Clinicaltrials.gov, NCT01814878.

Study DesignA cross-sectional study.PurposeTo explore the impact of chronic low back pain (CLBP) on individuals' quality of life; to understand current treatment practices and level of satisfaction with treatment in patients with CLBP.Overview of LiteratureAssessing subjective, patient-reported outcomes such as quality of life is essential to health care research.MethodsInfluences of the CLBP were analyzed via a questionnaire, which contained the character of CLBP, effect of pain management, Korean version Oswestry Disability Index (K-ODI) and Korean version of 12-item Short Form Health Survey (SF-12v2).ResultsOf 3,121 subjects who responded, 67.3% had moderate to severe pain; 43.5% presented prolonged CLBP of more than two years; and 32.4% had suffered from sleep disturbance due to pain. 22.8% of the patients were not satisfied with current pain management. The mean K-ODI score was 37.63; and it was positively correlated with the mean pain intensity (r=0.6, p<0.001). The SF-12v2 result was negatively correlated with mean pain intensity (PCS: r=-0.5, p<0.001; MCS: r=-0.4, p<0.001) and also negatively correlated with the K-ODI score (PCS: r=-0.75, p<0.001; MCS: r=-0.5, p<0.001). The conformity between patients and doctors in pain assessment was fair (κ=0.2463).ConclusionsCLBP negatively affects quality of life. Of total 22.8% of the patients were not satisfied with current pain management. Such needs to be taken more seriously by doctors for improvement of satisfaction and quality of life in patients with CLBP.

Objective: To broaden the ethnic groups in which tapentadol IR is evaluated for treating acute postoperative pain to include Asians. Methods:In this phase 3, multicenter, double-blind, randomized study, 352 Korean adults with moderate-to-severe pain following hallux valgus surgery received tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours for 72 hours. Patients requesting other (rescue) analgesics during this period were discontinued for lack of efficacy. The primary endpoint, sum of pain intensity difference (SPID) over 48 hours, was evaluated based on the difference between tapentadol IR and placebo in least squares (LS) mean change from baseline using analysis of covariance (ANCOVA). Secondary endpoints included the time to first rescue medication use and the distribution of responder rates. Results:A treatment effect, favoring tapentadol IR, was observed for SPID 48 (p50.001 for both doses vs. placebo, ANCOVA). The between-group difference (vs. placebo) in LS means of SPID 48 was 76.4 (95% CI: 51.0, 101.7) for tapentadol IR 50 mg and 90.6 (95% CI: 65.1, 116

Abbreviations & AcronymsObjectives: To evaluate the safety and efficacy of abiraterone acetate and prednisolone in Korean and Taiwanese patients with metastatic castration-resistant prostate cancer not responding to docetaxel-based chemotherapy. Methods: In this single-arm study, 82 metastatic castration-resistant prostate cancer patients who failed docetaxel-based chemotherapy were treated with abiraterone (1000 mg, once daily) and prednisolone (5 mg, twice daily). Patients achieving a prostate-specific antigen decline ≥50% were considered as responding. Results: A total of 35 patients (43%) achieved prostate-specific antigen response (95% confidence interval 32-54). The median time to prostate-specific antigen progression was 4.7 months (95% confidence interval 3.7-8.3); the median overall survival was 11.8 months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21 nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725 μmol/L (baseline) to 0.080 μmol/L (cycle 4). The most common adverse event was bone pain (20%); grade 3/4 adverse event of special interest were hypokalemia (7%), fluid retention and liver function abnormalities (5% each), hypertension (2%), and cardiac disorders (1%). Conclusions: A combination of abiraterone acetate and prednisolone appears to be a favorable second-line treatment in Taiwanese and Korean patients with advanced metastatic castration-resistant prostate cancer after failed docetaxel-based chemotherapy.

ObjectivePrevious pathologic and roentgenographic studies have suggested a relation between aortic plaque and coronary artery disease but have lacked clinical utility. The study was undertaken to elucidate whether atherosclerotic aortic plaque detected by transesophageal echocardiography can be a clinically useful marker for significant obstructive coronary artery disease.MethodsClinical and angiographic features and intraoperative transesophageal echocardiographic findings were prospectively analyzed in 131 consecutive patients (58 women and 73 men, aged 17 to 75 years [mean 54±12]) undergoing open heart surgery. Significant obstructive coronary artery disease was defined as > or = 50% stenosis of > or = 1 major branch.ResultsSeventy-six (58%) of 131 patients were found to have obstructive coronary artery disease. In 76 patients with significant coronary artery disease, 71 had thoracic aortic plaque. In contrast, aortic plaque existed in only 10 of the remaining 55 patients with normal or minimally abnormal coronary arteries. The presence of aortic plaque on transesophageal echocardiographic studies had a sensitivity of 93%, a specificity of 82% and positive and negative predictive values of 88% and 90%, respectively, for significant coronary artery disease. There was a significant relationship between the degree of aortic intimal changes and the severity of coronary artery disease (r=0.74, P<0.0001). Multivariate logistic regression analysis of patient age, sex, risk factors of cardiovascular disease and transesophageal echocardiographic findings revealed that atherosclerotic aortic plaque was the most significant independent predictor of coronary artery disease.ConclusionThis study indicates that transesophageal echocardiographic detection of atherosclerotic plaque in the thoracic aorta is useful in the noninvasive prediction of the presence and severity of coronary artery disease.