1,923 results match your criteria Advances in therapy[Journal]


Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study.

Adv Ther 2019 Feb 14. Epub 2019 Feb 14.

Astellas Pharma Inc., Tokyo, Japan.

Introduction: The present interim report of the STELLA-LONG TERM study aimed to examine the safety and effectiveness of ipragliflozin in real-word clinical practice in Japan using data up to 12 months. We also evaluated the effect of ipragliflozin on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with normal vs. abnormal liver function. Read More

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http://dx.doi.org/10.1007/s12325-019-0895-1DOI Listing
February 2019

Clinical Management of High and Very High Risk Patients with Hyperlipidaemia in Central and Eastern Europe: An Observational Study.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Amgen Bulgaria EOOD, Sofia, Bulgaria.

Introduction: A retrospective/prospective observational study was conducted to explore the current management of hyperlipidaemia in high-risk (HR) and very high risk (VHR) patients in central/eastern Europe and Israel.

Methods: The study enrolled adult patients who were receiving lipid-lowering therapy and attending a specialist (cardiologist/diabetologist/lipidologist) or internist for a routine visit at 57 sites (including academic/specialist/internal medicine centres) across Bulgaria, Croatia, Czech Republic, Israel, Poland, Romania and Slovakia. Data were collected from medical records, for the 12 months before enrolment, with/without ≤ 6 months' additional prospective follow-up. Read More

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http://dx.doi.org/10.1007/s12325-019-0879-1DOI Listing
February 2019

Matching-Adjusted Indirect Comparison of Blinatumomab vs. Inotuzumab Ozogamicin for Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Centre for Health Economics, University of York, York, UK.

Introduction: In the absence of head-to-head trials, this analysis aimed to provide a fair indirect comparison of the efficacy between blinatumomab and inotuzumab ozogamicin (InO), two treatments for adult patients with relapsed or refractory acute lymphoblastic leukemia (R/R ALL) who received no more than one prior salvage therapy, by adjusting for cross-trial differences.

Methods: Patient-level data from the Phase 3 blinatumomab trial TOWER and published aggregated data from the Phase 3 InO trial INO-VATE-ALL were used to conduct matching-adjusted indirect comparisons. Patients with 2+ prior salvage therapies from TOWER were excluded because such patients were not included in INO-VATE-ALL. Read More

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http://dx.doi.org/10.1007/s12325-019-0873-7DOI Listing
February 2019

Effect of Caffeine on the Bioavailability and Pharmacokinetics of an Acetylsalicylic Acid-Paracetamol Combination: Results of a Phase I Study.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Medical Affairs CHC, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.

Introduction: Caffeine is used as an adjuvant in analgesic combinations to enhance their efficacy. The present study aimed to determine the effect of caffeine on the pharmacokinetics of acetylsalicylic acid (ASA) and paracetamol when used as a fixed-dose ASA/paracetamol/caffeine combination.

Methods: In this single-centre, two-way, cross-over phase I study, volunteers fasted overnight (≥ 12 h) and randomly received single oral doses of 250 mg ASA/200 mg paracetamol (reference) or 250 mg ASA/200 mg paracetamol/50 mg caffeine (test). Read More

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http://link.springer.com/10.1007/s12325-019-0891-5
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http://dx.doi.org/10.1007/s12325-019-0891-5DOI Listing
February 2019
1 Read

Micronized Purified Flavonoid Fraction (MPFF) for Patients Suffering from Chronic Venous Disease: A Review of New Evidence.

Authors:
Jorge H Ulloa

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Fundación Santa Fe de Bogotá, Universidad de Los Andes, Bogotá, Colombia.

Chronic venous disease (CVD) is both prevalent and unavoidable in many people as a result of persistent or unalterable risk factors, the most important of which are advanced age, excess body weight, and family history. Given this inevitability, medical treatment is required to alleviate symptoms and slow disease progression. Venoactive drug therapy is emerging as a valuable treatment option for many CVD patients and micronized purified flavonoid fraction (MPFF) is the most widely prescribed and well-studied venoactive drug available. Read More

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http://dx.doi.org/10.1007/s12325-019-0884-4DOI Listing
February 2019

The Progressive Multifocal Leukoencephalopathy Consortium as a Model for Advancing Research and Dialogue on Rare Severe Adverse Drug Reactions.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Drug Safety Research and Development, Pfizer Inc., La Jolla, CA, USA.

Progressive multifocal leukoencephalopathy (PML) is a rare but serious disease. Caused by the JC virus (JCV), it occurs in individuals with weakened immune systems and is a potential adverse reaction for certain immunomodulatory drugs. The PML Consortium was created to find better methods to predict, prevent, and treat PML. Read More

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http://dx.doi.org/10.1007/s12325-019-0886-2DOI Listing
February 2019

How Does Chronic Venous Disease Progress from the First Symptoms to the Advanced Stages? A Review.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Department of Surgery, Stony Brook University Medical Center, Stony Brook, NY, USA.

