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    New Method for Insomnia Mongolian Mind-Body Interactive Psychotherapy in the Assessment of Chronic Insomnia: A Retrospective Study.
    Adv Ther 2018 Jun 19. Epub 2018 Jun 19.
    Mongolian Psychosomatic Medicine Department, Inner Mongolia International Mongolian Hospital, Hohhot, Inner Mongolia, China.
    Introduction: Insomnia is a common clinical complaint, and if not addressed it can increase the risk of developing other underlying diseases such as hypertension, depression and anxiety. The use of Mongolian mind-body interactive therapy as a comprehensive psychotherapeutic approach in chronic insomnia has been shown in this retrospective study.

    Methods: Subjects who had suffered insomnia for more than 1 month participated in the Mongolian mind-body interactive psychotherapy program between June 2012 and February 2014. Read More

    Assessment of Relationship of Serum Neurokinin-B Level in the Pathophysiology of Pre-eclampsia: A Case-Control Study.
    Adv Ther 2018 Jun 19. Epub 2018 Jun 19.
    Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.
    Introduction: Pre-eclampsia is a pregnancy-induced disorder that complicates approximately 5-7% of pregnancies. It is the leading cause of maternal and foetal morbidity and mortality worldwide.

    Aim: To determine the role of serum neurokinin-B level in the pathophysiology of pre-eclampsia. Read More

    Use of Nimesulide During Early Pregnancy and the Risk of Congenital Malformations: A Population-Based Study from Italy.
    Adv Ther 2018 Jun 19. Epub 2018 Jun 19.
    National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.
    Introduction: Nimesulide is the most prescribed non-steroidal anti-inflammatory drug in Italy, and it is currently marketed in about 50 countries worldwide. The association between the use of nimesulide in early pregnancy and the risk of birth defects was investigated in a large cohort of pregnant women from Italy.

    Methods: Data were from the healthcare utilization databases of the Italian region of Lombardy. Read More

    Current Treatment of Endolymphatic Sac Tumor of the Temporal Bone.
    Adv Ther 2018 Jun 19. Epub 2018 Jun 19.
    Coordinator of the International Head and Neck Scientific Group, Padua, Italy.
    An endolymphatic sac tumor (ELST) is a rare, indolent but locally aggressive tumor arising in the posterior petrous ridge. Patients present with sensorineural hearing loss and tinnitus. As the tumor progresses, patients may experience vertigo, ataxia, facial nerve paresis, pain and otorrhea. Read More

    Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.
    Adv Ther 2018 Jun 5. Epub 2018 Jun 5.
    Fukushima Eye Clinic, Osaka, Japan.
    Introduction: This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM).

    Methods: This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. Read More

    Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).
    Adv Ther 2018 Jun 5. Epub 2018 Jun 5.
    Weill Cornell Medical College, New York, NY, USA.
    Introduction: To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

    Methods: Men with LUTs secondary to BPH (60-150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

    Results: One hundred seven males with mean age of 67. Read More

    Comparison of Outcomes of Different Postoperative Hormone Therapy in the Treatment of Ovarian Endometriosis: A Brief Report.
    Adv Ther 2018 Jun 5. Epub 2018 Jun 5.
    Department of Gynaecological, Tianjin Central Obstetrics and Gynecology Hospital, Nankai District, Tianjin, China.
    Introduction: Hormone therapy is widely used in the treatment of patients with ovarian endometriosis after surgery, and progestin and gonadotropin-releasing hormone (GnRH) are two of the most widely used hormones. This study aimed to compare the outcomes of progestin and GnRH in the treatment of ovarian endometriosis after surgery.

