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Clinical Therapeutics

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https://www.readbyqxmd.com/read/29759903/potential-adverse-drug-events-and-nephrotoxicity-related-to-prophylaxis-with-omeprazole-for-digestive-disorders-a-prospective-cohort-study
#1
Fabiana Rossi Varallo, Tales Rubens de Nadai, Alice Rosa Alves de Oliveira, Patricia de Carvalho Mastroianni
PURPOSE: The purpose of this study was to assess whether prophylaxis for digestive disorders with omeprazole is a risk factor for adverse drug events (ADEs) and kidney impairment. METHODS: This was a 9-month, prospective, double-blinded cohort study performed in a Brazilian public hospital. All inpatients 18 years or older admitted during the period of data collection were divided into 2 cohorts. The first group comprised 200 patients receiving prophylaxis for digestive disorders with omeprazole...
May 11, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29755005/assessing-the-financial-benefits-of-faster-development-times-the-case-of-single-source-versus-multi-vendor-outsourced-biopharmaceutical-manufacturing
#2
Joseph A DiMasi, Zachary Smith, Kenneth A Getz
PURPOSE: The extent to which new drug developers can benefit financially from shorter development times has implications for development efficiency and innovation incentives. We provided a real-world example of such gains by using recent estimates of drug development costs and returns. METHODS: Time and fee data were obtained on 5 single-source manufacturing projects. Time and fees were modeled for these projects as if the drug substance and drug product processes had been contracted separately from 2 vendors...
May 10, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29752039/impact-of-fungi-on-immune-responses
#3
Pio Conti, Lucia Tettamanti, Filiberto Mastrangelo, Gianpaolo Ronconi, Ilias Frydas, Spiros K Kritas, Alessandro Caraffa, Franco Pandolfi
Spores and fungal fragments found in indoor and outdoor environments originate from opportunistic fungi and they can contribute to inflammatory responses, causing a broad range of symptoms. Papers were selected and reviewed with an emphasis on the molecular mechanisms involved in the effect of fungi on immune cells, especially mast cells (MCs). Fungi can bind to antibodies and complement them, allowing them to be recognized by cells of the innate immune system, including macrophages, dendritic cells, and MCs, which are then stimulated via Toll-like receptor signaling...
May 8, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29748143/the-investigation-and-treatment-of-diabetic-gastroparesis
#4
REVIEW
Mohit Kumar, Adam Chapman, Saad Javed, Uazman Alam, Rayaz A Malik, Shazli Azmi
PURPOSE: This review provides an update on the investigations and treatment options for gastroparesis. METHODS: A comprehensive literature search of Medline, PubMed, Embase and OVID was conducted which included all systematic reviews and research articles that focused on the diagnosis, investigations and management diabetic gastroparesis. FINDINGS: Dietary modifications and pharmacologic treatment with prokinetics to increase gastric motility form the mainstay of treatment...
May 7, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29735297/utilization-patterns-of-lipid-lowering-therapies-in-patients-with-atherosclerotic-cardiovascular-disease-or-diabetes-a-population-based-study-in-south-korea
#5
Siin Kim, Hyungtae Kim, Eunju Kim, Sola Han, Pratik P Rane, Kathleen M Fox, Zhongyun Zhao, Yi Qian, Hae Sun Suh
PURPOSE: We aimed to study the utilization patterns of lipid-lowering treatment (LLT), including treatment modification, adherence, and possible statin intolerance, in patients with atherosclerotic cardiovascular disease (ASCVD) or diabetes using national claims data in South Korea. METHODS: A retrospective cohort study was conducted using data from the Korean Health Insurance Review & Assessment Service claims database. Patients aged ≥18 years with >1 outpatient pharmacy claim for a statin and/or ezetimibe dated January 1, 2012, to December 31, 2014, were identified and categorized into the following cohorts: patients with ASCVD, and patients with diabetes mellitus without ASCVD...
May 4, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29735296/an-anecdote-about-arthritis-and-boswellia-serrata
#6
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
May 4, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29729957/comparison-of-adherence-to-glimepiride-metformin-sustained-release-once-daily-versus-glimepiride-metformin-immediate-release-bid-fixed-combination-therapy-using-the-medication-event-monitoring-system-in-patients-with-type-2-diabetes
#7
Jong-Dai Kim, Cheol-Young Park, Bong-Yun Cha, Kyu Jeung Ahn, In Joo Kim, Kyong Soo Park, Hyung Woo Lee, Kyung-Wan Min, Jong Chul Won, Min Young Chung, Jae-Taek Kim, Jun Goo Kang, Sung-Woo Park
PURPOSE: The purpose of this study was to compare the adherence of the glimepiride/metformin sustained release (GM-SR) once-daily fixed-dose combination and glimepiride/metformin immediate release (GM-IR) BID fixed-dose combination in type 2 diabetes therapies. METHODS: An open-label, randomized, multicenter, parallel-group study was conducted at 11 hospitals in the Republic of Korea. A total of 168 patients with type 2 diabetes treated with >4 mg of glimepiride and 1000 mg of metformin by using free or fixed-dose combination therapy for at least 2 weeks were enrolled...
