Gérald Rajzbaum

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

ABSTRACT Objective: The European Forsteo* Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry. Methods: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL. Results: The mean (standard deviation [SD]) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T‑score was –3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ‑5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients. Conclusions: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.

Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study

Objectives To describe fracture rates, back pain, and health-related quality of life (HRQoL) in postmenopausal women with osteoporosis and prior bisphosphonate therapy, treated with teriparatide for up to 18 months and followed up for a further 18 months. Design Prospective, multinational, and observational study. Methods Data on prior bisphosphonate use, clinical fractures, back pain visual analog scale (VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed using a repeated measures model. Results Of the 1581 enrolled patients with follow-up data, 1161 (73.4%) had a history of prior bisphosphonate use (median duration: 36 months). Of them, 169 (14.6%) sustained ≥1 fracture during 36-month follow-up. Adjusted odds of fracture were significantly decreased at each 6-month interval compared with the first 6 months of teriparatide treatment: 37% decrease in the 12 to <18 months period during teriparatide treatment (P=0.03) and a 76% decrease in the 12- to 18-month period after teriparatide was discontinued (P<0.001). Significant reductions in back pain and improvement in HRQoL were observed. Conclusions Postmenopausal women with severe osteoporosis previously treated with bisphosphonates had a significant reduction in the incidence of fractures compared with the first 6 months of therapy, a reduction in back pain and an improvement in HRQoL during up to 18 months of teriparatide treatment. These outcomes were still evident for at least 18 months after teriparatide was discontinued. The results should be interpreted in the context of an uncontrolled, observational study in a routine clinical setting.

Off-label prescribing in a French hospital

ObjectiveIn contrast to paediatrics patients, data concerning the extent of off-label prescribing for adult patients are limited. The aim of our study was to investigate the frequency of off-label drug use for adult patients in a French general hospital.MethodThe study was conducted on a Wednesday in November 2004. Prescribing was prospectively assessed on the basis of conformity with the marketing authorizations.ResultsA total of 1341 prescriptions for 192 hospitalized patients were analysed. Twenty three per cent of the prescriptions were off-label. Among all patients, 70% received at least one off-label medicine. Most off-label prescriptions were related to an unapproved indication (75%). The main other reasons were dosage (14%) and dosing schedule (9%). Anti-thrombotic and anti-ulcer agents were found on more than 40% of the off-label prescriptions.ConclusionOff-label prescriptions occur frequently in the hospital and often alternatives with the proper marketing authorizations are available. An increased involvement of hospital pharmacists should reduce the incidence of off-label prescribing and thus contribute to patient safety and possibly cost reduction.

Serum uric acid and cardiovascular risk: state of the art and perspectives.

Hyperuricaemia is commonly found in subjects with cardiovascular disease, but its role as risk factor is very controversial. Although several studies reported serum uric acid as a marker of an underlying pathophysiological process, other studies hypothesis a potential causal link between serum uric acid and cardiovascular diseases. Some studies suggest that uric acid is biologically active and may have an atherogenesis role in development of cardiovascular diseases, although the mechanisms are not fully understood. Other studies have shown that uric acid can independently predict the development of some cardiovascular risk factors such as hypertension and metabolic syndrome, as well as myocardial infarction and stroke. The relations between serum uric acid and established cardiovascular risk factors are complex, and these latter could be considered as confounding factors. In this report, we review the inextricably link of serum uric acid to known cardiovascular risk factors, and we describe the possible mechanisms and potential causative role between serum uric acid and cardiovascular events in the general population, in subjects with cardiovascular risk factors and in those with pre-existing cardiovascular diseases. Limited information however is available concerning the impact of urate-lowering treatments on cardiovascular events, whereas only a positive therapeutic trial could give definite answers to the difficult problem of causality of uric acid in relation to cardiovascular risk. Thus, it is time to propose the design of a therapeutic trial, integrating cardiologists and rheumatologists, in order to further decrease cardiovascular risk.

Effective osteoporosis treatment with teriparatide is associated with enhanced quality of life in postmenopausal women with osteoporosis: the European Forsteo Observational Study

BackgroundTo describe changes in health-related quality of life (HRQoL) of postmenopausal women with osteoporosis treated with teriparatide for up to 18 months and followed-up for a further 18 months, and to assess the influence of recent prior and incident fractures.MethodsThe European Forsteo Observational Study (EFOS) is an observational, prospective, multinational study measuring HRQoL using the EQ-5D. The primary objective was to assess changes in HRQoL during 36 months in the whole study population. A secondary post-hoc analysis examined fracture impact on HRQoL in four subgroups classified based on recent prior fracture 12 months before baseline and incident clinical fractures during the study. Changes from baseline were analysed using a repeated measures model.ResultsOf the 1581 patients, 48.4% had a recent prior fracture and 15.6% of these patients had an incident fracture during follow-up. 10.9% of the 816 patients with no recent prior fracture had an incident fracture. Baseline mean EQ-VAS scores were similar across the subgroups. In the total study cohort (n = 1581), HRQoL (EQ-VAS and EQ-5D index scores) improved significantly from baseline to 18 months and this improvement was maintained over the 18-month post-teriparatide period. Improvements were seen across all five EQ-5D domains during teriparatide treatment that were maintained after teriparatide was discontinued. Subjects with incident clinical fractures had significantly less improvement in EQ-VAS than those without incident fractures. Recent prior fracture did not influence the change in EQ-VAS during treatment.ConclusionsEFOS is the first longitudinal study in women with severe postmenopausal osteoporosis in the real world setting to show a substantial improvement in HRQoL during teriparatide treatment that was sustained during subsequent treatment with other medications. The increase in HRQoL was lower in the subgroups with incident fracture but was not influenced by recent prior fracture. The results should be interpreted in the context of the design of an observational study.

Septic arthritis of the hip with Propionibacterium avidum bacteremia after intraarticular treatment for hip osteoarthritis.

Propionibacterium avidum is a Gram-positive, nonsporulating, facultative anaerobe that has a low level of virulence and is rarely pathogenic. This ubiquitous inhabitant of the sebaceous glands and hair follicles can cause acne vulgaris. Very rarely, P. avidum causes systemic infections after invasive procedures, most notably in immunocompromised patients. Two cases of sacroiliitis due to P. avidum have been reported. We report a case of P. avidum arthritis of the hip with severe sepsis that developed in a 78-year-old woman after intraarticular glucocorticoid treatment for hip osteoarthritis. We are unaware of previous reports of P. avidum hip arthritis.

Management of glucocorticoid-induced osteoporosis: Lessons for clinical practice

aUniversité Paris-Descartes, service de rhumatologie B, hôpital Cochin, 27 rue du faubourg Saint-Jacques, 75014 Paris, France bService de rhumatologie, groupe hospitalier Paris Saint-Joseph, 185 rue Raymond Losserand, 75674 Paris cedex 14, France cService de rhumatologie, centre hospitalier, avenue Desandrouins, BP 479, 59322 Valenciennes cedex, France dUniversité d’Angers, service de rhumatologie, CHU Angers, 4 rue Larrey, 49033 Angers cedex 01, France eService de rhumatologie, hôpital Purpan, 1 place du docteur Baylac, 31059 Toulouse, France fINSERM U1059, service de rhumatologie, CHU Bellevue, 25 boulevard Pasteur, 42055 Saint-Étienne, France gDépartement universitaire de rhumatologie, hôpital Roger Salengro, rue du Professeur Emile Laine, 59037 Lille cedex, France