Abstract：
BACKGROUND:Tapentadol hydrochloride is a centrally acting oral analgesic approved by the US Food and Drug Administration in November 2008 for the treatment of moderate to severe acute pain. It is available as immediate-release 50-, 75-, and 100-mg tablets. OBJECTIVE:The purpose of this article is to review animal studies, pharmacokinetic studies, drug-drug interaction studies, and Phase II/III trials of tapentadol in various conditions producing moderate to severe pain. Efficacy and tolerability data from these studies are summarized. METHODS:A search of MEDLINE and International Pharmaceutical Abstracts was conducted from January 2005 through June 30, 2009. Search terms included tapentadol, tapentadol hydrochloride, and (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride. Relevant information was extracted from the identified articles, and the reference lists of these articles were reviewed for additional pertinent publications. The manufacturer was contacted for clinical trials, abstracts, and poster presentations that were not identified by the literature search. ClinicalTrials.gov was searched to identify recently completed studies. RESULTS:Tapentadol produces analgesia through a dual mechanism of action: mu-opioid-receptor activation and norepinephrine reuptake inhibition. Its efficacy has been reported in a number of animal studies, as well as in Phase II/III clinical trials. Primary pain disorders in which efficacy has been reported include dental extraction pain, pain after bunionectomy surgery, osteoarthritis pain of the knee and hip, and low back pain. Major adverse effects reported in Phase II/III trials primarily involved the gastrointestinal system (2%-66% of subjects) and the central nervous system (4%-65% of subjects). The occurrence of gastrointestinal adverse effects appeared to be less frequent in tapentadol recipients than in those receiving oxycodone. CONCLUSIONS:Tapentadol appears to be a well-tolerated and effective analgesic for the treatment of moderate to severe acute pain. Although not currently approved for the management of chronic pain, tapentadol has been reported to be effective in managing pain associated with osteoarthritis and low back pain.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Wade WE,Spruill WJdoi
10.1016/j.clinthera.2009.12.003subject
Has Abstractpub_date
2009-12-01 00:00:00pages
2804-18issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(09)00453-6journal_volume
31pub_type
杂志文章,评审abstract：:A double-blind clinical trial was conducted to evaluate the efficacy and safety of flumazenil, a benzodiazepine antagonist, in 146 hospitalized patients, who had had general anesthesia induced by midazolam and a long-acting opioid. Ninety-eight patients received flumazenil and 48 received placebo. Administered postope...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：
更新日期：1992-11-01 00:00:00
abstract：:Zuclopenthixol acetate is a rapid-acting, injectable neuroleptic drug with a duration of action that allows for administration once every 2 to 3 days, in contrast to injectable haloperidol, which may require administration more than once daily. To assess the place of zuclopenthixol acetate in the treatment of acute ep...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(97)80120-8
更新日期：1997-03-01 00:00:00
abstract：BACKGROUND:Although the metabolic effects of the thiazolidinediones have been well studied, there is a lack of comparative data on their effects on certain cardiovascular risk factors, such as elevated plasma levels of lipoprotein (a) (Lp[a]) and homocysteine (Hcy). OBJECTIVE:This study compared the effects of pioglit...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2006.05.012
更新日期：2006-05-01 00:00:00
abstract：:A total of 804 pediatric patients (572 neonates and 232 infants and children) with suspected or documented serious infections were enrolled in a multicenter open study of netilmicin, a new semisynthetic aminoglycoside. All patients were evaluable for safety; 161 (20%) had bacteriologically documented infections and we...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1983-01-01 00:00:00
abstract：:A single 5-gm dose of mezlocillin or a placebo was administered intravenously 30 minutes before surgery to patients undergoing emergency cesarean section. The assignment of drug or placebo was randomized. Postoperative morbidity occurred in 62.5% of patients receiving placebo and in 18.4% of those receiving mezlocilli...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1985-01-01 00:00:00
abstract：PURPOSE:The effects of air pollutants have been receiving increased attention both clinically and in the media. One such pollutant is mold, fungal growth in the form of multicellular filaments known as hyphae. The growth of molds is omnipresent not only in outdoor settings but also in indoor environments containing exc...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2018.05.004
