progression and decline of FVC after 6 months, but none of the patients with less 68Ga-FAPI-04 accumulation. In consecutive 68Ga-FAPI-04-PET/CTs, changes in 68Ga-FAPI-04 uptake correlated with response to the fibroblast-targeting antifibrotic agent nintedanib. Interpretation: Our study presents first in human evidence that fibroblast activation correlates with fibrotic activity and disease progression in the lungs of SSc-ILD patients and that 68Ga-FAPI-04-PET/CT may improve risk stratification. Funding: German Research Foundation, ELAN-Foundation-Erlangen and Bundesministerium fur Bildung und Forschung. Conflict of Interest: O.D. has consulted for, or has received research funding from, 4D Science, Actelion, Active Biotech, Bayer-Schering, Biogen, Biovitrium, BMS, Boehringer, EpiPharm, Ergonex, GSK, Inventiva, Medac, Novartis, Pfizer, Roche/Genentech, Sanofi/Genzyme, Serodapharm, Sinoxa and United BioSource Corporation; JHWD has consultancy relationships and/or has received research funding from Actelion, BMS, Celgene, Bayer Pharma, Boehringer Ingelheim, JBTherapeutics, Sanofi-Aventis, Novartis, UCB, GSK, Array Biopharma, Galapagos, Inventiva and Active Biotech in the area of potential treatments of SSc and is stock owner of 4D Science. Ethical Approval: File number 30_19B, Ethics Committee Friedrich-Alexander-University Erlangen.

Application of Six Sigma to Achieve Sales Lifecycle Optimization

The objective of this paper is to optimize sales lifecycle performance at United Biosource Corporation through the Six Sigma DMAIC methodology to produce fact based, and data driven approaches with reduced process inconsistency. This methodology was applied to identify inefficiencies within the current sales lifecycle process, including excessive data collection and workflow activities. Evaluations of these inefficiencies identified critical to quality and critical to process inputs. On average, 285.33 hours per month are lost as a result of Smartweb related data and workflow performance activities. The identified drivers of these activities are: (i) external workflows; (ii) data cleaning; and (iii) outside reporting. The goal is to decrease the total number of hours per month spent performing these activities by 75% by the end of 2014. These results will be included in a subsequent publication. To date, the application of the Six Sigma DMAIC methodology to optimize sales lifecycle helped identify inefficiencies, develop solutions and a control plan to ensure the improvements are sustainable.

PCV103 - Economic Evaluation of Apixaban for the Prevention of Stroke in Atrial Fibrillation in the Netherlands

Objectives: Stroke prevention is the main goal in treating patients with atrial fibrillation (AF). Treatment with anticoagulants, such as vitamin-K antagonists (VKAs; e.g. warfarin and cumarines), was demonstrated to be an effective strategy. However, even though VKAs are the current standard therapy recommended by different guidelines, the significant risk of bleeding and the requirement for a regular monitoring are limiting its use. Apixaban is a novel oral anticoagulant (NOAC) associated with significantly lower hazard rates for stroke/systemic embolism major hemorrhage and discontinuations, compared to VKAs. This study evaluated the cost-effectiveness (CE) of apixaban compared to VKAs in the base-case analysis and alternatively to other NOACs for stroke prevention in non-valvular AF patients in The Netherlands. Methods: A global Markov model developed by United BioSource Corporation was modified to reflect the use of oral anticoagulants in The Netherlands. The model used efficacy data from a published indirect treatment comparison of NOACs and cost data from Dutch costing studies as inputs. Following health states were included in the model: non-valvular AF, primary and recurrent ischemic and hemorrhagic stroke, systemic embolism, myocardial infarction intracranial hemorrhage, other major and non-major bleedings, treatment discontinuations and death. Main outcomes were quality adjusted life years (QALY) and costs. Univariate and probabilistic sensitivity analyses (PSA) were conducted on the incremental cost-effectiveness ratio (ICER). Results: In the base-case analysis apixaban treatment compared to VKAs has an ICER well below an informal minimal willingness-to-pay threshold of € 20,000/QALY for The Netherlands (i.e. around € 7,000/QALY). PSA showed that the results of the base-case analysis were quite robust. Potentials exist for apixaban to be dominant over the other NOACs, rivaroxaban and dabigatran depending on hazard ratios, risks for complications and local price levels. patients in The Netherlands. Conclusions: In patients with AF, we found apixaban to be a cost-effective option in The Netherlands, compared to VKAs.

