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https://www.readbyqxmd.com/read/27663572/cost-effectiveness-of-naloxegol-for-opioid-induced-constipation-in-the-uk
#1
Richard Lawson, James Ryan, Frederic King, Jo Wern Goh, Eszter Tichy, Kevin Marsh
BACKGROUND AND OBJECTIVES: Opioid-induced constipation (OIC) is the most common adverse effect reported in patients receiving opioids to manage pain. Initial treatment with laxatives provides inadequate response in some patients. Naloxegol is a peripherally acting µ-opioid receptor antagonist used to treat patients with inadequate response to laxative(s) (laxative inadequate responder [LIR]). A cost-effectiveness model was constructed from the UK payer perspective to compare oral naloxegol 25 mg with placebo in non-cancer LIR patients receiving opioids for chronic pain, and a scenario analysis of naloxegol 25 mg with rescue laxatives compared with placebo with rescue laxatives in the same patient population...
September 23, 2016: PharmacoEconomics
https://www.readbyqxmd.com/read/27582887/the-role-of-naloxegol-in-the-management-of-opioid-induced-bowel-dysfunction
#2
REVIEW
Wojciech Leppert, Jaroslaw Woron
Opioid-induced constipation (OIC) and other gastrointestinal (GI) symptoms of opioid-induced bowel dysfunction (OIBD) significantly deteriorate patients' quality of life and may lead to noncompliance with opioid schedule and undertreatment of pain. Although traditional oral laxatives are the first-line treatment of OIC, they do not address OIBD pathophysiology, and display numerous adverse effects. OIC treatment includes prokinetics (lubiprostone), opioid switch, and changing route of opioid administration...
September 2016: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/27486521/persistent-constipation-and-abdominal-adverse-events-with-newer-treatments-for-constipation
#3
Irene Sonu, George Triadafilopoulos, Jerry D Gardner
BACKGROUND: Clinical trials of several new treatments for opioid-induced constipation (OIC), chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C) have focused on differences between subjects relieved of constipation with placebo and active treatment. Patients and clinicians however, are more interested in the probability these treatments provide actual relief of constipation and its associated symptoms. METHODS: We searched the medical literature using MEDLINE and Cochrane central register of controlled trials...
2016: BMJ Open Gastroenterology
https://www.readbyqxmd.com/read/27435972/population-exposure-response-modeling-of-naloxegol-in-patients-with-noncancer-related-pain-and-opioid-induced-constipation
#4
N Al-Huniti, J C Nielsen, M M Hutmacher, J Lappalainen, K Cantagallo, M Sostek
Naloxegol is a polyethylene glycol derivative of naloxone approved in the US as a once-daily oral treatment for opioid-induced constipation (OIC) in adults with chronic noncancer pain. Population exposure-response models were constructed based on data from two phase III studies comprising 1,331 adults with noncancer pain and OIC. In order to characterize the protocol-defined naloxegol responder rate, the number of daily spontaneous bowel movements (SBMs) was characterized by a longitudinal ordinal nonlinear mixed-effects logistic regression dose-response model, and the incidence of diary entry discontinuation was described by a time-to-event model...
July 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27417446/constipation-in-elderly-patients-with-noncancer-pain-focus-on-opioid-induced-constipation
#5
Sita Chokhavatia, Elizabeth S John, Mary Barna Bridgeman, Deepali Dixit
Constipation is a common and often debilitating condition in the elderly, which may be caused by underlying disease conditions, structural abnormalities in the bowel, and a variety of medications such as anticholinergics, antidepressants, and opiates. In this review, we focus on opioid-induced constipation (OIC), which is often underrecognized and undertreated in the elderly. When opioid therapy is initiated, healthcare providers are encouraged to evaluate risk factors for the development of constipation as part of a thorough patient history...
August 2016: Drugs & Aging
https://www.readbyqxmd.com/read/27342744/impact-of-treatment-with-naloxegol-for-opioid-induced-constipation-on-patients-health-state-utility
#6
Richard Lawson, Frederic King, Kevin Marsh, Arman Altincatal, Ali Cimen
INTRODUCTION: Opioid-induced constipation (OIC) is the most common side effect of opioid treatment. Treatment for OIC typically involves a laxative. However, some patients have an inadequate response to these (laxative inadequate responders, or LIR). This has led to the development of treatments such as naloxegol. This analysis estimates the impact of naloxegol on the health state utility of LIR patients, examines if this utility impact is driven by the change in OIC status, and estimates the utility impact of relief of OIC...
