Abstract:
INTRODUCTION:This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, chronic pain. METHODS:In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100-250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20-50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100-250 mg bid) or oxycodone HCl CR (20-50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group. RESULTS:In the placebo (n = 993), tapentadol ER (n = 1,874), and oxycodone CR (n = 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥ 1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively. CONCLUSION:Results from this large patient population showed that tapentadol ER (100-250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Etropolski M,Kuperwasser B,Flügel M,Häufel T,Lange B,Rauschkolb C,Laschewski Fdoi
10.1007/s12325-014-0128-6subject
Has Abstractpub_date
2014-06-01 00:00:00pages
604-20issue
6eissn
0741-238Xissn
1865-8652journal_volume
31pub_type
杂志文章,meta分析abstract::The prognosis for patients with rheumatoid arthritis or spondyloarthritides has improved dramatically due to earlier diagnosis, recognition of the need to treat early with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), alone or in combinations, the establishment of treatment targets, and the ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0142-8
更新日期:2014-08-01 00:00:00
abstract::Data from the Framingham Heart Study and risk-appraisal models were used to develop a Coronary Heart Disease (CHD) Risk Factor Calculator for early identification of high-risk individuals. The Calculator was tested at an employee health fair for a large northeastern US corporation. Of the 590 employees who registered ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850248
更新日期:2001-01-01 00:00:00
abstract::The aims of this study were to determine whether the nursing costs of functional disability could be assessed retrospectively and, if so, whether this method was sensitive enough to show the influence of a treatment on economic costs. Four studies were available for this purpose: three randomized, double-blind, place...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:
更新日期:1993-09-01 00:00:00
abstract:INTRODUCTION:To evaluate, from the patient's perspective, the burden of pain associated with hip/knee osteoarthritis (OA) in the USA and selected European Union (EU) countries. METHODS:Data were drawn from the 2017 global Adelphi OA Disease Specific Programme™ (DSP). Patients with hip/knee OA were stratified based on ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01445-4
更新日期:2020-09-01 00:00:00
abstract::The article "Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials", written by Michael J. Noss, Renee Ciesla, and Gilbert Shanga, was originally published electronically on the publisher's internet portal (currently SpringerLink) on June 17, 2019 without Open Access. The artic...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-019-01069-3
更新日期:2019-11-01 00:00:00
abstract:INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of ep...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0029-0
更新日期:2013-05-01 00:00:00
abstract::Salivary gland carcinomas of the larynx are uncommon. Adenoid cystic carcinoma is the most prevalent type of salivary gland carcinoma in this region, although other histologies such as mucoepidermoid carcinoma and adenocarcinomas have been reported. These tumors may present with advanced-stage due to nonspecific sympt...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-017-0494-y
更新日期:2017-04-01 00:00:00
abstract::This study was conducted to assess clinical and cost outcomes associated with the use of daptomycin. This objective was addressed through a consecutive patient chart review of the first 50 inpatients treated with daptomycin. Type of infection, identity of isolated pathogens, prior therapy, duration of therapy, length ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/BF02848774
更新日期:2007-05-01 00:00:00
abstract:INTRODUCTION:The anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) alectinib was approved in Japan in 2014 for the treatment of ALK fusion gene-positive advanced non-small cell lung cancer (NSCLC). With the approvals of crizotinib in 2012 and ceritinib in 2017, Japan became the first country with multipl...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01392-0
更新日期:2020-07-01 00:00:00
abstract:INTRODUCTION:The Medicare Part D prescription plan has a coverage gap from $2250 to $5100 per year (2006 thresholds) in which patients pay full drug costs (the "donut hole"). We examined prescription costs in patients aged >or=65 years with atrial fibrillation (AF), and the proportions entering/exiting the donut hole i...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0054-1
更新日期:2009-08-01 00:00:00
abstract:INTRODUCTION:Most cases of small cell lung cancer (SCLC) are diagnosed at an advanced stage. The objective of this study was to investigate patient characteristics, survival, chemotherapy treatments, and health care use after a diagnosis of advanced SCLC in subjects enrolled in a health system network. METHODS:This wa...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01161-8
更新日期:2020-01-01 00:00:00
abstract::Dyspnea is the most common symptom experienced by patients with chronic obstructive pulmonary disease (COPD). To avoid exertional dyspnea, many patients adopt a sedentary lifestyle which predictably leads to extensive skeletal muscle deconditioning, social isolation, and its negative psychological sequalae. This "dysp...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-01128-9
更新日期:2020-01-01 00:00:00
abstract::Retinal vein occlusions are common retinal vascular disorders with the potential for significant vision-related morbidity. Retinal vein occlusions are classified as either branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), or hemiretinal vein occlusion (HRVO) based on the specific occlusion s...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0088-4
更新日期:2011-01-01 00:00:00