Budget impact analysis of peritoneal dialysis vs. conventional in-center hemodialysis in the United Kingdom

Objectives: The increasing prevalence of patients with end-stage renal disease (ESRD) is driving up the costs of dialysis care dramatically. The National Institute of Clinical Excellence (NICE) has projected significant cost savings by increasing the proportion of patients on peritoneal dialysis (PD). This study investigates the five-year budget impact on UK national healthcare spending on dialysis of changing the distribution of adult patients undergoing peritoneal dialysis and in-center hemodialysis (ICHD). Methods: An Excel®-based budget impact model was constructed to assess dialysis-associated costs when changing adult patients between PD and ICHD. The model incorporates the current modality distribution in the UK and accounts for dialysis payments, drug costs (including ESAs), and the costs and probabilities of adverse events including access failure, access infection, pneumonia, and cardiovascular events. Data from the UK Renal Registry reports were used to estimate the size of the UK adult dialysis patient population for the next five years. The baseline scenario assumed a stable distribution of PD (15%) and ICHD (82%) over five years; the remaining 3% is assumed to be home hemodialysis. Alternative scenarios included: 1). increasing the prevalence of PD by 1.5% each year for five years; 2). increasing the prevalence of PD by 3.0% each year for five years; 3). decreasing the prevalence of PD by 1.5% each year for five years. All three scenarios were accompanied by commensurate changes in ICHD, assuming no change in home hemodialysis. Differences among scenarios were evaluated in terms of costs to UK National Health Services (NHS). Results: Under the current UK national tariff, an increase in the prevalent PD population from 15% in 2013 to 21% or 27% in 2017 is predicted to result in fiveyear cumulative savings for NHS of £28.3 million and £78.9 million, respectively. If the prevalent PD population were to decrease from 15% in 2013 to 9.0% by 2017, the total NHS payment for adult dialysis patients would increase by £73.0 million over the next five years. Conclusions: Under the current UK national tariff, incentives to increase the proportion of patients on PD could help reduce dialysis-associated costs. The main driver of the savings comes from the reduction of the estimated transportation costs. Budget Impact Analysis of Peritoneal Dialysis vs. Conventional In-center Hemodialysis in the United Kingdom Frank Xiaoqing Liu1, Robert Leipold2, Murat Arici3, Usman Farooqui3 1 Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 2 United BioSource Corporation, Bethesda, MD 20814 USA; 3 Baxter Healthcare Ltd., Compton, RG20 7QW United Kingdom. Poster No. SP442

OP0181 Vegf induces vasculopathy and fibrosis in vivo closely resembling human systemic sclerosis

BackgroundLevels of VEGF (vascular endothelial growth factor) are significantly elevated in systemic sclerosis (SSc) patients even before the development of skin fibrosis.ObjectivesTo analyze the effects of VEGF on vasculopathy and...

OP0034 Performance of the New EULAR/ACR Classification Criteria for Systemic Sclerosis in Clinical Practice

BackgroundThe preliminary classification criteria for systemic sclerosis (SSc) developed in 1980 lack sensitivity for early and mild SSc patients. Therefore, the ACR-EULAR committee developed new classification criteria for SSc (1)....

OP0226 Expert consensus for performing right heart catheterization in suspicion of pulmonary arterial hypertension associated with systemic sclerosis: A delphi consensus study with cluster analysis from the eposs group

BackgroundPulmonary hypertension (PH) has emerged as a critical cause of death in systemic sclerosis (SSc). Recent data have highlighted the poorer outcomes of SSc associated PAH as compared to the...

