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Current Medical Research and Opinion

Jessica Davies, Michael Martinec, Mathieu Coudert, Paul Delmar, Gracy Crane
BACKGROUND: The anaplastic lymphoma kinase (ALK) treatment landscape is crowded following recent ALK inhibitor approvals, and updated information on real-world treatment patterns in advanced non-small-cell lung cancer (aNSCLC) with ALK rearrangement (ALK+) is needed. METHODS: This retrospective US cohort study used Flatiron Health's longitudinal electronic health record (EHR)-derived database. Patients (≥18 years old) diagnosed with stage IIIB/IV aNSCLC, with documented ALK rearrangement and ≥2 visits after January 1, 2011 were followed until February 28, 2016...
October 8, 2018: Current Medical Research and Opinion
Camille Vatier, Marie-Christine Vantyghem, Caroline Storey, Isabelle Jéru, Sophie Christin-Maitre, Bruno Fève, Olivier Lascols, Jacques Beltrand, Jean-Claude Carel, Corinne Vigouroux, Elise Bismuth
Lipodystrophic syndromes are rare diseases of genetic or acquired origin characterized by partial or generalized lack of body fat. Early detection and diagnosis are crucial to prevent and manage associated metabolic dysfunctions, i.e. insulin resistance, dyslipidemia, fatty liver and diabetes, and to provide appropriate genetic counselling. By means of several representative case studies, this article illustrates the diagnostic and management challenges of lipodystrophic syndromes. Berardinelli-Seip congenital lipodystrophy (BSCL) is typically diagnosed at birth, or soon thereafter, with generalized lipoatrophy and hepatomegaly secondary to hepatic steatosis...
October 8, 2018: Current Medical Research and Opinion
Kevin W Olden, William D Chey, Reshma Shringarpure, Jean Paul Nicandro, Emil Chuang, David L Earnest
OBJECTIVE: Severe diarrhea-predominant irritable bowel syndrome (IBS-D) is associated with decreased health-related quality of life (HRQOL) and increased health care costs. Treatment recommendations for IBS-D often start with traditional pharmacotherapy (TP), with escalation to alosetron, rifaximin or eluxadoline if there is no success. There has been no previous head-to-head clinical trial comparing IBS-D treatment outcome for alosetron versus TP. This study evaluated resource use, work productivity, health-related quality of life, and global symptom response in women with IBS-D who were treated with alosetron or TP...
October 8, 2018: Current Medical Research and Opinion
Beatrice Setnik, Kenneth W Sommerville, Glenn C Pixton, Lynn Webster
OBJECTIVE: To review the effects of naltrexone on withdrawal-related adverse events (AEs) and euphoria-related effects, and relationship between plasma naltrexone concentrations and withdrawal across EMBEDA® (MSN; extended-release morphine sulfate with sequestered naltrexone) studies. METHODS: Five studies in pain patients and a safety review summarizing AE reports during the first year following approval of MSN were assessed for withdrawal reports. Three of these studies also assessed Clinical Opiate Withdrawal Scale (COWS) scores...
October 6, 2018: Current Medical Research and Opinion
Ming-Hui Tai, Jason Shepherd, Hollie Bailey, Nathan Williams, Hatz Maximilian, Ignasi Campos Tapias, David Catterick, Gavin Worth
OBJECTIVE: Proprotein convertase subtilisin/kexin type 9 antibody inhibitors (PCSK9i) are approved as adjuncts to maximal tolerated statin therapy to lower low-density lipoprotein cholesterol (LDL-C). This study describes real-world use, characteristics of PCSK9i users and non-users, and factors influencing treatment choice. METHODS: A physician and patient survey was conducted in Germany, Spain, and United Kingdom (UK) from December 2016 to April 2017 through the Adelphi Dyslipidemia Disease Specific Programme...
October 5, 2018: Current Medical Research and Opinion
Daisy Ng-Mak, K Rajagopalan
OBJECTIVE: This descriptive study examined the quality of care received by individuals with serious mental illness observed in clinical care using established Healthcare Effectiveness Data and Information Set (HEDIS) measures for individuals with serious mental illness. METHODS: Administrative claims (Medicaid, Medicare, and commercial) from a national health and well-being company were used to identify adults with schizophrenia or bipolar disorder. Performance rates for 5 HEDIS mental health quality measures were computed...
