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Baar, Switzerland
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News Article | May 3, 2017
Site: marketersmedia.com

Wiseguyreports.Com Adds “Oral Vaccines -Market Demand, Growth, Opportunities and Analysis of Top Key Player Forecast To 2022” To Its Research Database This report studies Oral Vaccines in Global market, especially in North America, China, Europe, Southeast Asia, Japan and India, with production, revenue, consumption, import and export in these regions, from 2012 to 2016, and forecast to 2022. This report focuses on top manufacturers in global market, with production, price, revenue and market share for each manufacturer, covering By types, the market can be split into By Application, the market can be split into Polio Rabies Rotavirus Cholera HIV Respiratory Infections Influenza Tuberculosis Others By Regions, this report covers (we can add the regions/countries as you want) North America China Europe Southeast Asia Japan India Global Oral Vaccines Market Professional Survey Report 2017 1 Industry Overview of Oral Vaccines 1.1 Definition and Specifications of Oral Vaccines 1.1.1 Definition of Oral Vaccines 1.1.2 Specifications of Oral Vaccines 1.2 Classification of Oral Vaccines 1.2.1 Live Attenuated Vaccines 1.2.2 Killed/Inactivated Vaccines 1.2.3 Recombinant Vaccines 1.2.4 Others 1.3 Applications of Oral Vaccines 1.3.1 Polio 1.3.2 Rabies 1.3.3 Rotavirus 1.3.4 Cholera 1.3.5 HIV 1.3.6 Respiratory Infections 1.3.7 Influenza 1.3.8 Tuberculosis 1.3.9 Others 1.4 Market Segment by Regions 1.4.1 North America 1.4.2 China 1.4.3 Europe 1.4.4 Southeast Asia 1.4.5 Japan 1.4.6 India 8 Major Manufacturers Analysis of Oral Vaccines 8.1 GlaxoSmithKline Plc. 8.1.1 Company Profile 8.1.2 Product Picture and Specifications 8.1.2.1 Product A 8.1.2.2 Product B 8.1.3 GlaxoSmithKline Plc. 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.1.4 GlaxoSmithKline Plc. 2016 Oral Vaccines Business Region Distribution Analysis 8.2 PaxVax Corporation 8.2.1 Company Profile 8.2.2 Product Picture and Specifications 8.2.2.1 Product A 8.2.2.2 Product B 8.2.3 PaxVax Corporation 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.2.4 PaxVax Corporation 2016 Oral Vaccines Business Region Distribution Analysis 8.3 Merial, Inc. 8.3.1 Company Profile 8.3.2 Product Picture and Specifications 8.3.2.1 Product A 8.3.2.2 Product B 8.3.3 Merial, Inc. 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.3.4 Merial, Inc. 2016 Oral Vaccines Business Region Distribution Analysis 8.4 Merck Sharp & Dohme Corp 8.4.1 Company Profile 8.4.2 Product Picture and Specifications 8.4.2.1 Product A 8.4.2.2 Product B 8.4.3 Merck Sharp & Dohme Corp 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.4.4 Merck Sharp & Dohme Corp 2016 Oral Vaccines Business Region Distribution Analysis 8.5 VALNEVA Canada Inc. 8.5.1 Company Profile 8.5.2 Product Picture and Specifications 8.5.2.1 Product A 8.5.2.2 Product B 8.5.3 VALNEVA Canada Inc. 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.5.4 VALNEVA Canada Inc. 2016 Oral Vaccines Business Region Distribution Analysis 8.6 QUíMICA SUIZA S.A 8.6.1 Company Profile 8.6.2 Product Picture and Specifications 8.6.2.1 Product A 8.6.2.2 Product B 8.6.3 QUíMICA SUIZA S.A 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.6.4 QUíMICA SUIZA S.A 2016 Oral Vaccines Business Region Distribution Analysis 8.7 Immunitor, Inc 8.7.1 Company Profile 8.7.2 Product Picture and Specifications 8.7.2.1 Product A 8.7.2.2 Product B 8.7.3 Immunitor, Inc 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.7.4 Immunitor, Inc 2016 Oral Vaccines Business Region Distribution Analysis 8.8 Aventis (Sanofi S.A.) 8.8.1 Company Profile 8.8.2 Product Picture and Specifications 8.8.2.1 Product A 8.8.2.2 Product B 8.8.3 Aventis (Sanofi S.A.) 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.8.4 Aventis (Sanofi S.A.) 2016 Oral Vaccines Business Region Distribution Analysis 8.9 Serum Institute of India Pvt. Ltd 8.9.1 Company Profile 8.9.2 Product Picture and Specifications 8.9.2.1 Product A 8.9.2.2 Product B 8.9.3 Serum Institute of India Pvt. Ltd 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.9.4 Serum Institute of India Pvt. Ltd 2016 Oral Vaccines Business Region Distribution Analysis 8.10 Swiss Serum and Vaccine Institute Berne 8.10.1 Company Profile 8.10.2 Product Picture and Specifications 8.10.2.1 Product A 8.10.2.2 Product B 8.10.3 Swiss Serum and Vaccine Institute Berne 2016 Oral Vaccines Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.10.4 Swiss Serum and Vaccine Institute Berne 2016 Oral Vaccines Business Region Distribution Analysis 8.11 Bull Bio - NCIPD Ltd. 8.12 Vaxart, Inc. 8.13 Shantha Biotechnics 8.14 Crucell (Janssen Global Services, LLC) For more information, please visit https://www.wiseguyreports.com/sample-request/1240272-global-oral-vaccines-market-professional-survey-report-2017


