A Review of Chronic Granulomatous Disease
AbstractChronic granulomatous disease (CGD) is a primary immunodeficiency caused by defects in any of the five subunits of the NADPH oxidase complex responsible for the respiratory burst in phagocytic leukocytes. Patients with CGD are at increased risk of life-threatening infections with catalase-positive bacteria and fungi and inflammatory complications such as CGD colitis. The implementation of routine antimicrobial prophylaxis and the advent of azole antifungals has considerably improved overall survival. Nevertheless, life expectancy remains decreased compared to the general population. Inflammatory complications are a...
Source: Advances in Therapy - November 22, 2017 Category: Drugs & Pharmacology Source Type: research

Dispensing Patterns of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration: A Retrospective Cohort Study in Australia
ConclusionsRanibizumab and aflibercept are dispensed in a similar manner by Australian pharmacies during the first year of treatment.FundingNovartis Pharma AG. (Source: Advances in Therapy)
Source: Advances in Therapy - November 21, 2017 Category: Drugs & Pharmacology Source Type: research

Systematic Literature Review of the Impact of Endocrine Monotherapy and in Combination with Targeted Therapy on Quality of Life of Postmenopausal Women with HR+/HER2 − Advanced Breast Cancer
ConclusionsET  + TT users experienced similar QoL in the first-line and ET-failure setting relative to patients on ET mono. Moreover, ET + TT users experienced better QoL outcomes in some domains in the ET-failure setting relative to ET mono users.FundingNovartis. (Source: Advances in Therapy)
Source: Advances in Therapy - November 16, 2017 Category: Drugs & Pharmacology Source Type: research

Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer
ConclusionA regimen incorporating a moisturizer plus body wash delayed AD flares by nearly 2  months compared to body wash alone, and yielded high patient satisfaction.FundingGalderma R&D.Trial RegistrationClinicalTrials.gov identifier, NCT02589392. (Source: Advances in Therapy)
Source: Advances in Therapy - November 16, 2017 Category: Drugs & Pharmacology Source Type: research

Update on the Treatment of Uveitis in Patients with Juvenile Idiopathic Arthritis: A Review
AbstractChronic uveitis is a common extra-articular manifestation of juvenile idiopathic arthritis. The classic clinical picture is one of chronic anterior uveitis, which usually remains asymptomatic until ocular complications arise. The risk of uveitis is increased in girls with an early onset of oligoarthritis and positive antinuclear antibodies. Even though the inflammation in patients with juvenile idiopathic arthritis is initially limited in the anterior part of the eye, chronic active inflammation may eventually cause significant damage to the posterior pole. Complications may include band keratopathy, cataract, seco...
Source: Advances in Therapy - November 16, 2017 Category: Drugs & Pharmacology Source Type: research

The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies
ConclusionThe findings of the hepatic impairment study indicate that no dosing adjustment is required in patients with moderate hepatic impairment. In the renal impairment study, systemic amenamevir exposure was increased by renal impairment. However, it is unlikely that renal impairment will have a significant effect on the safety of amenamevir given that in previous pharmacokinetic and safety studies in healthy individuals amenamevir was safe and well tolerated after a single dose (5 –2400 mg, fasted condition) and repeated doses for 7 days (300 or 600 mg, fed condition), and the amount of amenamevir expo...
Source: Advances in Therapy - November 13, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies
ConclusionAmenamevir had less than dose proportional pharmacokinetic characteristics. Age may have an influence on amenamevir pharmacokinetics; however, the effect was considered minimal. The pharmacokinetics of amenamevir were affected by food, with AUCinf almost doubling when amenamevir was administered with food. The concentration versus time profile of the tablet was slightly lower than that of the capsule; the relative bioavailability of the tablet versus the capsule was 86%. Amenamevir was safe and well tolerated in the dose range investigated.FundingAstellas Pharma.Trial registrationClinicalTrials.gov identifiers NC...
Source: Advances in Therapy - November 13, 2017 Category: Drugs & Pharmacology Source Type: research

Overall Survival of Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma Treated with Nimotuzumab in the Real World
ConclusionsOur study shows that nimotuzumab treatment concurrent with chemoradiotherapy increases the survival of real-world patients with locally advanced or metastatic esophageal squamous cell carcinoma. Further prospective studies are required to confirm the therapeutic effectiveness of nimotuzumab in esophageal cancer. (Source: Advances in Therapy)
Source: Advances in Therapy - November 13, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice
AbstractIntroductionThe effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler®) in the daily clinical practice of asthma therapy.MethodsThis multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8  ± 17.9 years) with asthma treated with Bufomix...
Source: Advances in Therapy - November 8, 2017 Category: Drugs & Pharmacology Source Type: research

