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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/28913735/efficacy-and-safety-of-tazarotene-0-1-plus-clindamycin-1-gel-versus-adapalene-0-1-plus-clindamycin-1-gel-in-facial-acne-vulgaris-a-randomized-controlled-clinical-trial
#1
Rituparna Maiti, Chandra Sekhar Sirka, M A Ashique Rahman, Anand Srinivasan, Sansita Parida, Debasish Hota
BACKGROUND: Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics. OBJECTIVES: The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris. METHODS: This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center...
September 14, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28900877/genetic-polymorphisms-of-slco1b1-cyp2e1-and-ugt1a1-and-susceptibility-to-anti-tuberculosis-drug-induced-hepatotoxicity-a-chinese-population-based-prospective-case-control-study
#2
Qin Sun, Hai-Peng Liu, Rui-Juan Zheng, Peng Wang, Zhi-Bin Liu, Wei Sha, He-Ping Xiao
BACKGROUND: Drug transporters and drug-metabolizing enzymes have been linked to drug-induced hepatotoxicity. Solute carrier organic anion transporter family member 1B1 (SLCO1B1), cytochrome P450 2E1 (CYP2E1), and UDP glucuronosyltransferase 1A1 (UGT1A1) were selected as candidate genes to explore their association with susceptibility to anti-tuberculosis drug-induced hepatotoxicity (ATDH). METHODS: Thirty-four tag single nucleotide polymorphisms (tagSNPs) in SLCO1B1, CYP2E1, and UGT1A1 with 10-kb expansion up- and down-stream were genotyped in 461 patients with ATDH and 466 patients without ATDH in a prospective 1:1 matched case-control study...
September 12, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28895089/bilateral-salpingo-oophorectomy-versus-gnrh-analogue-in-the-adjuvant-treatment-of-premenopausal-breast-cancer-patients-cost-effectiveness-evaluation-of-breast-cancer-outcome-ovarian-cancer-prevention-and-treatment
#3
Gabriella Ferrandina, Giulia Amadio, Andrea Marcellusi, Elena Azzolini, Anna Puggina, Roberta Pastorino, Walter Ricciardi, Giovanni Scambia
BACKGROUND AND OBJECTIVE: There is no available evidence to recommend gonadotropin-releasing hormone (GnRH) analogue-based ovarian suppression versus bilateral salpingo-oophorectomy (BSO) in the adjuvant treatment of early breast cancer, since the two approaches are considered equivalent in terms of oncologic outcome. The role of surgical ovarian ablation has been revitalized based on the advances of minimally invasive surgery, and a better understanding of clinical and molecular basis of hereditary breast/ovarian cancer syndromes...
September 11, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28871475/safety-and-efficacy-of-ombitasvir-paritaprevir-ritonavir-and-dasabuvir-with-or-without-ribavirin-for-treatment-of-hepatitis-c-virus-genotype-1-a-systematic-review-and-meta-analysis
#4
REVIEW
Hussien Ahmed, Abdelrahman Ibrahim Abushouk, Amr Menshawy, Arwa Mohamed, Ahmed Negida, Samah A Loutfy, Mohamed M Abdel-Daim
BACKGROUND AND OBJECTIVE: Interferon-free regimens are rapidly evolving for patients with chronic hepatitis C virus (HCV) infection. We performed this meta-analysis to investigate the safety and efficacy of a combination regimen (ombitasvir [OBV]/paritaprevir [PTV]/ritonavir [r] ± dasabuvir [DSV]) for the treatment of patients with HCV genotype 1 infection. METHODS: A computerized literature search for relevant clinical trials was conducted during May 2017. Data on sustained virological response (SVR), virological relapse, and safety outcomes were extracted and calculated as pooled proportion (PP) or risk ratio (RR) with their 95% confidence interval (CI), using StatsDirect and RevMan software...
