Read by QxMD icon Read

Adverse drug events

Nilesh Chande, Cassandra M Townsend, Claire E Parker, John K MacDonald
BACKGROUND: The results from controlled clinical trials investigating the efficacy of azathioprine and 6-mercaptopurine for the treatment of active Crohn's disease have been conflicting and controversial. An updated meta-analysis was performed to assess the effectiveness of these drugs for the induction of remission in active Crohn's disease. OBJECTIVES: The primary objective was to determine the efficacy and safety of azathioprine and 6-mercaptopurine for induction of remission in active Crohn's disease...
October 26, 2016: Cochrane Database of Systematic Reviews
L P Zanaga, N Miotto, L C Mendes, R S B Stucchi, A G Vigani
Hepatitis C virus (HCV) genotype 3 is responsible for 30.1% of chronic hepatitis C infection cases worldwide. In the era of direct-acting antivirals, these patients have become one of the most challenging to treat, due to fewer effective drug options, higher risk of developing cirrhosis and hepatocellular carcinoma and lower sustained virological response (SVR) rates. Currently there are 4 recommended drugs for the treatment of HCV genotype 3: pegylated interferon (PegIFN), sofosbuvir (SOF), daclatasvir (DCV) and ribavirin (RBV)...
October 24, 2016: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
So Miyoshi, Judith Hey-Hadavi, Makoto Nagaoka, Brinda Tammara
OBJECTIVE: Fosdagrocorat (PF-04171327) is a pro-drug form of PF-00251802, a dissociated agonist of the glucocorticoid receptor, under investigation for the treatment of rheumatoid arthritis. This study investigates the pharmacokinetics (PK) of single and multiple doses of fosdagrocorat in healthy Japanese and Western volunteers, the effect of food on fosdagrocorat PK, and the effect of fosdagrocorat on bone biomarkers. METHODS: This was a phase 1, randomized, placebo-controlled, dose-escalation study...
October 26, 2016: International Journal of Clinical Pharmacology and Therapeutics
Su Lee, Chan-Duck Kim, Kyu Huh, Baik-Hwan Cho, Man Ju, Dong Lee, Hong Cho, Jong-Won Park, Jung Lee, Samuel Lee, Byung So, Chang-Kwon Oh, Yu Kim
AIMS: The tablet form (500 mg) of mycophenolate mofetil (MMF) provides more convenience of taking drugs and cost-effectiveness than the capsule form (250 mg). We examined the efficacy and safety of MMF in its different forms combined with tacrolimus in kidney transplant recipients. METHODS: This multicenter, 26-week, randomized trial was performed to compare the efficacy and safety of the tablet form of MMF versus the capsule form of MMF in 156 kidney transplant recipients...
October 26, 2016: Clinical Nephrology
Cristina Solomon, Wolfgang Korte, Dietmar Fries, Inna Pendrak, Christine Joch, Albrecht Gröner, Ingvild Birschmann
BACKGROUND: Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. METHODS: Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. RESULTS: Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient...
September 2016: Transfusion Medicine and Hemotherapy
Yushui Ma, Likun Hou, Fei Yu, Xiaoming Zhong, Gaixia Lu, Shanshan Qin, Ruting Xie, Huiqiong Yang, Tingmiao Wu, Pei Luo, Chengyou Jia, Li Chai, Haidong Cai, Zhongwei Lv, Chunyan Wu, Da Fu
To clarify the association between carboplatin and electrolyte abnormality, a pooled-analysis was performed with the adverse event reports of non-small cell lung cancer patients. A total of 19901 adverse events were retrieved from the FDA Adverse Event Reporting System (FAERS). Pooled reporting odds ratios (RORs) and 95% CIs suggested that carboplatin was significantly associated with hyponatremia (pooled ROR = 1.57, 95% CI 1.18-2.09, P = 1.99×10-3) and hypokalemia (pooled ROR = 2.37, 95% CI 1.80-3.10, P = 5...
October 21, 2016: Oncotarget
Jeffrey S Borer, Prakash C Deedwania, Jae B Kim, Michael Böhm
Heart rate (HR) is a risk factor in patients with chronic systolic heart failure (HF) that, when reduced, provides outcome benefits. It is also a target for angina pectoris prevention and a risk marker in chronic coronary artery disease without HF. HR can be reduced by drugs; however, among those used clinically, only ivabradine reduces HR directly in the sinoatrial nodal cells without other known effects on the cardiovascular system. This review provides current information regarding the safety and efficacy of HR reduction with ivabradine in clinical studies involving >36,000 patients with chronic stable coronary artery disease and >6,500 patients with systolic HF...
