Navigational Bronchoscopy for Early Lung Cancer: A Road to Therapy
This article provides a comprehensive review of these emerging technologies. (Source: Advances in Therapy)
Source: Advances in Therapy - March 22, 2016 Category: Drugs & Pharmacology Source Type: research

Exposure–Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study
Conclusions In Japanese patients, there were no associations or only shallow relationships between DAA exposures and peripheral edema or laboratory abnormalities. Consequently, therapeutic drug monitoring is not expected to be beneficial in managing patients on the 2-DAA regimen. Trial registration ClinicalTrials.gov identifier, NCT02023099. Funding AbbVie Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - March 21, 2016 Category: Drugs & Pharmacology Source Type: research

Cervical Lymph Node Metastasis in Adenoid Cystic Carcinoma of the Larynx: A Collective International Review
Abstract Adenoid cystic carcinoma (AdCC) of the head and neck is a well-recognized pathologic entity that rarely occurs in the larynx. Although the 5-year locoregional control rates are high, distant metastasis has a tendency to appear more than 5 years post treatment. Because AdCC of the larynx is uncommon, it is difficult to standardize a treatment protocol. One of the controversial points is the decision whether or not to perform an elective neck dissection on these patients. Because there is contradictory information about this issue, we have critically reviewed the literature from 1912 to 2015 on all rep...
Source: Advances in Therapy - March 19, 2016 Category: Drugs & Pharmacology Source Type: research

Impact of the Topical Ophthalmic Corticosteroid Loteprednol Etabonate on Intraocular Pressure
Abstract Corticosteroids are a mainstay therapeutic option for the treatment of ocular inflammation. However, safety remains a concern for clinicians, particularly with long-term use. Though highly effective at suppressing inflammatory and allergic responses, topical ophthalmic corticosteroids carry an inherent risk of side effects, including elevated intraocular pressure (IOP), a risk factor for the development of glaucoma. The corticosteroid loteprednol etabonate (LE) contains an ester rather than a ketone at the C-20 position, minimizing the potential for side effects, including IOP elevation. In early pivotal ...
Source: Advances in Therapy - March 17, 2016 Category: Drugs & Pharmacology Source Type: research

Expert Consensus on the Management of Patients with Postmenopausal Osteoporosis in the Spanish Healthcare System
Conclusion Efforts should be focused on questions with high divergence between wishes and predictions, defining actions that will improve PMO management. Collaboration between scientific societies and health authorities to address the identified opportunities of improvement is proposed. Funding Amgen S.A. (Source: Advances in Therapy)
Source: Advances in Therapy - March 17, 2016 Category: Drugs & Pharmacology Source Type: research

Indirect Treatment Comparison of Talimogene Laherparepvec Compared with Ipilimumab and Vemurafenib for the Treatment of Patients with Metastatic Melanoma
Conclusion Even with limited data, talimogene laherparepvec, ipilimumab, and vemurafenib could be compared following adjustments, thereby providing a more reliable understanding of the relative effect of treatment on survival in a more comparable patient population. The results of this analysis suggest that OS with talimogene laherparepvec is at least as good as with ipilimumab and vemurafenib and improvement was more pronounced in patients with no bone, brain, lung or other visceral metastases. Funding Amgen Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - March 15, 2016 Category: Drugs & Pharmacology Source Type: research

A Retrospective Cohort Study Comparing Utilization and Costs of Biologic Therapies and JAK Inhibitor Therapy Across Four Common Inflammatory Indications in Adult US Managed Care Patients
Conclusion One-year treatment costs varied considerably between medications and indications. Some newly approved agents had lower costs but further research is needed to confirm these estimates as more patients are treated. Funding Immunex (a wholly owned subsidiary of Amgen Inc.) and Wyeth (acquired by Pfizer). (Source: Advances in Therapy)
Source: Advances in Therapy - March 12, 2016 Category: Drugs & Pharmacology Source Type: research

Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials
Abstract Introduction Erythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney di...
Source: Advances in Therapy - March 10, 2016 Category: Drugs & Pharmacology Source Type: research

