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https://www.readbyqxmd.com/read/28749698/the-safety-and-efficacy-of-the-5-ht-1f-receptor-agonist-lasmiditan-in-the-acute-treatment-of-migraine
#1
Bianca Raffaelli, Heike Israel, Lars Neeb, Uwe Reuter
Migraine is among the most disabling disorders worldwide, with a significant therapeutic need. Triptans are drugs of choice in the acute attack treatment, but they are contraindicated in patients with vascular conditions due to their potential vasoconstrictive properties. Further limitations include side effects, inconsistency in therapeutic action and possible non-response. Lasmiditan, a highly selective 5-HT1F receptor agonist, is a novel acute anti-migraine substance devoid of vasoconstriction. Areas covered: This article reviews the clinical efficacy and safety of oral and intravenous lasmiditan as a possible acute migraine treatment...
July 27, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28746164/implementation-of-a-novel-adherence-monitoring-strategy-in-a-phase-iii-blinded-placebo-controlled-hiv-1-prevention-clinical-trial
#2
Marla J Husnik, Elizabeth R Brown, Mark Marzinke, Edward Livant, Thesla Palanee-Phillips, Craig Hendrix, Flavia Matovu Kiweewa, Gonasagrie Nair, Lydia E Soto-Torres, Katie Schwartz, Sharon L Hillier, Jared M Baeten
BACKGROUND: Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence due to the potential risk of unblinding. However, several PrEP trials for HIV-1 prevention among women failed to show effectiveness due to low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. METHODS: During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system...
July 24, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28744892/decision-theoretic-designs-for-a-series-of-trials-with-correlated-treatment-effects-using-the-sarmanov-multivariate-beta-binomial-distribution
#3
Siew Wan Hee, Nicholas Parsons, Nigel Stallard
The motivation for the work in this article is the setting in which a number of treatments are available for evaluation in phase II clinical trials and where it may be infeasible to try them concurrently because the intended population is small. This paper introduces an extension of previous work on decision-theoretic designs for a series of phase II trials. The program encompasses a series of sequential phase II trials with interim decision making and a single two-arm phase III trial. The design is based on a hybrid approach where the final analysis of the phase III data is based on a classical frequentist hypothesis test, whereas the trials are designed using a Bayesian decision-theoretic approach in which the unknown treatment effect is assumed to follow a known prior distribution...
July 26, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28741970/efficacy-and-safety-of-once-weekly-semaglutide-for-the-treatment-of-type-2-diabetes
#4
Xueying Tan, Xiaojing Cao, Minzhi Zhou, Ping Zou, Jingbo Hu
Type 2 diabetes is a chronic metabolic disease characterized by persistent hyperglycemia resulting from progressive deficient of insulin in patients with a background of insulin resistance. Current treatment algorithms recommended by American Diabetes Association/The European Association for the Study of Diabetes promote a patient-centered approach that takes into account a comprehensive consideration of pharmacological properties of drugs, including glucose-lowering action, effects on body weight, correction on multiple pathophysiologic defects, tolerability, and long-term safety...
July 25, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28741405/optimized-tpa-a-non-neurotoxic-fibrinolytic-agent-for-the-drainage-of-intracerebral-hemorrhages
#5
Romain Goulay, Mikaël Naveau, Thomas Gaberel, Denis Vivien, Jérôme Parcq
Intracerebral hemorrhage (ICH) is the most severe form of stroke. Catheter-delivered thrombolysis with recombinant tissue-type plasminogen activator (rtPA) for the drainage of ICH is currently under evaluation in a phase III clinical trial (MISTIE III). However, in a pig model of ICH, in situ fibrinolysis with rtPA was reported to increase peri-lesional edema by promoting N-methyl-D-aspartate (NMDA)-dependent excitotoxicity. In the present study, we engineered a non-neurotoxic tPA variant, OptPA, and investigated its safety and efficacy for in situ fibrinolysis in a rat model of ICH...
January 1, 2017: Journal of Cerebral Blood Flow and Metabolism
https://www.readbyqxmd.com/read/28741274/cyclin-dependent-kinase-4-6-inhibitors-in-breast-cancer-palbociclib-ribociclib-and-abemaciclib
#6
REVIEW
Dorota Kwapisz
PURPOSE: The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway plays a crucial role in cell cycle progression and its dysregulation is an important contributor to endocrine therapy resistance. CDK4/6 inhibitors trigger cell cycle arrest in Rb protein (pRb)-competent cells. Recent years have seen the development of selective CDK4/6 inhibitors, which have delivered promising results of efficacy and manageable safety profiles. The main objective of this review is to discuss preclinical and clinical data to date, and ongoing clinical trials with palbociclib, ribociclib, and abemaciclib in breast cancer...
