Availability of Paracetamol Sold Over the Counter in Europe: A Descriptive Cross‐Sectional International Survey of Pack Size Restriction

Due to the risk of hepatotoxicity when excessive amounts of paracetamol are consumed, Poisons Information Centers (PICs) frequently receive paracetamol‐related enquiries. This study examined how widely pack size restrictions of paracetamol sold over the counter have been implemented in Europe and also availability of paracetamol through non‐pharmacy outlets and their possible associations with frequency of poisoning enquiries. A cross‐sectional European multi‐centre questionnaire study was performed using a questionnaire to identify the extent and nature of paracetamol pack size restrictions, non‐pharmacy outlet sales and the frequency of paracetamol‐related enquiries to PICs. In total, 21 European countries participated. All PICs provided telephone hotline services. In 14 (67%) countries, pack size restrictions had been implemented in pharmacies (range: 8–30 g). No significant difference (median difference 0.7%, p‐value = 0.36) was found when comparing median frequencies of paracetamol‐related enquiries in countries with pack size restriction to countries without restrictions. A significantly lower median frequency of paracetamol‐related enquiries was found in countries without non‐pharmacy outlet sales compared to those with such sales (median difference 2.2%, p = 0.02). Pack size restrictions on pharmacy sales of paracetamol have been implemented in two‐thirds of examined countries. There was no difference in the proportion of paracetamol‐related enquiries to PICs among countries with and without pack size restrictions. However, a lower rate of paracetamol‐related enquiries was noted in countries where paracetamol was not available in non‐pharmacy outlets.     

Effects of Odanacatib on Bone Structure and Quality in Postmenopausal Women With Osteoporosis: 5-Year Data From the Phase 3 Long-Term Odanacatib Fracture Trial (LOFT) and its Extension

Odanacatib (ODN), a selective oral inhibitor of cathepsin K, was an investigational agent previously in development for the treatment of osteoporosis. In this analysis, the effects of ODN on bone remodeling/modeling and structure were examined in the randomized, double-blind, placebo-controlled, event-driven, Phase 3, Long-term Odanacatib Fracture Trial (LOFT; NCT00529373) and planned double-blind extension in postmenopausal women with osteoporosis. A total of 386 transilial bone biopsies, obtained from consenting patients at baseline (ODN n = 17, placebo n = 23), month 24 (ODN n = 112, placebo n = 104), month 36 (ODN n = 42, placebo n = 41), and month 60 (ODN n = 27, placebo n = 20) were assessed by dynamic and static bone histomorphometry. Patient characteristics at baseline and BMD changes over 5 years for this subset were comparable to the overall LOFT population. Qualitative assessment of biopsies revealed no abnormalities. Consistent with the mechanism of ODN, osteoclast number was higher with ODN versus placebo over time. Regarding bone remodeling, dynamic bone formation indices in trabecular, intracortical, and endocortical surfaces were generally similar in ODN-treated versus placebo-treated patients after 2 years of treatment. Regarding periosteal modeling, the proportion of patients with periosteal double labels and the bone formation indices increased over time in the ODN-treated patients compared with placebo. This finding supported the observed numerical increase in cortical thickness at month 60 versus placebo. In conclusion, ODN treatment for 5 years did not reduce bone remodeling and increased the proportion of patients with periosteal bone formation. These results are consistent with the mechanism of action of ODN, and are associated with continued BMD increases and reduced risk of fractures compared with placebo in the LOFT Phase 3 fracture trial. © 2020 American Society for Bone and Mineral Research.     

Management of bladder dysfunction and satisfaction of life after spinal cord injury in Norway

Background

There is limited knowledge about bladder dysfunction and bladder management in persons with spinal cord injury (SCI) after discharge from the hospital in Norway. The impact of bladder dysfunction on satisfaction of life has been rarely explored.

Setting

Community-based survey from Norway.

Methods

An anonymous cross-sectional postal survey. A questionnaire was sent to the registered members of the Norwegian Spinal Cord Injuries Association. A total of 400 participants, with traumatic or non-traumatic SCI, received the questionnaire.

Results

A total of 248 subjects (62%), 180 men and 68 women, answered the questionnaire. Mean age was 54 years and mean time since injury 13.4 years. A total of 164 participants (66.1%) used intermittent catheterization for bladder emptying (48.5% women versus 72.8% men); more paraplegics than tetraplegics (77.2% versus 55.7%). Recommendations given at the Spinal Cord Units were thoroughly followed by persons who had used catheters more than 5 years. Use of incontinence pads were associated with reduced satisfaction of life.

Conclusions

The most common method of management of bladder dysfunction is clean intermittent catheterization in Norway. Recommendations were followed more thoroughly by persons who have used intermittent catheterization for more than 5 years. Spinal Cord Units are important source for information and guidance.     

Biomarkers of inflammation in patients with unclassified polyarthritis and early rheumatoid arthritis. Relationship to disease activity and radiographic outcome

OBJECTIVE: To determine plasma interleukin 6 (pIL-6), plasma vascular endothelial growth factor (pVEGF), and serum (s) YKL-40 in patients with early rheumatoid arthritis (RA) and unclassified polyarthritis (PA), and investigate their relationship with radiographic outcome. METHODS: pIL-6 and pVEGF were determined by ELISA and sYKL-40 by an in-house radioimmunoassay in 51 patients with early RA and 21 with PA. Patients were followed with clinical and biochemical measurement every month for 2 years. Conventional radiographs of hands, wrists, and forefeet were scored according to the Larsen method, and magnetic resonance imaging of 2nd to 5th metacarpophalangeal joints of the dominant hand were evaluated for presence or absence of bone erosions. RESULTS: Baseline pIL-6, pVEGF, sYKL-40, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were elevated in RA patients compared to healthy persons (p < 0.001), but were not in patients with PA. Patients with early RA had higher pIL-6 (p = 0.007), pVEGF (p = 0.02), and sYKL-40 (p = 0.024) compared to PA patients. pIL-6, sYKL-40, CRP, and ESR but not pVEGF decreased in patients that responded to treatment after 2 years. The mean value of pIL-6 during the first and second year were higher in patients with early RA with progression in bone erosions (n = 14) compared to early RA patients without progression (n = 30; first year 8.4 vs 2.8 ng/l, p = 0.04; second year 6.1 vs 3.6 ng/l, p = 0.03). CONCLUSION:Plasma IL-6 was the only biomarker related to treatment response and progressive erosive disease in patients with early RA, but it may not give additional information compared to CRP in relation to disease activity and treatment response.     

Recent Developments in Metabolic Bone Diseases: a Gnathic Perspective

Metabolic bone diseases often are asymptomatic and progress sub clinically. Many patients present at a late stage with catastrophic skeletal and extra skeletal complications. In this article, we provide an overview of normal bone remodeling and a synopsis of recent developments in the following conditions: osteoporosis, rickets/osteomalacia, endocrine-induced bone disease, chronic kidney disease-mineral bone disorder and Paget’s disease of bone. Our discussion will emphasize the clinical and microscopic manifestations of these diseases in the jaws.