Using Patient-Level Data to Develop Meaningful Cross-Trial Comparisons of Visual Impairment in Individuals with Diabetic Macular Edema
Conclusion After adjusting for baseline characteristics, the difference in letters gained between patients receiving ranibizumab versus aflibercept was non-significant across trials, highlighting the importance of adjusting for baseline characteristics in future comparisons. Funding Novartis Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - March 7, 2016 Category: Drugs & Pharmacology Source Type: research

Healthcare Cost of Over-Diagnosis of Low-Grade Dysplasia in Barrett’s Esophagus
Conclusions The healthcare cost of over-diagnosis of BE-LGD is significant. To reduce the overall healthcare cost impact of over-diagnosis of BE-LGD, strict adherence to the recommendations of the American Gastroenterological Association, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy that pathology review of all BE biopsy specimens be performed by a gastrointestinal pathologist is warranted. (Source: Advances in Therapy)
Source: Advances in Therapy - March 4, 2016 Category: Drugs & Pharmacology Source Type: research

Current Perspectives of Prophylaxis and Management of Acute Infective Endophthalmitis
Abstract Endophthalmitis is an intraocular inflammatory condition which may or may not be caused by infective agents. Noninfectious (sterile) endophthalmitis may be attributable to various causes including postoperative retained soft lens matter or toxicity following introduction of other agents into the eye. Infectious endophthalmitis is further subdivided into endogenous and exogenous. In endogenous endophthalmitis there is hematogenous spread of organisms from a distant source of infection whereas in exogenous endophthalmitis direct microbial inoculation may occur usually following ocular surgery or penetrating...
Source: Advances in Therapy - March 2, 2016 Category: Drugs & Pharmacology Source Type: research

The Role of Nuclear Receptors in the Pathophysiology, Natural Course, and Drug Treatment of NAFLD in Humans
Abstract Nonalcoholic fatty liver disease (NAFLD) describes steatosis, nonalcoholic steatohepatitis with or without fibrosis, and hepatocellular carcinoma, namely the entire alcohol-like spectrum of liver disease though observed in the nonalcoholic, dysmetabolic, individual free of competing causes of liver disease. NAFLD, which is a major public health issue, exhibits intrahepatic triglyceride storage giving rise to lipotoxicity. Nuclear receptors (NRs) are transcriptional factors which, activated by ligands, are master regulators of metabolism and also have intricate connections with circadian control accounting...
Source: Advances in Therapy - February 26, 2016 Category: Drugs & Pharmacology Source Type: research

Effect of Telbivudine Versus Other Nucleos(t)ide Analogs on HBeAg Seroconversion and Other Outcomes in Patients with Chronic Hepatitis B: A Network Meta-Analysis
Conclusion At 1 year, telbivudine was superior to adefovir, entecavir and lamivudine in HBeAg seroconversion, and to entecavir and lamivudine in HBeAg loss. Telbivudine was also superior to lamivudine in ALT normalization and to adefovir and lamivudine in suppressing HBV DNA levels. Funding Novartis Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - February 26, 2016 Category: Drugs & Pharmacology Source Type: research

24-h Efficacy of Glaucoma Treatment Options
This article first reviews the concept and value of diurnal and 24-h IOP monitoring. It then critically evaluates selected available evidence on the 24-h efficacy of medical, laser and surgical therapy options. During the past decade several controlled trials have significantly enhanced our understanding on the 24-h efficacy of all glaucoma therapy options. Nevertheless, more long-term evidence is needed to better evaluate the 24-h efficacy of glaucoma therapy and the precise impact of IOP characteristics on glaucomatous progression and visual prognosis. (Source: Advances in Therapy)
Source: Advances in Therapy - February 24, 2016 Category: Drugs & Pharmacology Source Type: research

