Read by QxMD icon Read

Clinical Drug Investigation

Rieko Kikuchi, Junichiro Irie, Nobuko Yamada-Goto, Eri Kikkawa, Yosuke Seki, Kazunori Kasama, Hiroshi Itoh
BACKGROUND AND OBJECTIVES: Bariatric surgery improves metabolic diseases and alters the intestinal microbiota in animals and humans, but different procedures reportedly have different impacts on the intestinal microbiota. We developed laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB) as an alternative to laparoscopic Roux-en-Y gastric bypass (LRYGB) in addition to laparoscopic sleeve gastrectomy (LSG) for Japanese patients with obesity. We investigated the precise change in the intestinal microbiota induced by these procedures in the present study...
March 5, 2018: Clinical Drug Investigation
Silvia L Nunes, Sune Forsberg, Hans Blomqvist, Lars Berggren, Mikael Sörberg, Toni Sarapohja, Carl-Johan Wickerts
BACKGROUND: Intensive care unit patients undergoing mechanical ventilation have traditionally been sedated to make them comfortable and to avoid pain and anxiety. However, this may lead to prolonged mechanical ventilation and a longer length of stay. OBJECTIVE: The aim of this retrospective study was to explore whether different sedation regimens influence the course and duration of the weaning process. PATIENTS AND METHODS: Intubated adult patients (n = 152) from 15 general intensive care units in Sweden were mechanically ventilated for ≥ 24 h...
March 3, 2018: Clinical Drug Investigation
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval...
March 2, 2018: Clinical Drug Investigation
Pablo Barrio, Lluisa Ortega, Josep Guardia, Carlos Roncero, Lara Yuguero, Antoni Gual
No abstract text is available yet for this article.
February 26, 2018: Clinical Drug Investigation
Rachel Gurrell, Sridhar Duvvuri, Pengling Sun, Nicholas DeMartinis
BACKGROUND AND OBJECTIVES: There is an unmet medical need for additional treatment options for Parkinson's disease. This was a Phase I, double-blind clinical trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of the novel dopamine D1 receptor partial agonist, PF-06669571, in subjects with idiopathic Parkinson's disease on a stable dose of L-DOPA. METHODS: Subjects received PF-06669571 (or matching placebo) titrated from 1 mg to 3 mg over 7 days...
February 24, 2018: Clinical Drug Investigation
Mohamad Badr Jandali
BACKGROUND AND OBJECTIVE: Diltiazem is a nondihydropyridine calcium channel blocker that is used to control rapid ventricular response in patients who have atrial fibrillation or flutter. Diltiazem has a negative inotropic effect and may cause hemodynamic decompensation in patients with reduced ejection fraction. This study evaluated outcomes in patients who had low ejection fraction and were treated with diltiazem. METHODS: This was a retrospective chart review in 635 patients who were hospitalized because of rapid atrial fibrillation and who were treated with intravenous diltiazem...
February 24, 2018: Clinical Drug Investigation
Alain Braillon, Francoise Taiebi, Amal Bernoussi
No abstract text is available yet for this article.
February 23, 2018: Clinical Drug Investigation
Vladimir M Moiseyenko, Fedor V Moiseyenko, Grigoriy A Yanus, Ekatherina Sh Kuligina, Anna P Sokolenko, Ilya V Bizin, Alexey A Kudriavtsev, Svetlana N Aleksakhina, Nikita M Volkov, Vyacheslav A Chubenko, Kseniya S Kozyreva, Mikhail M Kramchaninov, Alexandr S Zhuravlev, Kseniya V Shelekhova, Denis V Pashkov, Alexandr O Ivantsov, Aigul R Venina, Tatyana N Sokolova, Elena V Preobrazhenskaya, Natalia V Mitiushkina, Alexandr V Togo, Aglaya G Iyevleva, Evgeny N Imyanitov
BACKGROUND: Colorectal carcinomas (CRCs) are sensitive to treatment by anti-epidermal growth factor receptor (EGFR) antibodies only if they do not carry activating mutations in down-stream EGFR targets (KRAS/NRAS/BRAF). Most clinical trials for chemo-naive CRC patients involved combination of targeted agents and chemotherapy, while single-agent cetuximab or panitumumab studies included either heavily pretreated patients or subjects who were not selected on the basis of molecular tests...
February 22, 2018: Clinical Drug Investigation
Isabel Barrachina-Martínez, David Vivas-Consuelo, Anna Piera-Balbastre
In the original publication, the abstract, conclusion was incorrectly published.
February 20, 2018: Clinical Drug Investigation
Wenxin Chen, Monica Cepoiu-Martin, Antonia Stang, Diane Duncan, Chris Symonds, Lara Cooke, Tamara Pringsheim
BACKGROUND AND OBJECTIVE: Antipsychotic medication use has steadily increased in Canada, with an expansion in the profile of users and the diagnoses for which they are used. The use of antipsychotics is associated with a number of adverse effects for which routine monitoring is recommended. The objectives of this study were to determine the most common diagnoses associated with antipsychotic use in children in Alberta, Canada and the proportion who receive recommended laboratory tests for adverse effects...