Risk factors for the development of progression chronic venous disease (CVD) and varicose veins are widespread and include advanced age, excess body weight, sedentary lifestyles and occupations, family history, and pregnancy. Varicose veins and CVD are associated with venous hypertension, venous reflux, dysfunctional venous valves, and vein wall inflammation, though the precise etiologies are unclear. Once venous pathology develops, it can progress through a vicious cycle of inflammation and leukocyte recruitment that leads to further deterioration of vein walls and valves, increased hypertension, and release of additional proinflammatory mediators. Read More

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http://link.springer.com/10.1007/s12325-019-0885-3
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http://dx.doi.org/10.1007/s12325-019-0885-3DOI Listing
February 2019
1 Read

The Association Between Type 2 Diabetes and Cardiovascular Disease: The "For Your SweetHeart™" Survey.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.

Introduction: It is unclear whether patients and their loved ones appreciate that cardiovascular disease (CVD) is the major cause of morbidity and mortality in type 2 diabetes mellitus (T2DM). The purpose of this survey was to evaluate the degree of awareness regarding the link between T2DM and CVD.

Methods: An online survey was conducted among US adults (general population) and adults with self-reported T2DM. Read More

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http://dx.doi.org/10.1007/s12325-019-0871-9DOI Listing
February 2019

Burden and Suffering in Chronic Venous Disease.

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Department of Surgery, Stony Brook University Medical Center, Stony Brook, NY, USA.

Chronic venous disease (CVD) is widespread, underdiagnosed, and can progress to chronic venous insufficiency and venous ulcers, which can require extensive treatment and hospitalization. These conditions negatively impact patient quality of life and place substantial burdens on healthcare resources. The two main risk factors for CVD are age and obesity. Read More

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http://dx.doi.org/10.1007/s12325-019-0882-6DOI Listing
February 2019

The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence.

Authors:
Alun H Davies

Adv Ther 2019 Feb 13. Epub 2019 Feb 13.

Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, Charing Cross Hospital, London, UK.

Chronic venous disease (CVD) is a prevalent condition that tends to worsen with age. Patients initially seek treatment to relieve symptoms of leg pain, discomfort, heaviness and swelling, all of which impact their quality of life. As the disease increases in severity to include varicose veins, skin changes, and venous ulcer, the demand for treatment increases while the quality of life further diminishes. Read More

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http://dx.doi.org/10.1007/s12325-019-0881-7DOI Listing
February 2019

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives.

Adv Ther 2019 Feb 11. Epub 2019 Feb 11.

Novartis Healthcare Pvt. Ltd., Hyderabad, India.

Maintenance bronchodilator therapy with long-acting β-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) is the cornerstone treatment for patients with stable chronic obstructive pulmonary disease (COPD). Fixed-dose combinations (FDCs) of LABA/LAMA are recommended for the majority of symptomatic COPD patients by global guidelines; regional guidelines such as the Japanese and Korean guidelines also provide similar recommendations for the use of LABA/LAMA FDCs. This review comprehensively describes the latest clinical evidence from key studies on the efficacy and safety of four approved LABA/LAMA fixed-dose combinations: indacaterol/glycopyrronium, vilanterol/umeclidinium, formoterol/aclidinium, and olodaterol/tiotropium. Read More

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http://dx.doi.org/10.1007/s12325-019-0893-3DOI Listing
February 2019
1 Read

Subgroup Analysis for Chinese Patients Included in the INPULSIS Trials on Nintedanib in Idiopathic Pulmonary Fibrosis.

Adv Ther 2019 Feb 7. Epub 2019 Feb 7.

Department of Respiratory Diseases, The First Hospital of China Medical University, Shenyang, China.

Purpose: To investigate the efficacy and safety of nintedanib versus placebo in Chinese patients with idiopathic pulmonary fibrosis (IPF).

Methods: The INPULSIS trials consisted of two replicate, randomized, placebo-controlled, double-blind trials comparing nintedanib 150 mg bid with placebo over a 52-week treatment period. The primary endpoint was annual rate of decline in forced vital capacity (FVC); key secondary endpoints were change from baseline in Saint George's Respiratory Questionnaire's total score and time to first investigator-reported acute exacerbation. Read More

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http://dx.doi.org/10.1007/s12325-019-0887-1DOI Listing
February 2019
1 Read

Insights on Medical Nutrition Therapy for Type 2 Diabetes Mellitus: An Indian Perspective.

Adv Ther 2019 Feb 7. Epub 2019 Feb 7.

Dr. Mohan's Diabetes Specialties Centre, New Delhi, India.

It is critical to integrate medical nutrition therapy (MNT) provided by a registered dietician (RD) into primary care of type 2 diabetes mellitus (T2DM). This is necessary to achieve the goals of improving overall metabolic measures beyond calorie restriction and weight loss. Misconceptions about nutrition in T2DM add to the challenges of executing MNT in a culturally sensitive population. Read More

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http://link.springer.com/10.1007/s12325-019-0872-8
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http://dx.doi.org/10.1007/s12325-019-0872-8DOI Listing
February 2019
2 Reads

Intravitreal Ranibizumab for the Treatment of Visual Impairment Due to Choroidal Neovascularization Associated with Rare Diseases: Cost-Effectiveness in the UK.

Adv Ther 2019 Feb 6. Epub 2019 Feb 6.

BresMed Health Solutions Ltd, Sheffield, UK.

Introduction: This study sought to determine the cost-effectiveness of intravitreal ranibizumab compared with best supportive care (BSC; considered to be no active treatment) for the treatment of visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD) and pathologic myopia (PM) in a UK setting.