News Article | April 19, 2017
Site: www.PR.com

Future Market Insights has announced the addition of the "Auto-Injectors Market: Global Industry Analysis and Opportunity Assessment 2016- 2026" report to their offering. Valley Cottage, NY, April 19, 2017 --( Auto-injectors are pen like devices used to deliver a fixed dose of drug to patients and are intended for self-administration. Auto-injectors are gradually becoming the gold-standard in the treatment of various indications like anaphylaxis, multiple sclerosis, rheumatoid arthritis and others. Most of the auto-injectors are spring loaded, and the procedure is relatively simple. These are specialised instruments that can be used to avoid needle stick injury and reduce needle phobia among patients. In 1990, the first reusable auto-injector, known as Imigran was launched for the treatment of migraine. Auto-injector manufacturers are focussed on user centric design approaches to enhance ease-of-use and overcome the unwillingness associated with self-administration of intramuscular injections. Auto-Injectors are expected to present vast opportunities to investors due to high demand in biologics development. Overall revenues from the pre-filled syringes segment is expected to grow during the forecast period due to the rising need for targeted and sustained drug delivery. In September 2015, Bayer Healthcare reported the launch of Betaconnect – the only electronic auto-injector for the treatment of relapsing-remitting multiple sclerosis (RRMS). The procedure does not require a visit to hospitals, clinics, etc. and reduces dependency on healthcare professionals, which is why auto-injectors are becoming a choice of therapy for patients suffering from anaphylaxis, multiple sclerosis, rheumatoid arthritis and others. Increasing adoption of auto-injectors due to benefits such as increased safety, accuracy and minimal discomfort is expected to fuel market revenue growth over the forecast period. Request For Sample @ http://www.futuremarketinsights.com/reports/sample/rep-gb-1642 The global auto-injectors market was valued at nearly US$ 1700 Mn in 2016. The market is anticipated to exhibit a CAGR of 15.1% during the forecast period and is projected to be valued at nearly US$ 7,000 Mn by the end of 2026. Global Auto-Injectors Market Analysis & Forecast, By Indication, 2016–2026 Anaphylaxis segment dominated the global auto-injectors market by indication in terms of revenue in 2015 and the trend is projected to sustain throughout the forecast period. Anaphylaxis segment is the most attractive segment with an attractiveness index of 3.55 over the forecast period. Revenue from the anaphylaxis segment is anticipated to register a CAGR of 15% over 2016–2026, to reach more than US$ 6,000 Mn by 2026. Multiple sclerosis segment is expected to be the second most lucrative segment in the global auto-injectors market by indication, with an attractiveness index of 0.2 during the forecast period. Multiple sclerosis segment accounted for 5.3% value share in 2016 and is projected to account for 5.5% share by 2026 end. Global trend: Reduction in reliance on healthcare provisions due to auto-injectors Auto-injectors are economical as they reduce about 95% of primary healthcare costs, as there is no need to attend clinics and hospitals for administration of the injection by healthcare professionals. Auto-injectors provide inexpensive home medication and reduce the time consumed at in-patient and out-patient care units. For patients requiring frequent dose administration on weekly and daily basis, the use of auto-injectors reduces the average cost per injection. In addition, auto-injectors reduce needle-stick injuries. Reduction in dependence on healthcare professionals is boosting the use of auto-injectors and is likely to increase the revenue growth of the market over the forecast period. Send An Enquiry @ http://www.futuremarketinsights.com/askus/rep-gb-1642 Key players in the global auto-injectors market Some key players in the global auto-injectors market included in this report are Becton, Dickinson and Company, Sanofi, Pfizer, Inc., Mylan N.V., Novartis AG, Bayer AG, Janssen Global Services, LLC, Antares Pharma, Inc., Amgen Inc. and Eli Lilly and Company. Mylan N.V. is a leader in the global auto-injectors market in terms of revenue share. Mylan holds a market share of about 83.7% in the global auto-injectors market owing to the fact that the blockbuster product “Epipen” is a widely sold auto-injector and has a tremendous contribution to the global auto-injectors market. Becton, Dickinson and Company is one of the leading manufacturers of refillable auto-injectors focussing on manufacturing Physioject that is compatible with several injectable drugs. In terms of revenue, Becton, Dickinson and Company holds about 8.4% of the global auto-injectors market share owing to a rising adoption of Physioject. Analyst’s Viewpoint Reduction in price due to approved generic versions will boost the sales revenue of global auto injector devices over the forecast period Drop in price of Epipen from US$ 600 to US$ 300 Auto-injectors manufacturers are introducing generic versions in order to reduce the overall cost of the device. In order to better serve anaphylaxis patients with epinephrine at an affordable cost, Mylan N.V. has implemented the decision of introducing the generic version of Epipen at half the price. The initial pack of two was sold at US$ 600 till December 2016 which will be sold at US$ 300 from January 2017. This has increased the affordability of insured as well as non-insured patients to opt for Epipen. This drop in price will increase the penetration of the EpiPen auto-injector, which holds around 90% share of the overall market. Browse Full Report @ http://www.futuremarketinsights.com/reports/auto-injectors-market Valley Cottage, NY, April 