    Methods: A total of 399 patients with ovarian endometriosis were included and divided into four groups to receive different treatments. Read More

    To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.
    Adv Ther 2018 Jun 5. Epub 2018 Jun 5.
    Biogen International GmbH, Zug, Switzerland.
    In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice. Read More

    Safety and Efficacy of High Versus Standard Starting Doses of Insulin Glargine in Overweight and Obese Chinese Individuals with Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Medications (Beyond VII): Study Protocol for a Randomized Controlled Trial.
    Adv Ther 2018 Jun 5. Epub 2018 Jun 5.
    Sanofi China, 19 Floor, Tower III, Jing'An Kerry Centre, 1228 Middle Yan'an Road, Shanghai, 200040, China.
    Background: Treatment with basal insulin in Chinese populations is currently sub-optimal, with delayed initiation of insulin treatment and inadequate dose titration. Increasing the initial dose of insulin may be a practicable and effective solution to the problem of titration. A higher initial dose will be helpful for patients to achieve the blood glucose target and improve treatment satisfaction and compliance as well require fewer steps to titrate. Read More

    Luteal Phase Ovarian Stimulation May Improve Oocyte Retrieval and Oocyte Quality in Poor Ovarian Responders Undergoing In Vitro Fertilization: Preliminary Results from a Single-Center Prospective Pilot Study.
    Adv Ther 2018 Jun 4. Epub 2018 Jun 4.
    Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
    Introduction: Luteal phase ovarian stimulation (LPOS) has been proven a feasible protocol for infertile patients. High progesterone level in the luteal phase could physiologically inhibit premature luteinizing hormone surge, from which poor ovarian responders (PORs) could obtain benefits. Therefore, we aimed to compare clinical outcomes between LPOS and follicular phase ovarian stimulation (FPOS) protocol in PORs undergoing in vitro fertilization (IVF). Read More

    Dosing Patterns and Economic Burden of Palbociclib Drug Wastage in HR+/HER2- Metastatic Breast Cancer.
    Adv Ther 2018 Jun 4. Epub 2018 Jun 4.
    Houston Methodist Hospital, Houston, TX, 77030, USA.
    Introduction: Targeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. Read More

    Effects of the SGLT-2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-Diabetic Subjects: A Randomized, Double-Blind, Placebo-Controlled Study Protocol.
    Adv Ther 2018 May 25. Epub 2018 May 25.
    Service of Nephrology and Hypertension, Department of Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
    Introduction: Empagliflozin is an SGLT-2 inhibitor (SGLT-2i) which belongs to a new class of hypoglycemic drugs with the unique property of decreasing blood glucose independently from insulin, through an increase in glycosuria. In addition to decreasing cardiovascular morbidity and mortality, empagliflozin has nephroprotective properties in high cardiovascular risk patients with type 2 diabetes. Decreased hyperfiltration and shifting towards more favorable renal fuel energetics with improved renal oxygenation may explain some of these properties. Read More

    Multinational Consensus: Insulin Initiation with Insulin Degludec/Aspart (IDegAsp).
    Adv Ther 2018 May 23. Epub 2018 May 23.
    Chellaram Diabetes Institute, Pune, India.
    Insulin degludec/aspart (IDegAsp) is the first soluble insulin co-formulation, combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In type 2 diabetes patients with oral antidiabetes agent (OAD) inadequacy, insulin initiation with IDegAsp once daily provides superior long-term glycemic control compared to insulin glargine, with similar fasting plasma glucose (FPG) and insulin doses, and numerically lower rates of overall and nocturnal hypoglycemia. Furthermore, in patients with uncontrolled type 2 diabetes previously treated with insulins, IDegAsp twice daily effectively improves glycated hemoglobin and FPG, with fewer hypoglycemic episodes versus premix insulins and basal bolus therapy. Read More

    Safety of Polysorbate 80 in the Oncology Setting.
    Adv Ther 2018 May 23. Epub 2018 May 23.
    Division of Hematology and Oncology, University of Alabama Birmingham, Birmingham, AL, USA.
    Polysorbate 80 is a synthetic nonionic surfactant used as an excipient in drug formulation. Various products formulated with polysorbate 80 are used in the oncology setting for chemotherapy, supportive care, or prevention, including docetaxel, epoetin/darbepoetin, and fosaprepitant. However, polysorbate 80, like some other surfactants, is not an inert compound and has been implicated in a number of systemic and injection- and infusion-site adverse events (ISAEs). Read More

    Application of Cu-64 NODAGA-PSMA PET in Prostate Cancer.
    Adv Ther 2018 May 17. Epub 2018 May 17.
    Department of Nuclear Medicine/PET-Center, Wilhelminenspital, Vienna, Austria.
    Introduction: The high diagnostic potential of Cu-PSMA PET-CT imaging was clinically investigated in prostate cancer patients with recurrent disease and in the primary staging of selected patients with advanced local disease. The aim of our study is to assess the uptake behavior in the clinical setting of 64Copper Prostate-Specific Membrane Antigen (Cu PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) in prostate cancer.