Methods: An individual patient-level simulation model was developed to estimate the lifetime costs and quality-adjusted life years (QALYs) of ranibizumab vs. BSC. Read More

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http://dx.doi.org/10.1007/s12325-019-0894-2DOI Listing
February 2019

SOFA Score Can Effectively Predict the Incidence of Sepsis and 30-Day Mortality in Liver Transplant Patients: A Retrospective Study.

Adv Ther 2019 Feb 5. Epub 2019 Feb 5.

Intensive Care Unit, People's Hospital of Zhengzhou, Zhengzhou, 450000, China.

Introduction: This study aims to evaluate the early predictive value for postoperative sepsis and 30-day mortality in liver transplant patients using sequential organ failure assessment (SOFA).

Methods: A total of 96 liver transplant patients were enrolled into this study from February 2015 to June 2018. The general information, biochemical findings, and postoperative 30-day mortality of these patients were statistically analyzed. Read More

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http://dx.doi.org/10.1007/s12325-019-0889-zDOI Listing
February 2019

Characterizing the Health-Related Quality of Life Burden of Overactive Bladder Using Disease-Specific Patient-Reported Outcome Measures: A Systematic Literature Review.

Adv Ther 2019 Feb 4. Epub 2019 Feb 4.

Broadstreet Health Economics and Outcomes Research, Vancouver, BC, Canada.

Introduction: The objective was to identify the most commonly used patient-reported outcome (PRO) instruments for overactive bladder (OAB), determine which are the most useful for measuring burden in OAB and characterize the findings of recent studies that have employed PRO instruments to assess OAB symptoms and the effects of treatment.

Methods: A systematic search of OAB literature published between January 2006 and November 2017 using Medline/PubMed and EMBASE databases.

Results: Of 3425 abstracts and 500 full-text articles reviewed, 58 studies (both clinical trials and observational studies) were included in the review. Read More

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http://dx.doi.org/10.1007/s12325-019-0880-8DOI Listing
February 2019
1 Read

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics.

Adv Ther 2019 Jan 31. Epub 2019 Jan 31.

Flexion Therapeutics, Inc., Burlington, MA, USA.

Introduction: Intra-articular (IA) corticosteroids are used extensively for the treatment of patients with knee osteoarthritis pain. In clinical practice, local anesthetics are frequently combined with corticosteroids prior to IA injection to provide rapid-onset analgesia. From this common practice there is no evidence to suggest that the addition of local anesthetics to corticosteroid preparations, including triamcinolone acetonide (TA), alters the physical properties or efficacy of the corticosteroid. Read More

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http://dx.doi.org/10.1007/s12325-019-0878-2DOI Listing
January 2019
1 Read

Safety Profile of HTX-019 Administered as an Intravenous Push in Cancer Patients: A Retrospective Review.

Authors:
Gary D Walton

Adv Ther 2019 Jan 31. Epub 2019 Jan 31.

Department of Pharmacy, Clearview Cancer Institute, Huntsville, AL, USA.

Introduction: HTX-019 [CINVANTI (aprepitant injectable emulsion)] is a neurokinin 1 receptor antagonist (NK-1 RA) approved as a 30-min infusion for preventing acute and delayed chemotherapy-induced nausea and vomiting. HTX-019 has been generally well tolerated when administered as a 30-min infusion or 2-min injection [intravenous (IV) push] in healthy subjects. This real-world analysis assesses safety of HTX-019 via IV push in patients with cancer and addresses a recent IV bag shortage. Read More

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http://dx.doi.org/10.1007/s12325-019-0877-3DOI Listing
January 2019

Unmet Clinical Need in the Management of Locally Advanced Unresectable Lung Cancer: Treatment Strategies to Improve Patient Outcomes.

Adv Ther 2019 Jan 29. Epub 2019 Jan 29.

Mangalore Institute of Oncology, Mangalore, India.

Stage III locally advanced non-small cell lung cancer (LA NSCLC) comprises the most heterogeneous group of patients, accounts for one-third of patients with lung cancer, and is unresectable at presentation. Multiple treatment approaches have evolved over the past few decades focusing on timing of chemoradiation (concurrent vs. sequential) and sequencing of therapy (induction vs. Read More

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http://dx.doi.org/10.1007/s12325-019-0876-4DOI Listing
January 2019
2.438 Impact Factor

Prospective Observational Cohort Study to Describe the Use of Panitumumab in Combination with Chemotherapy in Real-World Clinical Practice for Patients with Wild-Type RAS mCRC.

Adv Ther 2019 Jan 28. Epub 2019 Jan 28.

Department of Oncology, First Faculty of Medicine, Charles University and Thomayer Hospital, Prague, Czech Republic.

Introduction: This study aimed to better understand panitumumab use in real-life clinical practice in first- and second-line treatment of metastatic colorectal cancer in five European countries.

Methods: This is a combined analysis of two observational, non-interventional prospective cohort studies, one of which was conducted in Germany and France, the other in Bulgaria, Czech Republic, and Hungary. The studies observed patients with wild-type [Kirsten] rat sarcoma viral oncogene homolog ([K]RAS/RAS) metastatic colorectal cancer (mCRC), who had been treated with panitumumab in combination with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) in the first line or with panitumumab combined with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the second line following fluoropyrimidine-based chemotherapy. Read More

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http://dx.doi.org/10.1007/s12325-019-0874-6DOI Listing
January 2019

Posttraumatic Arterial Priapism Treated with Superselective Embolization: Our Clinical Experience and a Review of the Literature.