19, 2017 --( PR.com )-- Prefilled auto-injectors segment anticipated to contribute to the highest growth opportunity due to growing demand for intramuscular drug delivery in the global auto-injectors market.Auto-injectors are pen like devices used to deliver a fixed dose of drug to patients and are intended for self-administration. Auto-injectors are gradually becoming the gold-standard in the treatment of various indications like anaphylaxis, multiple sclerosis, rheumatoid arthritis and others. Most of the auto-injectors are spring loaded, and the procedure is relatively simple. These are specialised instruments that can be used to avoid needle stick injury and reduce needle phobia among patients. In 1990, the first reusable auto-injector, known as Imigran was launched for the treatment of migraine. Auto-injector manufacturers are focussed on user centric design approaches to enhance ease-of-use and overcome the unwillingness associated with self-administration of intramuscular injections.Auto-Injectors are expected to present vast opportunities to investors due to high demand in biologics development. Overall revenues from the pre-filled syringes segment is expected to grow during the forecast period due to the rising need for targeted and sustained drug delivery. In September 2015, Bayer Healthcare reported the launch of Betaconnect – the only electronic auto-injector for the treatment of relapsing-remitting multiple sclerosis (RRMS). The procedure does not require a visit to hospitals, clinics, etc. and reduces dependency on healthcare professionals, which is why auto-injectors are becoming a choice of therapy for patients suffering from anaphylaxis, multiple sclerosis, rheumatoid arthritis and others. Increasing adoption of auto-injectors due to benefits such as increased safety, accuracy and minimal discomfort is expected to fuel market revenue growth over the forecast period.Request For Sample @ http://www.futuremarketinsights.com/reports/sample/rep-gb-1642The global auto-injectors market was valued at nearly US$ 1700 Mn in 2016. The market is anticipated to exhibit a CAGR of 15.1% during the forecast period and is projected to be valued at nearly US$ 7,000 Mn by the end of 2026.Global Auto-Injectors Market Analysis & Forecast, By Indication, 2016–2026Anaphylaxis segment dominated the global auto-injectors market by indication in terms of revenue in 2015 and the trend is projected to sustain throughout the forecast period. Anaphylaxis segment is the most attractive segment with an attractiveness index of 3.55 over the forecast period. Revenue from the anaphylaxis segment is anticipated to register a CAGR of 15% over 2016–2026, to reach more than US$ 6,000 Mn by 2026. Multiple sclerosis segment is expected to be the second most lucrative segment in the global auto-injectors market by indication, with an attractiveness index of 0.2 during the forecast period. Multiple sclerosis segment accounted for 5.3% value share in 2016 and is projected to account for 5.5% share by 2026 end.Global trend: Reduction in reliance on healthcare provisions due to auto-injectorsAuto-injectors are economical as they reduce about 95% of primary healthcare costs, as there is no need to attend clinics and hospitals for administration of the injection by healthcare professionals. Auto-injectors provide inexpensive home medication and reduce the time consumed at in-patient and out-patient care units. For patients requiring frequent dose administration on weekly and daily basis, the use of auto-injectors reduces the average cost per injection. In addition, auto-injectors reduce needle-stick injuries. Reduction in dependence on healthcare professionals is boosting the use of auto-injectors and is likely to increase the revenue growth of the market over the forecast period.Send An Enquiry @ http://www.futuremarketinsights.com/askus/rep-gb-1642Key players in the global auto-injectors marketSome key players in the global auto-injectors market included in this report are Becton, Dickinson and Company, Sanofi, Pfizer, Inc., Mylan N.V., Novartis AG, Bayer AG, Janssen Global Services, LLC, Antares Pharma, Inc., Amgen Inc. and Eli Lilly and Company. Mylan N.V. is a leader in the global auto-injectors market in terms of revenue share. Mylan holds a market share of about 83.7% in the global auto-injectors market owing to the fact that the blockbuster product “Epipen” is a widely sold auto-injector and has a tremendous contribution to the global auto-injectors market. Becton, Dickinson and Company is one of the leading manufacturers of refillable auto-injectors focussing on manufacturing Physioject that is compatible with several injectable drugs. In terms of revenue, Becton, Dickinson and Company holds about 8.4% of the global auto-injectors market share owing to a rising adoption of Physioject.Analyst’s ViewpointReduction in price due to approved generic versions will boost the sales revenue of global auto injector devices over the forecast periodDrop in price of Epipen from US$ 600 to US$ 300Auto-injectors manufacturers are introducing generic versions in order to reduce the overall cost of the device. In order to better serve anaphylaxis patients with epinephrine at an affordable cost, Mylan N.V. has implemented the decision of introducing the generic version of Epipen at half the price. The initial pack of two was sold at US$ 600 till December 2016 which will be sold at US$ 300 from January 2017. This has increased the affordability of insured as well as non-insured patients to opt for Epipen. This drop in price will increase the penetration of the EpiPen auto-injector, which holds around 90% share of the overall market.Browse Full Report @ http://www.futuremarketinsights.com/reports/auto-injectors-market Click here to view the list of recent Press Releases from Future Market Insights


