Pharmacokinetic and pharmacodynamic evaluation of oxycodone and naltrexone for the treatment of chronic lower back pain.

Abstract:

INTRODUCTION:Chronic low back pain (CLBP) is a common and difficult illness to manage. Some individuals with CLBP have pain processing disorders and are also at risk for opioid abuse, misuse; addiction and diversion. Guidelines have been published to guide management; neuromodulation, exercise, mindfulness-based stress reduction and cognitive behavior therapies among other non-pharmacological reduce the pain of CLBP with minimal toxicity. Pharmacological management includes acetaminophen, NSAIDs and antidepressants, mainly duloxetine. Abuse-deterrent opioids have been developed which have been shown to reduce pain and opioid abuse risk. ALO-02 is a tamper-resistant sustained release opioid consisting of extended release oxycodone and sequestered naltrexone. Pivotal studies of ALO-02 have centered on patients with CLBP. AREAS COVERED:This manuscript will review CLBP, the pivotal analgesic and clinical abuse potential studies of ALO-02. The opinion will cover whether opioids should be used for CLBP, when they should be used and opioid choices. EXPERT OPINION:ALO-02 is one of several opioids which can be considered in the management of CLBP. The outcome to a trial of opioids should be function rather than analgesia. Most analgesic trials for CLBP have had analgesia as the primary outcome and function has not been vigorously studied as an outcome. Opioids should be considered as a trial only when other non-opioid analgesics have failed to improve analgesia and function. Universal precautions should be routinely part of phase III analgesic trial particularly for chronic non-malignant pain.

authors

Davis MP

doi

10.1080/17425255.2016.1191469

subject

Has Abstract

pub_date

2016-07-01 00:00:00

pages

823-31

issue

7

eissn

1742-5255

issn

1744-7607

journal_volume

12

pub_type

杂志文章,评审
  • The regulation of human hepatic drug transporter expression by activation of xenobiotic-sensing nuclear receptors.

    abstract:INTRODUCTION:If a drug is found to be an inducer of hepatic drug metabolizing enzymes via activation of nuclear receptors such as pregnane X receptor (PXR) or constitutive androstane receptor (CAR), it is likely that drug transporters regulated through these same receptors will be induced as well. This review highlight...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2016.1223626

    authors: Amacher DE

    更新日期:2016-12-01 00:00:00

  • Current understanding of the mechanisms of idiosyncratic drug-induced agranulocytosis.

    abstract:INTRODUCTION:Idiosyncratic drug-induced agranulocytosis (IDIAG) is a life-threatening adverse reaction characterized by an absolute neutrophil count < 500 cells/μl of blood. It shares many of the characteristics of other idiosyncratic drug reactions (IDRs), and this presumably reflects mechanistic similarities. AREAS ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.985649

    authors: Johnston A,Uetrecht J

    更新日期:2015-02-01 00:00:00

  • Early pregnancy exposure to selective serotonin reuptake inhibitors, risks of major structural malformations, and hypothesized teratogenic mechanisms.

    abstract:INTRODUCTION:Selective serotonin reuptake inhibitors (SSRIs) are commonly used to manage antenatal depression. Hence, the aim of this systematic review is to assess the prevalence of birth defects associated with pregnancy exposure to such agents and summarize the hypothesized teratogenic mechanisms. AREAS COVERED:Med...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1063614

    authors: Gentile S

    更新日期:2015-01-01 00:00:00

  • The impact of advancing age on P-glycoprotein expression and activity: current knowledge and future directions.

    abstract::With the progressive ageing of the population, an increasing number of elderly patients are being exposed to multiple drugs because of co-existing morbidity states requiring pharmacological management. However, the knowledge of the effects of ageing on the pharmacokinetics and pharmacodynamics of individual drugs is f...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 社论,评审

    doi:10.1517/17425255.3.3.315

    authors: Mangoni AA

    更新日期:2007-06-01 00:00:00

  • Bioaccessibility of polycyclic aromatic hydrocarbons: relevance to toxicity and carcinogenesis.

