The first biosimilar approved for the treatment of osteoporosis

To demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency in 2017.Teriparatide, the first bone anabolic agent, is the biologically active fragment of human parathyroid hormone. The imminent patent expiry of the originator will open the door for biosimilars to enter the osteology market, thereby improving access to a highly effective, yet prohibitively expensive therapy.Subsequent to establishing comparability on the quality and non-clinical levels between RGB-10, a biosimilar teriparatide, and its reference product (Forsteo®), a randomised, double-blind, 2-way cross-over comparative study (duration: four days) was conducted in 54 healthy women (ages: 18 to 55 years) to demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence and comparable safety of these products. Extents of exposure (AUC0-tlast) and peak exposure (Cmax), as measured by means of ELISA, were evaluated as co-primary PK endpoints, and serum calcium levels, as measured using standard automated techniques, were assessed for PD effects. Safety was monitored throughout the study.The 94.12% CIs for the ratio of the test to the reference treatments, used due to the two-stage design (85.20-98.60% and 85.51-99.52% for AUC0-tlast and Cmax, respectively), fell within the 80.00-125.00% acceptance range. The calcium PD parameters were essentially identical with geometric mean ratios (GMRs) of 99.93% and 99.87% for AUC and Cmax, respectively. Analysis of the safety data did not reveal any differences between RGB-10 and its reference.Based on the high level of similarity in the preclinical data and the results of this clinical study, marketing authorisation for RGB-10 (Terrosa®) was granted by the European Medicines Agency (EMA) in 2017

Identification and management of chronic pain in primary care:a review

Chronic pain is a common, complex, and challenging condition, where understanding the biological, social, physical and psychological contexts is vital to successful outcomes in primary care. In managing chronic pain the focus is often on promoting rehabilitation and maximizing quality of life rather than achieving cure. Recent screening tools and brief intervention techniques can be effective in helping clinicians identify, stratify and manage both patients already living with chronic pain and those who are at risk of developing chronic pain from acute pain. Frequent assessment and reassessment are key to ensuring treatment is appropriate and safe, as well as minimizing and addressing side effects. Primary care management should be holistic and evidence-based (where possible) and incorporates both pharmacological and non-pharmacological approaches, including psychology, self-management, physiotherapy, peripheral nervous system stimulation, complementary therapies and comprehensive pain-management programmes. These may either be based wholly in primary care or supported by appropriate specialist referral

How does comorbidity affect cost of health care in patients with irritable bowel syndrome? A cohort study in general practice

<p>Abstract</p> <p>Background</p> <p>Irritable bowel syndrome (IBS) is associated with other disorders (comorbidity), reduced quality of life and increased use of health resources. We aimed to explore the impact of comorbidity on cost of health care in patients with IBS in general practice.</p> <p>Methods</p> <p>In this cohort study 208 consecutive patients with IBS (Rome II) were recruited. Sociodemographic data, IBS symptoms, and comorbidity (somatic symptoms, organic diseases and psychiatric disorders) were assessed at baseline. Based on a follow up interview after 6-9 months and use of medical records, IBS and non-IBS related health resource use were measured as consultations, hospitalisations, use of medications and alternative health care products and sick leave days. Costs were calculated by national tariffs and reported in Norwegian Kroner (NOK, 1 EURO equals 8 NOK). Multivariate analyses were performed to identify predictors of costs.</p> <p>Results</p> <p>A total of 164 patients (mean age 52 years, 69% female, median duration of IBS 17 years) were available at follow up, 143 patients (88%) had consulted their GP of whom 31 (19%) had consulted for IBS. Mean number of sick- leave days for IBS and comorbidity were 1.7 and 16.3 respectively (p < 0.01), costs related to IBS and comorbidity were 954 NOK and 14854 NOK respectively (p < 0.001). Age, organic diseases and somatic symptoms, but not IBS severity, were significant predictors for total costs.</p> <p>Conclusion</p> <p>Costs for health resource use among patients with IBS in general practice were largely explained by comorbidity, which generated ten times the costs for IBS.</p

Socioeconomic conditions and number of pain sites in women

<p>Abstract</p> <p>Background</p> <p>Women in deprived socioeconomic situations run a high pain risk. Although number of pain sites (NPS) is considered highly relevant in pain assessment, little is known regarding the relationship between socioeconomic conditions and NPS.</p> <p>Methods</p> <p>The study population comprised 653 women; 160 recurrence-free long-term gynecological cancer survivors, and 493 women selected at random from the general population. Demographic characteristics and co-morbidity over the past 12 months were assessed. Socioeconomic conditions were measured by Socioeconomic Condition Index (SCI), comprising education, employment status, income, ability to pay bills, self-perceived health, and satisfaction with number of close friends. Main outcome measure NPS was recorded using a body outline diagram indicating where the respondents had experienced pain during the past week. Chi-square test and forward stepwise logistic regression were applied.</p> <p>Results and Conclusion</p> <p>There were only minor differences in SCI scores between women with 0, 1-2 or 3 NPS. Four or more NPS was associated with younger age, higher BMI and low SCI. After adjustment for age, BMI and co-morbidity, we found a strong association between low SCI scores and four or more NPS, indicating that there is a threshold in the NPS count for when socioeconomic determinants are associated to NPS in women.</p

The epidemiology of chronic pain in Libya: a cross-sectional telephone survey.