The Concomitant Use of Diuretics, Non-Steroidal Anti-Inflammatory Drugs, and Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers (Triple Whammy), Extreme Heat, and In-Hospital Acute Kidney Injury in Older Medical Patients
ConclusionsTW use on admission did not predict in-hospital AKI, LOS, or mortality in older medical patients admitted either during periods of normal environmental temperature or during HWs. (Source: Advances in Therapy)
Source: Advances in Therapy - November 7, 2017 Category: Drugs & Pharmacology Source Type: research

The Better Understanding and Recognition of the Disconnects, Experiences, and Needs of Patients with Chronic Idiopathic Constipation (BURDEN-CIC) Study: Results of an Online Questionnaire
ConclusionBURDEN-CIC identified that many patients and HCPs are frustrated and not satisfied with current CIC treatments due to lack of efficacy and side effects, such as diarrhea. The survey identified that many patients are “accepting” of their disease, potentially compromising treatment outcomes. More dialogue is needed between HCPs and CIC patients, especially regarding management of treatment expectations and side effects. Further, additional treatment options would be useful for both patients and HCPs.FundingSynergy Pharmaceuticals Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - November 6, 2017 Category: Drugs & Pharmacology Source Type: research

Paliperidone Palmitate Improves and Maintains Functioning in Asia –Pacific Patients with Schizophrenia
AbstractIntroductionPost hoc analyses (two single-arm studies) were conducted to determine the impact of once-monthly injection of paliperidone palmitate on functioning in adult patients with schizophrenia in the Asia –Pacific region.MethodsStudy 1 enrolled hospitalized patients with acute exacerbation of schizophrenia, and study 2 enrolled patients with recently diagnosed schizophrenia unsatisfactorily treated with oral antipsychotics. Patients received paliperidone palmitate, 150  mg eq. on day 1, 100 mg eq. on day 8, then once monthly (50–150 mg eq.) (study 1, days 36 and 64; st...
Source: Advances in Therapy - November 3, 2017 Category: Drugs & Pharmacology Source Type: research

Changes in Healthcare Spending After Diagnosis of Comorbidities Among Endometriosis Patients: A Difference-in-Differences Analysis
AbstractIntroductionWe sought to characterize changes in healthcare spending associated with the onset of 22 endometriosis-related comorbidities.MethodsWomen aged 18 –49 years with endometriosis (N = 180,278) were extracted from 2006–2015 de-identified Clinformatics® DataMart claims data. For 22 comorbidities, comorbidity patients were identified on the basis of having a first comorbidity diagnosis after their initial endometriosis diagnosis. Controls were identified on the basis of having no comorbidity diagnosis and were matched 1:1 to comorbidity patients on demographics and baseline spend...
Source: Advances in Therapy - November 3, 2017 Category: Drugs & Pharmacology Source Type: research

Muscle Relaxants as a Risk Factor for Vis- à-tergo During Penetrating Keratoplasty: A Prospective Interventional Study
This study aimed to investigate the influence of three muscle relaxants on intraocular pressure (IOP), ocular pulse amplitude (OPA), and vis- à-tergo (VAT) in patients undergoing penetrating keratoplasty (PKP) under general anesthesia.MethodsNinety-five patients undergoing PKP were included in this prospective single-center interventional study. IOP and OPA were measured with a dynamic contour tonometer before and 5 min after onset of general anesthesia. Mivacurium (n = 30), atracurium (n = 35), and rocuronium (n = 30) were administered as nondepolarizing muscle relaxants. VAT was asses...
Source: Advances in Therapy - November 3, 2017 Category: Drugs & Pharmacology Source Type: research

Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study
We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD.MethodsThis was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age  40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and  50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled c...
Source: Advances in Therapy - November 1, 2017 Category: Drugs & Pharmacology Source Type: research

Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews
ConclusionBloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening.FundingIronwood Pharmaceuticals.Trial RegistrationClinicalTrials.gov identifier NCT02289846. (Source: Advances in Therapy)
Source: Advances in Therapy - October 27, 2017 Category: Drugs & Pharmacology Source Type: research