Adv Ther 2019 Jan 25. Epub 2019 Jan 25.

Department of Urology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, China.

Introduction: To present 12 cases of arterial priapism treated by superselective embolization and propose our management algorithm for this condition.

Methods: Between February 2013 and May 2018, 12 cases of arterial priapism caused by blunt trauma were treated by superselective embolization. The mean age of patients was 36 years (25-47 years). Read More

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http://dx.doi.org/10.1007/s12325-019-0875-5DOI Listing
January 2019
1 Read

Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis.

Adv Ther 2019 Jan 19. Epub 2019 Jan 19.

Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Introduction: This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan.

Methods: This 24-week, single-arm, postmarketing surveillance study (2014-2017), conducted at 75 centers in Japan, enrolled adalimumab-naïve patients (paid workers, including part-time) meeting ClASsification criteria for Psoriatic ARthritis (CASPAR). The primary endpoint was improvement in overall work impairment (OWI) scores from baseline to week 24. Read More

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http://link.springer.com/10.1007/s12325-018-0866-y
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http://dx.doi.org/10.1007/s12325-018-0866-yDOI Listing
January 2019
18 Reads

Continuous Glucose Monitoring: A Brief Review for Primary Care Practitioners.

Adv Ther 2019 Jan 18. Epub 2019 Jan 18.

Department of Medicine and Community and Family Medicine, Duke Southern Regional AHEC, Fayetteville, NC, USA.

Glycated hemoglobin A1c (HbA1c) is routinely used as a marker of average glycemic control, but it fails to provide data on hypoglycemia and glycemic variability, both of which are associated with adverse clinical outcomes. Self-monitoring of blood glucose (SMBG), particularly in insulin-treated patients, is a cornerstone in the management of patients with diabetes. SMBG helps with treatment decisions that aim to reduce high glucose levels while avoiding hypoglycemia and limiting glucose variability. Read More

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http://link.springer.com/10.1007/s12325-019-0870-x
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http://dx.doi.org/10.1007/s12325-019-0870-xDOI Listing
January 2019
6 Reads

Clinical Outcomes, Treatment Patterns, and Health Resource Utilization Among Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutation: A Real-World Retrospective Study.

Adv Ther 2019 Jan 17. Epub 2019 Jan 17.

Statistics, Pfizer Inc., New York, NY, USA.

Introduction: With evolving treatment guidelines for germline BRCA1/2 mutation (gBRCAm) in breast cancer, we present the latest gBRCA testing rates among metastatic breast cancer (mBC) patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) or triple-negative breast cancer (TNBC). Among these patients with gBRCAm, we analyzed clinical outcomes, treatment patterns, and health resource utilization (HRU).

Methods: The Flatiron Health electronic health record database was used to assess gBRCA testing rates in a real-world retrospective analysis of US patients at least 18 years old with HR+/HER2- or TNBC, and with mBC diagnosed from January 2011 to February 2018. Read More

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http://dx.doi.org/10.1007/s12325-018-0867-xDOI Listing
January 2019
2 Reads

Long-Term Efficacy of Tumor Necrosis Factor Inhibitors for the Treatment of Methotrexate-Naïve Rheumatoid Arthritis: Systematic Literature Review and Meta-Analysis.

Adv Ther 2019 Jan 12. Epub 2019 Jan 12.

Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary.

Introduction: Synthesis of evidence on the long-term use of first-line biologic therapy in patients with early rheumatoid arthritis (RA) is required. We compared the efficacy of up to 5 years' treatment with first-line tumor necrosis factor inhibitors (TNFis) versus other treatment strategies in this population.

Methods: Previous systematic reviews, PubMed and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials (RCTs) involving treatment of methotrexate-naïve RA patients with first-line TNFis. Read More

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http://link.springer.com/10.1007/s12325-018-0869-8
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http://dx.doi.org/10.1007/s12325-018-0869-8DOI Listing
January 2019
5 Reads

Correction to: Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.

Adv Ther 2019 Feb;36(2):492-494

Fukushima Eye Clinic, Osaka, Japan.

In the original publication, the range to derive the P values is incorrectly represented in Table 2 and Table 3. The corrected tables are provided below. Read More

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http://dx.doi.org/10.1007/s12325-018-0864-0DOI Listing
February 2019
3 Reads

Patient Preferences for Metastatic Hormone-Sensitive Prostate Cancer Treatments: A Discrete Choice Experiment Among Men in Three European Countries.

Adv Ther 2019 Feb 7;36(2):318-332. Epub 2019 Jan 7.

Acaster Lloyd Consulting Ltd, London, UK.

Introduction: Various treatment options are available for metastatic hormone-sensitive prostate cancer. This study aimed to quantify how men with prostate cancer in the United Kingdom (UK), Germany, and Spain perceive the risks and benefits of hypothetical abiraterone acetate plus prednisone treatment and docetaxel-based chemotherapy treatment options.