更新日期：2018-06-01 00:00:00
abstract：BACKGROUND:A sprinkle capsule formulation containing enteric-coated, delayed-release rabeprazole granules is being developed for the treatment of children with gastrointestinal reflux disease. The granules are designed to be mixed with vehicles that facilitate delivery to children, who may be unable to swallow solid fo...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2012.06.008
更新日期：2012-07-01 00:00:00
abstract：PURPOSE:We applied Multi-Criteria Decision Analysis (MCDA) methods in a structured benefit-risk assessment of cladribine and newer approved disease-modifying drugs (DMDs) for patients with relapsing-remitting multiple sclerosis (RRMS). METHODS:Decision conferencing with clinical neurologists as decision makers was use...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2018.12.015
更新日期：2019-02-01 00:00:00
abstract：PURPOSE:Coadministration of morphine with oral gabapentin has been shown to increase plasma gabapentin concentrations. This study evaluated whether there was any interaction between gabapentin enacarbil (GEn), which is a prodrug of gabapentin, and morphine in terms of pharmacokinetics, pharmacodynamics, safety, and tol...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2014.10.015
更新日期：2015-02-01 00:00:00
abstract：BACKGROUND:Due to Mexico's complicated socioeconomic environment, causing a high occurrence of >1 person sharing a single room, respiratory conditions are spread easily. Respiratory conditions are the main reason for consultation with a physician. The most frequent symptoms are throat soreness and cough; therefore, a n...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0149-2918(03)80215-1
更新日期：2003-08-01 00:00:00
abstract：BACKGROUND:Alendronate, an oral bisphosphonate, is available for the treatment of osteoporosis in a 70-mg once-weekly and a 10-mg once-daily formulation. OBJECTIVES:This study aimed to determine patient preference for once-weekly versus once-daily dosing with alendronate, and to determine which treatment regimen the p...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0149-2918(02)80085-6
更新日期：2002-11-01 00:00:00
abstract：BACKGROUND:Since the recognition that asthma is characterized by extensive inflammation of the airways, the use of inhaled corticosteroids (ICSs) as controller therapy has become central to successful disease management. As the prevalence of asthma increases worldwide, there is concern about increasing numbers of patie...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)80302-8
更新日期：2003-01-01 00:00:00
abstract：BACKGROUND:Plasma concentrations of cloxacillin have been found to vary as much as 20-fold among individuals receiving the same oral dose. There is evidence that cloxacillin may be a substrate for P-glycoprotein, suggesting that polymorphisms in the ABCB1 gene may be a contributing factor to the observed variability in...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2009.05.014
更新日期：2009-05-01 00:00:00
abstract：PURPOSE:The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.03.004
更新日期：2016-05-01 00:00:00
abstract：:Healing rates were examined retrospectively in 124 outpatients with peptic ulcer who had received cimetidine for at least four weeks. Treatment was unsuccessful in 73 patients. A statistical analysis of the factors involved in treatment failure revealed that in patients with duodenal ulcers 60.6% of the treatment succ...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：:A total of 128 corticosteroid-independent adults with chronic allergic asthma were treated for six weeks with 400 micrograms/day of beclomethasone dipropionate aerosol. Most patients (114 or 89%) had a good to excellent response, characterized by a marked improvement in the signs and symptoms of asthma. Substantial im...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:To determine the cost relative to efficacy and tolerability of two antimicrobial regimens, a prospective, multicenter study compared imipenem-cilastatin (I-C) monotherapy with clindamycin+aminoglycoside (C+A) in the treatment of serious lower respiratory, intra-abdominal, gynecologic, and urinary tract infections. The...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：
更新日期：1992-01-01 00:00:00
abstract：BACKGROUND:Preclinical studies have reported that the relative bioavailability of dalcetrapib, a modulator of cholesteryl ester transfer protein (CETP) inhibitor activity, was ∼60% higher when administered in the fed state compared with the fasting state. OBJECTIVE:This article reports on 3 studies conducted to assess...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2011.05.046
更新日期：2011-06-01 00:00:00