Clinical and Economic Outcomes in Elderly Advanced Renal Cell Carcinoma Patients Starting Pazopanib or Sunitinib Treatment: A Retrospective Medicare Claims Analysis
ConclusionsAmong elderly Medicare patients with advanced RCC, first-line pazopanib tretament was associated with significantly longer OS, as well as lower healthcare costs and HRU, compared with first-line sunitinib treatment. (Source: Advances in Therapy)
Source: Advances in Therapy - October 26, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic Evaluation of the Interactions of Amenamevir (ASP2151) with Ketoconazole, Rifampicin, Midazolam, and Warfarin in Healthy Adults
ConclusionThese findings confirm that amenamevir (as a cytochrome P450 3A4 substrate) can interact with ketoconazole or rifampicin, and (as a cytochrome P450 3A4 inducer) can interact with midazolam; however, no interaction between amenamevir and (S)-warfarin was observed, indicating that amenamevir is not an inducer of cytochrome P450 2C9.FundingAstellas Pharma.Trial registrationEudraCT2007-002227-33 (study 15L-CL-008), EudraCT2007-002228-14 (study 15L-CL-009), EudraCT2007-002761-13 (study 15L-CL-010), and EudraCT2007-002779-14 (study 15L-CL-018). (Source: Advances in Therapy)
Source: Advances in Therapy - October 26, 2017 Category: Drugs & Pharmacology Source Type: research

Prevalence of Co-existing Autoimmune Disease in Rheumatoid Arthritis: A Cross-Sectional Study
ConclusionPatients with RA have more concurrent autoimmune diseases than patients with OA. These data suggest that the interrelationship between RA and other autoimmune diseases, and outcomes associated with the occurrence of multiple autoimmune diseases, may play an important role in disease understanding, management, and treatment decisions.FundingBristol-Myers Squibb. (Source: Advances in Therapy)
Source: Advances in Therapy - October 24, 2017 Category: Drugs & Pharmacology Source Type: research

Treatment Persistence and Healthcare Costs Among Patients with Rheumatoid Arthritis Changing Biologics in the USA
This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers.MethodsThis study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1  year. The index date was the date of the change in therapy. Treatment persistence was defined as no subsequent switch or 60-day...
Source: Advances in Therapy - October 16, 2017 Category: Drugs & Pharmacology Source Type: research

Treatment Patterns, Complications, and Health Care Utilization Among Endometriosis Patients Undergoing a Laparoscopy or a Hysterectomy: A Retrospective Claims Analysis
ConclusionThis study indicated significantly different 1-year post-surgical outcomes for patients who underwent an endometriosis-related hysterectomy relative to a laparoscopy. Furthermore, the endometriosis patients in this analysis had a considerable risk of surgical complications, subsequent surgeries, and hospital admissions, both during and after their initial therapeutic laparoscopy or hysterectomy.FundingAbbVie. (Source: Advances in Therapy)
Source: Advances in Therapy - October 16, 2017 Category: Drugs & Pharmacology Source Type: research

Effects of Ketoconazole on the Pharmacokinetics of Mifepristone, a Competitive Glucocorticoid Receptor Antagonist, in Healthy Men
ConclusionSystemic exposure to mifepristone increased following multiple doses of mifepristone 600  mg daily plus ketoconazole 200 mg twice daily. Little to no increase in AEs occurred. Dose adjustment of mifepristone may be needed when given with ketoconazole.FundingCorcept Therapeutics. (Source: Advances in Therapy)
Source: Advances in Therapy - October 11, 2017 Category: Drugs & Pharmacology Source Type: research

Sepsis: A Review of Advances in Management
This article reviews key elements of sepsis management, focusing on diagnosis, biomarkers and therapy. The main recent advance in therapy is the strategy of personalized medicine, based on a precise approach using biomarkers to identify specific individuals who are likely to benefit from more personalized attention. (Source: Advances in Therapy)
Source: Advances in Therapy - October 11, 2017 Category: Drugs & Pharmacology Source Type: research

Assessing the Role of Reversible Contraceptives in the Health Care of Women as it Pertains to Cancer Prevention
We present here the current understanding of the role of effective and reversible contraceptives in the prevention and development of female genital cancers along with breast and colon cancers. Despite ongoing but unsubstantiated concerns regarding the use of hormonal and intrauterine contraceptives for a variety of clinical outcomes including cancer, contraceptive use in high- and low-risk reproductive-aged women remains an important part of cancer risk reduction for many malignancies. (Source: Advances in Therapy)
Source: Advances in Therapy - October 11, 2017 Category: Drugs & Pharmacology Source Type: research

