Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year,open-label,Phase III safety study

Introduction. Diclofenac is used for the treatment of osteoarthritis (OA); however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related adverse events (AEs). Low-dose SoluMatrix® diclofenac has been developed to provide efficacy at lower diclofenac doses. A recently published Phase III study evaluated the efficacy and safety of SoluMatrix diclofenac 35 mg twice daily (b.i.d.) and thrice daily (t.i.d.) in patients with OA pain treated for 12 weeks. Methods. This Phase III multicenter, open-label study assessed the safety of SoluMatrix diclofenac in patients with OA dosed up to 52 weeks (ClinicalTrials.gov: NCT01510912). The study enrolled 602 chronic NSAID/acetaminophen users, aged ≥40 years with OA of the knee or hip. Patients received SoluMatrix diclofenac 35 mg b.i.d., which could be increased to t.i.d. and subsequently reduced to b.i.d. as needed. Safety assessments included AEs, vital signs, physical examination findings, 12-lead electrocardiogram, and clinical laboratory test results. Patient-reported outcomes were evaluated by the Short Form-36 (SF-36). Results. A total of 601 patients received SoluMatrix diclofenac; 373 of 601 patients (62.1%) received treatment for ≥11 months. The most frequent AEs included upper respiratory tract infection, headache, urinary tract infection, diarrhea, nasopharyngitis, and nausea. Serious gastrointestinal, cardiovascular, renal, and hepatic AEs were uncommon. A small proportion (99 patients, 16.5%) of patients discontinued participation in the study due to AEs. Clinically meaningful improvements from baseline in Physical Component Summary Scores of the SF-36 were noted at week 12 and were sustained through week 52. Improvements in six of the eight individual physical and mental SF-36 domains were also noted. Conclusion. SoluMatrix diclofenac treatment for up to 1 year was generally well tolerated in patients with OA pain and associated with improvement in quality of life measures. Trial Registration: www.clinicaltrials.gov identifier: NCT01510912.     

OMERACT workshop: repair of structural damage in rheumatoid arthritis

This article describes the process and results of a workshop aimed at reviewing data on repair of structural damage collected by the OMERACT Subcommittee on Healing of Erosions and at defining a priority list for the subsequent research agenda.     

Relocation to ordinary or special housing in very old age: aspects of housing and health

Relocation in very old age is considered to be a major life event and a move could be triggered by many different economic, social, health-related, or environmental reasons. Based on the notion of person–environment (P–E) fit as expressed in the Ecological Theory of Ageing, the aim of this prospective study over 4 years was to explore which aspects of housing and health predict relocation to ordinary or special housing among very old people. At baseline, the participants (80–89 years old) lived alone in ordinary housing in Sweden (N = 384). Data collection at home visits included assessments and observations on aspects of objective and perceived housing as well as on aspects of health. After 4 years, 18 % (n = 70) of the participants had moved, either to ordinary housing (n = 24) or to special housing (n = 46). Cox regression models showed dependence in cleaning, perceived functional independence, and living in a one-family house to predict moves to ordinary housing. Dependence in cooking, cognitive deficits, and accessibility problems predicted moves to special housing. In conclusion, aspects of housing and health are related to relocation in very old age, but in different patterns for relocation to ordinary housing and special housing, respectively. This kind of knowledge has practical implications for relocation counselling and societal planning targeting very old people.     

Longitudinal Development of Mother–Infant Interaction During the First Year of Life Among Mothers with Substance Abuse and Psychiatric Problems and Their Infants

The quality of mother–infant interaction during the first year may be hampered by maternal substance abuse and co-existing non-optimal factors such as psychiatric problems and difficult relational experiences. In the present study three groups of women were recruited during pregnancy: One group with substance abuse problems from residential treatment centers (n = 28), a second group from psychiatric outpatient treatment centers (n = 22), and a third group from well-baby clinics (n = 30). Four maternal optimality indexes were assessed (substance abuse, psychiatric problems, relational experiences and SES). Mother–infant interaction was observed at 3 and 12 months. The substance abuse group showed the most disturbed mother–infant interaction at 12 months. Low maternal optimality as well as impairments in maternal affective involvement at 3 months influenced negatively both on infant and dyadic affective behavior in interaction at 12 months. Long-term interventions are needed to promote affective reciprocity among mother–baby pairs with low optimality.     

Hematological features in adolescents with periodontitis

The aim of this study was to assess whether adolescent cases of periodontitis present with different hemogram findings than control subjects. This case-control study comprised 87 adolescent cases presenting with clinical attachment loss ≥3 mm in at least two teeth and 73 control subjects. Blood samples were obtained by venipuncture and analyzed in an Abbott Cell-Dyn 3,500 hematology analyzer for values of white blood cells and red blood cells, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red-cell distribution width, platelets, and mean platelet volume. Hematocrit values were obtained using volume fractions read from capillary tubes. The associations between log-transformed hemogram variables with each of the three exposure variables "case status" (yes/no), a "high percent sites with PD ≥4 mm" (yes/no), and a "high percent sites with BOP" (yes/no) were investigated using multivariate linear regression analyses. Periodontitis cases presented with 5% higher values for the mean platelet volume than did controls. Subjects with a high percent sites with probing depth ≥4 mm had eosinophil counts that were on average 27% lower than among subjects with fewer deepened pockets. They also had 7% higher values for the mean platelet volume than did persons with less pocketing. Eosinophil counts and mean platelet volumes may be associated with the parameters of periodontitis in adolescents. While standard hematological testing did not show abnormalities in adolescents with periodontitis compared to healthy controls, eosinophil counts and mean platelet volumes may reflect periodontal inflammation.     

A 24-month evaluation of amalgam and resin-based composite restorations: Findings from The National Dental Practice-Based Research Network

BackgroundKnowing which factors influence restoration longevity can help clinicians make sound treatment decisions. The authors analyzed data from The National Dental Practice-Based Research Network to identify predictors of early failures of amalgam and resin-based composite (RBC) restorations.MethodsIn this prospective cohort study, the authors gathered information from clinicians and offices participating in the network. Clinicians completed a baseline data collection form at the time of restoration placement and annually thereafter. Data collected included patient factors, practice factors and dentist factors, and the authors analyzed them by using mixed-model logistic regression.ResultsA total of 226 practitioners followed up 6,218 direct restorations in 3,855 patients; 386 restorations failed (6.2 percent) during the mean (standard deviation) follow-up of 23.7 (8.8) months. The number of tooth surfaces restored at baseline helped predict subsequent restoration failure; restorations with four or more restored surfaces were more than four times more likely to fail. Restorative material was not associated significantly with longevity; neither was tooth type. Older patient age was associated highly with failure (P N/A .001). The failure rate for children was 4 percent, compared with 10 percent for people 65 years or older. Dentist’s sex and practice workload were associated significantly with restoration longevity.ConclusionsIn this prospective cohort study, these factors were significantly predictive of failure for amalgam and RBC restorations: patient’s age, a higher number of surfaces restored at baseline, the dentist’s sex and the practice workload. Material choice was not significantly predictive in these early results.Practical ImplicationsIf clinicians can recognize and identify the risk factors associated with early restoration failure, more effective treatment plans may be offered to the patient.