August 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27299937/simulation-and-prediction-of-the-drug-drug-interaction-potential-of-naloxegol-by-physiologically-based-pharmacokinetic-modeling
#7
D Zhou, K Bui, M Sostek, N Al-Huniti
Naloxegol, a peripherally acting μ-opioid receptor antagonist for the treatment of opioid-induced constipation, is a substrate for cytochrome P450 (CYP) 3A4/3A5 and the P-glycoprotein (P-gp) transporter. By integrating in silico, preclinical, and clinical pharmacokinetic (PK) findings, minimal and full physiologically based pharmacokinetic (PBPK) models were developed to predict the drug-drug interaction (DDI) potential for naloxegol. The models reasonably predicted the observed changes in naloxegol exposure with ketoconazole (increase of 13...
May 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27231750/management-of-opioid-induced-constipation
#8
REVIEW
David Prichard, Christine Norton, Adil E Bharucha
Up to 40% of patients taking opioids develop constipation. Opioid-induced constipation (OIC) may limit the adequate dosing of opioids for pain relief and reduce quality of life. Health professionals must therefore inquire about bowel function in patients receiving opioids. The management of OIC includes carefully re-evaluating the necessity, type and dose of opioids at each visit. Lifestyle modification and alteration of aggravating factors, the use of simple laxatives and, when essential, the addition of newer laxatives or opioid antagonists (naloxone, naloxegol or methylnaltrexone) can be used to treat OIC...
May 26, 2016: British Journal of Nursing: BJN
https://www.readbyqxmd.com/read/27137716/safety-tolerability-and-pharmacokinetics-of-multiple-ascending-doses-of-naloxegol
#9
Michael A Eldon, Alan R Kugler, Robert A Medve, Khanh Bui, Kathleen Butler, Mark Sostek
Opioid-induced constipation (OIC) is the most common and often a treatment-limiting adverse event (AE) of opioid therapy for chronic pain. Naloxegol (previously NKTR-118), a PEGylated derivative of naloxone that has minimal penetration of the central nervous system, has received regulatory approval as an oral therapy for OIC. This randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study was performed to assess safety, tolerability, and pharmacokinetics of multiple doses of naloxegol in healthy volunteers...
November 2015: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27137715/safety-tolerability-pharmacokinetics-and-pharmacodynamic-effects-of-naloxegol-at-peripheral-and-central-nervous-system-receptors-in-healthy-male-subjects-a-single-ascending-dose-study
#10
Michael A Eldon, Alan R Kugler, Robert A Medve, Khanh Bui, Kathleen Butler, Mark Sostek
This randomized, double-blind, placebo-controlled, ascending-dose, crossover study evaluated single oral doses of naloxegol (NKTR-118; 8, 15, 30, 60, 125, 250, 500, and 1000 mg), a PEGylated derivative of naloxone, for safety and tolerability, antagonism of peripheral and central nervous system (CNS) effects of intravenous morphine, and pharmacokinetics. Healthy men were randomized 1:1 to naloxegol or naloxegol-matching placebo administered with morphine and lactulose in a 2-period crossover design. Periods were separated by a 5- to 7-day washout...
November 2015: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27033126/diagnosis-and-management-of-chronic-constipation-in-adults
#11
REVIEW
Satish S C Rao, Kulthep Rattanakovit, Tanisa Patcharatrakul
Constipation is a heterogeneous, polysymptomatic, multifactorial disease. Acute or transient constipation can be due to changes in diet, travel or stress, and secondary constipation can result from drug treatment, neurological or metabolic conditions or, rarely, colon cancer. A diagnosis of primary chronic constipation is made after exclusion of secondary causes of constipation and encompasses several overlapping subtypes. Slow-transit constipation is characterized by prolonged colonic transit in the absence of pelvic floor dysfunction...
May 2016: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/26945548/novel-oral-therapies-for-opioid-induced-bowel-dysfunction-in-patients-with-chronic-noncancer-pain
#12
REVIEW
Renee M Holder, Diane Rhee
Opioid analgesics are frequently prescribed and play an important role in chronic pain management. Opioid-induced bowel dysfunction, which includes constipation, hardened stool, incomplete evacuation, gas, and nausea and vomiting, is the most common adverse event associated with opioid use. Mu-opioid receptors are specifically responsible for opioid-induced bowel dysfunction, resulting in reduced peristaltic and secretory actions. Agents that reverse these actions in the bowel without reversing pain control in the central nervous system may be preferred over traditional laxatives...
March 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/26757469/naloxegol-movantik-for-opioid-induced-constipation
#13
(no author information available yet)
No abstract text is available yet for this article.