    Methods: A retrospective study was performed in 23 patients with intermediate, high risk and progressive disease at primary staging of prostate cancer. Read More

    Impact of Insulin Degludec in Hospitalized Patients With and Without Type 2 Diabetes Requiring Parenteral/Enteral Nutrition: An Observational Study.
    Adv Ther 2018 May 17. Epub 2018 May 17.
    Unit of Diabetology, Dietology and Clinical Nutrition, S. Maria Hospital, Terni, Italy.
    Introduction: Hyperglycemia in inpatients is a major problem, especially when nutritional support is required. This study aims to assess the impact of treatment with insulin degludec (IDeg) on mean blood glucose (BG) and glycemic variability in noncritical hospitalized patients with and without type 2 diabetes (T2DM) receiving enteral and/or parenteral nutrition (EN, PN).

    Methods: Mean BG and glycemic variability from admission up to 7 days of hospitalization were evaluated in consecutive cases with and without T2DM. Read More

    An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction.
    Adv Ther 2018 May 17. Epub 2018 May 17.
    Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
    Introduction: Sacubitril/valsartan has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice.

    Methods: This study included data from medical and pharmacy claims and medical records review for patients (n = 200) who initiated sacubitril/valsartan between August 2015 and March 2016 preceding issuance of American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) focused update on new pharmacological therapy for HF (May 2016), which included recommendations for sacubitril/valsartan. A within-subject analysis compared symptoms and healthcare resource utilization before and after treatment initiation. Read More

    Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.
    Adv Ther 2018 May 17. Epub 2018 May 17.
    Ikuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
    Introduction: Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. Read More

    Combination Glucose-Lowering Therapy Plans in T2DM: Case-Based Considerations.
    Adv Ther 2018 May 18. Epub 2018 May 18.
    Arizona Grand Medical Center, Phoenix, AZ, USA.
    Type 2 diabetes mellitus (T2DM) is a complex disease, and while lifestyle interventions remain the cornerstone of therapy, most patients will also require pharmacotherapy. Current diabetes treatment guidelines and algorithms recommend an individualized approach to setting glycemic goals and selecting treatment. Although a single antihyperglycemic agent may be appropriate as the initial T2DM pharmacotherapy, the progressive nature of the disease due to declining pancreatic β-cell function will result in the vast majority of T2DM patients eventually requiring two or more antihyperglycemic agents. Read More

    The Effectiveness of Trimetazidine Treatment in Patients with Stable Angina Pectoris of Various Durations: Results from the CHOICE-2 Study.
    Adv Ther 2018 May 15. Epub 2018 May 15.
    Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University, Moscow, Russia.
    Introduction: Trimetazidine (TMZ) has been shown to reduce angina symptoms and to increase exercise capacity in randomized clinical trials, but more extensive data would be useful to assess its effects in real-world clinical practice and in patients with different durations of disease.

    Methods: CHOICE-2 was a Russian, multicenter, 6-month, open-label, prospective observational study that assessed the effect of adding TMZ modified release 35 mg bid to antianginal treatment in a real-world setting. The present analysis of CHOICE-2 results explored the effects of adding TMZ to background antianginal therapies with regard to the duration of stable angina. Read More

    Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: A Retrospective Analysis.
    Adv Ther 2018 May 10. Epub 2018 May 10.
    Valeritas, Inc., Bridgewater, NJ, USA.
    Introduction: Advances in insulin delivery have improved outcomes in patients with diabetes. This study evaluated the impact of V-Go Wearable Insulin Delivery device on glycated hemoglobin (A1C) and insulin total daily dose (TDD) in patients with diabetes not achieving glycemic targets.