September 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28856602/pharmacokinetic-profiles-of-ticagrelor-orodispersible-tablets-in-healthy-western-and-japanese-subjects
#5
Renli Teng, Maria Hammarberg, Glenn F Carlson, Sara Bokelund-Singh, Terese Ruderfelt, Eva Blychert
BACKGROUND AND OBJECTIVES: Ticagrelor is an antiplatelet agent for patients with acute coronary syndrome or a history of myocardial infarction. Two studies compared pharmacokinetic profiles of orodispersible (OD) ticagrelor tablets versus immediate-release (IR) tablets in Western and Japanese subjects. METHODS: Both studies were open-label, randomized, crossover, single-center trials. Thirty-six healthy subjects (94% white, 6% other race; Western study NCT02400333) and 42 Japanese healthy subjects (Japanese study NCT02436577) received a single 90-mg ticagrelor dose as an OD tablet [with/without water, and via a nasogastric tube (Western study only)], and an IR tablet; washout between treatments was ≥7 days...
August 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28856572/safety-of-antiplatelet-agents-analysis-of-real-world-data-from-the-italian-national-pharmacovigilance-network
#6
Lucia Gozzo, Andrea Navarria, Giuseppe Benfatto, Laura Longo, Silvana Mansueto, Laura Sottosanti, Luca Pani, Salvatore Salomone, Filippo Drago
INTRODUCTION: According to the Italian National Report on drug use, thienopyridines (ticlopidine, clopidogrel and prasugrel) and ticagrelor represent the most prescribed antiplatelet agents, beside aspirin. The aim of this study was to analyse the safety profile of these drugs using data from spontaneous reporting of suspected adverse reactions (ADRs). METHODS: Suspected ADRs for ticlopidine, clopidogrel, prasugrel and ticagrelor, reported on the Italian National Pharmacovigilance Network between January 2009 and December 2016, were included in the analysis...
August 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28856569/pharmacokinetics-of-cromolyn-and-ibuprofen-in-healthy-elderly-volunteers
#7
David Brazier, Robert Perry, Jim Keane, Katie Barrett, David R Elmaleh
BACKGROUND AND OBJECTIVES: The combination of cromolyn and ibuprofen is being investigated as a treatment for early Alzheimer's disease (AD). This study investigated the pharmacokinetics, safety, and tolerability of cromolyn and ibuprofen co-administration in healthy elderly adult volunteers. METHODS: In this open-labeled study, 26 subjects, aged 55-75 years, received co-administration of inhaled cromolyn (single dose 17.1 mg; double dose 34.2 mg total) and oral ibuprofen (single dose 10 mg; double dose 20 mg total)...
August 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28836132/lactate-levels-with-chronic-metformin-use-a-narrative-review
#8
REVIEW
Weiyi Huang, Ronald L Castelino, Gregory M Peterson
Metformin has been associated with lactic acidosis. Lactate levels are not commonly tested in clinical practice, and it is unclear to what extent metformin would typically increase lactate levels with chronic use. The aim of this review was to determine whether regular monitoring of the plasma lactate level would be beneficial in avoiding lactate accumulation and, ultimately, minimising the incidence of lactic acidosis in metformin-treated patients.A comprehensive search of PubMed, Embase, Web of Science, Cochrane and International Pharmaceutical Abstracts databases covering the period up to 30 May 2017 was performed...
August 23, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28831689/balancing-the-need-for-personalization-of-qt-correction-and-generalization-of-study-results-going-beyond-thorough-qt-studies
#9
LETTER
Igor Diemberger, Emanuel Raschi, Gianluca Trifirò
No abstract text is available yet for this article.
August 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28791591/age-related-differences-in-non-persistence-with-statin-treatment-in-patients-after-a-transient-ischaemic-attack
#10
Martin Wawruch, Dusan Zatko, Gejza Wimmer, Jan Luha, Sona Wimmerova, Petra Matalova, Peter Kukumberg, Jan Murin, Tomas Tesar, Beata Havelkova, Rashmi Shah
BACKGROUND AND OBJECTIVE: Non-persistence with secondary preventive measures, including medications such as statins, adversely affects the prospects of successful outcomes. This study was aimed at evaluating non-persistence with statin therapy in cohorts of young and elderly patients after a transient ischaemic attack (TIA) and identifying patient-associated characteristics that influence the risk for non-persistence. METHODS: The study cohorts included 797 adult patients who were initiated on statin therapy following a TIA diagnosis between 1 January 2010 and 31 December 2010...
