A retrospective, pooled data analysis of the safety of pegaptanib sodium in the treatment of age-related macular degeneration in subjects with or without diabetes mellitus

ABSTRACT: BACKGROUND: To evaluate the safety of pegaptanib sodium 0.3 mg intravitreal injection in the treatment of neovascular age-related macular degeneration in subjects with or without diabetes mellitus. METHODS: A pooled, retrospective, analysis was conducted of data from 9 sponsor-administered, randomized, open-label trials. Subjects who received pegaptanib by randomization or change in dose assignment, crossover design, or protocol amendment, were included. Reports of endophthalmitis, increased intraocular pressure, retinal injury, intraocular hemorrhage, traumatic cataract, hypersensitivity reactions, stroke, myocardial infarction, and other arterial thromboembolic events defined by the Antiplatelet Trialists' Collaboration were identified by Medical Dictionary for Regulatory Activities preferred terms. Adverse events were summarized from the first injection to 42 days after the last injection. The incidence of adverse events was stratified by the presence/absence of diabetes. RESULTS: Of 1,586 subjects enrolled, 165 (10.4%) had a history of diabetes mellitus and 1,421 (89.6%) did not. The 2 populations were similar at baseline. Based on the comparison of prespecified ocular, hypersensitivity, and Antiplatelet Trialists' Collaboration event terms, the safety review did not identify any notable differences between the 2 populations. CONCLUSIONS: This retrospective analysis found no increased safety risk resulting from treatment with pegaptanib 0.3 mg in individuals with neovascular age-related macular degeneration and concomitant diabetes mellitus.     

Sphygmomanometry-Evoked Allodynia in Chronic Pain Patients With and Without Fibromyalgia

BACKGROUND:: Fibromyalgia is a chronic pain syndrome that affects about 2% of the U.S. general population, with greater prevalence among women (3.5%) than men (0.5%). Previous research results suggest that the experience of pain (allodynia) upon sphygmomanometry may indicate the presence of fibromyalgia. OBJECTIVE:: The aim of this study was to confirm these findings in patients with fibromyalgia and other chronic pain conditions and evaluate the use of sphygmomanometry as a potential screening tool for the identification of patients with fibromyalgia. METHODS:: A total of 150 people participated in this multicenter, cross-sectional observational study. The study included a physician-conducted evaluation to determine if the participant met the American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia. The presence of sphygmomanometry-evoked allodynia was assessed during a seated cuff pressure inflation that was repeated three times on each arm. Each site was provided a sphygmomanometer to ensure standardization, and the pressure of the cuff at the moment of pain initiation was recorded. If the patient did not indicate pain prior to 180 mmHg, then the inflation was stopped, a notation of no pain was made, and a cuff pressure of 180 mmHg was recorded. The mean of the six cuff pressure measurements was used for the analyses. Logistic regression was performed to analyze the relationship between sphygmomanometry-evoked allodynia and fibromyalgia. RESULTS:: The evaluable sample was 148 (one participant had too large an arm circumference for the sphygmomanometer and another did not receive the clinician evaluation of ACR-determined fibromyalgia diagnosis). Over half of the participants were determined to have an ACR diagnosis of fibromyalgia. Of these, 71 (91%) were women and had an average age of 54 years. Of the 70 participants with no fibromyalgia diagnosis, 42 (60%) were women and also had an average age of 54 years. Sixty-one (78%) of the fibromyalgia participants, compared with 25 (36%) of those with no fibromyalgia diagnosis, reported sphygmomanometry-evoked allodynia. The participants with fibromyalgia reported pain ata lower cuff pressure compared with those without fibromyalgia (132 mmHg vs. 166 mmHg, p < .01). The logistic regression showed that sphygmomanometry-evoked allodynia predicted an ACR-determined FM diagnosis (χ = 19.4, p < .01). DISCUSSION:: These findings support previous research suggesting that patients who report pain upon sphygmomanometry may warrant further evaluation for the presence of fibromyalgia.     