    Methods: Electronic medical record data was obtained for adult patients with A1C > 7% treated at a multicenter endocrine practice who initiated V-Go between August 2012 and August 2015. Read More

    Is Patient Support Program Participation Associated with Longer Persistence and Improved Adherence Among New Users of Adalimumab? A Retrospective Cohort Study.
    Adv Ther 2018 May 10. Epub 2018 May 10.
    Clalit Health Services, Clalit Research Institute, Tel Aviv, Israel.
    Introduction: Adalimumab (ADA) is a medication used in the treatment of several autoimmune diseases. Despite the beneficial effects of ADA, its adherence and persistence rates are low. Patients treated with ADA from Clalit Health Services (CHS) can enroll in AbbVie's patient support program (PSP), which aims to improve ADA adherence and persistence. Read More

    Efficacy and Tolerability of Fixed-Dose Combination Perindopril/Indapamide in Hypertensive Patients with a History of Stroke or Transient Ischemic Attack: PICASSO Trial.
    Adv Ther 2018 May 10. Epub 2018 May 10.
    Hospital Outpatient Care for Hypertensive Patients, St. Imre University Teaching Hospital, Budapest, Hungary.
    Introduction: In everyday medical practice, physicians often need to manage patients whose blood pressure is not well controlled. Those with a history of cerebrovascular disease are a high-risk group in need of rapid blood pressure control.

    Methods: The PICASSO study was a real-life, observational trial involving 9257 inadequately treated hypertensive patients who were switched from previous therapy to the fixed-dose combination of perindopril 10 mg/indapamide 2. Read More

    Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities.
    Adv Ther 2018 May 5. Epub 2018 May 5.
    Cardiology Department, Royal Victoria Hospital, Belfast Health and Social Care Trust, Belfast, UK.
    Introduction: Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality.

    Methods: All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead. Read More

    Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma.
    Adv Ther 2018 May 3. Epub 2018 May 3.
    Sanofi, Bridgewater, NJ, USA.
    Introduction: Dupilumab, a fully human anti-IL-4Rα monoclonal antibody, inhibits signaling of both interleukin (IL)-4 and IL-13, which are key drivers of type 2-mediated inflammation. Dupilumab is approved in the EU, USA, and other countries for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. Following positive phase 2 results in asthma, the phase 3 Liberty Asthma QUEST trial was initiated to provide further evidence for dupilumab efficacy and safety in patients with uncontrolled, moderate-to-severe asthma. Read More

    Medication Adherence Patterns Among Patients with Multiple Serious Mental and Physical Illnesses.
    Adv Ther 2018 May 3. Epub 2018 May 3.
    Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Drive, Princeton, NJ, 08540, USA.
    Introduction: Patients with mental and physical health conditions are complex to treat and often use multiple medications. It is unclear how adherence to one medication predicts adherence to others. A predictive relationship could permit less expensive adherence monitoring if overall adherence could be predicted through tracking a single medication. Read More

    Clinical Efficacy and Safety of Current Interventions for Choroidal Neovascularization Associated with Rare Diseases: A Systematic Literature Review.
    Adv Ther 2018 May 23;35(5):591-603. Epub 2018 Apr 23.
    Ophthalmology, DCN, B Floor Eye and ENT Centre, University of Nottingham, University Hospital, QMC, Nottingham, UK.
    Introduction: The aim of this systematic literature review was to evaluate the efficacy and safety of interventions for the treatment of choroidal neovascularization (CNV) secondary to etiologies other than age-related macular degeneration and pathologic myopia.

    Methods: Relevant randomized controlled trials (RCTs) and prospective observational studies were identified by searching MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL.

    Results: The search identified 5 RCTs; no relevant observational studies were identified. Read More

    Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy.
    Adv Ther 2018 May 23;35(5):686-696. Epub 2018 Apr 23.
    Glaucoma Unit, IRCCS Fondazione G.B. Bietti, Via Livenza 3, 00198, Rome, Italy.
    Introduction: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0. Read More

    Randomized Controlled Study to Investigate the Effect of Topical Diquafosol Tetrasodium on Corneal Sensitivity in Short Tear Break-Up Time Dry Eye.
    Adv Ther 2018 May 18;35(5):697-706. Epub 2018 Apr 18.
    Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
    Introduction: Complex mechanisms underlie dry eye (DE) symptom provocation. In particular, corneal hypersensitivity may provoke symptoms in short tear break-up time (BUT) DE characterized by tear film instability. We hypothesized that improved tear film stability may alleviate corneal sensitivity in patients with short tear BUT DE. Read More