AB0837 Circulating micrornas in systemic sclerosis patients reflect microrna profile of cultured scleroderma fibroblasts and correlate with distinct disease features

BackgroundMicroRNAs (miRs) play a role in many pathophysiologic processes, and have been proposed as tissue-based biomarkers, which are released and stably detectable in body fluids.ObjectivesTo analyse serum expression of miRs...

FRI0249 Pulmonary arterial hypertension in very early systemic sclerosis

BackgroundPulmonary arterial hypertension (PAH) is mainly considered a late complication of systemic sclerosis (SSc), but it occurs also in patients with short disease duration. We recently did not find evidence...

13 Genotype, disease severity, and healthcare resource use by patients with CF in the UK National Health Service

13 Genotype, disease severity, and healthcare resource use by patients with CF in the UK National Health Service H. Wyatt1, A. Ingram2, R. Wasiak3, D. Lambrelli3, J. Davies4, D. Bilton4,5, C. Becker6, B. Harrow6. King’s College Hospital, London, United Kingdom; Xcelerate Health Outcomes, London, United Kingdom; United BioSource Corporation, London, United Kingdom; Imperial College, London, United Kingdom; Royal Brompton Hospital, London, United Kingdom; Vertex Pharmaceuticals Incorporated, Cambridge, United States

FRI0265 Rituximab improves skin fibrosis and prevents worsening of lung function in patients with systemic sclerosis in the eustar cohort

BackgroundThere is pathophysiological rationale and clinical data from case series suggesting a potential role for B-cell targeting in the treatment of systemic sclerosis (SSc).ObjectivesTo assess the effect of RTX on...

OP0229 Effect of endothelin-1 receptor antagonists on skin fibrosis in scleroderma patients – a EUSTAR analysis

BackgroundPreclinical studies showed that endothelin signalling is a major factor in perpetuating fibrotic responses in systemic sclerosis (SSc). Positive effects of endothelin-1 receptor antagonists (ETRA) have been demonstrated in pulmonary...

SAT0024 Increased production of leukotrienes by peripheral blood mononuclear cells is associated with more severe disease and worse prognosis in patients with systemic sclerosis

BackgroundLeukotrienes (LTs) are a group of pro-inflammatory and pro-fibrotic, arachidonic acid-derived lipid mediators. We have shown that LTs are increased in the lungs of patients with interstitial lung disease (ILD)...

OP0018 Microrna-145 down-regulation in systemic sclerosis is limited to skin fibroblasts and influenced by epigenetic modifications and negative feedback loop by TGF-β

BackgroundWe recently found that miR-145 plays anti-fibrotic effects in SSc fibroblasts via the regulation of the TGF-β pathway in a multi-step fashion.ObjectivesTo elucidate the mechanisms regulating the expression of miR-145...

Factors Associated with Gastroprotective Agent Use and Adherence among Adults with Arthritis Taking NSAIDs in the United States