May 2, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29724499/changes-in-weight-associated-with-telotristat-ethyl-in-the-treatment-of-carcinoid-syndrome
#8
Martin O Weickert, Gregory Kaltsas, Dieter Hörsch, Pablo Lapuerta, Marianne Pavel, Juan W Valle, Martyn E Caplin, Emily Bergsland, Pamela L Kunz, Lowell B Anthony, Enrique Grande, Kjell Öberg, Staffan Welin, Catherine Lombard-Bohas, John K Ramage, Ashwin Kittur, Qi M Yang, Matthew H Kulke
PURPOSE: In the placebo-controlled Phase III TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) trial, the oral tryptophan hydroxylase inhibitor telotristat ethyl significantly reduced bowel movement (BM) frequency during a 12-week, double-blind treatment period in 135 patients with metastatic neuroendocrine tumors with carcinoid syndrome and ≥4 BMs per day. Patients (mean [SD] age, 63.5 [8.9] years; mean [SD] body mass index, 24.9 [4...
April 30, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29724497/retraction-notice-to-multiple-papers-in-clinical-therapeutics
#9
(no author information available yet)
No abstract text is available yet for this article.
April 30, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29709457/diabetic-peripheral-neuropathy-epidemiology-diagnosis-and-pharmacotherapy
#10
REVIEW
Zohaib Iqbal, Shazli Azmi, Rahul Yadav, Maryam Ferdousi, Mohit Kumar, Daniel J Cuthbertson, Jonathan Lim, Rayaz A Malik, Uazman Alam
PURPOSE: Diabetic peripheral neuropathy (DPN) is the commonest cause of neuropathy worldwide, and its prevalence increases with the duration of diabetes. It affects approximately half of patients with diabetes. DPN is symmetric and predominantly sensory, starting distally and gradually spreading proximally in a glove-and-stocking distribution. It causes substantial morbidity and is associated with increased mortality. The unrelenting nature of pain in this condition can negatively affect a patient's sleep, mood, and functionality and result in a poor quality of life...
April 27, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29709456/drug-registries-and-approval-of-drugs-promises-placebo-or-a-real-success
#11
Carla J Jonker, Marcel S G Kwa, H Marijke van den Berg, Arno W Hoes, Peter G M Mol
PURPOSE: As part of the approval process, regulatory authorities often require postauthorization studies that involve patient registries; it is unknown, however, whether such registry studies are adequately completed. We investigated whether registry studies for new drugs were performed as agreed at time of approval. METHODS: This study reviewed protocols and follow-up reports for 73 registry studies that were proposed for 43 drugs approved by the Committee for Medicinal Products for Human Use in Europe in the period 2007 to 2010...
April 27, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29703432/antiviral-activity-safety-and-tolerability-of-multiple-ascending-doses-of-elbasvir-or-grazoprevir-in-participants-infected-with-hepatitis-c-virus-genotype-1-or-3
#12
Wendy W Yeh, Iain P Fraser, Patricia Jumes, Amelia Petry, Inge De Lepeleire, Martine Robberechts, Christina Reitmann, Kristien Van Dyck, Xiaobi Huang, Zifang Guo, Deborah Panebianco, Robert B Nachbar, Edward O'Mara, John A Wagner, Joan R Butterton, Frank J Dutko, Valentin Moiseev, Zhanna Kobalava, Andreas Hüser, Sorin Visan, Christian Schwabe, Edward Gane, Serghei Popa, Nelea Ghicavii, Markus Uhle, Frank Wagner
PURPOSE: Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A phosphoprotein and the nonstructural protein 3/4A protease, respectively. The aims of these studies were to evaluate the antiviral activity and safety of different doses of elbasvir or grazoprevir each administered as monotherapy to participants infected with either HCV genotype (GT) 1 or GT3. METHODS: These 2 double-blind, randomized, placebo-controlled, sequential-panel, multiple ascending dose studies were conducted to assess the safety and pharmacodynamics of 5 days of once-daily elbasvir or 7 days of once-daily grazoprevir in adult male participants chronically infected with either HCV GT1 or GT3...
April 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29703431/safety-versus-tolerability
#13
EDITORIAL
Richard I Shader
No abstract text is available yet for this article.
April 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29703430/relative-bioavailability-of-methylphenidate-extended-release-chewable-tablets-chewed-versus-swallowed-whole
#14
Richat Abbas, Ann C Childress, Praneeta Nagraj, Richard Rolke, Sally A Berry, Donna R Palumbo
PURPOSE: Methylphenidate hydrochloride extended-release chewable tablet (MPH ERCT) is approved for treatment of attention deficit hyperactivity disorder in patients aged 6 years and older. This article evaluates the pharmacokinetic parameters and relative bioavailability of MPH ERCT when chewed versus swallowed whole. METHODS: In this open-label, single-dose, 3-period, 3-treatment crossover study, 12 healthy adult volunteers were randomly assigned to treatment sequence...