Review of the Clinical and Economic Burden of Antibody-Mediated Rejection in Renal Transplant Recipients
Abstract Antibody-mediated rejection (AbMR) is a leading cause of late graft loss in kidney transplant recipients, accounting for up to 60% of late graft failures. AbMR manifests as two distinct phenotypes: the first occurs in the immediate post-transplant period in sensitized patients; the second occurs in the late post-transplant period and has been associated with non-adherence to immunosuppression. The present review summarizes the current treatment options for AbMR, its clinical and economic burden, and approaches for reducing the risk of AbMR. While AbMR is typically refractory to treatment with corticos...
Source: Advances in Therapy - February 23, 2016 Category: Drugs & Pharmacology Source Type: research

Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study
Conclusion Mesalazine modified-release tablets were non-inferior to the enteric-coated tablets and may be considered an effective and safe treatment alternative for the maintenance of remission in Chinese patients with UC. Trial registration ClinicalTrials.gov identifier: NCT01257399. Funding Tillotts Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - February 23, 2016 Category: Drugs & Pharmacology Source Type: research

Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study
Conclusion Mesalazine modified-release tablets are non-inferior to enteric-coated tablets and are an effective and safe treatment option in Chinese patients with mildly to moderately active UC. Trial registration ClinicalTrials.gov identifier: NCT01257386. Funding Tillotts Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - February 22, 2016 Category: Drugs & Pharmacology Source Type: research

Cervical Lymph Node Metastasis in High-Grade Transformation of Head and Neck Adenoid Cystic Carcinoma: A Collective International Review
Abstract Adenoid cystic carcinoma (AdCC) is among the most common malignant tumors of the salivary glands. It is characterized by a prolonged clinical course, with frequent local recurrences, late onset of metastases and fatal outcome. High-grade transformation (HGT) is an uncommon phenomenon among salivary carcinomas and is associated with increased tumor aggressiveness. In AdCC with high-grade transformation (AdCC–HGT), the clinical course deviates from the natural history of AdCC. It tends to be accelerated, with a high propensity for lymph node metastasis. In order to shed light on this rare event and, i...
Source: Advances in Therapy - February 19, 2016 Category: Drugs & Pharmacology Source Type: research

Obese Patients with Type 2 Diabetes on Conventional Versus Intensive Insulin Therapy: Efficacy of Low-Calorie Dietary Intervention
Abstract Introduction The aim of this prospective study was to assess the results of a standard low-calorie dietary intervention (7.5 MJ/day) on body weight (BW) and the metabolic profile of obese patients with type 2 diabetes mellitus (T2DM) on intensive insulin therapy (IIT: 4 insulin injections/day) versus conventional insulin therapy (CIT: 2/3 insulin injections/day). Methods A total of 60 patients (n = 60, 23 males and 37 postmenopausal females) were recruited and categorized into two groups according to the scheme of i...
Source: Advances in Therapy - February 17, 2016 Category: Drugs & Pharmacology Source Type: research

Two-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age
Abstract Introduction This ongoing, prospective, open-label, non-comparative, multicenter phase IV study is evaluating the safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope®, Sandoz GmbH) in short children born small for gestational age (SGA). Here we report data from patients who have completed 2 years’ treatment. Methods Eligibility criteria included prepubertal children born SGA with growth disturbances defined as current height standard deviation score (HSDS) 
Source: Advances in Therapy - February 17, 2016 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Aclidinium/Formoterol versus Tiotropium in COPD: Results of an Indirect Treatment Comparison
Conclusion Based on the ITC, aclidinium/formoterol is expected to be more efficacious than tiotropium in terms of lung function and symptom control while providing comparable HRQoL results and safety profile. Funding AstraZeneca. (Source: Advances in Therapy)
Source: Advances in Therapy - February 16, 2016 Category: Drugs & Pharmacology Source Type: research

Current and Future Considerations for the Treatment of Hospital-Acquired Pneumonia
Abstract Hospital-acquired pneumonia (HAP) and health-care-associated pneumonia (HCAP) are leading causes of death, morbidity, and resource utilization in hospitalized patients, and are associated with a broad range of Gram-positive and Gram-negative pathogens. Here, we discuss the different definitions of HAP and HCAP, review current guidelines regarding the treatment of these conditions, highlight the shortcomings of current therapeutic options, and discuss new antibiotic treatments. To optimize therapeutic outcomes in patients with HAP/HCAP, initial antimicrobial treatment must be appropriate and should be giv...
Source: Advances in Therapy - February 9, 2016 Category: Drugs & Pharmacology Source Type: research

Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review
Abstract Introduction Nicorandil is a popular anti-anginal drug in Europe and Japan. Apart from some common adverse drug reactions (ADR), its safety is satisfactory. Several reports have suggested a link between nicorandil, gastrointestinal (GI) ulceration and fistulas. The review aims to critically appraise, synthesize and present the available evidence of all known GI ADR per anatomical location. Methods The study complied with the PRISMA statement. Literature and pharmacovigilance databases were used to provide rate and/or calculate parameters (median...
Source: Advances in Therapy - February 9, 2016 Category: Drugs & Pharmacology Source Type: research

Sustainability of Intraocular Pressure Reduction of Travoprost Ophthalmic Solution in Subjects with Normal Tension Glaucoma
We examined the sustainability of the intraocular pressure (IOP)-lowering efficacy of travoprost (0.004%) ophthalmic solution in subjects with normal tension glaucoma (NTG). Methods Travoprost ophthalmic solution was given once daily at 9 PM to subjects with newly diagnosed NTG or with NTG who had not received any ocular hypotensives within the previous 30 days. IOP was measured at three time points (9 AM, 1 PM, and 5 PM) at baseline and week 12 visits, and at one time point (9 AM) at week 4 and week 8 visits. Conjunctival hyperemia, super...
Source: Advances in Therapy - February 9, 2016 Category: Drugs & Pharmacology Source Type: research

Impact of Reduced Renal Function on the Glucose-Lowering Effects of Luseogliflozin, a Selective SGLT2 Inhibitor, Assessed by Continuous Glucose Monitoring in Japanese Patients with Type 2 Diabetes Mellitus
Abstract Introduction We investigated the impact of reduced renal function on 24-h glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM) treated with luseogliflozin. Methods In this double-blind, placebo-controlled, crossover study, 37 Japanese patients with T2DM [glycated hemoglobin (HbA1c) 7.0–10.0%] and estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 were randomized into two groups in which patients first received luseogliflozin then placebo, or vice versa, for 7 days each. Twenty-four-hou...
Source: Advances in Therapy - February 5, 2016 Category: Drugs & Pharmacology Source Type: research

Methotrexate and Rheumatoid Arthritis: Current Evidence Regarding Subcutaneous Versus Oral Routes of Administration
Abstract Methotrexate (MTX) is still considered the drug of choice in rheumatoid arthritis (RA) management. Comparing subcutaneous (MTX SC) and oral (MTX OR) routes of administration is important to optimize the everyday therapeutic strategy in the real-life setting. This review summarizes scientific evidence currently available on this topic. As shown by pharmacokinetic studies, at the same dose level, bioavailability of MTX SC is significantly higher and less variable than that of MTX OR. This difference is even more pronounced for medium-to-high dosages (i.e., >15 mg/week). With regard to clinical...
Source: Advances in Therapy - February 4, 2016 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics, Pharmacodynamics, and Safety of MEDI4212, an Anti-IgE Monoclonal Antibody, in Subjects with Atopy: A Phase I Study
Conclusions The increased potency of MEDI4212 may be of clinical interest for individuals with high-diagnostic IgE levels where more extensive IgE suppression is required for clinical response. However, the modest duration of free IgE suppression below the target concentration noted with MEDI4212 in this study suggests limited potential for dosing schedule advantages over omalizumab. Funding MedImmune. Trial registration ClinicalTrials.gov identifier, NCT01544348. (Source: Advances in Therapy)
Source: Advances in Therapy - February 3, 2016 Category: Drugs & Pharmacology Source Type: research