    abstract:INTRODUCTION:Bioaccessibility is a growing area of research in the field of risk assessment. As polycyclic aromatic hydrocarbons (PAHs) are ubiquitous environmental pollutants, they are the toxicants of focus to establish cancer risks in humans. Orally ingested PAHs also cause toxicity and even affect the pharmacokinet...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.823157

    authors: Harris KL,Banks LD,Mantey JA,Huderson AC,Ramesh A

    更新日期:2013-11-01 00:00:00

  • Cytochrome P450 enzyme regulation by glucocorticoids and consequences in terms of drug interaction.

    abstract:INTRODUCTION:Due to their multiple effects, glucocorticoids (GCs) have versatile medical uses. They can regulate many xenobiotic-metabolizing enzymes of the cytochrome P450 (CYP) superfamily, and thus, influence pharmacotherapy. AREAS COVERED:The aim of this paper is to summarize the molecular effects of GCs on CYP as...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2014.878703

    authors: Matoulková P,Pávek P,Malý J,Vlček J

    更新日期:2014-03-01 00:00:00

  • Drug-disease interactions: narrative review of aspirin in gastric ulcer.

    abstract:INTRODUCTION:Drug-disease interactions include the impact of a drug and a particular disease condition on each other. However, the current practice in addressing drug-disease interaction is unbalanced and mostly limited to how the drug worsens the disease or health condition. AREAS COVERED:Aspirin and gastric ulcer in...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2016.1201064

    authors: Nwose EU,Yee KC

    更新日期:2016-09-01 00:00:00

  • The influence of pharmacogenetics and cofactors on clinical outcomes in kidney transplantation.

    abstract:INTRODUCTION:Immunosuppressive drugs have a narrow therapeutic range and large inter-individual response variability. This has prompted pharmacogenetic studies, mostly with regard to their dose-concentration relationships, but also about proteins involved in their pharmacodynamics. Some polymorphisms of genes involved ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2011.570260

    authors: Picard N,Marquet P

    更新日期:2011-06-01 00:00:00

  • Pharmacokinetic and pharmacodynamic evaluation of panitumumab in the treatment of colorectal cancer.

    abstract:INTRODUCTION:Integration of targeted therapy and additional chemotherapy options has improved median overall survival (OS) in patients with unresectable metastatic colorectal cancer (mCRC). Cetuximab and panitumumab are examples of targeted therapies, specifically against the epidermal growth factor receptor (EGFR). Th...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1112787

    authors: Lo L,Patel D,Townsend AR,Price TJ

    更新日期:2015-01-01 00:00:00

  • Telmisartan in the treatment of hypertension.

    abstract:BACKGROUND:Telmisartan is an orally active angiotensin II receptor antagonist prescribed once daily. OBJECTIVE:To evaluate the efficacy of telmisartan on blood pressure control, and on other end points, when given as monotherapy or in combination. METHODS:Review of published literature. RESULTS:Telmisartan produces ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.4.4.485

    authors: Rosario BH,Hendra TJ

    更新日期:2008-04-01 00:00:00

  • Genetics or environment in drug transport: the case of organic anion transporting polypeptides and adverse drug reactions.

    abstract:INTRODUCTION:Organic anion transporting polypeptide (OATP) uptake transporters are important for the disposition of many drugs and perturbed OATP activity can contribute to adverse drug reactions (ADRs). It is well documented that both genetic and environmental factors can alter OATP expression and activity. Genetic fa...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2012.656087

    authors: Clarke JD,Cherrington NJ

    更新日期:2012-03-01 00:00:00

  • Prediction of cis-regulatory elements for drug-activated transcription factors in the regulation of drug-metabolising enzymes and drug transporters.

    abstract::The expression of drug-metabolising enzymes is affected by many endogenous and exogenous factors, including sex, age, diet and exposure to xenobiotics and drugs. To understand fully how the organism metabolises a drug, these alterations in gene expression must be taken into account. The central process, the definition...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2.3.367

    authors: Podvinec M,Meyer UA

    更新日期:2006-06-01 00:00:00

  • Balsalazide: a novel 5-aminosalicylate prodrug for the treatment of active ulcerative colitis.

    abstract:BACKGROUND:5-Aminosalicylate (5-ASA) agents are the mainstay of oral therapy for ulcerative colitis (UC). Balsalazide, a prodrug of 5-ASA, has recently been approved for the treatment of UC. OBJECTIVE:To summarize current data on balsalazide and to discuss its impact on management of UC. METHODS:A systematic review o...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425250903206996

    authors: Wiggins JB,Rajapakse R

    更新日期:2009-10-01 00:00:00

  • Piperine-mediated drug interactions and formulation strategy for piperine: recent advances and future perspectives.