Purpose: To examine factors associated with gastroprotective agent (GPA) use and adherence among adults with arthritis taking NSAIDs. Methods: A Web-based community panel of US men and women age ≥40 with self-reported arthritis was invited via e-mail to participate in a Web survey. Interested panelists consented and completed the screening questions. Respondents who reported NSAID use in the last 30 days were eligible to continue the survey. NSAID and GPA use were asked, as were questions about comorbid conditions, gastrointestinal (GI) history, and other risk factors. Logistic regressions were performed to assess the associations of predictor variables with GPA use and adherence. Results: Invitations were sent to 7,605 adults with arthritis; 4,108 (54%) responded; 2,208 completed. The final sample consisted of 2,000 participants: 1,525 (76%) with osteoarthritis, 354 (18%) with rheumatoid arthritis and 121 (6%) with both. Mean age was 62.0 years; 64% were female; 83% were white; 25% worked full-time and 39% were retired. Mean duration with arthritis was 13.0 years; 47% and 19% experienced arthritis symptoms “daily” and “almost always”, respectively. The most frequently-used NSAIDs were ibuprofen (54%), aspirin (35%) and naproxen (33%). GPA use was more frequent among higher frequency NSAID users; 36% of single NSAID users and 43% of participants taking 4+ NSAIDs reported taking GPAs. The most frequently-used GPAs were omeprazole (48%), esomeprazole (17%), and ranitidine (17%); 39% of daily NSAID users reported taking a GPA. Variables significantly associated with GPA use were: older age (odds ratio (OR) 1.02); male gender (OR 0.76); being white (vs. Hispanic) (OR 0.24); taking an NSAID at least daily (OR 1.5 for daily use; 2.2 for 2x daily use; and 1.8 for use ≥ 3 times per day); taking fewer NSAIDs (OR 0.83); taking a COX-2 inhibitor (OR 1.6) or a prescription NSAID (OR 1.9); history of ulcer (OR 2.2), Barrett's esophagus (OR 8.8), or GERD (OR 12.6); prescription antiplatelet use (OR 1.9); and more frequent GI symptoms as indicated by GSRS total score (OR 1.5). Variables significantly associated with GPA adherence were: (OR 1.02); inflammatory bowel disease (OR 1.57); GERD (OR 1.72); less frequent GI symptoms (OR 0.62); prescription antiplatelet use (OR 1.97); and prescription NSAID use (OR 1.65). Conclusion: Slightly more than 1/3 of daily NSAID users routinely take GPAs. Older age; taking a prescription NSAID; history of GERD; prescription antiplatelet use; and GI symptoms were all associated with GPA use and adherence to GPA regimen in this sample of adults with arthritis using NSAIDs. These data may be useful for clinicians treating patients with arthritis. Disclosure: Karin S. Coyne, Mary Kay Margolis, and Ray Hsieh are employees of United BioSource Corporation who were paid scientific consultants to Pfizer in connection with this research. Joseph C. Cappelleri, Margaret Noyes Essex, Peter W. Park and Ashish V. Joshi are employees and stockholders of Pfizer Inc. This study was funded by Pfizer Inc. This research was supported by an industry grant from Pfizer Inc.

597P - Overall Survival in Metastatic Colorectal Cancer (MCRC) Patients Receiving 2nd-Line therapy: A Systematic Review

ABSTRACT Background Currently, oxaliplatin or irinotecan-based regimens are the standard of care (SOC) in 1st– and 2nd-line therapy of mCRC, often combined with bevacizumab or an EGFR inhibitor. A systematic literature review was conducted to address gaps in the current evidence and gain an understanding of the clinical efficacy of 2nd-line chemotherapy in patients with mCRC. Methods Searches were conducted in EMBASE, PubMed, CENTRAL, and key congresses using keywords for CRC and chemotherapy to identify relevant randomized trials assessing 2nd-line clinical efficacy, published between 1992 and April 2012. Results Twenty-three primary trials evaluating 2nd-line treatment of mCRC were identified for inclusion. Chemotherapeutic agents investigated included irinotecan monotherapy (k = 11), FOLFOX4 (k = 6), FOLFIRI (k = 4), IROX (k = 3), irinotecan/5-FU/FA (k = 3) and IRIS (k = 1). FU-based regimens were the most common prior therapy, with 13 studies reporting that 100% of patients received FU as 1st-line therapy for metastatic disease. Eight studies excluded patients who previously received irinotecan. Of the included studies, the VELOUR trial, comparing aflibercept + FOLFIRI versus FOLFIRI, was the only trial evaluating the current SOC (FOLFIRI based regimens) in patients who received oxaliplatin-based chemotherapy as a 1st-line agent. Overall survival (OS) ranged from 6.4 to 18 mos across studies. The addition of specific targeted agents to chemotherapy regimens demonstrated significant incremental survival gains. Addition of bevacizumab to FOLFOX4 in the 2nd-line setting was associated with a median OS of 12.9 mos, compared with 10.8 mos for FOLFOX4 alone. Similarly, the addition of panitumumab to FOLFIRI improved median OS from 12.5 mos to 14.5 mos in KRAS wild type patients and addition of aflibercept improved median OS from 12.1 mos to 13.5 mos. Conclusions OS in 2nd-line trials showed significant survival gains when targeted agents were added to chemotherapy regimens. However, variability in treatment choices, prior chemotherapy regimen, patient selection and study approaches may hamper efforts to conduct reliable pooled analyses on outcomes to examine comparative effectiveness. VELOUR was one of the few trials that investigated patients who had received the current SOC in their 1st-line therapy. Disclosure A.L. Martin: I am an employee of United BioSource Corporation (UBC), which received funding from Sanofi to conduct the study on which this abstract is based. Y. Xu: I am an employee of United BioSource Corporation (UBC), which received funding from Sanofi to conduct the study on which this abstract is based. K. Knopf: I am a paid consultant of United BioSource Corporation (UBC), which received funding from Sanofi to conduct the study on which this abstract is based. S.U. Iqbal: I am a paid employee of Sanofi which provided funding to conduct the study on which this abstract is based. J. Jasso-Mosqueda: I am a paid employee of Sanofi which provided funding to conduct the study on which this abstract is based.