April 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29699853/monoclonal-antibody-biosimilars-in-oncology-critical-appraisal-of-available-data-on-switching
#15
Paul Declerck, Georgios Bakalos, Elias Zintzaras, Bettina Barton, Thomas Schreitmüller
PURPOSE: With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies...
April 23, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29699852/relative-bioavailability-of-a-single-4-mg-dose-of-somatropin-administered-by-subcutaneous-injection-or-by-needle-free-device-and-coadministered-with-the-growth-hormone-inhibitor-octreotide-acetate-in-healthy-adult-subjects
#16
Darin B Brimhall, Niclas Petri, Pina D'Angelo
PURPOSE: Somatropin, used to treat growth hormone deficiency, has been traditionally administered by subcutaneous (SC) injection with needle and syringe. Needle-free devices offer ease of administration and may improve adherence and outcomes. This study evaluated the relative bioavailability of somatropin delivered with a needle-free device compared with traditional SC injection. METHODS: In this randomized, single-dose, crossover study, healthy adults aged 18 to 35 years received single 4-mg doses of somatropin via a needle-free device or SC injection, along with octreotide to suppress endogenous growth hormone production...
April 23, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29685599/hypoparathyroidism-in-total-thyroidectomy-due-to-benign-thyroid-diseases
#17
Burak Ertaş, Bayram Veyseller, Abdullah Karataş, Alper Özdilek, Remzi Doğan, Orhan Ozturan
PURPOSE: Our aim was to compare the effects of exposing the recurrent laryngeal nerve throughout its entire course with exposing the nerve only at its entry to the larynx in patients undergoing total thyroidectomy due to benign thyroid diseases, and to evaluate the effects of these methods on the risk for hypoparathyroidism. METHODS: The medical records of 437 patients who had undergone total thyroidectomy at the ear, nose, and throat clinic between 2001 and 2015 for benign thyroid diseases were evaluated retrospectively...
April 20, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29678279/the-psychiatric-consequences-of-cannabinoids
#18
Joao P De Aquino, Mohamed Sherif, Rajiv Radhakrishnan, John D Cahill, Mohini Ranganathan, Deepak C D'Souza
With rising rates of cannabis use in the general population and an increasing number of US states legalizing both recreational and medical cannabis use, it is important to be informed about the adverse consequences of cannabinoids. This Commentary provides an overview of the psychiatric effects of plant-based and synthetic cannabinoids, differentiating acute effects from effects associated with persistent use. Cannabinoids produce multiphasic and dose-dependent effects on anxiety, mood, and perception, in addition to impairing cognition and psychomotor function...
April 17, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29673891/burden-of-acute-myeloid-leukemia-among-older-newly-diagnosed-patients-retrospective-analysis-of-data-from-the-2010-2012-medicare-limited-data-set
#19
Naomi C Sacks, Philip L Cyr, Arthur C Louie, Yanmei Liu, Michael T Chiarella, Abhishek Sharma, Karen C Chung
PURPOSE: Acute myeloid leukemia (AML) disproportionately affects older adults; the prognosis in this subpopulation is generally poor, with variable use of inpatient chemotherapy. This study characterizes treatment patterns, hospitalizations, and outcomes among older patients with AML. METHODS: Using the Centers for Medicare & Medicaid Services' 2010-2012 100% Limited Data Set (LDS), data from all hospital claims from fee-for-service Medicare beneficiaries between 60 and 75 years of age with newly diagnosed AML and ≥1 hospitalization were analyzed...
April 16, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29673890/efficacy-and-safety-of-fixed-dose-combination-therapy-with-telmisartan-and-rosuvastatin-in-korean-patients-with-hypertension-and-dyslipidemia-telsta-yu-telmisartan-rosuvastatin-from-yuhan-a-multicenter-randomized-4-arm-double-blind-placebo-controlled-phase
#20
Gyu Chul Oh, Jung-Kyu Han, Ki Hoon Han, Min-Su Hyon, Joon Hyung Doh, Moo Hyun Kim, Jin-Ok Jeong, Jang-Ho Bae, Sang Hyun Kim, Byung-Su Yoo, Sang Hong Baek, Moo-Yong Rhee, Sang-Hyun Ihm, Jung Hoon Sung, Young Jin Choi, Soo-Joong Kim, Kyung-Soon Hong, Byoung Kwon Lee, JangHyun Cho, Eun Seok Shin, Jay Young Rhew, Hyunsu Kim, Hyo-Soo Kim
PURPOSE: Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combination (FDC) therapy with a single pill may be a solution in these situations. METHODS: This multicenter, 8-week, randomized, double-blind, Phase III study evaluated the efficacy and safety of FDC treatment with telmisartan (80 mg) and rosuvastatin calcium (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia...
April 16, 2018: Clinical Therapeutics
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