    Efficacy and Safety of Zofenopril Versus Ramipril in the Treatment of Myocardial Infarction and Heart Failure: A Review of the Published and Unpublished Data of the Randomized Double-Blind SMILE-4 Study.
    Adv Ther 2018 May 17;35(5):604-618. Epub 2018 Apr 17.
    Unit of Internal Medicine, Policlinico S. Orsola, University of Bologna, Bologna, Italy.
    Zofenopril is a lipophilic, sulfhydryl group-containing angiotensin-converting enzyme (ACE)-inhibitor, characterized by wide tissue distribution, long duration of action, and pleiotropic effects on endothelial dysfunction. Its clinical efficacy and safety have been described in the four randomized controlled trials of the SMILE program, which globally enrolled more than 3600 patients in post-acute myocardial infarction (AMI) setting. The SMILE-4 study specifically selected patients with left ventricular dysfunction at admission, and compared the effects of zofenopril or ramipril in combination with acetylsalicylic acid (ASA). Read More

    Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study.
    Adv Ther 2018 May 16;35(5):707-723. Epub 2018 Apr 16.
    Epidemiology, Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA.
    Introduction: Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy procedures for whom powered versus manual endoscopic surgical staplers were used.

    Methods: Patients ≥ 18 years of age undergoing elective VATS lobectomy during an inpatient admission from January 1, 2012 to September 30, 2016 were identified from the Premier Healthcare Database (first admission = index admission). Read More

    Incidence, Prevalence, and Survival of Patients with Idiopathic Pulmonary Fibrosis in the UK.
    Adv Ther 2018 May 11;35(5):724-736. Epub 2018 Apr 11.
    NIHR Biomedical Research Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK.
    Introduction: Recent developments in the care of patients with idiopathic pulmonary fibrosis have the potential to improve survival rates. Population-based estimates of the current disease burden are needed to evaluate the future impact of newly approved therapies. The objective of this study is to describe incidence, prevalence, and survival of idiopathic pulmonary fibrosis patients in the UK. Read More

    A Review of the Clinical Usefulness of Selective Laser Trabeculoplasty in Exfoliative Glaucoma.
    Adv Ther 2018 May 11;35(5):619-630. Epub 2018 Apr 11.
    Department of Ophthalmology, Hospital Universitario "Principe de Asturias," Universidad de Alcalá, Alcalá de Henares, Spain.
    In the last decade, selective laser trabeculoplasty (SLT) has been commonly used in the management of several different types of glaucoma, as either primary or adjunct therapy. The technique has an excellent safety profile and is at least as effective as argon laser trabeculoplasty. Although the actual mechanism of action of SLT remains unclear, evidence has shown that it does not induce morphologically evident trabecular meshwork alterations. Read More

    Decline in Buprenorphine/Naloxone Prescriptions in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail.
    Adv Ther 2018 Apr 6;35(4):457-466. Epub 2018 Apr 6.
    hc1 Insight LLC, Indianapolis, IN, USA.
    Introduction: A large, statewide, fee-for-service Medicaid plan recently (October 2015) executed a complete switch from sublingual buprenorphine-naloxone [(SLBN), Suboxone] to buccal buprenorphine-naloxone [(BBN), Bunavail] on its preferred drug formulary. This complete formulary switch provided an opportunity to assess dynamic changes in prescribing patterns, patient/physician acceptance, and indices of potential misuse/diversion.