Challenges Associated with Estimating Utility in Wet Age-Related Macular Degeneration: A Novel Regression Analysis to Capture the Bilateral Nature of the Disease
AbstractIntroductionThe estimation of utility values for the economic evaluation of therapies for wet age-related macular degeneration (AMD) is a particular challenge. Previous economic models in wet AMD have been criticized for failing to capture the bilateral nature of wet AMD by modelling visual acuity (VA) and utility values associated with the better-seeing eye only.MethodsHere we present a de novo regression analysis using generalized estimating equations (GEE) applied to a previous dataset of time trade-off (TTO)-derived utility values from a sample of the UK population that wore contact lenses to simulate visual de...
Source: Advances in Therapy - October 10, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacotherapy Choice Is Associated with 2-Year Mortality for Patients with Heart Failure and Reduced Ejection Fraction
ConclusionIPT was associated with decreased 2-year mortality risk. Timely consideration of triple IPT therapies may be warranted once HFrEF diagnosis is confirmed.FundingNovartis Pharmaceuticals Corp. located in East Hanover, NJ, USA. (Source: Advances in Therapy)
Source: Advances in Therapy - October 10, 2017 Category: Drugs & Pharmacology Source Type: research

Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development
This article is a companion paper to G. Salles, et al., which is also published in this issue.FundingF. Hoffmann-La Roche Ltd. (Source: Advances in Therapy)
Source: Advances in Therapy - October 5, 2017 Category: Drugs & Pharmacology Source Type: research

Rituximab in B-Cell Hematologic Malignancies: A Review of 20 Years of Clinical Experience
This article is a companion paper to A. Davies, et al., which is also published in this issue.FundingF. Hoffmann-La Roche Ltd., Basel, Switzerland. (Source: Advances in Therapy)
Source: Advances in Therapy - October 5, 2017 Category: Drugs & Pharmacology Source Type: research

Mechanical Ventilation During Resuscitation: How Manual Chest Compressions Affect a Ventilator ’s Function
AbstractIntroductionGuidelines for resuscitation recommend positive-pressure ventilation with a fixed ventilation rate as provided by an automated transport ventilator during cardiopulmonary resuscitation (CPR) with a secured airway. We investigated the influence of manual chest compressions (CC) on the accuracy of ventilator presets and the quality of CC with intermittent positive-pressure ventilation (IPPV), bilevel ventilation (BiLevel), and the novel ventilation mode chest compression synchronized ventilation (CCSV) in a simulation model.MethodsNinety paramedics performed continuous CC for 2 min on a modified advanced ...
Source: Advances in Therapy - October 5, 2017 Category: Drugs & Pharmacology Source Type: research

Modeled Health Economic Impact of a Hypothetical Certolizumab Pegol Risk-Sharing Scheme for Patients with Moderate-to-Severe Rheumatoid Arthritis in Finland
ConclusionThe present analysis estimated that CZP, with or without the risk-sharing scheme, is a cost-effective alternative treatment for RA patients in Finland. The surplus provided by the CZP risk-sharing scheme could fund treatment for 6% more Finnish RA patients.FundingUCB Pharma. (Source: Advances in Therapy)
Source: Advances in Therapy - October 3, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacological and Non-pharmacological Treatments for Stroke Prevention in Patients with Atrial Fibrillation
AbstractAtrial fibrillation (AF) is associated with significant risk of stroke and other thromboembolic events, which can be effectively prevented using oral anticoagulation (OAC) with either vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, or edoxaban. Until recently, VKAs were the only available means for OAC treatment. NOACs had similar efficacy and were safer than or as safe as warfarin with respect to reduced rates of hemorrhagic stroke or other intracranial bleeding in the respective pivotal randomized clinical trials (RCTs) of stroke prevention in non-valvular AF...
Source: Advances in Therapy - September 27, 2017 Category: Drugs & Pharmacology Source Type: research

Content Validity of a Willingness to Quit Tool for Use with Current Smokers in Clinical Practice
ConclusionThe WTQ tool is a brief tool to assess willingness to quit and to engage communication between patients and physicians. All smokers should be offered smoking cessation support and facilitating a discussion on willingness to quit further supports a personalized quit plan.FundingPfizer Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - September 22, 2017 Category: Drugs & Pharmacology Source Type: research

Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study
ConclusionNB may be effective in reducing binge eating symptoms associated with MDD and overweight/obesity. Evaluation of NB in BED appears warranted.FundingOrexigen Therapeutics, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - September 16, 2017 Category: Drugs & Pharmacology Source Type: research

Methodological Aspects in Studies Based on Clinical Routine Data
AbstractAbstractRandomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demo...
Source: Advances in Therapy - September 12, 2017 Category: Drugs & Pharmacology Source Type: research

Insulin Resistance and Hunger in Childhood Obesity: A Patient and Physician ’s Perspective
This article is co-authored by the mother of a child with obesity and insulin resistance, who gives her perspective. It is also co-authored by the treating Obesity Medicine clinician and an investigator in obesity clinical research (both certified in Obesity Medicine), who give their perspectives. The discussion focuses upon the potential clinical use of metformin in managing young patients with obesity and insulin resistance. The article integrates what is scientifically known about the mechanisms of actions of metformin and how these mechanisms are reflected in the clinical response of young patients. (Source: Advances in Therapy)
Source: Advances in Therapy - September 7, 2017 Category: Drugs & Pharmacology Source Type: research

Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial
ConclusionsThis healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol.Trial RegistrationClinicalTrials.gov number: NCT02345161.FundingGSK (Source: Advances in Therapy)
Source: Advances in Therapy - September 5, 2017 Category: Drugs & Pharmacology Source Type: research

The Impact of Histologic Phenotype in the Treatment of Sinonasal Cancer
AbstractThe management of sinonasal cancer is a challenge due to its low occurrence and anatomical and significant diversity of histological types. The therapeutic modality used should be tailored individually according to the histology, tumour stage, molecular profile and previous treatments. The clinical management of sinonasal cancer has improved greatly owing to developments in endoscopic surgery and precision radiotherapy. Complete surgical resection is the mainstay of sinonasal malignancies' management but multimodality therapy is associated with improved outcomes in certain histologies. The recognition of various hi...
Source: Advances in Therapy - September 4, 2017 Category: Drugs & Pharmacology Source Type: research

Erratum to: Multicenter, Randomized, Investigator-Masked Study Comparing Brimonidine Tartrate 0.1% and Timolol Maleate 0.5% as Adjunctive Therapies to Prostaglandin Analogues in Normal-Tension Glaucoma
(Source: Advances in Therapy)
Source: Advances in Therapy - August 30, 2017 Category: Drugs & Pharmacology Source Type: research

Erratum to: Gluten and Aluminum Content in Synthroid ® (Levothyroxine Sodium Tablets)
(Source: Advances in Therapy)
Source: Advances in Therapy - August 30, 2017 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Linagliptin in 2681 Asian Patients Stratified by Age, Obesity, and Renal Function: A Pooled Analysis of Randomized Clinical Trials
AbstractIntroductionAsian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes.MethodsData from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin  ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at le...
Source: Advances in Therapy - August 17, 2017 Category: Drugs & Pharmacology Source Type: research

The Challenge of Assessing Adherence to Subcutaneous Biological Drugs in Immune-Mediated Inflammatory Diseases. Letter to the Editor Regarding Michetti P, Weinman J, Mrowietz U, et al. Adv Ther (2017);34:91 –108. doi:10.1007/s12325-016-0441-3
(Source: Advances in Therapy)
Source: Advances in Therapy - August 17, 2017 Category: Drugs & Pharmacology Source Type: research

A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers
ConclusionsThe pirfenidone 801-mg tablet met bioequivalence criteria when compared with three 267-mg capsules in the fasted state. The tabletCmax was slightly higher relative to capsules in the fed state, but this is not expected to have a clinically meaningful impact on the benefit –risk profile of pirfenidone.FundingThis work was supported by F. Hoffmann-La Roche Ltd. (Source: Advances in Therapy)
Source: Advances in Therapy - August 14, 2017 Category: Drugs & Pharmacology Source Type: research

Assessment of Pharmacokinetic Interactions Between Obeticholic Acid and Caffeine, Midazolam, Warfarin, Dextromethorphan, Omeprazole, Rosuvastatin, and Digoxin in Phase 1 Studies in Healthy Subjects
ConclusionIn these studies, OCA showed weak to no suppression/inhibition of metabolic enzymes and drug transporters at the highest recommended therapeutic dose in patients with PBC. On the basis on these analyses, monitoring and maintenance of target INR range are required during coadministration of OCA with drugs that are metabolized by CYP1A2 (R-warfarin).FundingIntercept Pharmaceuticals, Inc. (Source: Advances in Therapy)
Source: Advances in Therapy - August 14, 2017 Category: Drugs & Pharmacology Source Type: research