Effect of Plasma Sterilization on the Hemostatic Efficacy of a Chitosan Hemostatic Agent in a Rat Model
Abstract Introduction The United States military has had success with chitosan (CS)-based hemostatic agents to control trauma-induced hemorrhages. Despite the positive reviews, additional physical forms of CS may enhance its hemostatic efficacy. Additionally, standard sterilization techniques may negatively affect the hemostatic efficacy of CS. We studied the effects of a CS-based hemostatic pad, the Clo-Sur P.A.D.™ (Scion Cardio-Vascular, Inc.), on severe femoral vessel bleeding in a rat model. The effects of different sterilization techniques on the bioadhesivity, surface atomic concen...
Source: Advances in Therapy - January 30, 2016 Category: Drugs & Pharmacology Source Type: research

Usability and Acceptability of the Abatacept Pre-Filled Autoinjector for the Subcutaneous Treatment of Rheumatoid Arthritis
Conclusion The abatacept autoinjector demonstrated usability without patterns of preventable use errors, and with high acceptability ratings across all key attributes assessed. Preference over competitor autoinjectors was due to device ergonomics, visualization of dose progression, confidence of dose delivery, and overall ease of use. Funding Bristol-Myers Squibb. (Source: Advances in Therapy)
Source: Advances in Therapy - January 30, 2016 Category: Drugs & Pharmacology Source Type: research

Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling
Conclusion Evidence showed that changes in signs and symptoms are closely related to changes in HRQoL. However, analyses were performed on clinical trial results of an extremely effective treatment; a less effective treatment with much smaller changes over time may not show such close correlations. Results suggest that any of these PROMs may be used to understand changes in CSU. (Source: Advances in Therapy)
Source: Advances in Therapy - January 30, 2016 Category: Drugs & Pharmacology Source Type: research

Pivotal Bioequivalence Study of Clopacin ® , a Generic Formulation of Clopidogrel 75 mg Film-Coated Tablets
Conclusion This bioequivalence study provided robust clopidogrel pharmacokinetic data that established the bioequivalence of Clopacin® and the reference originator drug. Funding Acino Pharma AG (formerly Cimex AG) (Source: Advances in Therapy)
Source: Advances in Therapy - January 29, 2016 Category: Drugs & Pharmacology Source Type: research

Differential Protein Expression Profiles in Glaucomatous Trabecular Meshwork: An Evaluation Study on a Small Primary Open Angle Glaucoma Population
Conclusion The analysis of this small TM population highlighted some proteins linked to POAG, some previously reported and others of new detection (IL7, MIPs, sTNFαRI). A larger POAG population is required to select promising disease-associated biomarker candidates. Funding This study was partially supported by the Fondazione Roma, the Italian Ministry of Health and the “National 5xMille 2010 tax donation to IRCCS-G.B. Bietti Foundation”. (Source: Advances in Therapy)
Source: Advances in Therapy - January 28, 2016 Category: Drugs & Pharmacology Source Type: research

Selecting Patients with Ovarian Cancer for Germline BRCA Mutation Testing: Findings from Guidelines and a Systematic Literature Review
Conclusion With the availability of BRCA mutation-targeted therapies, identification of patients with OC with germline BRCA mutations has potential therapeutic consequences. For identified gene carriers, predictive testing to allow cancer prevention strategies, including bilateral salpingo-oophorectomy, provides wider benefit to identifying such gene carriers. Updating guidelines will increase the opportunity for targeted treatment among patients and risk reduction in relatives. Funding AstraZeneca (Source: Advances in Therapy)
Source: Advances in Therapy - January 25, 2016 Category: Drugs & Pharmacology Source Type: research

25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives
Abstract In 1988, the first contrast agent specifically designed for magnetic resonance imaging (MRI), gadopentetate dimeglumine (Magnevist®), became available for clinical use. Since then, a plethora of studies have investigated the potential of MRI contrast agents for diagnostic imaging across the body, including the central nervous system, heart and circulation, breast, lungs, the gastrointestinal, genitourinary, musculoskeletal and lymphatic systems, and even the skin. Today, after 25 years of contrast-enhanced (CE-) MRI in clinical practice, the utility of this diagnostic imaging modality has expand...
Source: Advances in Therapy - January 25, 2016 Category: Drugs & Pharmacology Source Type: research