    Methods: For the period January 1, 2015 through December 31, 2016, two datasets were analyzed: prescriptions and associated costs for buprenorphine-naloxone (BN) products and urine toxicology test results for patients in the Medicaid plan. Read More

    Correction to: Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals.
    Adv Ther 2018 Apr;35(4):590
    Gynaecological Oncology Group, University of Manchester, Manchester, UK.
    The article "Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals", written by Garth Funston, Helena O'Flynn, Neil A. J. Ryan, Willie Hamilton, Emma J. Read More

    Impact of a Health Management Program on Healthcare Outcomes among Patients on Augmentation Therapy for Alpha 1-Antitrypsin Deficiency: An Insurance Claims Analysis.
    Adv Ther 2018 Apr 3;35(4):467-481. Epub 2018 Apr 3.
    Optum Life Sciences, HEOR, 11000 Optum Circle, Eden Prairie, MN, 55344, USA.
    Introduction: Alpha 1-antitrypsin deficiency (AATD) is a genetic disorder which reduces serum alpha 1-antitrypsin (AAT or alpha1-proteinase inhibitor, A1PI) and increases the risk of chronic obstructive pulmonary disease (COPD). Management strategies include intravenous A1PI augmentation, and, in some cases, a health management program (Prolastin Direct; PD).

    Objectives: This study compared clinical and economic outcomes between patients with and without PD program participation. Read More

    Current Treatment Patterns Among Postmenopausal Women with HR+/HER2- Metastatic Breast Cancer in US Community Oncology Practices: An Observational Study.
    Adv Ther 2018 Apr 26;35(4):482-493. Epub 2018 Mar 26.
    Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
    Introduction: Recent approval of novel agents has changed the treatment landscape for post menopausal women with hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC). The objective of this study was to describe contemporary treatment patterns among postmenopausal women with HR+/HER2- mBC in the real-world setting.

    Methods: Data were collected from 64 community oncologists in the US between February and June 2017 using an online medical records extraction tool. Read More

    The Proteolytic Fraction from Latex of Vasconcellea cundinamarcensis (P1G10) Enhances Wound Healing of Diabetic Foot Ulcers: A Double-Blind Randomized Pilot Study.
    Adv Ther 2018 Apr 21;35(4):494-502. Epub 2018 Mar 21.
    Departamentos de Farmacologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
    Introduction: The aim of the study was to investigate the role of the proteolytic fraction from Vasconcellea cundinamarcensis, designated as P1G10, on the healing of chronic foot ulcers in neuropathic patients with diabetes 2.

    Methods: Fifty patients were enrolled in a prospective, randomized, double-blind trial, to verify the efficacy and safety of a topical dressing formulated with 0.1% P1G10, intended for wound healing, versus a hydrogel (control) protocol. Read More

    Economic Burden of HR+/HER2- Metastatic Breast Cancer Among Adult Premenopausal Women.
    Adv Ther 2018 Apr 20;35(4):503-514. Epub 2018 Mar 20.
    Novartis Pharmaceuticals Corporation, East Hanover, NJ, 07936, USA.
    Introduction: Premenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) have complex treatment needs and may receive sequential combinations of endocrine therapy (ET) or chemotherapy. This study describes healthcare utilization (HRU) and costs among premenopausal women with HR+/HER2- mBC in real-world settings from a payer's perspective.

    Methods: In this retrospective cohort study, premenopausal women with HR+/HER2- mBC who received ET or chemotherapy were identified from the Truven Health Analytics MarketScan database (1 January 2006-31 December 2015). Read More

    Perioperative Management of Patients with Inflammatory Rheumatic Diseases Undergoing Major Orthopaedic Surgery: A Practical Overview.
    Adv Ther 2018 Apr 20;35(4):439-456. Epub 2018 Mar 20.
    Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
    Patients with inflammatory rheumatic diseases often need orthopaedic surgery due to joint involvement. Total hip replacement and total knee replacement are frequent surgical procedures in these patients. Due to the complexity of the inflammatory rheumatic diseases, the perioperative management of these patients must envisage a multidisciplinary approach. Read More

    A Comparison Between Rheological Properties of Intra-articular Hyaluronic Acid Preparations and Reported Human Synovial Fluid.
    Adv Ther 2018 Apr 14;35(4):523-530. Epub 2018 Mar 14.
    Department of Orthopaedics and Rehabilitation, New York Presbyterian Queens, New York, USA.
    Introduction: This study aims to compare the properties of currently available intra-articular hyaluronate (IA-HA) products widely available in the USA to those of healthy knee synovial fluid with respect to their bulk rheological properties. We hypothesize that products would have differing rheological properties, with some more closely resembling the properties and physiological aspects of healthy joint fluid HA.

