Effect of subcutaneous methylnaltrexone on patient-reported constipation symptoms

AbstractBackgroundMethylnaltrexone, a selective peripheral acting mu-opioid receptor antagonist, alleviates the constipating effects of opioids without affecting centrally mediated analgesia.ObjectivesTo assess the effect of subcutaneous (SC) methylnaltrexone injection on patient-reported constipation symptoms and pain scores.MethodsA total of 469 subjects on opioids for chronic non-malignant pain with opioid-induced constipation were randomized to methylnaltrexone SC with once daily (QD) or every other day (QOD) dosing or placebo for 4 weeks. Constipation symptoms and pain were assessed using the patient assessment of constipation–symptoms (PAC-SYM) questionnaire and a 11-point scale, respectively, at baseline, Day 14 and Day 28. Change from baseline in PAC-SYM and pain scores were compared between methylnaltrexone and placebo arms at Day 28 using analysis of covariance, with treatment group as factor and baseline score as covariate.ResultsA majority of patients were women (60%), average age was 49 years old, and back pain (60%) was the primary pain condition. At Day 28, the methylnaltrexone SC QD group showed a significant improvement over placebo for rectal symptoms (−0.56 vs. –0.30; P < 0.05), stool symptoms (−0.76 vs. –0.43; P < 0.001) and global scores (−0.62 vs. –0.37; P < 0.001). Improvement in stool symptoms (−0.69 vs.−0.43; P < 0.05) and the global scores (−0.52 vs. –0.37; P < 0.05) were significantly greater than placebo in the methylnaltrexone QOD group. Differences in change from baseline in abdominal symptoms and pain scores between the methylnaltrexone SC QD or QOD dosing arms and placebo were not significant.ConclusionThe results of our study indicate significant improvement in constipation symptoms with methylnaltrexone QD or QOD dosing compared to placebo without a significant effect on pain scores

Disparities in the use of ambulatory surgical centers: a cross sectional study

<p>Abstract</p> <p>Background</p> <p>Ambulatory surgical centers (ASCs) provide outpatient surgical services more efficiently than hospital outpatient departments, benefiting patients through lower co-payments and other expenses. We studied the influence of socioeconomic status and race on use of ASCs.</p> <p>Methods</p> <p>From the 2005 State Ambulatory Surgery Database for Florida, a cohort of discharges for urologic, ophthalmologic, gastrointestinal, and orthopedic procedures was created. Socioeconomic status was established at the zip code level. Logistic regression models were fit to assess associations between socioeconomic status and ASC use.</p> <p>Results</p> <p>Compared to the lowest group, patients of higher socioeconomic status were more likely to have procedures performed in ASCs (OR 1.07 CI 1.05, 1.09). Overall, the middle socioeconomic status group was the most likely group to use the ASC (OR 1.23, CI 1.21 to 1.25). For whites and blacks, higher status is associated with increased ASC use, but for Hispanics this relationship was reversed (OR 0.84 CI 0.78, 0.91).</p> <p>Conclusion</p> <p>Patients of lower socioeconomic status treated with outpatient surgery are significantly less likely to have their procedures in ASCs, suggesting that less resourced patients are encountering higher cost burdens for care. Thus, the most economically vulnerable group is unnecessarily subject to higher charges for surgery.</p

Redistribution of membrane proteins in isolated mouse intestinal epithelial cells

ABSTRACT Single mouse intestinal epithelial cells (IEC) may be isolated by the use of a combination of methods used for the isolation of IEC from other species. Isolated cells remain viable for several hours. The membrane integral enzymes alkaline phosphatase and leucine aminopeptidase of isolated IEC are localized to the brush borders of IEC in tissue and in most newly isolated IEC. With time, both enzymes are found distributed over the entire cell surface. Redistribution appears to occur by diffusion in the plane of the membrane. It is slowed, but not blocked, if cells are maintained at 0 ° C instead of at 37 ° C, and it is not blocked by fixation in 0.5-3 % paraformaldehyde. Drugs that alter cell membrane potential or that affect cell levels of ATP enhance the rate of redistribution of the enzymes. Diffusion of integral membrane proteins in the plane of the plasma membrane has been demonstrated in many cells and by several different techniques (for review, see reference 7). The diffusion constants measured are often smaller than predicted for free diffusion. This suggests that lateral diffusion of membrane proteins is somewhat restricted, even in cultured cells with little surface differentiation. Extremes of spatial localization of proteins in the plasma membrane and, by implication, extremes of restriction on lateral diffusion of these proteins are seen in cells of differentiate

Economic Content in Medical Journal Advertisements for Medical Devices and Prescription Drugs

Background: Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. Objective: To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Methods: Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Results: Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p - 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p - 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p - 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. Conclusion: The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.Advertising, Economic-implications, Medical-Devices, Pharmaceutical-industry, Pharmaceutical-preparations