July 24, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28740892/chemoradiation-therapy-with-docetaxel-in-elderly-patients-with-stage-ii-iii-esophageal-cancer-a-phase-2-trial
#7
Akihiro Ohba, Ken Kato, Yoshinori Ito, Chikatoshi Katada, Hiromichi Ishiyama, Sachiko Yamamoto, Takashi Ura, Takeshi Kodaira, Shigehiro Kudo, Yoshio Tamaki
PURPOSE: The most effective treatments in elderly patients with esophageal cancer remain a subject of debate. This multicenter phase 2 study was designed to evaluate the efficacy and toxicity of chemoradiation therapy (CRT) with docetaxel (DTX) in elderly patients with stage II/III (non-T4) esophageal cancer. METHODS AND MATERIALS: Patients ≥70 years of age with clinical stage II/III esophageal cancer received DTX at a weekly dose of 10 mg/m(2) during 6 consecutive weeks and concurrent radiation therapy (60 Gy in 30 fractions)...
October 2016: Advances in Radiation Oncology
https://www.readbyqxmd.com/read/28740389/methylphenidate-dose-optimization-for-adhd-treatment-review-of-safety-efficacy-and-clinical-necessity
#8
REVIEW
Michael Huss, Praveen Duhan, Preetam Gandhi, Chien-Wei Chen, Carsten Spannhuth, Vinod Kumar
Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28738794/escaschool-study-trial-protocol-of-an-adaptive-treatment-approach-for-school-age-children-with-adhd-including-two-randomised-trials
#9
Manfred Döpfner, Christopher Hautmann, Christina Dose, Tobias Banaschewski, Katja Becker, Daniel Brandeis, Martin Holtmann, Thomas Jans, Carolin Jenkner, Sabina Millenet, Tobias Renner, Marcel Romanos, Elena von Wirth
BACKGROUND: The ESCAschool study addresses the treatment of school-age children with attention-deficit/hyperactivity disorder (ADHD) in a large multicentre trial. It aims to investigate three interrelated topics: (i) Clinical guidelines often recommend a stepped care approach, including different treatment strategies for children with mild to moderate and severe ADHD symptoms, respectively. However, this approach has not yet been empirically validated. (ii) Behavioural interventions and neurofeedback have been shown to be effective, but the superiority of combined treatment approaches such as medication plus behaviour therapy or medication plus neurofeedback compared to medication alone remains questionable...
July 24, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28738768/current-status-of-the-pharmacokinetics-and-pharmacodynamics-of-hiv-1-entry-inhibitors-and-hiv-therapy
#10
Fengyan Xu, Edward P Acosta, Liyu Liang, Yingchun He, Juan Yang, Corenna Kerstner-Wood, Qingshang Zheng, Jihan Huang, Kun Wang
Human immunodeficiency virus (HIV) entry inhibitors target the first step of the HIV life cycle and efficiently inhibit HIV from infecting the immune cells which is a key prerequisite for viral spread. Because of their unique mechanism of action on cell-cell transmission they may provide a promising perspective for the treatment of AIDS. Maraviroc (MVC) and Enfuvirtide (ENF) have been approved by the FDA for the treatment of HIV-1 infection. Attachment inhibitors (BMS-663068 and TNX-355) and co-receptor inhibitors (PRO-140 and Cenicriviroc (CVC)) have reached phase II or III clinical trials...
July 24, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28738235/treatment-decisions-in-metastatic-colorectal-cancer-beyond-first-and-second-line-combination-therapies
#11
REVIEW
A Vogel, R D Hofheinz, S Kubicka, D Arnold
Median overall survival (OS) of patients with metastatic colorectal cancer (mCRC) has reached up to 30months in recent clinical trials of first line therapies. Following disease progression after the standard in both, 1st and 2nd line, combination chemotherapy with monoclonal antibodies, many patients maintain a good performance status and a significant proportion is motivated to undergo further therapy. Choices of treatment beyond the second line setting for mCRC are therefore becoming increasingly important...
May 4, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28737050/efficacy-of-elagolix-in-the-treatment-of-endometriosis
#12
Alexandra Perricos, René Wenzl
Much research has gone into developing medications that can be used to alleviate endometriosis-associated symptoms. In addition to already established medications, a new GnRH antagonist, elagolix, is in development. The novelty of this drug compared to other GnRH antagonists, is its nonpeptide structure, allowing it to be administered orally. Areas covered: We analyzed several Phase I, II and III clinical trials that have evaluated the safety and efficacy of this new medication. Expert opinion: Since many medications have been put on the market and have gained popularity for the treatment of endometriosis-associated symptoms, the demonstration of equality or superiority of effect, tolerability, as well as patient compliance should be assessed when introducing a new drug...
July 24, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28736629/biologic-therapy-in-esophageal-and-gastric-malignancies-current-therapies-and-future-directions
#13
REVIEW
Pamela Samson, A Craig Lockhart
Biologic agents, including targeted antibodies as well as immunomodulators, are demonstrating unparalleled development and study across the entire spectrum of human malignancy. This review summarizes the current state of biologic therapies for esophageal, esophagogastric, and gastric malignancies, including those that target human epidermal growth factor receptor 2 (HER2), epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), c-Met, mechanistic target of rapamycin (mTOR) and immunomodulators...