September 15, 2016: American Journal of Cardiology
Arne Ring, Tom Morris, Marcin Wozniak, Nikol Sullo, William Dott, Veerle Verheyden, Tracy Kumar, Nigel Brunskill, Rakesh Vaja, Gavin J Murphy
BACKGROUND: Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. There is no effective prevention or treatment. Sildenafil citrate (Revatio®, Pfizer Inc), a phosphodiesterase type 5 inhibitor, prevents post cardiac surgery AKI in pre-clinical studies, however its use is contraindicated in patients with symptomatic cardiovascular disease. METHODS: To assess the safety and pharmacokinetics of intravenous sildenafil in cardiac surgery patients we conducted an open label, dose escalation study with 6 patients per dose level...
October 25, 2016: British Journal of Clinical Pharmacology
Amanda C Capino, Jamie L Miller, Peter N Johnson
The need for sedation and analgesia and treatment of iatrogenic drug withdrawal is common in critically ill children. First-line therapy typically includes opioid agonists. However, clonidine, a central alpha2 agonist, has been suggested as a treatment option for sedation and analgesia and iatrogenic drug withdrawal. Therefore, we conducted a literature search to identify articles evaluating the use of enteral and transdermal clonidine in critically ill infants and children for sedation and analgesia and treatment of iatrogenic drug withdrawal...
October 25, 2016: Pharmacotherapy
Billy Sin, Kimberly Koop, Michelle Liu, Jun-Yen Yeh, Pardeep Thandi
BACKGROUND: The efficacy, safety, opioid-sparing effects, and cost-benefit analyses of intravenous (IV) acetaminophen (APAP) in treating renal colic remain controversial. STUDY QUESTION: To evaluate the safety, efficacy, opioid-sparing effects, and cost-benefits of IV APAP in patients who present with renal colic in the emergency department (ED). DATA SOURCES: We systematically searched PubMed (January 1970 to April 2016). STUDY DESIGN: Randomized controlled trials which evaluated IV APAP for renal colic in the ED were eligible...
October 24, 2016: American Journal of Therapeutics
Yu Karpov, N Logunova, D Tomilova, V Buza, Yu Khomitskaya
OBJECTIVE: The OPTIMA II study sought to evaluate rates of major adverse cardiac and cerebrovascular events (MACCE) during the long-term follow-up of chronic statin users who underwent percutaneous coronary intervention (PCI) with implantation of a drug-eluting stent (DES). RESEARCH DESIGN AND METHODS: OPTIMA II was a non-interventional, observational study conducted at a single center in the Russian Federation. Included patients were aged ≥18 years with stable angina who had received long-term (≥1 month) statin therapy prior to elective PCI with DES implantation and who had participated in the original OPTIMA study...
October 25, 2016: Current Medical Research and Opinion
Emuella M Flood, Kelly F Bell, Marie C de la Cruz, France M Ginchereau-Sowell
OBJECTIVE: To identify which treatment attributes are most influential in determining patient preferences for diabetes treatments and explore patient preferences for diabetes drug classes. RESEARCH DESIGN AND METHODS: U.S. adults with type 1 or type 2 diabetes completed an online adaptive conjoint analysis survey. The survey examined 14 attributes, including efficacy, regimen, and risk of common side effects and rare, but serious adverse events. Respondents selected between hypothetical treatments with different attributes...
October 25, 2016: Current Medical Research and Opinion
Juan P Boriosi, Jens C Eickhoff, Kristi B Klein, Gregory A Hollman
BACKGROUND AND AIM: Both propofol and dexmedetomidine have been found to be safe and effective sedation for magnetic resonance imaging (MRI). Our program experienced an increase in patients arousing and experiencing an adverse airway event during propofol sedation for MRI in the first months of using a new 3T (Tesla) MRI scanner that was found to have a longer reverberation time compared to the previous 1.5 T MRI. In an effort to decrease patient arousal and adverse airway events during MRI, we administered a dexmedetomidine load prior to our standard propofol protocol...