843P - Axitinib (AXI) and Everolimus (EVE) in the Treatment (TX) of Sunitinib-Refractory (SU-R) Patients (PTS) with Metastatic Renal Cell Carcinoma (MRCC): Results of a Simulated TX Comparison (STC) Analyses

ABSTRACT Background Axi is a novel VEGF targeted agent for mRCC pts who failed 1 prior systemic therapy. the The AXIS trial compared axi to sorafenib and showed a significantly longer PFS in pts treated with axi, including the su-r subgroup. No direct comparison is available between axi and eve but is an important clinical question. The goal of this analysis was to compare OS and PFS in su-r pts treated with axi and eve. Methods Pts who were su-r and received axi in the AXIS trial and eve in RECORD-1 trial were considered for this analysis. A STC method (Caro et al 2010) was used to derive OS and PFS curves for a hypothetical cohort of “axi like” pts had they received eve in the AXIS trial. Pt level AXIS data was used to derive predictive equations for OS and PFS. Parametric survival analysis identified the best fitting distribution and significant predictors of OS and PFS. These equations were calibrated using pt characteristics and median OS and PFS reported in the literature. Results 194 axi and 124 eve pts who were su-r were analyzed. While AXIS trial included only pts that progressed on 1 line of tx, 65% of su-r eve pts had 3 plus lines of therapy. Some pts were included in the eve trial without having progressed on 1st line tx. Available pt characteristics were comparable across two groups, except for difference in MSKCC risk categories (36% vs 17% poor risk pts in axi and eve respectively), mean duration of prior su (57 vs 44 weeks) and ECOG score (52% vs 60% with ECOG 0). A log-normal distribution provided the best fit for both OS and PFS. MSKCC risk category and duration of prior sunitinib were significant predictors of OS. The final PFS equation included MSKCC risk group and age. Estimated median OS and PFS was 15.2 and 5.1 months for axi compared to 10.6 and 3.6 months for eve group respectively. Estimated difference in mean OS and PFS between axi and eve was 7.6 and 2.6 months. Conclusion This analysis suggest that su-r RCC pts treated with axi may have an improved OS and PFS compared to pts treated with eve. Our analysis could not account for all differences between trials, such as number of prior therapies, however, a STC can provide additional comparative context. Disclosure I. Proskorovsky: I am an employee of United BioSource Corporation. As a research consulting organization, it received funding from Pfizer for the research undertaken in this abstract. A. Benedict: I am an employee of United BioSource Corporation. As a research consulting organization, it received funding from Pfizer for the research undertaken in this abstract. S. Negrier: Dr. Negrier has received honorariums from Pfizer and Novartis as well as research grants from GlaxoSmithKline and Roche. J. Larkin: research funding from Pfizer and Novartis, advisory role to Pfizer, Novartis, GSK, BMS, Aveo. R. Sandin: Employee of Pfizer AB. Stock or other ownership interests in Pfizer Inc. C. Chen: Employee and stockholder of Pfizer only