A Liquid Biopsy, also known as Fluid Biopsy is the Sampling and Analysis of Non-Solid Biological Tissue, Primarily Blood. Like traditional biopsy this type of technique is mainly used as a Diagnostic and monitoring tool for diseases such as Cancer, with the added benefit of being largely non-invasive. With their unique quality of simplifying the Market Study Reports, “Market Research Future” presents a Brilliant study Report on the “Global Liquid Biopsy Market” Empowering you to browse through the full Market Analysis, Opportunities, Price, Growth, Trends and the market forecast up to the year 2022 Global Liquid Biopsy Market Report has been segmented on the basis of Therapeutic Area which comprises of Bladder cancer, Lung cancer, Brain cancer, Melanoma, Breast cancer, Non-Hodgkin lymphoma and others. On the basis of application the market is segmented into cancer Drug Development, Device Development, detection of Genetic Alterations in Tumors, cfDNA and others. On the basis of end user, market is segmented into Pharmaceutical Companies, Hospital/Clinics, Reference Laboratories, Research Institutes and others. Globally the market for Liquid Biopsy is expected to grow at a substantial rate during the period 2016 to 2022. Applications for Liquid Biopsy are expected to Witness Significant market development over the coming decade. Brain Cancer holds the largest share of the market. Some of the Key Players in this Market are: Myriad Genetics, F. Hoffmann-La Roche Ltd, QIAGEN, Biocept Inc., Trovagene, Inc, Genomic Health, RainDance Technologies, Inc, Bio-Rad Laboratories, Inc., Janssen Global Services, LLC, and others. The Report is advantageous mainly to the following Entities • Biotechnology Companies • Research Institutes • Research and Development (R&D) Companies • Liquid biopsy market service providers • Government Research Laboratories • Contract Research Organizations • Research and Consulting Companies • Liquid Biopsy Product Manufacturers and Distributors • Pharmaceutical Companies Access the market data and market information presented through more than 50 market data tables and 25 figures spread over 85 numbers of pages of the project report “Liquid biopsy Market –Forecast to 2022” Depending on geographic region, Liquid biopsy market is segmented into four key regions: Americas, Europe, Asia Pacific, and Middle East & Africa. Globally developed countries led by North America are the largest market for Liquid biopsy. Europe is the second-largest market for liquid biopsy. The developing regions market such as Asia pacific region and Middle East & Africa however is rising much faster. • Provides detailed analysis of the market structure along with forecast for the next 7 years of the various segments and sub-segments of the Liquid Biopsy Market • Offers insights about factors affecting the market growth • Enables to analyze the market based on various factors- Price Analysis, Supply Chain Analysis, Porters Five Force Analysis etc. • Provides historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia-Pacific, and Middle East & Africa. • Offers country level analysis of the market with respect to the current market size and future prospective At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. In order to stay updated with technology and work process of the industry, MRFR often plans & conducts meet with the industry experts and industrial visits for its research analyst members. For more information, please visit https://www.marketresearchfuture.com