abstract:INTRODUCTION:Real-world data are sparse on longitudinal associations of opioid use with pain interference with activities (PIA) and daily function with osteoarthritis (OA) in the USA. METHODS:Data from the 2010-2015 Medical Expenditure Panel Surveys were analyzed for community-dwelling adults with OA. Opioid use patte...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01200-4
更新日期:2020-02-01 00:00:00
abstract:INTRODUCTION:Comparisons between brand and biosimilar basal insulin in hospitalized patients are lacking. We aimed to compare the efficacy and safety of brand insulin glargine vs. biosimilar insulin glargine in non-critical hospitalized patients with type 2 diabetes mellitus (T2DM). METHODS:This retrospective study wa...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-00922-9
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Diabetes-related healthcare costs are increasing in the United States, with inpatient hospitalization the largest component of medical expenditures. The aims of this study were to characterize hospitalized type 2 diabetes mellitus (T2DM) patients, understand the relationship between hospitalization and hea...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0223-3
更新日期:2015-07-01 00:00:00
abstract:INTRODUCTION:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome meas...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00920-x
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Although chronic opioid therapy is usually initiated using short-acting opioids, many patients with chronic pain are subsequently converted to long-acting and extended-release preparations. In clinical practice, optimal management requires careful individualization of dosage in order to achieve an appropri...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-012-0051-7
更新日期:2012-10-01 00:00:00
abstract::The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in ai...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0074-x
更新日期:2009-10-01 00:00:00
abstract:INTRODUCTION:Data regarding the prevalence of immune thrombocytopenia (ITP) is limited, and is derived from North American population-based analyses. Therefore, the authors conducted the first study outside the United States (US) using the United Kingdom (UK) General Practice Research Database (GPRD) to estimate the ad...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0084-3
更新日期:2011-12-01 00:00:00
abstract:INTRODUCTION:The healthcare sector contributes 5-8% of the global greenhouse gas emissions. Global and regional organizations and governments have started to design and implement measures to reduce global greenhouse gas emissions in the healthcare sector, e.g. by green public procurement policies and inclusion of ecolo...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01114-1
更新日期:2019-12-01 00:00:00
abstract:INTRODUCTION:Advanced renal cell carcinoma (RCC) shows a propensity for extending into the tributaries of the renal veins, which poses a notable surgical challenge. In this study we addressed the question as to whether patients with RCC and vein involvement can be identified as having a significant risk of immediate de...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0235-z
更新日期:2015-08-01 00:00:00
abstract::Liver transplantation has become a highly standardized, acceptable option for selected patients with end-stage liver disease and/or hepatocellular carcinoma in the setting of cirrhosis. Both conditions are associated with loss of skeletal muscle mass (sarcopenia) and physical deconditioning. Both conditions result in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0797-7
更新日期:2018-11-01 00:00:00
abstract::Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections in adolescents. Such infection is associated with substantial health risks and is unpredictable in its resolution. Genital warts are the most common clinical manifestations of genital HPV infections. Most genital warts are c...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/BF02849928
更新日期:2005-05-01 00:00:00
abstract:INTRODUCTION:Spinal muscular atrophy (SMA) is a neurodegenerative disease of the motor neurons that results in progressive muscle weakness. It is also the leading hereditary cause of infant mortality. Homozygous loss of the survival motor neuron (SMN1) gene causes SMA, and the number of copies of the SMN2 gene modulate...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0030-1
更新日期:2008-03-01 00:00:00
abstract:INTRODUCTION:Claims data (IBM MarketScan Commercial and MarketScan Medicare Supplemental databases) from June 30, 2011 to September 30, 2017 were used to evaluate the cost impact of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in this retrospective cohort study. METHODS:The p...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01283-4
更新日期:2020-04-01 00:00:00
abstract::Intensive postremission chemotherapy has produced disease-free survival comparable to that of bone marrow transplantation in patients with acute myelogenous leukemia (AML), but its efficacy was unknown in Taiwan. We assessed the efficacy of intensive postremission chemotherapy, consisting of high-dose arabinoside-C (H...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02852390
更新日期:2001-03-01 00:00:00
abstract::This study was undertaken to evaluate the effectiveness of prophylactic intranasal mupirocin for peritonitis in patients on continuous ambulatory peritoneal dialysis (CAPD). A total of 49 patients undergoing CAPD for at least 6 mo were followed for 1 year. A nasal smear was obtained from each patient at the beginning ...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF02849908
更新日期:2007-03-01 00:00:00
abstract:INTRODUCTION:The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS:The authors revi...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-017-0560-5
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:This clinical study aimed to investigate the effect of brinzolamide, a topical carbonic anhydrase inhibitor, on corneal endothelial cells (CECs) in patients with glaucoma using a follow-up clinical study design. METHODS:Patients with primary open-angle glaucoma or ocular hypertension were administrated an...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:10.1007/s12325-016-0373-y
更新日期:2016-08-01 00:00:00