February 16, 2018: Clinical Drug Investigation
Simone Pisano, Giangennaro Coppola, Gennaro Catone, Marco Carotenuto, Raffaella Iuliano, Vittoria D'Esposito, Serena Cabaro, Emanuele Miraglia Del Giudice, Carmela Bravaccio, Pietro Formisano
BACKGROUND: Youth exposed to antipsychotics may experience several metabolic consequences that often limit the effectiveness of this class of drugs. OBJECTIVES: The aim of this study was to compare several metabolic markers between subjects who experienced antipsychotic-induced weight gain and untreated obese patients. METHODS: Nineteen non-diabetic youth (mean age 159 months, mean body mass index z-score 1.81) experiencing antipsychotic-induced weight gain and an age-, sex-, and body mass index-matched group of non-diabetic obese patients with no record of treatment (n = 19, mean age 147 months, mean body mass index z-score 2) were compared for a wide range of metabolic factors using a Bioplex Multiplex system...
February 12, 2018: Clinical Drug Investigation
Vinicius Lins Ferreira, Letícia Paula Leonart, Fernanda Stumpf Tonin, Helena Hiemisch Lobo Borba, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C...
February 12, 2018: Clinical Drug Investigation
Yuchen Liu, Zhenhua Wang, Ruoyan Gai Tobe, Houwen Lin, Bin Wu
BACKGROUND AND OBJECTIVES: Daclatasvir plus asunaprevir has shown superior efficacy and safety for treating hepatitis C virus genotype 1b infection in comparison with pegylated interferon and ribavirin. The objective of this analysis is to investigate the cost effectiveness of daclatasvir plus asunaprevir compared with interferon-α-based therapies from the perspective of the Chinese healthcare system. METHODS: A Markov model was established to measure economic and health outcomes of daclatasvir plus asunaprevir compared with general interferon-α plus ribavirin and pegylated interferon plus ribavirin for hepatitis C virus genotype 1b infection...
February 7, 2018: Clinical Drug Investigation
Ehab Rasmy Bendas, Mamdouh R Rezk, Kamal A Badr
BACKGROUND AND OBJECTIVES: The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers. METHODS: The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks...
February 7, 2018: Clinical Drug Investigation
Ramakrishna Nirogi, Koteshwara Mudigonda, Gopinadh Bhyrapuneni, Nageswara Rao Muddana, Vinod Kumar Goyal, Santosh Kumar Pandey, Raghava Choudary Palacharla
BACKGROUND AND OBJECTIVE: SUVN-502, a selective 5-HT6 receptor antagonist, was found to be active in preclinical models of cognitive deterioration suggesting a potential role in the treatment of dementia related to Alzheimer's disease. The objective of this study was to characterize the safety, tolerability and pharmacokinetics of SUVN-502 in healthy young adults and elderly subjects following single and multiple oral doses. METHODS: Single doses (5, 15, 50, 100 and 200 mg SUVN-502) and multiple doses (50, 100 and 130 mg SUVN-502 once daily for 7 days) were evaluated in healthy young adults and multiple doses (50 and 100 mg SUVN-502 once daily for 14 days) were evaluated in elderly subjects using randomized, double-blind, placebo-controlled, dose-escalating study designs...
January 29, 2018: Clinical Drug Investigation
David P Rosenbaum, Andrew Yan, Jeffrey W Jacobs
BACKGROUND: Tenapanor, a small molecule with minimal systemic availability, is a first-in-class sodium/hydrogen exchanger 3 (NHE3) inhibitor that acts in the gut. Here, we evaluate the pharmacodynamics and safety of tenapanor in healthy adults. METHODS: Two phase I, single-center, randomized, double-blind, placebo-controlled studies were performed. The first study assessed single-ascending oral tenapanor doses of 10, 50, 150, 450, and 900 mg (n = 8 per group; six tenapanor, two placebo) and multiple ascending doses over 7 days of 3, 10, 30, and 100 mg q...
January 23, 2018: Clinical Drug Investigation
Alessandra Iurlo, Daniele Cattaneo, Nicola Orofino, Cristina Bucelli, Matteo Molica, Massimo Breccia
No abstract text is available yet for this article.
January 23, 2018: Clinical Drug Investigation
George Gourzoulidis, Charalampos Tzanetakos, Ioannis Ioannidis, Apostolos Tsapas, Georgia Kourlaba, Giannis Papageorgiou, Nikos Maniadakis
BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece...
January 18, 2018: Clinical Drug Investigation
Manon Auffret, Sophie Drapier, Marc Vérin
The present paper consists of a comprehensive review of the literature on apomorphine pharmacological properties and its usefulness in Parkinson's disease (PD). The chemistry, structure-activity relationship, pharmacokinetics and pharmacodynamics of apomorphine are described with regard to its effects on PD symptoms, drug interactions, interindividual variability and adverse events. Apomorphine chemical structure accounts for most of its beneficial and deleterious properties, both dopaminergic and non-dopaminergic...
January 11, 2018: Clinical Drug Investigation
Paola Bozzatello, Paola Rocca, Silvio Bellino
BACKGROUND AND OBJECTIVES: Some evidence of efficacy has been found for omega-3 fatty acids in patients with borderline personality disorder (BPD). In a previous 12-week randomized trial we assessed the efficacy of the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) with valproic acid, in comparison with valproic acid monotherapy, in 43 BPD outpatients. Combined therapy was superior to valproic acid monotherapy (the control group) in the treatment of some BPD symptoms: impulsive-behavioral dyscontrol, outbursts of anger, and self-harm...
January 5, 2018: Clinical Drug Investigation
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"