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#14
A S Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28735067/treatment-sequence-with-either-irinotecan-cetuximab-followed-by-folfox-4-or-the-reverse-strategy-in-metastatic-colorectal-cancer-patients-progressing-after-first-line-folfiri-bevacizumab-an-italian-group-for-the-study-of-gastrointestinal-cancer-phase-iii-randomised
#15
Stefano Cascinu, Gerardo Rosati, Guglielmo Nasti, Sara Lonardi, Alberto Zaniboni, Paolo Marchetti, Francesco Leone, Domenico Bilancia, Rosario Vincenzo Iaffaioli, Vittorina Zagonel, Monica Giordano, Domenico C Corsi, Francesco Ferraú, Roberto Labianca, Monica Ronzoni, Mario Scartozzi, Francesca Galli
INTRODUCTION: The optimal treatment strategy for RAS wild type (WT) mCRC is controversial. Our phase III study investigated the effect of introducing earlier (second-line) or later (third-line) cetuximab in patients progressed after FOLFIRI/bevacizumab first-line. PATIENTS AND METHODS: mCRC patients progressing after FOLFIRI/bevacizumab first-line were randomised to receive second-line irinotecan/cetuximab followed by third-line FOLFOX-4 (arm A) or the reverse sequence (arm B)...
July 20, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28732819/individual-dose-adjustment-of-riociguat-in-patients-with-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension
#16
REVIEW
Nicholas S Hill, Franck F Rahaghi, Namita Sood, Reiner Frey, Hossein-Ardeschir Ghofrani
Riociguat is a soluble guanylate cyclase stimulator that has been approved for the treatment of pulmonary arterial hypertension and inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension following pulmonary endarterectomy. Riociguat is administered using an 8-week individual dose-adjustment scheme whereby a patient initially receives riociguat 1.0 mg three times daily (tid), and the dose is then increased every 2 weeks in the absence of hypotension, indicated by systolic blood pressure measurements and symptoms, up to a maximum dose of 2...
August 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28732369/efficacy-and-safety-of-accelerated-partial-breast-irradiation-a-meta-analysis-of-published-randomized-studies
#17
Gengchun Liu, Zhongyi Dong, Baqun Huang, Yuelong Liu, Yan Tang, Qing Li, Yihui Zhu
BACKGROUND AND PURPOSE: Accelerated partial breast irradiation (APBI) technology has theoretical advantages in comparison with traditional adjuvant radiation therapy (whole-breast irradiation; WBI) after breast-conserving surgery. However, published randomized controlled trials have shown inconsistent outcomes. Therefore, a comprehensive assessment of the effectiveness and safety of APBI technology is needed. RESULTS: A total of 7 studies of 7452 patients were included in this analysis...
July 13, 2017: Oncotarget
https://www.readbyqxmd.com/read/28732152/secukinumab-in-the-treatment-of-psoriasis-and-psoriatic-arthritis-a-review-of-the-literature
#18
M Abrouk, J Gandy, M Nakamura, K Lee, M Brodsky, R Singh, H Zhu, B Farahnik, T Bhutani, J Koo
While there are several commercially available treatment options for psoriasis and psoriatic arthritis, there remains a large number of individuals who are refractory to current modalities. In the recent past, there has been increasing evidence that interleukin (IL)-17 plays a vital role in the pathophysiology of psoriasis. Preclinical, phase II, and phase III studies of secukinumab (Cosentyx®) targeting IL-17 and its receptor have thus far proved to be promising. We reviewed the results of phase II and phase III clinical trials for secukinumab in the treatment of psoriasis and psoriatic arthritis...
July 2017: Skin Therapy Letter
https://www.readbyqxmd.com/read/28730885/ataluren-in-cystic-fibrosis-development-clinical-studies-and-where-are-we-now
#19
Noreen Zainal Abidin, Iram J Haq, Aaron I Gardner, Malcolm Brodlie
Cystic fibrosis (CF) is one of the most common genetically-acquired life-limiting conditions worldwide. The underlying defect is dysfunction of the cystic fibrosis transmembrane-conductance regulator (CFTR) which leads to progressive lung disease and other multi-system effects. Around 10% of people with CF have a class I nonsense mutation that leads to production of shortened CFTR due to a premature termination codon (PTC). Areas covered: We discuss the discovery of the small-molecule drug ataluren, which in vitro has been shown to allow read-through of PTCs and facilitate synthesis of full-length protein...
July 21, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28730115/diabetic-macular-edema-in-proliferative-stage-treated-with-anti-vascular-endothelial-growth-factor-agent-and-triamcinolone-acetonide-by-laser-based-strategies
#20
Gang Qiao, Wan-Jiang Dong, Yan Dai, Zhen-Hua Jiang, Hai-Ke Guo
AIM: To appraise the effect of treatment for diabetic macular edema (DME) in proliferative stage with sufficient panrentinal photocoagulation (PRP) therapy and intravitreal injections (IV) Conbercept and posterior subtenon's triamcinolone acetonide (STTA) sequential therapy. METHODS: This prospective clinical randomized controlled trial of cross-over design was conducted in three phases. The participants included cases of DME in proliferative stage. They were divided into two groups and treated with PRP before enrollment...
2017: International Journal of Ophthalmology
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