Cost-Effectiveness of Posaconazole Tablets for Invasive Fungal Infections Prevention in Acute Myelogenous Leukemia or Myelodysplastic Syndrome Patients in Spain
ConclusionFrom the Spanish NHS perspective, posaconazole tablets are cost-effective compared to FLU or ITRA in AML or MSD patients with chemotherapy-induced neutropenia and at high risk for IFDs.FundingMSD Sharp& Dohme. (Source: Advances in Therapy)
Source: Advances in Therapy - August 14, 2017 Category: Drugs & Pharmacology Source Type: research

Foveal Microstructure Analysis in Eyes with Diabetic Macular Edema Treated with Vitrectomy
AbstractIntroductionThe purpose of this study was to evaluate baseline and postoperative factors affecting outcomes after vitrectomy for diabetic macular edema (DME) using optical coherence tomography (OCT).MethodsVitrectomy combined with inner limiting membrane (ILM) peeling and additional laser photocoagulation therapy was performed on 36 eyes of 30 DME patients. Evaluations included the logarithm of the minimal angle of resolution (logMAR), best-corrected visual acuity (BCVA) and OCT parameters at baseline and 1, 3, 6, and 12  months postoperatively. Correlations between OCT parameters and BCVA were assessed at eac...
Source: Advances in Therapy - August 14, 2017 Category: Drugs & Pharmacology Source Type: research

Health-Related Quality of Life in Individuals with Down Syndrome: Results from a Non-Interventional Longitudinal Multi-National Study
ConclusionThe findings of this study underline that further research is needed to better understand the nature of HRQoL in DS. Further research using a shorter time interval between assessment time points to examine test-retest reliability is also required.FundingF. Hoffmann-La Roche Ltd. (Source: Advances in Therapy)
Source: Advances in Therapy - August 9, 2017 Category: Drugs & Pharmacology Source Type: research

The Patterns of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Use in Patients with Atrial Fibrillation in Seven Balkan Countries: a Report from the BALKAN-AF Survey
AbstractIntroductionData on management of atrial fibrillation (AF) in the Balkan Region are scarce. To capture the patterns in AF management in contemporary clinical practice in the Balkan countries a prospective survey was conducted between December 2014 and February 2015, and we report results pertinent to the use of non-vitamin K antagonist oral anticoagulants (NOACs).MethodsA 14-week prospective, multicenter survey of consecutive AF patients seen by cardiologists or internal medicine specialists was conducted in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Romania, and Serbia (a total of about 50 mil...
Source: Advances in Therapy - August 9, 2017 Category: Drugs & Pharmacology Source Type: research

Hypoglycemia After Initiation of Basal Insulin in Patients with Type 2 Diabetes in the United States: Implications for Treatment Discontinuation and Healthcare Costs and Utilization
This study aimed to determine the impact of hypoglycemia soon after basal insulin initiation on treatment discontinuation and economic outcomes in patients with T2D.MethodsHypoglycemic events within 6  months of basal insulin initiation were identified using retrospective cohort data from patients with T2D, at least 18 years of age, initiated on basal insulin therapy in the Clinformatics™ Data Mart for Multiplan claims database from January 1, 2008, through August 31, 2012. Data were adjusted for baseline characteristics. Discontinuation was established for patients with 12-month follow-up data, while disco...
Source: Advances in Therapy - August 4, 2017 Category: Drugs & Pharmacology Source Type: research

Changes in Healthcare Utilization After Etanercept Initiation in Patients with Rheumatoid Arthritis: A Retrospective Claims Analysis
ConclusionOverall healthcare utilization decreased after etanercept initiation. Patients who were most compliant with etanercept had significantly lower utilization than less compliant patients.FundingAmgen, Inc (Source: Advances in Therapy)
Source: Advances in Therapy - August 2, 2017 Category: Drugs & Pharmacology Source Type: research

Erratum to: Patient Perspectives on Gene Transfer Therapy for Sickle Cell Disease
(Source: Advances in Therapy)
Source: Advances in Therapy - August 2, 2017 Category: Drugs & Pharmacology Source Type: research