August 8, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28785879/a-randomized-trial-to-assess-the-effect-of-doravirine-on-the-qtc-interval-using-a-single-supratherapeutic-dose-in-healthy-adult-volunteers
#11
Sauzanne G Khalilieh, Ka Lai Yee, Li Fan, Rachael Liu, Walter Heber, Elise Dunzo, Ilias Triantafyllou, Azra Hussaini, Marian Iwamoto
INTRODUCTION: Doravirine is a novel HIV-1 non-nucleoside reverse transcriptase inhibitor exhibiting a robust safety and efficacy profile in combination with other antiretrovirals. While existing data do not suggest that doravirine delays cardiac repolarization, the aim of this trial was to evaluate the effects of a supratherapeutic dose of doravirine on the heart-rate corrected QT (QTc) interval in healthy adults. METHODS: A randomized, three-period, crossover, placebo-controlled trial was conducted in healthy adults, 18-55 years of age...
August 7, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28779268/effectiveness-of-switch-to-erythropoiesis-stimulating-agent-esa-biosimilars-versus-maintenance-of-esa-originators-in-the-real-life-setting-matched-control-study-in-hemodialysis-patients
#12
Roberto Minutolo, Piergiorgio Bolasco, Paolo Chiodini, Stefano Sposini, Maurizio Borzumati, Cataldo Abaterusso, Alessandra A Mele, Domenico Santoro, Valeria Canale, Alberto Santoboni, Oliviero Filiberti, Fulvio Fiorini, Carlo Mura, Patrizio Imperiali, Silvio Borrelli, Luigi Russo, Luca De Nicola, Domenico Russo
BACKGROUND: In hemodialysis (HD), switching from erythropoiesis-stimulating agent (ESA) originators to biosimilars is associated with the need for doses approximately 10% higher, according to industry-driven studies. OBJECTIVE: The aim of this study was to evaluate the efficacy on anemia control of switching from ESA originators to biosimilars in daily clinical practice. METHODS: We retrospectively selected consecutive HD patients receiving stable intravenous ESA doses, and who had not been transfused in the previous 6 months, from 12 non-profit Italian centers...
August 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28766264/acetaminophen-paracetamol-induces-hypothermia-during-acute-cold-stress
#13
Josh Foster, Alexis R Mauger, Andrew Govus, David Hewson, Lee Taylor
BACKGROUND: Acetaminophen is an over-the-counter drug used to treat pain and fever, but it has also been shown to reduce core temperature (T c) in the absence of fever. However, this side effect is not well examined in humans, and it is unknown if the hypothermic response to acetaminophen is exacerbated with cold exposure. OBJECTIVE: To address this question, we mapped the thermoregulatory responses to acetaminophen and placebo administration during exposure to acute cold (10 °C) and thermal neutrality (25 °C)...
August 1, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28756557/effects-of-central-nervous-system-drugs-on-recovery-after-stroke-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#14
REVIEW
See-Hwee Yeo, Zheng-Jie Ian Lim, Jia Mao, Wai-Ping Yau
BACKGROUND AND OBJECTIVE: Pilot trials have suggested that pharmacotherapy may aid stroke recovery. The aim of this study was to systematically review the effects of antidepressants, anti-Alzheimer drugs, anti-Parkinson drugs, central nervous system (CNS) stimulants and piracetam on gross motor function, cognition, disability, dependency and quality of life (QOL) after stroke. METHODS: PubMed, EMBASE and the Cochrane Central Register of Controlled Trials databases were searched, and 44 randomized controlled trials that compared outcomes of interest between drug treatment and placebo or no treatment were included...