January 12, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/26702846/opioid-induced-constipation-in-chronic-noncancer-pain
#14
REVIEW
H Christian Weber
PURPOSE OF REVIEW: Opioid-based management of noncancer pain has become much more prevalent over the last 2 decades and is responsible for a wide range of side-effects, particularly affecting the intestinal tract causing opioid-induced constipation (OIC). This review will consider results of recent clinical trials that have provided evidence of new pharmacological management options for the treatment of OIC. RECENT FINDINGS: Supportive use of conventional agents, such as stool softeners, osmotic laxatives, and stimulating laxatives in OIC has limited efficacy...
February 2016: Current Opinion in Endocrinology, Diabetes, and Obesity
https://www.readbyqxmd.com/read/26678015/effects-of-cyp3a-modulators-on-the-pharmacokinetics-of-naloxegol
#15
Khanh Bui, Diansong Zhou, Mark Sostek, Fahua She, Nidal Al-Huniti
Naloxegol, a peripherally acting μ-opioid receptor antagonist, was recently approved in the United States for the treatment of opioid-induced constipation. This study evaluated the effects of CYP3A inhibition and induction on the pharmacokinetics, safety, and tolerability of naloxegol. Separate open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover studies of naloxegol (25 mg by mouth [PO]) in the absence or presence of the inhibitors ketoconazole (400 mg PO) and diltiazem extended release (240 mg PO), or the inducer rifampin (600 mg PO) were conducted in healthy volunteers...
August 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/26660436/%C3%A2-naloxegol-for-opioid-induced-constipation
#16
(no author information available yet)
▼Naloxegol (Moventig-AstraZeneca) is a peripherally acting mu-opioid receptor antagonist licensed for the treatment of opioid-induced constipation in adults who have had an inadequate response to laxative treatment. It was launched in the United Kingdom in October 2015. Here, we review the evidence for naloxegol and consider its place in the management of opioid-induced constipation.
December 2015: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/26535126/efficacy-and-safety-of-naloxegol-in-patients-with-opioid-induced-constipation-and-laxative-inadequate-response
#17
Jan Tack, Jaakko Lappalainen, Ulysses Diva, Raj Tummala, Mark Sostek
BACKGROUND: Treatment options for patients with opioid-induced constipation (OIC) and inadequate response to laxatives (LIR) are few. OBJECTIVE: Assess the efficacy and safety of orally administered naloxegol in patients with prospectively confirmed OIC and LIR. METHODS: We analyzed pooled data from two identical randomized, double-blind, placebo-controlled, Phase 3 trials of naloxegol in patients with non-cancer pain, OIC and LIR in which naloxegol (12...
October 2015: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/26450143/treating-opioid-induced-constipation-in-older-adults-new-options
#18
Halima Sani, Rebecca J Mahan
Numerous factors, such as changes in gastrointestinal physiology, reduced mobility, decreased liquid and nutritional intake, and certain comorbidities, predispose older adults to constipation. Use of opioid medications further compounds this problem. Unlike other side effects associated with opioid use, patients do not develop tolerance to constipation and other opioid-induced bowel dysfunctions. Although opioid-induced constipation has a prevalence rate of 80% in this population, it remains highly undertreated...
October 2015: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
https://www.readbyqxmd.com/read/26449843/new-options-in-constipation-management
#19
REVIEW
Mellar Davis, Pamela Gamier
Constipation is common in the general population and for those on opioids and/or who are suffering from advanced cancer. Self-management consists of dietary changes, exercise, and laxatives. However, responses to self-management efforts are often inadequate to relieve the subjective and objective experience of constipation. Multiple new anti-constipating medications have recently been tested in randomized trials and the following are available commercially: probiotics, prucalopride, lubiprostone, linaclotide, elobixibat, antidepressants, methylnaltrexone, alvimopan, and naloxegol...
December 2015: Current Oncology Reports
https://www.readbyqxmd.com/read/26424199/key-findings-from-preclinical-and-clinical-drug-interaction-studies-presented-in-new-drug-and-biological-license-applications-approved-by-the-food-and-drug-administration-in-2014
#20
REVIEW
Jingjing Yu, Tasha K Ritchie, Zhu Zhou, Isabelle Ragueneau-Majlessi
Regulatory approval documents contain valuable information, often not published, to assess the drug-drug interaction (DDI) profile of newly marketed drugs. This analysis aimed to systematically review all drug metabolism, transport, pharmacokinetics, and DDI data available in the new drug applications and biologic license applications approved by the U.S. Food and Drug Administration in 2014, using the University of Washington Drug Interaction Database, and to highlight the significant findings. Among the 30 new drug applications and 11 biologic license applications reviewed, 35 new molecular entities (NMEs) were well characterized with regard to drug metabolism, transport, and/or organ impairment and were fully analyzed in this review...
January 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
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