Clinical and Neuropsychological Features of Pure and Mixed Hippocampal Sclerosis Dementia (P05.039)

Objective: To characterize the clinical and neuropsychological features of pure and mixed hippocampal sclerosis dementia (HS) compared to Alzheimer9s disease (AD). Background HS dementia accounts for about 10% of cases of dementia in the elderly. At present it is diagnosed only at autopsy, as it lacks distinctive clinical features. It is often found along with neurodegenerative conditions including AD, Lewy body and fronto-temporal dementias, labeled 9mixed9 HS dementia. A proportion of HS is found without concomitant classical neurodegenerative pathology, and is labeled 9pure9 HS. There is a need to clinically characterize HS in relation to dementia, as its underlying etiology and subsequent treatment might be expected to differ from other neurodegenerative dementias. Design/Methods: Retrospective case control study comparing the clinical and neuropsychological profile of a series of pure HS cases and a series of mixed HS/AD with matched samples of neuropathologically confoirmed pure AD cases. Each series was matched on gender, age at death, and interval from last MMSE to death. The groups were compared in MMSE, Mattis DRS (total and subscales), and a panel of psychometric tests. Results: At first presentation, pure HS subjects (n=17) differed from matched AD patients (n=102) only regarding relatively preserved logical memory immediate recall (p=0.02). At last clinical examination prior to death, pure HS subjects had a significantly higher mean MMSE and DRS memory subscale scores compared to matched AD cases. Mixed HS+AD subjects (n=22) did not differ in any of the cognitive measures compared to matched AD cases (n=66) at initial examination or at last examination prior to death. Conclusions: Relative deterioration of learning and delayed recall, and slower progression of cognitive decline may help to distinguish pure HS dementia from AD. Mixed HS dementia appeared indistinguishable from AD. Disclosure: Dr. Pillai has nothing to disclose. Dr. Edland has nothing to disclose. Dr. Gahagan has nothing to disclose. Dr. Salmon has received personal compensation for activities with Bristol Myer Squibb as a consultant. Dr. Galasko has received personal compensation for activities with United BioSource Corporation, Elan Pharmaceuticals and Janssen Pharmaceuticals(DSMB) as a consultant. Dr. Galasko has received personal compensation in an editorial capacity for Alzheimer9s Disease Research and Treatment, published by Biomed Central. Dr. Galasko has received research support from Pfizer Pharmaceuticals and Eli Lilly, Inc.

Comment on FDA's quality assessment of ADE reports from an electronic health record project

Pharmacoepidemiology and Drug SafetyVolume 21, Issue 6 p. 571-572 Commentary Comment on FDA's quality assessment of ADE reports from an electronic health record project Gerald Faich, Corresponding Author Gerald Faich gfaich@yahoo.com United Biosource Corporation, 920 Harvest Drive, Blue Bell, PA, 19422 USAG. Faich, United Biosource Corporation, 920 Harvest Drive, Blue Bell, PA 19422, USA. E-mail: gfaich@yahoo.comSearch for more papers by this author Gerald Faich, Corresponding Author Gerald Faich gfaich@yahoo.com United Biosource Corporation, 920 Harvest Drive, Blue Bell, PA, 19422 USAG. Faich, United Biosource Corporation, 920 Harvest Drive, Blue Bell, PA 19422, USA. E-mail: gfaich@yahoo.comSearch for more papers by this author First published: 13 March 2012 https://doi.org/10.1002/pds.3237Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume21, Issue6June 2012Pages 571-572 RelatedInformation