Methods: A targeted literature review, exploratory interviews with prostate cancer patients and oncologists, and pre-test interviews were used to develop a discrete choice experiments (DCE). Read More

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http://link.springer.com/10.1007/s12325-018-0861-3
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http://dx.doi.org/10.1007/s12325-018-0861-3DOI Listing
February 2019
11 Reads

Safety and Efficacy of Ripasudil in Japanese Patients with Glaucoma or Ocular Hypertension: 3-month Interim Analysis of ROCK-J, a Post-Marketing Surveillance Study.

Adv Ther 2019 Feb 4;36(2):333-343. Epub 2019 Jan 4.

Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.

Introduction: To evaluate the safety and intraocular pressure (IOP)-lowering effects of a ripasudil 0.4% ophthalmic solution in Japanese patients with glaucoma and ocular hypertension (OH) as a post-marketing surveillance.

Methods: This was a 2-year prospective observational study in patients with glaucoma or OH who had not previously received ripasudil. Read More

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http://dx.doi.org/10.1007/s12325-018-0863-1DOI Listing
February 2019
15 Reads

Optimizing Fixed-Ratio Combination Therapy in Type 2 Diabetes.

Adv Ther 2019 Feb 4;36(2):265-277. Epub 2019 Jan 4.

Department of Family and Community Medicine, University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA.

The progressive nature of type 2 diabetes (T2D) means that many patients will require basal insulin therapy at some point in the course of the disease due to β-cell failure. As basal insulin primarily targets fasting plasma glucose, patients may still experience considerable postprandial glucose excursions and therefore require an additional agent to achieve good glycemic control. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) provide an alternative to prandial insulin, with the benefits of fewer daily injections, and a lower risk of hypoglycemia and weight gain. Read More

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http://link.springer.com/10.1007/s12325-018-0868-9
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http://dx.doi.org/10.1007/s12325-018-0868-9DOI Listing
February 2019
7 Reads

Efficacy and Safety of Deep Sedation in Percutaneous Radiofrequency Ablation for Hepatocellular Carcinoma.

Adv Ther 2019 Feb 3;36(2):344-354. Epub 2019 Jan 3.

Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.

Introduction: Radiofrequency ablation (RFA) has been accepted as safe and effective for treating early-stage hepatocellular carcinoma (HCC). However, it often causes severe pain. Therefore, in this study, we performed RFA under deep sedation and investigated its efficacy and safety. Read More

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http://dx.doi.org/10.1007/s12325-018-0865-zDOI Listing
February 2019
1 Read

Efficacy, Tolerability and Pharmacokinetic Impact of Aprepitant in Sarcoma Patients Receiving Ifosfamide and Doxorubicin Chemotherapy: A Randomized Controlled Trial.

Adv Ther 2019 Feb 3;36(2):355-364. Epub 2019 Jan 3.

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.

Introduction: Aprepitant, a selective neurokinin-1 receptor antagonist approved for prevention of chemotherapy-induced nausea and vomiting (CINV), is an inhibitor of the cytochrome P450 3A4 (CYP3A4) enzyme, which is involved in the clearance of several chemotherapeutic agents. Here we evaluated the efficacy and toxicity of a combination of aprepitant, palonosetron, and dexamethasone as antiemetic prophylaxis in sarcoma patients receiving ifosfamide and doxorubicin chemotherapy, and examined the potential of aprepitant to affect the pharmacokinetics of ifosfamide, which is primarily metabolized by CYP3A4.

Methods: A total of 108 sarcoma patients were randomly assigned to either the aprepitant group (antiemetic regimen: aprepitant, palonosetron, and dexamethasone) or the control group (antiemetic regimen: palonosetron and dexamethasone). Read More

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http://dx.doi.org/10.1007/s12325-018-0862-2DOI Listing
February 2019
1 Read

Angiotensin Receptor Blockers Versus Angiotensin Converting Enzyme Inhibitors for the Treatment of Arterial Hypertension and the Role of Olmesartan.

Adv Ther 2019 Feb 27;36(2):278-297. Epub 2018 Dec 27.

Chair and Division of Cardiology, Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sant'Andrea Hospital, University of Rome Sapienza, Rome, Italy.

Blood pressure lowering by all classes of antihypertensive drugs is accompanied by significant reductions of stroke and major cardiovascular (CV) events. Drugs acting on the renin-angiotensin-aldosterone system, such as angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), showed similar benefit on major CV events to other antihypertensive medications. In real-world practice, ARBs reduced by 10% the incidence of CV mortality, non-fatal myocardial infarction, non-fatal stroke and provided superior protection against CV events than ACEIs in high-risk patients. Read More

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http://dx.doi.org/10.1007/s12325-018-0859-xDOI Listing
February 2019
3 Reads

Healthcare Costs of Smokers Using Varenicline Versus Nicotine-Replacement Therapy Patch in the United States: Evidence from Real-World Practice.

Adv Ther 2019 Feb 19;36(2):365-380. Epub 2018 Dec 19.

Medical Affairs, Pfizer, Inc., New York, NY, USA.

Introduction: Varenicline (VAR) is an effective smoking-cessation therapy compared to the commonly used nicotine-replacement therapy patch (NRT-P). However, comparative real-world evidence on smoking-cessation therapies is limited, especially for economic outcomes.

