Rationale and evidence for the incorporation of heparin to the diclofenac epolamine medicated plaster

The nonsteroidal anti-inflammatory drug (NSAID) diclofenac epolamine (DHEP) formulated as a topical patch has demonstrated efficacy and safety in the localized treatment of acute pain from minor strains, sprains, and contusions, and for epicondylitis and knee osteoarthritis. The glycosaminoglycan heparin enhances the activity of topical NSAIDs formulated as a medicated plaster, even in the absence of any significant release of heparin. Therefore, DHEP Plus, a new formulation of the DHEP medicated plaster containing a small amount of heparin sodium as excipient has been developed. Methods: We reviewed the pivotal and supportive studies of the clinical development program of the new patch and evaluated the role of heparin as an enhancer in the treatment of localized pain/inflammation of musculoskeletal structures, associated with post-traumatic and/or rheumatic conditions. Results: The data were consistent with the concept that heparin increased the clinical activity of the DHEP Plus medicated plaster versus the reference DHEP medicated plaster through improved bioavailability due to enhanced movement of diclofenac from the plaster. Both DHEP formulations have the same dissolution profile, indicating that heparin does not change the physical and chemical characteristics of the plaster. Permeation testing showed that heparin is not released from the DHEP Plus medicated plaster. Efficacy studies showed that the DHEP Plus medicated plaster was significantly more effective in reducing pain than the reference marketed DHEP medicated plaster. Conclusions: The benefit/risk assessment of DHEP Plus 180 mg medicated plaster is favorable, with a safety profile equal to placebo and improved efficacy over the reference marketed DHEP medicated plaster

A Photo Score for Aesthetic Outcome in Sagittal Synostosis:An ERN CRANIO Collaboration

European Reference Network (ERN) CRANIO is focused on optimizing care for patients with rare or complex craniofacial anomalies, including craniosynostosis and/or rare ear, nose, and throat disorders. The main goal of ERN CRANIO is to collect uniform data on treatment outcomes for multicenter comparison. We aimed to develop a reproducible and reliable suture-specific photo score that can be used for cross-center comparison of phenotypical severity of sagittal synostosis and aesthetic outcome of treatment. We conducted a retrospective study among nonsyndromic sagittal synostosis patients aged &lt;19 years. We included preoperative and postoperative photo sets from 6 ERN CRANIO centers. Photo sets included bird's eye, lateral, and anterior-posterior views. The sagittal synostosis photo score was discussed in the working group, and consensus was obtained on its contents. Interrater agreement was assessed with weighted Fleiss' Kappa and intraclass correlation coefficients.The photo score consisted of frontal bossing, elongated skull, biparietal narrowness, temporal hollowing, vertex line depression, occipital bullet, and overall phenotype. Each item was scored as normal, mild, moderate, or severe. Results from 36 scaphocephaly patients scored by 20 raters showed kappa values ranging from 0.38 [95% bootstrap CI: 0.31, 0.45] for biparietal narrowness to 0.56 [95% bootstrap CI: 0.47, 0.64] for frontal bossing. Agreement was highest for the sum score of individual items [intraclass correlation coefficients agreement 0.69 [95% CI: 0.57, 0.82]. This is the first large-scale multicenter study in which experts investigated a photo score to assess the severity of sagittal synostosis phenotypical characteristics. Agreement on phenotypical characteristics was suboptimal (fair-moderate agreement) and highest for the summed score of individual photo score items (substantial agreement), indicating that although experts interpret phenotypical characteristics differently, there is consensus on overall phenotypical severity.</p

The epidemiology of homicide-suicide in Italy: A newspaper study from 1985 to 2008

Homicide-suicide is an event in which the murderer commits suicide after the homicide. There are at least 14 epidemiological studies on the topic, and all have found that homicide-suicide is more common among family members. The murderers are most often males and the victims females. There is no recent research on this phenomenon in Italy. The purpose of the study was to evaluate the incidence of homicide-suicide in Italy over a period of 24 yrs and to compare Italian data with published international data. We used information gathered by press agencies and from the four major Italian newspapers. Between 1985 and 2008, 662 cases of homicide-suicide were identified, with 1776 deaths. The murderer was male in 84.6% of the cases, typically using a firearm. The most common motivation was romantic jealousy, followed by socio-economic stress. The rate of homicide-suicide was 0.04%. Comparison with international studies is not always possible due to the lack of information for certain categories. The common factors identified may be helpful for preventio

Does a personalized approach improve patient satisfaction in thoracic oncology?

Objective: To evaluate patients' quality of life (QOL) at admission to permit definition and implementation of a personalized plan of multidimensional care. Methods: In 2007, patients hospitalized for more than 24 hours at the Thoracic Surgery Department of a tertiary referral cancer center received QOL assessment at admission by European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and LC13. Patients were asked to anonymously express their satisfaction with care at discharge by using the EORTC IN-PATSAT32 questionnaire. During the second part of the study (July-December 2007), specific interventions were proposed in critical areas identified by the questionnaires. Results: During 2007, 898 patients completed QOL assessment at admission and 805 patients anonymously expressed their satisfaction with care at discharge. Overall patient satisfaction significantly improved in the second part of the study (85.4 \ub1 16.7 vs 91.9 \ub1 13.1; P = .009). The most significant improvement was recorded in nurses' information provision (67.7 \ub1 24.1 vs 80.2 \ub1 20.2; P = .0014) and availability (70.4 \ub1 22.8 vs 84.3 \ub1 19.2; P <.001). Surprisingly, the third-ranking improvement was recorded for the hospital access scale, which was the item with the lowest score in both periods and for which no specific modification occurred during the study period. Conclusions: Use of a simple and reliable evaluation of QOL at admission contributed to improved quality of administered care. This approach permits focused management of ongoing problems, close cooperation between caregivers, and a more flexible response to patient needs

Hypertrophic Long-Bone Nonunions Extracorporeal Shock-Wave Therapy Compared with Surgery for Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions

This information is current as of September 16, 201