    abstract:INTRODUCTION:Piperine has various pharmacological effects and can modulate the functional activity of metabolic enzymes and drug transporters. Consequently, there is a great interest in the application of piperine as an alternative medicine or bioavailability enhancer. Areas covered: This review deals with the effects ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2018.1418854

    authors: Lee SH,Kim HY,Back SY,Han HK

    更新日期:2018-01-01 00:00:00

  • Profound changes in drug metabolism enzymes and possible effects on drug therapy in neonates and children.

    abstract:INTRODUCTION:There are profound changes that take place in drug metabolism enzymes during fetal and postnatal development. These changes may significantly impact drug therapy in children. AREAS COVERED:A combination of focused and comprehensive literature searches using PubMed and reference lists (from inception to 7 ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2011.577739

    authors: de Wildt SN

    更新日期:2011-08-01 00:00:00

  • What is the role of pharmacogenetics in clinical psychiatry?

    abstract::Psychiatric disorders are a leading cause of disability worldwide and despite significant pharmacologic advances, often remain difficult to diagnose correctly and treat fully. Factors which contribute to these difficulties include imprecise understanding of etiology, syndromal nature of many disorders and overlap in d...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 社论

    doi:10.1517/17425255.2013.733696

    authors: Lombard J,Doraiswamy PM

    更新日期:2013-01-01 00:00:00

  • Regulation of drug transporter expression and function in the placenta.

    abstract:INTRODUCTION:Medication of pregnant women is increasingly common in developed countries. Several placental drug transporters have been shown to transfer their substrates from the trophoblast back to the maternal circulation, thus hindering the transplacental passage of xenobiotics and protecting the fetus. However, the...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1005073

    authors: Staud F,Ceckova M

    更新日期:2015-04-01 00:00:00

  • Systems biology and functional genomics approaches for the identification of cellular responses to drug toxicity.

    abstract::Extensive growth in the field of molecular biology in recent decades has led to the development of new and powerful experimental and computational tools that enable the analysis of complex biological responses to chemical exposure on both a functional and structural genetic level. The ability to profile global respons...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.4.11.1379

    authors: Harrill AH,Rusyn I

    更新日期:2008-11-01 00:00:00

  • Pharmacokinetic drug evaluation of albutrepenonacog alfa (CSL654) for the treatment of hemophilia.

    abstract:INTRODUCTION:Replacement therapy for FVIII/IX in hemophilia A/B is more than 50 years old following the discovery of cryoprecipitate by Judith Pool in 1964. On-demand therapy and prophylaxis to treat or prevent bleedings is very demanding owing to the short half-life (HL) of factor concentrates (no more than 12-14 h fo...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1080/17425255.2016.1240168

    authors: Morfini M

    更新日期:2016-11-01 00:00:00

  • A pharmacokinetic evaluation of topotecan as a cervical cancer therapy.

    abstract:INTRODUCTION:Topotecan was initially approved for the treatment of recurrent ovarian cancer. In cervical cancer, it has been investigated for its potential as part of systemic therapy for advanced and/or recurrent disease and in combination with cisplatin and radiation as a first-line treatment for advanced disease. As...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.758249

    authors: Musa F,Blank S,Muggia F

    更新日期:2013-02-01 00:00:00

  • Arylamine N-acetyltransferase acetylation polymorphisms: paradigm for pharmacogenomic-guided therapy- a focused review.

    abstract:INTRODUCTION:The N-acetylation polymorphism has been the subject of comprehensive reviews describing the role of arylamine N-acetyltransferase 2 (NAT2) in the metabolism of numerous aromatic amine and hydrazine drugs. AREAS COVERED:We describe and review data that more clearly defines the effects of NAT2 haplotypes an...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1080/17425255.2021.1840551

    authors: Hein DW,Millner LM

    更新日期:2021-01-01 00:00:00

  • In silico models for genotoxicity and drug regulation.