July 29, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28755059/nusinersen-the-first-option-beyond-supportive-care-for-spinal-muscular-atrophy
#15
REVIEW
Vikas Maharshi, Shazia Hasan
Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder characterized by degeneration of spinal motor neurons and poses significant adverse outcome in affected population. Survival motor neuron 1 (SMN1) protein encoded by SMN1 gene located on 5q(13) is critical for survival and functioning of motor neurons. Almost identical gene SMN2, present on the same chromosome, produces a small truncated protein (SMN2) because of skipping of exon 7 from translation due to translation silent C6U substitution in exon 7 of SMN2 pre-mRNA transcript...
July 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28755058/novel-biologic-agents-targeting-interleukin-23-and-interleukin-17-for-moderate-to-severe-psoriasis
#16
REVIEW
Zeyu Chen, Yu Gong, Yuling Shi
Psoriasis is a common, chronic inflammatory skin disease and cannot be cured. The treatment of moderate-to-severe plaque psoriasis has been revolutionized with the development of biologic agents for nearly 20 years. Current studies show that interleukin-23 and interleukin-17 play remarkable roles in the pathogenesis of psoriasis. Interleukin-23 can sustain the differentiation and maintenance of T helper-17 lineage. Interleukin-17 can recruit and stimulate many cells, which play important parts in psoriasis through interacting with the interleukin-17 receptor...
July 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28748412/pharmacokinetics-of-dfn-15-a-novel-oral-solution-of-celecoxib-versus-celecoxib-400-mg-capsules-a-randomized-crossover-study-in-fasting-healthy-volunteers
#17
Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan, Joga Gobburru
BACKGROUND: COX-2 inhibitors can be effective for acute migraine, but none is supplied in a rapidly absorbed, ready-to-use oral liquid formulation. DFN-15, a novel oral liquid formulation of celecoxib, is being developed for the acute treatment of migraine with or without aura. Clinical studies with this formulation are ongoing. OBJECTIVES: The objectives of the present study were to compare the bioavailability of DFN-15 with that of the commercial formulation of celecoxib 400-mg oral capsules (Celebrex(®)) and to determine the dose proportionality of DFN-15 in healthy fasted volunteers...
July 26, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28735450/prescription-drug-price-paradox-cost-analysis-of-canadian-online-pharmacies-versus-us-medicare-beneficiaries-for-the-top-100-drugs
#18
Sean Hyungwoo Kim, Young Joo Ryu, Na-Eun Cho, Andy Eunwoo Kim, Jongwha Chang
BACKGROUND AND OBJECTIVES: Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believed to be lower than US prescription drug prices. The objective of this study was to determine which top 100 Medicare drugs can be imported to the USA legally, and to determine which type of prescription drug would be more beneficial to be purchased from Canadian online pharmacies...
July 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28726075/effectiveness-adverse-effects-and-drug-compliance-of-long-acting-injectable-risperidone-in-children-and-adolescents
#19
Mehmet Fatih Ceylan, Betül Erdogan, Selma Tural Hesapcioglu, Esra Cop
BACKGROUND AND OBJECTIVES: Although the use of oral risperidone in children and adolescents has been well studied, there is little information on the intramuscular use of long-acting injectable risperidone (LAIR). The aims of this study were to investigate the effectiveness and adverse effects of LAIR in children and adolescents with conduct disorder, bipolar disorder, and schizophrenia. METHODS: In total, 42 patients (age range 12-17 years) who were non-adherent to oral antipsychotic drugs, received 25 mg of LAIR intramuscularly every 2 weeks...
July 19, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28717987/interventions-for-refractory-trigeminal-neuralgia-a-bayesian-mixed-treatment-comparison-network-meta-analysis-of-randomized-controlled-clinical-trials
#20
Kannan Sridharan, Gowri Sivaramakrishnan
INTRODUCTION: Patients with trigeminal neuralgia (TN) are often refractory to recommended first-line agents. Due to the absence of a systematic review, we undertook a network meta-analysis to assess various interventions that can be used to manage refractory TN. METHODS: Electronic databases were searched using appropriate strategies to identify randomized controlled clinical trials in patients with refractory TN, evaluating the proportion of patients with a minimum of 50% reduction in pain or a minimum of 2 cm reduction in score in an appropriate pain scale or complete pain relief by subjective pain scales...
July 17, 2017: Clinical Drug Investigation
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