Methods: Using national claims databases (2012-2016) in the United States (US), adults initiating VAR or NRT-P without use of any other smoking-cessation products were followed for up to 1 year on a quarterly basis. Read More

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http://dx.doi.org/10.1007/s12325-018-0858-yDOI Listing
February 2019
1 Read
2.438 Impact Factor

Comparative Bioavailability of Metformin Hydrochloride Oral Solution Versus Metformin Hydrochloride Tablets in Fasting Mexican Healthy Volunteers.

Adv Ther 2019 Feb 18;36(2):407-415. Epub 2018 Dec 18.

Research and Development Department, Laboratorios Silanes, S.A. de C.V., Mexico City, Mexico.

Introduction: Metformin tablets may be challenging to swallow not only for those patients with dysphagia but also for children and the elderly. A metformin solution was developed for easier administration and flexible dose adjustment mantained with the same bioavailability of tablets. The objective of this study was to assess the single-dose oral bioavailability of metformin hydrochloride administered as an oral solution (500 mg/5 mL) compared with metformin hydrochloride 500 mg tablets in fasting Mexican healthy volunteers. Read More

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http://link.springer.com/10.1007/s12325-018-0853-3
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http://dx.doi.org/10.1007/s12325-018-0853-3DOI Listing
February 2019
14 Reads

Short-Term Assessment of Intravitreal Dexamethasone Implant Using Enhanced-Depth Image Optical Coherence Tomography and Optical Coherence Tomography Angiography in Patients with Retinal Vascular Diseases.

Adv Ther 2019 Feb 18;36(2):416-425. Epub 2018 Dec 18.

Institute of Ophthalmology, Università Cattolica del Sacro Cuore, Rome, Italy.

Introduction: To evaluate the short-term efficacy and safety of intravitreal dexamethasone implant (IDI) in patients with macular oedema associated with diabetic retinopathy (DR) and retinal vein occlusion (RVO) using enhanced-depth image optical coherence tomography (EDI-OCT) and to estimate the effect of dexamethasone on the choroid and the retinal vascular network using OCT angiography (OCTA).

Methods: Fifteen eyes in 15 patients with macular oedema secondary to diabetes (DR, n = 8) or retinal vein occlusion (RVO, n = 7) were treated with intravitreal injection of sustained-release IDI. Primary efficacy end points were changes in best corrected visual acuity and central macular thickness (CMT). Read More

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http://dx.doi.org/10.1007/s12325-018-0848-0DOI Listing
February 2019
1 Read

Pan-European Expert Meeting on the Use of Metronomic Chemotherapy in Advanced Breast Cancer Patients: The PENELOPE Project.

Adv Ther 2019 Feb 18;36(2):381-406. Epub 2018 Dec 18.

IRCCS Mario Negri Institute for Pharmacological Research, Milan, Italy.

Introduction: Metronomic chemotherapy (mCHT) is a treatment regimen in which drugs are administered frequently or continuously and that maintains low, prolonged, and pharmacologically active plasma concentrations of drugs to avoid toxicity associated with traditional chemotherapy regimens, while achieving tumor response. Despite the increasing use of mCHT in patients with metastatic breast cancer (MBC) and the endorsement of mCHT in guidelines, no consensus exists about which patients may substantially benefit from mCHT, which agents can be recommended, and in which treatment setting mCHT is most appropriate.

Methods: In October 2017, ten international experts in the management of breast cancer convened to develop a report describing the current status of the use of mCHT for the treatment of advanced breast cancer, based not only on current literature but also on their opinion. Read More

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http://link.springer.com/10.1007/s12325-018-0844-4
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http://dx.doi.org/10.1007/s12325-018-0844-4DOI Listing
February 2019
11 Reads

Effectiveness of Adjustable Transobturator Male System (ATOMS) to Treat Male Stress Incontinence: A Systematic Review and Meta-Analysis.

Adv Ther 2019 Feb 17;36(2):426-441. Epub 2018 Dec 17.

Departamento Clínico, Universidad Europea de Madrid, Servicio de Urología, Hospital Universitario de Getafe, Getafe, Madrid, Spain.

Introduction: Adjustable transobturator male system (ATOMS) is a surgical device developed to treat male stress urinary incontinence (SUI) after prostate surgery. The objective was to assess the effectiveness of the ATOMS device to treat male SUI as described in the literature.

Methods: Two independent reviewers identified studies eligible for a systematic review and meta-analysis of various sources written in English, German and Spanish, using the databases PubMed, EMBASE and Web of Science. Read More

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http://dx.doi.org/10.1007/s12325-018-0852-4DOI Listing
February 2019
2 Reads

Idiopathic Pulmonary Fibrosis for Cardiologists: Differential Diagnosis, Cardiovascular Comorbidities, and Patient Management.

Adv Ther 2019 Feb 15;36(2):298-317. Epub 2018 Dec 15.

U.O. di Pneumologia e Terapia Semi-Intensiva Respiratoria - Servizio di Fisiopatologia Respiratoria ed Emodinamica Polmonare, Ospedale San Giuseppe - MultiMedica IRCCS, Milan, Italy.