Comparison of the Efficacy and Safety of Insulin Detemir and Insulin Glargine in Hospitalized Patients with Type 2 Diabetes: A Randomized Crossover Trial
This study compared the two insulin analogs once daily in hospitalized patients with type 2 diabetes (T2D). Methods A total of 55 patients aged 18–80 years with hyperglycemia admitted to the endocrinology wards were screened between June 2014 and February 2015. Forty-two enrolled patients were randomly assigned to receive either insulin detemir followed by insulin glargine once daily (n = 21), or vice versa (n = 21). The two insulin analogs were titrated 0.1 U/kg once daily based on fasting blood glucose (FBG). After achieving FBG
Source: Advances in Therapy - January 25, 2016 Category: Drugs & Pharmacology Source Type: research

The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals
Conclusions Distribution of targeted educational brochures may be an effective risk minimization strategy to raise HCP awareness of new rare and important AEs; educational brochures may also be an effective channel for sharing information on how these AEs can be best managed and on the importance and means of reporting AEs. Funding Celgene Pty Ltd, Melbourne, Australia. (Source: Advances in Therapy)
Source: Advances in Therapy - January 23, 2016 Category: Drugs & Pharmacology Source Type: research

Validation of the Greek Version of the Diabetes Management Self-Efficacy Scale (GR-DMSES)
Abstract Introduction Self-efficacy has been found to have a direct relation with self-care in diabetes. Several tools have been developed and used for evaluating self-efficacy of diabetic patients, the most widely used being the Diabetes Management Self-Efficacy Scale (DMSES). The aim of the present study was to translate, culturally adapt, and validate the Greek DMSES (GR-DMSES) in order for it to be used in the ATTICA pilot study of the SmartCare EU-funded project. Methods Using standard procedures, the original version of DMSES was translated and cul...
Source: Advances in Therapy - January 21, 2016 Category: Drugs & Pharmacology Source Type: research

Use Patterns and Costs of Isolated Limb Perfusion and Infusion in the Treatment of Regional Metastatic Melanoma: A Retrospective Database Analysis
Conclusions Isolated limb perfusion and infusion in patients with melanoma were associated with long hospital stays and high costs. These results provide useful source data for the economic evaluation of treatment options for regional metastatic melanoma. Funding This study was funded by Amgen, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - January 21, 2016 Category: Drugs & Pharmacology Source Type: research

Cost-Effectiveness of Ranibizumab Versus Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion: A UK Healthcare Perspective
Conclusions Ranibizumab provides greater health gains at a lower overall cost than aflibercept in the treatment of visual impairment due to macular edema secondary to BRVO. Ranibizumab is therefore cost-effective from a UK healthcare payer’s perspective. Funding Novartis Pharma AG, Basel, Switzerland (Source: Advances in Therapy)
Source: Advances in Therapy - January 8, 2016 Category: Drugs & Pharmacology Source Type: research

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model
Conclusions This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results. Trial registration Clinicaltrials.gov identifier: NCT02121301. Funding Miotech S.A. (Source: Advances in Therapy)
Source: Advances in Therapy - January 5, 2016 Category: Drugs & Pharmacology Source Type: research

Toxicity and Pharmacokinetics of Sustained-Release Dexamethasone in Beagle Dogs
Conclusion Sustained-release dexamethasone produced no identifiable ocular or systemic toxicity in this animal model, and pharmacokinetics demonstrated a tapered, sustained drug release. Funding Ocular Therapeutix. (Source: Advances in Therapy)
Source: Advances in Therapy - January 5, 2016 Category: Drugs & Pharmacology Source Type: research

Healthcare Costs Among Adults with Type 2 Diabetes Initiating DPP-4 Inhibitors
Abstract Introduction Oral antidiabetes medications, including dipeptidyl peptidase-4 inhibitors (DPP-4is) saxagliptin and sitagliptin, are used for the treatment of type 2 diabetes (T2D). The study objective was to compare all-cause and diabetes-related costs following initiation of saxagliptin or sitagliptin. Methods Patients aged ≥18 years initiating saxagliptin or sitagliptin between January 1, 2009 and January 31, 2012 in the Truven Health MarketScan Commercial and Medicare Supplemental databases were identified. Patients were required to ha...
Source: Advances in Therapy - January 2, 2016 Category: Drugs & Pharmacology Source Type: research

