NDLI: Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects.

Please wait, while we are loading the content...

Year: 2017 Volume: 39

Year: 2016 Volume: 38

Year: 2016 Volume: 38 Issue: 12

Year: 2016 Volume: 38 Issue: 11

Year: 2016 Volume: 38 Issue: 10S

Year: 2016 Volume: 38 Issue: 9

Year: 2016 Volume: 38 Issue: 8

Year: 2016 Volume: 38 Issue: 7

Year: 2016 Volume: 38 Issue: 6

Year: 2016 Volume: 38 Issue: 5

Year: 2016 Volume: 38 Issue: 4

Year: 2016 Volume: 38 Issue: 3

Year: 2016 Volume: 38 Issue: 2

New Formulations of Old Analgesics.

Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.

Nonutilization of Statins in a Community-based Population with a History of Coronary Revascularization.

Restless Legs Symptoms and Pregnancy and Neonatal Outcomes.

Correlation of Mast Cell Density With Angiogenic Cytokines in Patients With Active Multiple Myeloma.

Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects.

Association of Lower Socioeconomic Position in Pregnancy with Lower Diurnal Cortisol Production and Lower Birthweight in Male Infants.

Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties.

Pharmacokinetics, Safety, and Tolerability of Amygdalin and Paeoniflorin After Single and Multiple Intravenous Infusions of Huoxue-Tongluo Lyophilized Powder for Injection in Healthy Chinese Volunteers.

Effects on All-cause Mortality and Cardiovascular Outcomes in Patients With Type 2 Diabetes by Comparing Insulin With Oral Hypoglycemic Agent Therapy: A Meta-analysis of Randomized Controlled Trials.

The Impact Sex Differences Research Can Have on Women's Health.

Pharmacokinetics of Weekly Paclitaxel and Feasibility of Dexamethasone Taper in Japanese Patients with Advanced Non-small Cell Lung Cancer.

Microvascular Dysfunction as Opposed to Conduit Artery Disease Explains Sex-specific Chest Pain in Emergency Department Patients With Low to Moderate Cardiac Risk.

Evaluation of the Pharmacokinetics of Single- and Multiple-dose Buprenorphine Buccal Film in Healthy Volunteers.

Pharmacokinetic and Pharmacodynamic Properties of Cinacalcet (KRN1493) in Chinese Healthy Volunteers: A Randomized, Open-label, Single Ascending-dose and Multiple-dose, Parallel-group Study.

Factors Contributing to the Clinical Effectiveness of the DPP-4 Inhibitor Sitagliptin in Patients With Type 2 Diabetes.

Drug Information Services Today: Current Role and Future Perspectives in Rational Drug Therapy.

Meta-analysis of Ivabradine in Patients With Stable Coronary Artery Disease With and Without Left Ventricular Dysfunction.

Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.

More on Women's Health, Gender Medicine, and the Complexities of Personalized Medicine.

Year: 2016 Volume: 38 Issue: 1

Year: 2015 Volume: 37

Year: 2014 Volume: 36

Year: 2013 Volume: 35

Year: 2012 Volume: 34

Year: 2011 Volume: 33

Year: 2010 Volume: 32

Year: 2009 Volume: 31

Year: 2008 Volume: 30

Year: 2008 Volume: 30 Spec No

Year: 2008 Volume: 30 Pt 2

Year: 2007 Volume: 29

Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Darpo, Borje Zhou, Meijian Bai, Stephen A. Ferber, Georg Xiang, Qinfang Finn, Andrew
Description	Author Affiliation: Darpo B ( Karolinska Institute, Department of Clinical Sciences, Danderyd's Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden); Zhou M ( iCardiac Technologies, Rochester, New York.); Bai SA ( Endo Pharmaceuticals Inc, Malvern, Pennsylvania.); Ferber G ( Statistik Georg Ferber GmbH, Riehen, Switzerland.); Xiang Q ( Endo Pharmaceuticals Inc, Malvern, Pennsylvania.); Finn A ( BioDelivery Sciences International, Raleigh, North Carolina.)
Abstract	PURPOSE: A thorough QT study was conducted in healthy subjects to evaluate the effect of buprenorphine hydrochloride administered through a buccal soluble film under coverage of naltrexone to block confounding, secondary QT effects. METHODS: Healthy subjects were enrolled in a randomized, partially blinded, 4-way crossover designed study. Subjects received buprenorphine 3 mg with naltrexone, naltrexone alone (with placebo films), placebo (placebo films and placebo naltrexone), and open-label moxifloxacin 400 mg with placebo naltrexone in separate in-house treatment periods. Naltrexone treatment (50 mg) was initiated 12 hours before buprenorphine and was given every 12 hours for a total of 4 doses. ECG data were extracted from a continuous recording predose and serially after dosing on the treatment day. ECG intervals were measured at a central ECG laboratory by using the high-precision QT technique. The QT interval was corrected for heart rate with Fridericia's formula (QTcF), and change-from-predose baseline QTcF (∆QTcF) was analyzed by using a mixed effect model. FINDINGS: Fifty-eight subjects (35 males) with a mean age of 32 were enrolled into the study. Treatment with buprenorphine 3 mg resulted in a small QT effect with the largest mean naltrexone-corrected ∆QTcF reaching 5.8 msec at 8 hours' postdosing (upper bound of the 90% CI below 10 msec). Exposure response analysis with a linear model demonstrated a significant linear relationship between plasma levels and naltrexone-corrected ∆QTcF, with an estimated mean slope of 0.65 msec per nanogram/milliliter (90% CI, 0.22 to 1.08). Using the exposure response model, an effect on ∆QTcF of 4.5 msec (2.80 to 6.12) can be predicted at the observed geometric peak plasma level after administration of the 3-mg buprenorphine dose in this study (3.6 ng/mL [3.33 to 3.98]). Naltrexone alone did not have a relevant effect on the QTcF interval. IMPLICATIONS: The present study showed that buprenorphine plasma levels up to 5 ng/mL had no effect on the QTc above the level of clinical concern.
File Format	HTM / HTML
ISSN	01492918
Issue Number	2
Volume Number	38
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2016-02-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Buprenorphine Pharmacology Fluoroquinolones Naltrexone Adult Cross-over Studies Double-blind Method Electrocardiography Drug Effects Female Heart Heart Rate Humans Male Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

Central Library (ISO-9001:2015 Certified)
Indian Institute of Technology Kharagpur
Kharagpur, West Bengal, India | PIN - 721302

See location in the Map
03222 282435
Mail: support@ndl.gov.in

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in