BACKGROUND: Chronic pain is a public health problem although there is a paucity of prevalence data from countries in the Middle East and North Africa. The aim of this study was to estimate the prevalence of chronic pain and neuropathic pain in a sample of the general adult population in Libya. METHODS: A cross-sectional telephone survey was conducted before the onset of the Libyan Civil War (February 2011) on a sample of self-declared Libyans who had a landline telephone and were at least 18 years of age. Random sampling of household telephone number dialling was undertaken in three major cities and interviews conducted using an Arabic version of the Structured Telephone Interviews Questionnaire on Chronic Pain previously used to collect data in Europe. In addition, an Arabic version of S-LANSS was used. 1212 individuals were interviewed (response rate = 95.1 %, mean age = 37.8 ± 13.9 years, female = 54.6 %). RESULTS: The prevalence of chronic pain ≥ 3 months was 19.6 % (95 % CI 14.6 % to 24.6 %) with a mean ± SD duration of pain of 6 · 5 ± 5 · 7 years and a higher prevalence for women. The prevalence of neuropathic pain in the respondents reporting chronic pain was 19 · 7 % (95 % CI 14 · 6-24 · 7), equivalent to 3 · 9 % (95 % CI 2 · 8 to 5 · 0 %) of the general adult population. Only, 71 (29 · 8 %) of respondents reported that their pain was being adequately controlled. CONCLUSIONS: The prevalence of chronic pain in the general adult population of Libya was approximately 20 % and comparable with Europe and North America. This suggests that chronic pain is a public health problem in Libya. Risk factors are being a woman, advanced age and unemployment. There is a need for improved health policies in Libya to ensure that patients with chronic pain receive effective management

Work factors and psychological distress in nurses' aides: a prospective cohort study

<p>Abstract</p> <p>Background</p> <p>Nurses' aides (assistant nurses), the main providers of practical patient care in many countries, are doing both emotional and heavy physical work, and are exposed to frequent social encounters in their job. There is scarce knowledge, though, of how working conditions are related to psychological distress in this occupational group. The aim of this study was to identify work factors that predict the level of psychological distress in nurses' aides.</p> <p>Methods</p> <p>The sample of this prospective study comprised 5076 Norwegian nurses' aides, not on leave when they completed a mailed questionnaire in 1999. Of these, 4076 (80.3 %) completed a second questionnaire 15 months later. A wide spectrum of physical, psychological, social, and organisational work factors were measured at baseline. Psychological distress (anxiety and depression) was assessed at baseline and follow-up by the SCL-5, a short version of Hopkins Symptom Checklist-25.</p> <p>Results</p> <p>In a linear regression model of the level of psychological distress at follow-up, with baseline level of psychological distress, work factors, and background factors as independent variables, work factors explained 2 % and baseline psychological distress explained 34 % of the variance. Exposures to role conflicts, exposures to threats and violence, working in apartment units for the aged, and changes in the work situation between baseline and follow-up that were reported to result in less support and encouragement were positively associated with the level of psychological distress. Working in psychiatric departments, and changes in the work situation between baseline and follow-up that gave lower work pace were negatively associated with psychological distress.</p> <p>Conclusion</p> <p>The study suggests that work factors explain only a modest part of the psychological distress in nurses' aides. Exposures to role conflicts and threats and violence at work may contribute to psychological distress in nurses' aides. It is important that protective measures against violent patients are implemented, and that occupational health officers offer victims of violence appropriate support or therapy. It is also important that health service organisations focus on reducing role conflicts, and that leaders listen to and consider the views of the staff.</p

Chronic pain in primary care. German figures from 1991 and 2006

<p>Abstract</p> <p>Background</p> <p>Until now only limited research has been done on the prevalence of chronic pain in primary care. The aim of this investigation was to study the health care utilisation of patients suffering from pain. How many patients visit an outpatient clinic because of the symptom of pain? These data were compared with data from a similar study in 1991, to investigate whether improvements had been achieved.</p> <p>Methods</p> <p>A total of 1201 consecutive patients visiting outpatient clinics were surveyed in six practices in the western part of Germany on randomly selected days by means of questionnaires. Topics were the point prevalence of pain and the period prevalence of chronic pain, its characteristics and its impact on daily life, as well as data on previous therapies for pain. A retrospective comparison was made with the data from a similar study with same design surveying 900 patients that took place in five practices during 1991.</p> <p>Results</p> <p>In 2006, pain was the main reason for consulting a doctor in 42.5% of all patients (1991: 50.3%). Of all respondents, 62% suffered from pain on the particular day of the consultation, and 40% reported that they had been suffering from pain for more than six months (1991: 36.4%). As many as 88.3% of patients with chronic pain reported a negative impact on their daily life due to this pain (1991: 68%), and 88.1% reported impairment of their working life because of chronic pain (1991: 59.1%).</p> <p>Conclusion</p> <p>Pain, and chronic pain in particular, is a central problem in primary care. Over the last 15 years, the number of patients suffering from chronic pain has not decreased. In nearly half of all cases, pain is still the reason for health care utilisation in outpatient clinics. Pain represents a major primary health care problem with enormous impact on public health. Improvements can only be achieved by improving the quality of health care at the primary care level.</p

Parkinson's disease induced pluripotent stem cells with triplication of the α-synuclein locus

A major barrier to research on Parkinson's disease is inaccessibility of diseased tissue for study. One solution is to derive induced pluripotent stem cells from patients and differentiate them into neurons affected by disease. Triplication of SNCA, encoding α-synuclein, causes a fully penetrant, aggressive form of Parkinson's disease with dementia. α-Synuclein dysfunction is the critical pathogenic event in Parkinson's disease, multiple system atrophy and dementia with Lewy bodies. Here we produce multiple induced pluripotent stem cell lines from an SNCA triplication patient and an unaffected first-degree relative. When these cells are differentiated into midbrain dopaminergic neurons, those from the patient produce double the amount of α-synuclein protein as neurons from the unaffected relative, precisely recapitulating the cause of Parkinson's disease in these individuals. This model represents a new experimental system to identify compounds that reduce levels of α-synuclein, and to investigate the mechanistic basis of neurodegeneration caused by α-synuclein dysfunction