Response to breast health screening program at a not‐for‐profit clinic for working poor,uninsured, ethnically diverse women

Aims and objectives. Examine the effect of an ongoing breast health screening program, at a not‐for‐profit, non‐government assisted, volunteer clinic, specifically examining mammography usage and to discover variables to improve the rate of mammography. Background. Detection of breast cancer in women of low socio‐economic status, lacking health insurance, can be improved by increasing annual mammography rates, yet little is known about their screening behaviour. Design. Quantitative, retrospective subject‐controlled study. Methods. Subject‐controlled, longitudinal study of English and Spanish‐speaking women 40 years old and over, working poor, and uninsured, who participated in a comprehensive screening program that included a 7‐minute breast health educational DVD (n = 223). Results. Radiology records, breast health behaviours and beliefs indicated 76% of women invited for a second test completed it over a year after viewing the educational DVD. Chi‐square and t‐test indicated two significant findings for completing annual mammography in the 12th month: receiving a reminder postcard and scoring lower on perceptions of breast cancer susceptibility. Two significant findings for completing annual mammography even if late are knowledgeable about screening recommendations and ethnically identifying as Hispanic. Conclusions. This study shows statistically significant actions that can be undertaken to strengthen programs: reminder postcards, assessing susceptibility score and screening recommendation education. Relevance to clinical practice. Simple, inexpensive interventions encourage working, uninsured, Hispanic women to complete mammography.     

Prevalence of Obesity: A Public Health Problem Poorly Understood

This review article discusses the Dietary Guidelines for Americans (DGA) in support of a total diet approach to achieving diet and health goals, especially as they relate to the obesity epidemic. However, some scientists and organizations have identified one food, food group, or nutrient as the cause of the obesity epidemic and recommend that simply reducing that food/food group/nutrient will solve the problem. This is simplistic and unlikely to be effective in long term management of the obesity problem. This article also acknowledges discrepancies in the literature and the lack of consensus opinions from systematic reviews. Failure to consider the evidence as a whole can lead to inaccurate reports which may, in turn, adversely influence clinical practice, public policy, and future research. This article also considers where the line should be drawn between individual choice and responsibility and public regulation. Using sugar sweetened beverages as an example, the article considers the lack of a consistent association between added sugars and weight in the literature and calls for policy recommendations that are based on science and emphasizes the need for evidence-based policies rather than policy-based evidence.     

A comparison of different sealants preventing demineralization around brackets

Journal of Orofacial Orthopedics / Fortschritte der Kieferorthopädie - Aim of the study was to compare how six different sealants resisted thermal, mechanical, and chemical loading in vitro....     

New insights into the morphogenesis of the gubernaculum testis and the inguinal canal

There is no consensus about the role of the gubernaculum testis (GT). Nineteen human embryos (Carnegie stages 15–23), 36 fetuses (9 weeks to term), and eight neonates were examined. All the embryos and 25 fetuses (from weeks 9–16) were processed for paraffin wax histology and serially sectioned at 10 µm thickness. The remaining 11 fetuses and the eight neonates were fresh specimens that were dissected under a surgical microscope. The GT appeared during the embryonic period (stages 17–23) with a horseshoe‐shaped mesenchyme condensation of the superior concavity, which was observed in four different topographical regions sequentially through development. The GT was not attached at either of its ends in any of the specimens, not to the gonad or in the scrotal sac. The inguinal canal differentiates around the inguinal portion of the GT during the late embryonic period. After stage 21, the GT appears enveloped by an evagination of the peritoneal cavity. It has few striate muscular fibers and vessels. Although the GT does not appear to have the role traditionally attributed to it, it is still an essential structure and indirectly facilitates the descent of the testes. It contributes to the formation of the inguinal canal and then forges the pathway that the testes will subsequently take through the inguinal canal as they migrate from the abdominal cavity into the scrotal sac. Clin. Anat. 30:599–607, 2017. © 2017 Wiley Periodicals, Inc.