Utilization of Subcutaneous Methotrexate in Rheumatoid Arthritis Patients After Failure or Intolerance to Oral Methotrexate: A Multicenter Cohort Study
Conclusion The long treatment duration of SC MTX highlights its excellent tolerability compared to oral MTX, especially concerning the frequent adverse gastrointestinal events of MTX. Furthermore, long MTX treatment duration provides the opportunity to postpone or even avoid expensive therapies with biologics. The results obtained from the UMAR study provide important information for the utilization and public financing of SC MTX in Portugal. (Source: Advances in Therapy)
Source: Advances in Therapy - January 2, 2016 Category: Drugs & Pharmacology Source Type: research

Transitions in the Prophylaxis, Treatment and Care of Patients with Venous Thromboembolism
Conclusion The prevention and management of VTE can be optimized by the development and local implementation of standardized evidence-based clinical pathways. (Source: Advances in Therapy)
Source: Advances in Therapy - December 16, 2015 Category: Drugs & Pharmacology Source Type: research

Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome
Conclusion Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. Funding Mitotech LLC. (Source: Advances in Therapy)
Source: Advances in Therapy - December 11, 2015 Category: Drugs & Pharmacology Source Type: research

Cost Analyses in the US and Japan: A Cross-Country Comparative Analysis Applied to the PRONOUNCE Trial in Non-Squamous Non-Small Cell Lung Cancer
Conclusion When economic models are based on clinical trial data, many inputs and outcomes are held consistent. The alterable inputs were not in and of themselves large enough to significantly impact the results between countries, which were directionally consistent with greater variation seen in sensitivity analyses. The factors that vary across jurisdictions, even when minor, can have an impact on trial-based economic analyses. Funding Eli Lilly and Company. (Source: Advances in Therapy)
Source: Advances in Therapy - December 9, 2015 Category: Drugs & Pharmacology Source Type: research

Management of Chronic Kidney Disease: The Relationship Between Serum Uric Acid and Development of Nephropathy
Abstract Chronic kidney disease (CKD) is increasingly recognized as a global health problem, and new and effective strategies are needed for the management of this condition. Recently, there has been renewed interest in the relationship between serum uric acid (SUA) levels and CKD, and several recent trials have demonstrated a possible link between SUA and the development and/or progression of CKD in patients with and without diabetes. The identification of key urate transporters such as urate transporter 1 and glucose transporter 9 has provided not only insights into the pathophysiology of hyperuricemia, but also...
Source: Advances in Therapy - December 9, 2015 Category: Drugs & Pharmacology Source Type: research

A Prospective Comparison of the 21-Gene Recurrence Score and the PAM50-Based Prosigna in Estrogen Receptor-Positive Early-Stage Breast Cancer
Conclusion Consistent with prior comparisons between the 21-gene and other genomic assays, our study demonstrated substantial differences in the way patients are risk stratified, suggesting that the different assays are not interchangeable. Funding Genomic Health, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - November 26, 2015 Category: Drugs & Pharmacology Source Type: research

Quantitative Gene Expression by Recurrence Score in ER-Positive Breast Cancer, by Age
Abstract Introduction Breast cancer in young women (
Source: Advances in Therapy - November 26, 2015 Category: Drugs & Pharmacology Source Type: research

Evaluation of Effectiveness and Safety of High-Dose Daptomycin: Results from Patients Included in the European Cubicin ® Outcomes Registry and Experience
Conclusion These results suggested that daptomycin at doses>6 mg/kg/day was effective and well tolerated. High-dose daptomycin is a potential therapeutic option in patients with difficult-to-treat Gram-positive infections. Funding This study was funded by Novartis Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - November 26, 2015 Category: Drugs & Pharmacology Source Type: research