    abstract:INTRODUCTION:Whereas in the past, (Q)SAR methods have been largely used to support the design of new drugs, in the last few decades, there has been a new interest in its applications for the assessment of drug safety. In particular, the ICH M7 guideline has introduced the concept that (Q)SAR predictions for the Ames mu...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1080/17425255.2020.1785428

    authors: Benigni R,Bassan A,Pavan M

    更新日期:2020-08-01 00:00:00

  • Tools for predicting the PK/PD of therapeutic proteins.

    abstract:INTRODUCTION:Assessments of the pharmacokinetic/pharmacodynamic (PK/PD) characteristics are an integral part in the development of novel therapeutic agents. Compared with traditional small molecule drugs, therapeutic proteins possess many distinct PK/PD features that necessitate the application of modified or separate ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1041917

    authors: Diao L,Meibohm B

    更新日期:2015-07-01 00:00:00

  • Advances in the development and use of human tissue-based techniques for drug toxicity testing.

    abstract:INTRODUCTION:Unacceptable failure rates in clinical trials are largely responsible for the high costs of bringing successful drugs to market - costs that are passed on to patients, insurers or healthcare providers. Furthermore, failures in clinical trials deny patients much-needed new drugs and potentially expose them ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.802770

    authors: Clotworthy M,Archibald K

    更新日期:2013-09-01 00:00:00

  • Safety considerations for patients with epilepsy taking antiepileptic drugs alongside caffeine or other methylxanthine derivatives.

    abstract:INTRODUCTION:Antiepileptic drugs (AEDs) are widely used for the treatment of epilepsy. However, ∼ 30% of patients do not remain seizure free. It is possible that methylxanthine derivatives (e.g., caffeine and theophylline) may partially account for this outcome. AREAS COVERED:Data on the convulsive activity of methylx...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2014.920822

    authors: Chrościńska-Krawczyk M,Radzik I,Miziak B,Czuczwar SJ

    更新日期:2014-07-01 00:00:00

  • Fondaparinux in acute coronary syndromes.

    abstract::Antithrombotic therapies form the cornerstone of management of acute coronary syndromes (ACS). An ideal antithrombotic agent should reduce ischemic complications while keeping bleeding events to a minimum. Heparins, both unfractionated and low molecular weight, reduce ischemic outcomes but also significantly increase ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425250903456039

    authors: Chaturvedi V,Karthikeyan G

    更新日期:2009-12-01 00:00:00

  • 4th Annual Predictive Toxicology Summit 2012.

    abstract:INTRODUCTION:This meeting report presents a brief summary on the 4th Annual Predictive Toxicology Summit 2012, which was held on 15 - 16 February 2012 in London. AREAS COVERED:The majority of presentations came from global pharmaceutical companies, although small and medium enterprise (SME) and academic researchers we...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1517/17425255.2013.802306

    authors: Cui Z

    更新日期:2013-08-01 00:00:00

  • Pharmacokinetic evaluation of mycophenolate mofetil for pemphigus.

    abstract:INTRODUCTION:Pemphigus is an autoimmune blistering disease of the skin and mucous membranes characterized by the development of autoantibodies against the desmosomal proteins, desmoglein-1 and -3. Before the advent of corticosteroids, therapy was almost fatal. The introduction of high-dose corticosteroid therapy has re...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2011.542149

    authors: Doukaki S,Pistone G,Aricò M,Bongiorno MR

    更新日期:2011-02-01 00:00:00

  • Pharmacokinetic considerations in the use of antivirals in neonates.

    abstract:INTRODUCTION:Neonatal patients, because of the inability of their immune system to properly respond to microbial challenge, are highly susceptible to viral infections. Immunoglobulins, monoclonal antibody and antiviral drugs are used for prophylaxis and treatment of viral diseases in neonates. Neonates and, especially,...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1108963

    authors: Enioutina EY,Constance JE,Stockmann C,Linakis MW,Yu T,Rower JE,Balch AH,Sherwin CM

    更新日期:2015-01-01 00:00:00

  • Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma.

    abstract:INTRODUCTION:Omalizumab is a subcutaneously administrated monoclonal anti-IgE antibody indicated in adults, adolescents and children 6 years of age and older with moderate to severe allergic asthma uncontrolled by conventional pharmacological treatments and sensitization to at least one perennial allergen. Area covered...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2016.1248403

    authors: Luu M,Bardou M,Bonniaud P,Goirand F

    更新日期:2016-12-01 00:00:00