The osteoporosis treatment gap in patients at risk of fracture in European primary care: a multi-country cross-sectional observational study.

This study in 8 countries across Europe found that about 75% of elderly women seen in primary care who were at high risk of osteoporosis-related fractures were not receiving appropriate medication. Lack of osteoporosis diagnosis appeared to be an important contributing factor. INTRODUCTION: Treatment rates in osteoporosis are documented to be low. We wished to assess the osteoporosis treatment gap in women ≥ 70 years in routine primary care across Europe. METHODS: This cross-sectional observational study in 8 European countries collected data from women 70 years or older visiting their general practitioner. The primary outcome was treatment gap: the proportion who were not receiving any osteoporosis medication among those at increased risk of fragility fracture (using history of fracture, 10-year probability of fracture above country-specific Fracture Risk Assessment Tool [FRAX] thresholds, T-score ≤ - 2.5). RESULTS: Median 10-year probability of fracture (without bone mineral density [BMD]) for the 3798 enrolled patients was 7.2% (hip) and 16.6% (major osteoporotic). Overall, 2077 women (55%) met one or more definitions for increased risk of fragility fracture: 1200 had a prior fracture, 1814 exceeded the FRAX threshold, and 318 had a T-score ≤ - 2.5 (only 944 received a dual-energy x-ray absorptiometry [DXA] scan). In those at increased fracture risk, the median 10-year probability of hip and major osteoporotic fracture was 11.2% and 22.8%, vs 4.1% and 11.5% in those deemed not at risk. An osteoporosis diagnosis was recorded in 804 patients (21.2%); most (79.7%) of these were at increased fracture risk. The treatment gap was 74.6%, varying from 53% in Ireland to 91% in Germany. Patients with an osteoporosis diagnosis were found to have a lower treatment gap than those without a diagnosis, with an absolute reduction of 63%. CONCLUSIONS: There is a large treatment gap in women aged ≥ 70 years at increased risk of fragility fracture in routine primary care across Europe. The gap appears to be related to a low rate of osteoporosis diagnosis.

Formulation, and Evaluation of Pentoxifylline-Loaded Poly(epsilon-caprolactone) Microspheres.

Pentoxifylline-loaded poly(epsilon-caprolactone) microspheres were prepared by solvent evaporation technique with different drug to carrier ratio F1 (1:3), F2 (1:4), F3 (1:5) and F4 (1:6). The microspheres were characterized for particle size, scanning electron microscopy, FT-IR study, percentage yield, drug entrapment, stability studies and for in vitro release kinetics. The shape of microspheres was found to be spherical by SEM. The size of microspheres was found to be ranging 59.3+/-6.3mum to 86.22+/-4.23 mum. Among the four drug to carrier ratio, F3 (1:5) showed maximum percentage yield of 83.34+/-2.46% and F2 (1:4) showed highest drug entrapment of 76.92+/-3.24% w/w. It was found that there was no interaction between drug and polymer by FT-IR study. No appreciable difference was observed in the extent of degradation of product during 60 d in the microspheres, which were stored at various temperatures. In the in vitro release study formulation F2 (1:4) showed 90.34% drug release at 15 h and found to be sustained. The release followed Higuchi kinetics indicating diffusion controlled drug release.

Regression to the mean using the disease activity score in eligibility and response criteria for prescribing TNF-alpha inhibitors in adults with rheumatoid arthritis.

OBJECTIVES: When patients with rheumatoid arthritis (RA) are selected to start TNF-alpha inhibitors on the basis of high disease activity scores (DAS), some of the fall in DAS will be due to regression to the mean (RTM). We have assessed the extent to which such RTM explains DAS improvements on TNF-alpha inhibitors in routine clinical practice. METHODS: We retrospectively evaluated DAS28 scores that had been recorded as part of routine assessment for two RA cohorts. (i) Thirty-five patients receiving TNF-alpha inhibitors who had been assessed when starting TNF-alpha inhibitors, 9-21 months prior and 1.5-6 months post-treatment. (ii) One hundred and seventy-seven clinic patients assessed twice, a year apart in the years immediately before the introduction of TNF-alpha inhibitors. RESULTS: In patients receiving TNF-alpha inhibitors, mean DAS fell 1.8 (95% confidence interval [CI] 1.3, 2.3) from baseline but only 0.9 (95% CI 0.4, 1.4) from the previous routine assessment. Twenty-four (69%) patients showed a fall in DAS of >1.2 from baseline but only 17 (49%) from the previous assessment. Regression analysis of results from the pre-biological era estimated that as much as 0.6 of the 1.8 apparent DAS response to TNF-alpha inhibitors might be accounted for by RTM. CONCLUSIONS: Assessing change in DAS from commencement of biological therapy may overestimate response, due to the impact of RTM and fluctuation in disease. Adequacy of response might be better assessed by serial assessments and a wider range of patient-centred outcomes.