October 5, 2018: Current Medical Research and Opinion
Debajyoti Bhowmik, Xue Song, Michele Intorcia, Stephani Gray, Nianwen Shi
OBJECTIVES: Skeletal-related events (SREs), i.e. pathologic fractures, spinal cord compression, surgery and radiation to bone, are serious skeletal complications that occur frequently in patients with bone metastases (BM) from solid tumors (ST). Clinical guidelines recommend treatment with denosumab and intravenous bisphosphonates (IVBPs) to prevent SREs. However, therapy may be delayed by physicians due to perceived low risk of SREs or for other clinical reasons. This study estimated SRE incidence rates in treatment-naive (i...
October 5, 2018: Current Medical Research and Opinion
Karen Reckamp, Huamao M Lin, Joice Huang, Irina Proskorovsky, William Reichmann, Stanimira Krotneva, David Kerstein, Hui Huang, Joseph Lee
OBJECTIVE: Brigatinib, ceritinib, and alectinib are approved to treat crizotinib-refractory anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), but no trial has compared them head-to-head. A matching-adjusted indirect comparison (MAIC) was conducted to estimate the relative efficacy of these agents in the crizotinib-refractory setting. METHODS: MAIC is a propensity score-type method that adjusts for differences in baseline characteristics between trials to estimate relative efficacy...
October 5, 2018: Current Medical Research and Opinion
Yan-Guo Xin, Xin Chen, Yi-Nan Zhao, Jian Hu, Yingxian Sun, Wen-Yu Hu
AIM: The treatment effects of spironolactone on heart failure with reduced (HFrEF LVEF <40%) and preserved (HFpEF LVEF ≥50%) ejection fraction are well characterized. It is not clear whether heart failure patients with mid-range ejection fraction (HFmrEF, LVEF 40-49%) benefit from spironolactone. The present study aims to evaluate the efficacy of spironolactone in HFmrEF patients. METHOD: This study compared a high dosage of spironolactone (50 mg daily), a low dosage of spironolactone (25 mg daily), and an untreated group for the prevention of major adverse cardiovascular events (MACE) in 279 patients admitted to hospital diagnosed with HFmrEF...
October 5, 2018: Current Medical Research and Opinion
Duygu Özer, Cem Bölük, Ülkü Türk Börü, Deniz Altun, Mustafa Taşdemir, Cansu Köseoğlu Toksoy
OBJECTIVE: Nerve injections have been used for the acute and preventive treatment of migraine in recent decades. Most of these injections focused on greater occipital nerve (GON) blockade. However, few studies were placebo controlled and only a few of them investigated GON and supraorbital nerve (SON) blockade together. We aimed to evaluate the efficacy of GON and SON blockade with local anaesthetics for the preventive treatment of migraine without aura. METHODS: 87 patients diagnosed with migraine without aura, were included in the study...
October 4, 2018: Current Medical Research and Opinion
Charles F Barish, Robert A Crozier, Patrick Griffin
OBJECTIVE: This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). METHODS: Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies...
October 2, 2018: Current Medical Research and Opinion
Colleen A McHorney, Eric D Peterson, Veronica Ashton, François Laliberté, Concetta Crivera, Guillaume Germain, Naveed Sheikh, Jeff Schein, Patrick Lefebvre
OBJECTIVES: To estimate the real-world (RW) impact of adherence to once-daily (QD: rivaroxaban and edoxaban) and twice-daily (BID: apixaban and dabigatran) non-vitamin K antagonist (NOACs) on the risk of stroke and major bleeding (MB) among non-valvular atrial fibrillation (NVAF) patients. METHODS: First, claims from the Optum Clinformatics Data Mart database (07/2012-12/2016) were analyzed. Adult NVAF patients with ≥2 NOAC dispensings (index date) were included...