abstract：BACKGROUND:Linezolid is available in an oral as well as an intravenous formulation. It is an oxazolidinone antibiotic and is effective in treating resistant gram-positive organisms such as methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae. OBJECTIVES:The goals of this study w...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/S0149-2918(10)80027-X
更新日期：2010-12-01 00:00:00
abstract：:Exposure of the eye to airborne particles in patients predisposed to allergy often results in the signs and symptoms of allergic conjunctivitis such as red, itchy eyes and ocular discharge. The mediators of these allergic symptoms include histamine, inflammatory substances such as prostaglandins, and other products of...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究
doi：10.1016/0149-2918(95)80066-2
更新日期：1995-09-01 00:00:00
abstract：:Two studies were conducted to determine the prevalence of Chlamydia trachomatis in the urine and cervical exudates of women with genitourinary symptoms. In the first study, 873 women attending the World Health Organization-Sexually Transmitted Disease Center of the Alfred Fournier Institute, in Paris, were examined. I...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：BACKGROUND:Patients with grade 2 or 3 hypertension may require high-dose combination therapy to achieve blood pressure (BP) targets in a timely manner. OBJECTIVES:This study compared the effectiveness and tolerability of a single-pill combination (SPC) of telmisartan/hydrochlorothiazide 80/25 mg (T80/H25) with T80 mon...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2012.05.007
更新日期：2012-07-01 00:00:00
abstract：:Antihypertensive drugs are commonly prescribed for the treatment of patients with both diabetes and hypertension. However, the role of selected agents in the development of hypoglycemia remains controversial. The main objective of this study was to evaluate the effect of antihypertensive agents on the risk of hypoglyc...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(99)80039-3
更新日期：1999-08-01 00:00:00
abstract：BACKGROUND:Although third mandibular molar extraction is a widely used and validated model of acute pain for evaluating analgesic efficacy, a large proportion of patients experience moderate or severe pain following this procedure and require analgesia. Current treatment options have been associated with safety concern...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2012.01.004
更新日期：2012-02-01 00:00:00
abstract：:In two multicenter, double-blind studies, ciclopirox olamine cream 1% was compared with either its cream vehicle or with 1% clotrimazole cream for the treatment of patients with tinea pedis. Evaluations were made before treatment, weekly for four weeks during treatment, and for two weeks posttreatment. Ciclopirox olam...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1985-01-01 00:00:00
abstract：BACKGROUND:Physiologic changes of aging may affect processes of drug absorption and distribution, in some cases necessitating age-dependent dose adjustment. OBJECTIVE:The possibility of age dependence in the pharmacokinetic behavior and tolerability of levormeloxifene was investigated in a single-center, open-label st...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/s0149-2918(01)80030-8
更新日期：2001-01-01 00:00:00
abstract：PURPOSE:The recommended first-line treatment for young children infected with HIV includes the liquid formulation of the co-formulated protease inhibitors lopinavir/ritonavir (Kaletra® [Abbott Laboratories, Chicago, Illinois]). Clinical reports indicate that some children readily accept the taste of Kaletra, whereas ot...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2017.08.012
更新日期：2017-10-01 00:00:00
abstract：BACKGROUND:In 2002, fixed-dose combination therapy (FDCT) with rosiglitazone maleate plus metformin hydrochloride became available for the treatment of type 2 diabetes mellitus (DM-2) in subjects whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione. FDCT allows a reduced pill burden and a...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2004.12.018
更新日期：2004-12-01 00:00:00
abstract：PURPOSE:We conducted a retrospective cohort study to compare medication use patterns of a long-acting extended-release methylphenidate (Osmotic Release Oral System [OROS(®)] methylphenidate, CONCERTA(®)) and Teva-methylphenidate (methylphenidate ER-C), a generic drug determined by the Canadian regulatory authority, Hea...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.07.001
更新日期：2016-08-01 00:00:00
abstract：BACKGROUND:Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as "sinus' headache, while ignoring the possible diagnosis of migraine. OBJECTIVE:The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients wit...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2007.01.012
更新日期：2007-01-01 00:00:00