Lawitz E.,University of Texas Health Science Center at San Antonio | Zeuzem S.,Goethe University Frankfurt | Gane E.,Auckland Hospital Clinical Studies Unit | Bronowicki J.P.,University of Lorraine | And 11 more authors.
Gastroenterology | Year: 2014

Background & Aims Simeprevir is an oral, once-daily inhibitor of hepatitis c virus (HCV) protease NS3/4A. We investigated the safety and efficacy of simeprevir with peg-interferon α-2a and ribavirin (PR) in a randomized, double-blind, placebo-controlled, phase 3 trial of patients with HCV genotype 1 infection who relapsed after previous interferon-based therapy. Methods Patients were assigned randomly (2:1) to groups given simeprevir (150 mg, once daily) and PR (n = 260) or placebo and PR (n = 133) for 12 weeks. Patients then were given PR alone for 12 or 36 weeks (simeprevir group, based on response-guided therapy criteria) or 36 weeks (placebo group). Results Simeprevir and PR was significantly superior to placebo and PR; rates of sustained virologic response 12 weeks after planned end of treatment (SVR12) were 79.2% vs 36.1%, respectively (43.8% difference; 95% confidence interval, 34.6-53.0; P <.001). Among patients given simeprevir, 92.7% met the response-guided therapy criteria and were eligible to complete PR at week 24; of these, 83.0% achieved SVR12. HCV RNA was undetectable at week 4 in 77.2% of patients given simeprevir and 3.1% given placebo. On-treatment failure and relapse rates were lower among patients given simeprevir and PR than those given placebo and PR (3.1% vs 27.1%, and 18.5% vs 48.4%, respectively). Patients given simeprevir did not have adverse events beyond those that occurred in patients given PR alone. Most adverse events were grades 1/2; the prevalence of anemia and rash was similar in both groups. Patients in both groups reported similar severity of fatigue and functional impairments during the study, but duration was reduced among patients given simeprevir. Conclusions In a phase 3 trial of patients who had relapsed after interferon-based therapy, the addition of simeprevir to PR was generally well tolerated, with an SVR12 rate of 79.2%. Most patients (92.7%) receiving simeprevir were able to shorten therapy to 24 weeks. ClinicalTrials.gov number: NCT01281839. © 2014 by the AGA Institute.


Zeuzem S.,Goethe University Frankfurt | Demasi R.,Janssen Research and Development LLC | Baldini A.,Janssen | Coate B.,Janssen Research and Development LLC | And 3 more authors.
Journal of Hepatology | Year: 2014