September 28, 2018: Current Medical Research and Opinion
Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Brian Bernick, Shelli Graham, Sebastian Mirkin
OBJECTIVE: To review safety, efficacy and pharmacokinetic (PK) data from the phase 3 REJOICE trial, which evaluated a 17β-estradiol (E2) softgel vaginal insert approved in 2018 for moderate to severe dyspareunia associated with menopausal vulvar and vaginal atrophy (VVA). METHODS: REJOICE ( NCT02253173) was a randomized, double-blind, placebo-controlled trial in which women with moderate to severe dyspareunia due to menopausal VVA received 4 µg, 10 µg or 25 µg of an E2 vaginal insert or placebo for 12 weeks...
September 28, 2018: Current Medical Research and Opinion
Jose Curbelo, Pablo Rodriguez-Cortes, Maria Aguilera, Paloma Gil-Martinez, Daniel Martín, Carmen Suarez Fernandez
BACKGROUND: Heart failure (HF) is an important healthcare problem. Knowing volume status in outpatients with chronic HF to adjust treatment and to avoid decompensations is a challenge. The aim of this study is comparing the usefulness of inferior vena cava (IVC) ultrasound, lung ultrasound, bioelectrical impedance analysis (BIA), and natriuretic peptides in the follow-up of outpatients with chronic HF. METHODS: This was a prospective cohort study. Ninety-nine patients with chronic HF were included consecutively as they attended scheduled medical visits...
September 28, 2018: Current Medical Research and Opinion
P Gazerani, R Fuglsang, J G Pedersen, J Sørensen, J L Kjeldsen, H Yassin, B S Nedergaard
BACKGROUND: Vitamin D levels have been linked to certain pain states, including migraine. This study investigated whether vitamin D supplementation would be beneficial for adult patients with migraine ( Identifier: NCT01695460). METHODS: A randomized, double-blinded, placebo-controlled parallel trial was conducted in migraine patients (36 women and 12 men, 18-65 years of age). A 4-week baseline period was conducted before randomization to 24 weeks of treatment...
September 28, 2018: Current Medical Research and Opinion
Lucyna Woźnicka-Leśkiewicz, Anna Posadzy-Małaczyńska, Justyna Marcinkowska
BACKGROUND: The aims of the study were to assess the subclinical organ damage in men and women with hypertension and their subsequent effect on cardiovascular risk, and use of new statistical methods for more precise estimation of cardiovascular risk using vascular cardiovascular risk factors (ABI, IMT, PWV). METHODS: We studied 200 patients: hypertensive (100) and normotensive (100). The parameters we evaluated included: patient age, ABI, IMT, PWV, serum uric acid and serum CRP...
September 27, 2018: Current Medical Research and Opinion
Livia Puljak
In 2018 EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended withdrawal of marketing authorization for flupirtine-containing medicines in European Union. The case of flupirtine is important lesson for prescribers. If prescribers are not compliant with RMMs, they are negatively affecting benefit-risk balance of a medicine, and may contribute to withdrawal of medicine from the market. Prescribers may not perceive their lack of compliance with RMMs as a potential threat to a medicine, and therefore there is a need to increase prescribers' awareness about this issue...
September 25, 2018: Current Medical Research and Opinion
Rdlc Bernabe, Gjmw van Thiel, N S Breekveldt, C C Gispen-de Wied, Jjm van Delden
BACKGROUND: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. METHODS: We used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008-2012...
September 25, 2018: Current Medical Research and Opinion
Sara Malo, Przemyslaw Kardas, Enrica Menditto
No abstract text is available yet for this article.
September 25, 2018: Current Medical Research and Opinion
Marco Caminati, Gianenrico Senna
In the last decades bronchial asthma has represented a main focus of both basic and pharmacological research. In fact the knowledge about pathophysiological mechanisms and phenotypes as well as the treatment opportunities have substantially increased. Nevertheless asthma management still represents a challenge worldwide. Particularly severe asthma and asthma control are the main unmet needs in the field. Although severe asthma represents a small proportion of the overall asthma prevalence, it substantially contributes to the global burden of the disease, especially when uncontrolled...
September 25, 2018: Current Medical Research and Opinion
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