The presence of rare comorbidities in patients with cardiovascular disease (CVD) presents a diagnostic challenge to cardiologists. In evaluating these patients, cardiologists are faced with a unique opportunity to shorten diagnosis times and direct patients towards correct treatment pathways. Idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD), is an example of a rare disease where patients frequently demonstrate comorbid CVD. Read More

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http://dx.doi.org/10.1007/s12325-018-0857-zDOI Listing
February 2019
5 Reads

Efficacy and Safety of CFTR Corrector and Potentiator Combination Therapy in Patients with Cystic Fibrosis for the F508del-CFTR Homozygous Mutation: A Systematic Review and Meta-analysis.

Adv Ther 2019 Feb 15;36(2):451-461. Epub 2018 Dec 15.

Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.

Introduction: Cystic fibrosis (CF) is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time. The combination of a cystic fibrosis transmembrane conductance regulator (CFTR) corrector and potentiator has provided a benefit by decreasing sweat chloride concentration in CF for the F508del-CFTR homozygous mutation, but it remains controversial in lung function, nutritional status, clinical score and safety.

Methods: The authors performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of combination therapy on lung function, nutritional status, clinical score and safety in CF for the F508del-CFTR homozygous mutation. Read More

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http://link.springer.com/10.1007/s12325-018-0860-4
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http://dx.doi.org/10.1007/s12325-018-0860-4DOI Listing
February 2019
24 Reads

Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature.

Adv Ther 2019 Feb 15;36(2):442-450. Epub 2018 Dec 15.

Analytical Method Development Team, Samsung Bioepis Co., Ltd., Incheon, South Korea.

Introduction: Tumor necrosis factor (TNF-alpha) inhibitors, such as adalimumab, have shown success in treating autoimmune inflammatory diseases but are associated with substantial financial burdens to the healthcare system. Biosimilars, which are highly similar to biologic agents, offer the potential to reduce the financial burden of treatment. In the case of TNF-alpha inhibitors, they may also offer improved stability and enable prolonged use. Read More

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http://dx.doi.org/10.1007/s12325-018-0851-5DOI Listing
February 2019
2 Reads

Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study.

Adv Ther 2019 Feb 14;36(2):462-477. Epub 2018 Dec 14.

Service de Néphrologie, Dialyse, Aphérèses et Transplantation, CHU Grenoble Alpes, Grenoble, France.

Introduction: Different prolonged-release formulations of tacrolimus are available. To date, the pharmacokinetic (PK) profile of LCP-tacrolimus (LCPT; Envarsus) has not been compared with PR-Tac (Advagraf) in de novo kidney transplant recipients. These profiles will guide clinical recommendations for the initiation and dose titration strategies of once-daily tacrolimus formulations. Read More

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http://dx.doi.org/10.1007/s12325-018-0855-1DOI Listing
February 2019
2 Reads

Understanding Patient Preferences and Unmet Needs in Non-alcoholic Steatohepatitis (NASH): Insights from a Qualitative Online Bulletin Board Study.

Adv Ther 2019 Feb 13;36(2):478-491. Epub 2018 Dec 13.

Novartis Healthcare Pvt Ltd, Hyderabad, India.

Introduction: The aim of this work was to understand how patients with non-alcoholic steatohepatitis (NASH) perceive their disease, unmet needs, and expectations regarding future treatment through online bulletin board (OBB) qualitative research.

Methods: OBB is an asynchronous online qualitative market research tool that provides an open forum for interactive discussion among participants. Patients with NASH were recruited via physician referral and completed a screener questionnaire to ensure their eligibility and willingness to participate. Read More

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http://dx.doi.org/10.1007/s12325-018-0856-0DOI Listing
February 2019
1 Read

Venous Thromboembolism Prophylaxis and Risk in the Inpatient and Outpatient Continuum of Care Among Hospitalized Acutely Ill Patients in the US: A Retrospective Analysis.

Adv Ther 2019 Jan 12;36(1):59-71. Epub 2018 Dec 12.

Novosys Health, Green Brook, NJ, USA.

Introduction: Venous thromboembolism (VTE) is a leading cause of preventable morbidity and mortality among hospitalized patients in the US. The objectives of this study were to examine VTE prophylaxis patterns and risk for VTE events during hospitalization and post-discharge among patients hospitalized for acute illnesses in the US.

Methods: Acutely ill hospitalized patients were identified from the MarketScan databases (January 1, 2012-June 30, 2015). Read More

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http://dx.doi.org/10.1007/s12325-018-0846-2DOI Listing
January 2019
1 Read

Silodosin: An Update on Efficacy, Safety and Clinical Indications in Urology.

Adv Ther 2019 Jan 6;36(1):1-18. Epub 2018 Dec 6.

Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.

Introduction: Silodosin determines smooth muscle relaxation in bladder and prostate tissues, increases bladder blood flow in conditions of chronic bladder ischemia and regulates the activity of transcriptional factors responsible for stromal growth and prostate hyperplasia. Phase III trials have already demonstrated the efficacy and safety of silodosin in the treatment of patients bothered by lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Objective: We aimed to describe the rationality for the use of silodosin and to summarize the current literature on the use of Silodosin for the treatment of LUTS. Read More

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http://dx.doi.org/10.1007/s12325-018-0854-2DOI Listing
January 2019
2 Reads

Use of Micronized Purified Flavonoid Fraction Together with Rivaroxaban Improves Clinical and Ultrasound Outcomes in Femoropopliteal Venous Thrombosis: Results of a Pilot Clinical Trial.