October 25, 2016: Paediatric Anaesthesia
Vandit Sardana, Joanna Burzynski, Paul Zalzal
PURPOSE: Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis. Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with various side effects. Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration. The present systematic review aimed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis (OA). METHODS: A systematic literature review was performed...
October 24, 2016: Musculoskeletal Care
S A Harrison, S R Marri, N Chalasani, R Kohli, W Aronstein, G A Thompson, W Irish, M V Miles, S A Xanthakos, E Lawitz, M Noureddin, T D Schiano, M Siddiqui, A Sanyal, B A Neuschwander-Tetri, P G Traber
BACKGROUND: Non-alcoholic steatohepatitis (NASH) and resultant liver fibrosis is a major health problem without approved pharmacotherapy. Pre-clinical results of GR-MD-02, a galectin-3 inhibitor, suggested potential efficacy in NASH with advanced fibrosis/cirrhosis and prompted initiation of a clinical development programme in NASH with advanced fibrosis. AIM: To evaluate the safety, pharmacokinetics and exploratory pharmacodynamic markers of GR-MD-02 in subjects having NASH with bridging fibrosis...
October 24, 2016: Alimentary Pharmacology & Therapeutics
Bridgette A Kanz, Megan H Pollack, Romany Johnpulle, Igor Puzanov, Leora Horn, Alicia Morgans, Jeffrey A Sosman, Suthee Rapisuwon, R Martin Conry, Zeynep Eroglu, Douglas B Johnson
BACKGROUND: Anti-PD-1 therapy is increasingly used in various advanced malignancies. Patients with baseline organ dysfunction are largely excluded from clinical trials. Therefore it is unclear whether anti-PD-1 therapy is safe or effective in this setting. Further, these patients are often not candidates for other anti-cancer therapies, highlighting their need for active treatment options. METHODS: We performed a retrospective analysis of patients from multiple centers with advanced solid tumors and baseline organ dysfunction who received anti-PD-1 therapy...
2016: Journal for Immunotherapy of Cancer
Wei Liu, Xingjiang Xiong, Xiaochen Yang, Fuyong Chu, Hongxu Liu
We systematically assess the current clinical evidence of Gualouxiebaibanxia (GLXBBX) decoction for the treatment of angina pectoris (AP). We included RCTs testing GLXBBX against conventional drugs and GLXBBX combined with conventional drugs versus conventional drugs. 19 RCTs involving 1730 patients were finally identified, and the methodological quality was evaluated as generally low. The results of the meta-analysis showed that GLXBBX alone had significant effect on improving angina symptoms (RR: 1.24, 95% CI 1...
2016: Evidence-based Complementary and Alternative Medicine: ECAM
Stacy Cooper Bailey, Michael K Paasche-Orlow, William G Adams, Samantha A Brokenshire, Ryan P Hickson, Christine U Oramasionwu, Laura M Curtis, Mary J Kwasny, Michael S Wolf
BACKGROUND: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. OBJECTIVE: To compare the effectiveness of the Electronic Medication Complete Communication (EMC(2)) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care...
October 21, 2016: Contemporary Clinical Trials
N Alipanah, A Cattamanchi, R Menzies, P C Hopewell, R E Chaisson, P Nahid
SETTING: Several recent trials evaluating 4-month fluoroquinolone (FQ) containing regimens found that none of the experimental regimens were non-inferior to standard 6-month therapy in treating patients with drug-susceptible pulmonary tuberculosis (PTB). OBJECTIVE: To answer whether FQ-containing duration-shortened regimens are non-inferior to standard therapy in the treatment of patients with non-cavitary PTB. DESIGN: Systematic review of all randomized and quasi-randomized trials that substituted an FQ into standard therapy for less than 6 months' duration to treat drug-susceptible, non-cavitary PTB...
November 2016: International Journal of Tuberculosis and Lung Disease
Cunlin Wang, Robert Kane, Mark Levenson, Jeffrey Kelman, Michael Wernecke, Joo-Yeon Lee, Steven Kozlowski, Carmen Dekmezian, Zhiwei Zhang, Aliza Thompson, Kimberly Smith, Yu-Te Wu, Yuqin Wei, Yoganand Chillarige, Qin Ryan, Chris Worrall, Thomas E MaCurdy, David J Graham
Importance: In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect...
October 24, 2016: JAMA Internal Medicine
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"