    Methods: We obtained reported HA product molecular weights, as well as measurements of the presence of cross-linking, zero shear rate viscosity, shear thinning ratio, and crossover frequency for the following IA-HA products available in the USA: Euflexxa, Orthovisc, Supartz, Monovisc, Synvisc, Synvisc-One, Gel-One, and Hyalgan. Read More

    Long-term Efficacy of Safinamide on Parkinson's Disease Chronic Pain.
    Adv Ther 2018 Apr 14;35(4):515-522. Epub 2018 Mar 14.
    Medical Department, Zambon SpA, Bresso, MI, Italy.
    Introduction: Chronic pain is an important yet overlooked non-motor symptom of Parkinson's disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms.

    Objectives: To investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment. Read More

    A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.
    Adv Ther 2018 Apr 13;35(4):531-544. Epub 2018 Mar 13.
    SOUSEIKAI Global Clinical Research Center, Fukuoka, Japan.
    Introduction: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

    Methods: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0. Read More

    Adalimumab Reduces Extraintestinal Manifestations in Patients with Crohn's Disease: A Pooled Analysis of 11 Clinical Studies.
    Adv Ther 2018 Apr 7;35(4):563-576. Epub 2018 Mar 7.
    AbbVie Inc., North Chicago, IL, USA.
    Introduction: Extraintestinal manifestations (EIMs) in patients with Crohn's disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate to severe CD.

    Methods: EIM data were pooled from 11 induction, maintenance, and open-label extension studies of adalimumab. Read More

    Multidisciplinary Management of Spondyloarthritis-Related Immune-Mediated Inflammatory Disease.
    Adv Ther 2018 Apr 7;35(4):545-562. Epub 2018 Mar 7.
    Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
    Introduction: Immune-mediated inflammatory diseases (IMIDs) are chronic autoimmune conditions that share common pathophysiologic mechanisms. The optimal management of patients with IMIDs remains challenging because the coexistence of different conditions requires the intervention of several specialists. The aim of this study was to develop a series of statements defining overarching principles that guide the implementation of a multidisciplinary approach for the management of spondyloarthritis (SpA)-related IMIDs including SpA, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and uveitis. Read More

    Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals.
    Adv Ther 2018 Apr 7;35(4):577-589. Epub 2018 Mar 7.
    Gynaecological Oncology Group, University of Manchester, Manchester, UK.
    Early diagnosis of symptomatic gynecological cancer is likely to improve patient outcomes, including survival. The primary care practitioner has a key role to play in this-they must recognize the symptoms and signs of gynecological cancer and make prompt evidence-based decisions regarding further investigation and referral. However, this is often difficult as many of the symptoms of gynecological cancers are nonspecific and are more likely to be caused by benign rather than malignant disease. Read More

    Understanding Interactions of Smoking on Prognosis of HPV-Associated Oropharyngeal Cancers.
    Adv Ther 2018 Mar 6;35(3):255-260. Epub 2018 Mar 6.
    Coordinator of the International Head and Neck Scientific Group, Padua, Italy.
    The new 8th edition AJCC/UICC staging system for human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC), developed to account for improved survival outcomes over HPV-negative cancers, includes anatomic features strictly associated with tumor-node-metastasis (TNM) and does not account for patient-specific characteristics that may impact prognosis. This commentary evaluates the evidence of smoking as an adverse prognostic factor in HPV-associated OPSCC. We review the multifactorial biological, clinical, and social/behavioral characteristics of smokers with OPSCC that impact outcomes, discuss current challenges with incorporating smoking history in prognostic classifications, and consider opportunities for future investigation. Read More

    Complementary and Alternative Medicine Treatments for Generalized Anxiety Disorder: Systematic Review and Meta-analysis of Randomized Controlled Trials.
    Adv Ther 2018 Mar 5;35(3):261-288. Epub 2018 Mar 5.
    Department of Pharmacology, Zagreb University School of Medicine, Zagreb, Croatia.
    Introduction: The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults.

    Methods: Data sources. Six electronic databases ("generalized anxiety (disorder)" and "randomized trial") and reference lists of identified publications were searched to March 2017. Read More

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