Adv Ther 2019 Jan 11;36(1):72-85. Epub 2018 Dec 11.

Pirogov Russian National Research Medical University, Moscow, Russian Federation.

Introduction: The aim of this study was to assess the impact of adding long-term micronized purified flavonoid fraction (MPFF) to standard treatment of femoropopliteal deep vein thrombosis (DVT).

Methods: This pilot, comparative, open-label study with blinded outcome assessor enrolled patients with a first episode of femoropopliteal DVT confirmed by duplex ultrasound scanning (DUS). All participants were randomly allocated to one of two treatment groups: (1) control that received a standard treatment with oral rivaroxaban, and (2) experimental that involved additional treatment with MPFF 1000 mg/day. Read More

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http://dx.doi.org/10.1007/s12325-018-0849-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318234PMC
January 2019
1 Read

Real-World Use of Talimogene Laherparepvec in German Patients with Stage IIIB to IVM1a Melanoma: A Retrospective Chart Review and Physician Survey.

Adv Ther 2019 Jan 7;36(1):101-117. Epub 2018 Dec 7.

Amgen Ltd, Uxbridge, UK.

Introduction: Talimogene laherparepvec is a first-in-class oncolytic immunotherapy for intratumoral injection with proven efficacy and tolerability in patients with unresectable early metastatic melanoma (stage IIIB-IVM1a) in the pivotal phase III OPTiM study. The objective was to characterize melanoma patients treated with talimogene laherparepvec in routine clinical practice in Germany.

Methods: A retrospective chart review was conducted in unresectable stage IIIB-IVM1a melanoma patients. Read More

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http://dx.doi.org/10.1007/s12325-018-0850-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318239PMC
January 2019
3 Reads

Bridging the Gap Between Self-Reported and Claims-Derived Adherence Measures for Basal Insulin Among Patients with Type 2 Diabetes Mellitus.

Adv Ther 2019 Jan 7;36(1):118-130. Epub 2018 Dec 7.

Janssen Research & Development, Titusville, NJ, USA.

Introduction: Complex or personalized insulin regimens challenge traditional adherence measures. Our objective was to develop an improved basal insulin (BI) adherence measure using both patient-reported and administrative claims data, resulting in a more complete measure.

Methods: Patients' self-reported BI utilization over the previous 12 months was linked with their claims data for the same period. Read More

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http://link.springer.com/10.1007/s12325-018-0828-4
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http://dx.doi.org/10.1007/s12325-018-0828-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318230PMC
January 2019
13 Reads
2.438 Impact Factor

Efficacy and Safety of Lipase Inhibitor Orlistat in Japanese with Excessive Visceral Fat Accumulation: 24-Week, Double-Blind, Randomized, Placebo-Controlled Study.

Adv Ther 2019 Jan 10;36(1):86-100. Epub 2018 Dec 10.

Taisho Pharmaceutical Co., Ltd., Tokyo, Japan.

Introduction: Orlistat is an inhibitor of pancreatic lipase and is used as an anti-obesity drug in many countries. However, there are no data available regarding the effects of orlistat on visceral fat accumulation in Japanese subjects. Therefore, this comparative, placebo-controlled, double-blind, randomized study aimed to evaluate the efficacy and safety of orlistat in Japanese participants with excessive visceral fat accumulation and without dyslipidemia, diabetes mellitus, and hypertension ("metabolic diseases"). Read More

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http://dx.doi.org/10.1007/s12325-018-0835-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318260PMC
January 2019
3 Reads

The Impact of Excluding Patients with End-Stage Knee Disease in Intra-Articular Hyaluronic Acid Trials: A Systematic Review and Meta-Analysis.

Adv Ther 2019 Jan 1;36(1):147-161. Epub 2018 Dec 1.

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA.

Introduction: The Kellgren-Lawrence (K-L) grade is the most commonly used measure of radiographic disease severity in knee osteoarthritis (OA). Studies suggest that intra-articular hyaluronic acid (IA-HA) should only be considered in cases of early stage knee OA. The purpose of this review was to determine if trials administering IA-HA in early-moderate knee OA patients demonstrated greater pain relief than studies that also included patients with end-stage disease. Read More

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http://link.springer.com/10.1007/s12325-018-0847-1
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http://dx.doi.org/10.1007/s12325-018-0847-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318255PMC
January 2019
8 Reads

Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study.

Adv Ther 2019 Jan 30;36(1):232-243. Epub 2018 Nov 30.

Regional Referral Centre for Rare Lung Diseases, Department of Clinical and Experimental Medicine, University Hospital "Policlinico G. Rodolico", University of Catania, Catania, Italy.

Background/objectives: This study will aim to characterise disease behaviour during the peri-diagnostic period in patients with suspected interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF), using daily home spirometry and accelerometry. Additionally, this study will aim to increase collaboration between secondary and tertiary centres using a digital collaboration platform.

Methods: The STARLINER study (NCT03261037) will enrol approximately 180 symptomatic patients aged 50 years or more with radiological evidence of ILD/IPF from community and tertiary centres in Canada and Europe. Read More

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http://dx.doi.org/10.1007/s12325-018-0845-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318228PMC
January 2019
3 Reads