Background & Aims Anemia is a common adverse event associated with telaprevir-based triple therapy of chronic, genotype 1 hepatitis C. Identification of patients at risk of developing anemia could allow evaluation of suitability for therapy, and aid in determining frequency of anemia monitoring and treatment management. Methods This post-hoc analysis utilized data from the no lead-in telaprevir, peginterferon and ribavirin arm of the REALIZE study. Anemia was defined as a single occurrence of hemoglobin <10 g/dl at any point during treatment. Pre-treatment factors with potential to act as prognostic indicators of anemia including age, sex, BMI, and baseline hemoglobin were analysed by univariate and multivariate logistic regression analyses. Nomograms (graphical representations of risk factors) were developed to predict the likelihood of developing anemia. Results Among the 265 patients, 102 (38%) had anemia, with 78/102 (77%) developing anemia on or before week 12. Most patients developed anemia after week 2 and an inverse correlation was found between week 2 hemoglobin and the likelihood of developing anemia. Overall, 60% of patients (60/100) with week 2 hemoglobin <13 g/dl subsequently developed anemia. The multivariate analysis revealed older age (>45 years), lower BMI (≤25 mg/m2) and baseline hemoglobin (continuous variable) were significantly associated with the probability of developing anemia during telaprevir treatment. Conclusions These analyses indicate the potential of using predictive risk factors such as low baseline and on-treatment hemoglobin to identify patients at risk of developing anemia on telaprevir-based triple therapy, which may increase the potential for treatment success by careful patient monitoring. © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.


Bamber L.,Bayer AG | Wang M.Y.,Bayer AG | Prins M.H.,Maastricht University | Ciniglio C.,Janssen Global Services LLC | And 3 more authors.
Thrombosis and Haemostasis | Year: 2013

Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved for the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE as a fixed-dose, single-drug regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. This study evaluated patient-reported treatment satisfaction in EINSTEIN DVT - a large, open-label, randomised study that compared rivaroxaban with enoxaparin/ vitamin K antagonist (VKA) therapy in patients with acute symptomatic DVT without PE. As part of EINSTEIN DVT, a total of 1,472 patients in seven countries were asked to complete a new, validated measure of treatment satisfaction - the Anti-Clot Treatment Scale (ACTS) - at scheduled visits throughout 12 months of treatment. ACTS scores were compared between study groups in the intentionto-treat population. Patients reported greater satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 vs 52.6 (p<0.0001) in favour of rivaroxaban, equivalent to a moderate effect size of 0.42. The treatment effect was consistent over time, with the mean score difference ranging from 2.18 (month 2) to 3.18 (month 12). Overall mean ACTS Benefits scores were 11.7 vs 11.5 in favour of rivaroxaban (p=0.006). This was associated with a small overall effect size of 0.12. The improvement in ACTS Benefits for rivaroxaban became apparent at month 2 and subsequent visits. Rivaroxaban results in improved treatment satisfaction compared with enoxaparin/VKA among patients with DVT, particularly in reducing patient-reported anticoagulation burden. © Schattauer 2013.


Type 2 diabetes mellitus (T2DM) is primarily a self-managed disease in which selfcare behaviors play an important role in achieving optimal outcomes. Because self-care does not result in immediate tangible or noticeable benefits, adherence to such a regimen can be confusing, difficult, and frustrating. People are more likely to adhere to treatment regimens that offer benefits from the patient perspective, such as convenience, avoidance of hypoglycemic episodes, and weight loss, compared with regimens that do not. In this study, we explored the impact of the average weight loss amount demonstrated with canagliflozin treatment on improvement in 3 patient-relevant outcomes that have been linked to performance of healthy behaviors and better outcomes in T2DM: weight-related quality of life, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, and satisfaction with physical health and emotional health, as measured by the Current Health Satisfaction Questionnaire (CHES-Q), using data from a previously reported study. Weight loss of an amount demonstrated in clinical trials of canagliflozin was associated with improvements in weight-related quality of life and satisfaction with physical and emotional health, concepts shown to be important to the persistent and consistent performance of healthy behaviors. © Postgraduate Medicine.


Mehra M.,Janssen Global Services LLC | Hill K.,Janssen Global Services LLC | Nicholl D.,Janssen Global Services LLC | Schadrack J.,Janssen Global Services LLC
Journal of Medical Economics | Year: 2012

Background: This research addresses the need for population-based studies on the burden of chronic low back pain (CLBP) by examining healthcare service use and costs for patients with and without neuropathic components in the US population. Methods: Data were analyzed from PharMetrics IMS LifeLink™ US Claims Database (20062008). Patients (≥18 years) with 36 months continuous enrollment, ICD-9 code for low back pain, and claims in 3 out of 4 consecutive months in the 12-month prospective period were included and classified with CLBP. Patients were further classified with a neuropathic component (wNP) and without a neuropathic component (woNP) based on ICD-9 codes. Healthcare resources, physical therapy, prescription medication use, and associated costs were assessed for the period January 1December 31, 2008. Results: A number of patients (39,425) were identified with CLBP (90.4% wNP). Patients wNP included more women, were older and more likely to have clinically diagnosed depression, and made significantly greater use of any prescription medication at index event, opioids (particularly schedule II), and healthcare resources. Total direct costs of CLBP-related resource use were ∼US$96 million over a 12-month follow-up. CLBP wNP accounted for 96% of total costs and mean annual cost of care/patient was ∼160% higher than CLBP patients woNP (US$ 2577 vs US$ 1007, p<0.0001). Limitations: This study was descriptive and was not designed to demonstrate causality between diagnosis, treatment, and outcomes. Resource use and costs for reasons other than LBP were not included. Patients with neuropathic pain are more likely to seek treatment; therefore CLBP patients with a non-neuropathic component may be under-represented. Conclusions: The disproportionately high share of interventional resource use in CLBP wNP suggests greater need for new treatment options that more comprehensively manage the range of pain symptoms and signaling mechanisms involved, to help improve patient outcomes and reduce the burden on healthcare systems. © 2012 Informa UK Ltd.


Rosenstock J.,Dallas Diabetes and Endocrine Center at Medical City | Aggarwal N.,Aggarwal and Associates Ltd. | Polidori D.,Janssen Global Services LLC | Zhao Y.,Janssen Global Services LLC | And 4 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy. RESEARCH DESIGN AND METHODS - This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed. RESULTS - Canagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by -16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low. CONCLUSIONS - Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. © 2012 by the American Diabetes Association.


Willis M.,Swedish Institute for Health Economics | Asseburg C.,ESiOR Oy | He J.,Janssen Global Services LLC
Journal of Medical Economics | Year: 2013

Objective: This study constructed the Economic and Health Outcomes Model for type 2 diabetes mellitus (ECHO-T2DM), a long-term stochastic microsimulation model, to predict the costs and health outcomes in patients with T2DM. Naturally, the usefulness of the model depends upon its predictive accuracy. The objective of this work is to present results of a formal validation exercise of ECHO-T2DM. Methods: The validity of ECHO-T2DM was assessed using criteria recommended by the International Society for Pharmacoeconomics and Outcomes Research/Society for Medical Decision Making (ISPOR/SMDM). Specifically, the results of a number of clinical trials were predicted and compared with observed study end-points using a scatterplot and regression approach. An F-test of the best-fitting regression was added to assess whether it differs statistically from the identity (45°) line defining perfect predictions. In addition to testing the full model using all of the validation study data, tests were also performed of microvascular, macrovascular, and survival outcomes separately. The validation tests were also performed separately by type of data (used vs not used to construct the model, economic simulations, and treatment effects). Results: The intercept and slope coefficients of the best-fitting regression line between the predicted outcomes and corresponding trial end-points in the main analysis were -0.0011 and 1.067, respectively, and the R2 was 0.95. A formal F-test of no difference between the fitted line and the identity line could not be rejected (p=0.16). The high R2 confirms that the data points are closely (and linearly) associated with the fitted regression line. Additional analyses identified that disagreement was highest for macrovascular end-points, for which the intercept and slope coefficients were 0.0095 and 1.225, respectively. The R2 was 0.95 and the estimated intercept and slope coefficients were 0.017 and 1.048, respectively, for mortality, and the F-test was narrowly rejected (p=0.04). The sub-set of microvascular end-points showed some tendency to over-predict (the slope coefficient was 1.095), although concordance between predictions and observed values could not be rejected (p=0.16). Limitations: Important study limitations include: (1) data availability limited one to tests based on end-of-study outcomes rather than time-varying outcomes during the studies analyzed; (2) complex inclusion and exclusion criteria in two studies were difficult to replicate; (3) some of the studies were older and reflect outdated treatment patterns; and (4) the authors were unable to identify published data on resource use and costs of T2DM suitable for testing the validity of the economic calculations. Conclusions: Using conventional methods, ECHO-T2DM simulated the treatment, progression, and patient outcomes observed in important clinical trials with an accuracy consistent with other well-accepted models. Macrovascular outcomes were over-predicted, which is common in health-economic models of diabetes (and may be related to a general over-prediction of event rates in the United Kingdom Prospective Diabetes Study [UKPDS] Outcomes Model). Work is underway in ECHO-T2DM to incorporate new risk equations to improve model prediction. © 2013 All rights reserved: reproduction in whole or part not permitted.

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