Correction to: Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

Unfortunately in the original publication, the affiliation of the author N. Papaioannou was incorrectly provided.

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

OBJECTIVE: We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months. DESIGN: A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires. RESULTS: In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded. CONCLUSIONS: ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

Fracture Incidence, Quality of Life, and Back Pain during 18-Months Treatment with Teriparatide in Greek Postmenopausal Women with Osteoporosis: Results from the European Forsteo Observational Study.

Objective. To evaluate fracture incidence, effects on health-related quality of life(QoL), back pain (BP) occurrence and treatment compliance in Greek post-menopausal osteoporotic women treated with teriparatide (TPTD) for up to 18 months, in a naturalistic setting. Methods. 301 patients provided baseline information on demographic characteristics, fracture history, osteoporosis-related medication and risk factors. During treatment, QoL and BP severity were evaluated. Results. Mean (SD) age was 69.5 (±8.5) years. Fracture history was reported by 92.5% of patients. Incidence of fractures (per 10,000 patients/years) ranged from 402 during 0-6 months of treatment, to 346 during 12-18 months. All 5 dimensions of QoL showed improvement. At baseline and 18 months, BP was reported by 93.2% and 64.2% of patients, respectively. BP and limitation of activities were quantified as moderate or severe by 89.9% and 62.3% of patients at baseline versus 32.4% and 14.8% at 18 months. Patients on treatment at 6, 12, 17, and 18 months were 92.6%, 88.3%, 79.6%, and 36.5%, respectively. Conclusions. In the Greek EFOS study cohort, patients prescribed TPTD were severely osteoporotic, with considerable health-related problems. Significant improvements in QoL and BP together with low fracture rates and high compliance have been recorded during treatment.

Study comparing the effect of pioglitazone in combination with either metformin or sulphonylureas on lipid profile and glycaemic control in patients with type 2 diabetes (ECLA).

OBJECTIVE: To explore whether the improvement of lipid profile and glycaemic control observed in randomized control trials with pioglitazone (PIO) is replicated under conditions of general clinical practice. RESEARCH DESIGN AND METHODS: We studied 2388 patients with type 2 diabetes (T2DM) not adequately controlled by monotherapy on either metformin (MET) or sulphonylurea (SU). Addition of a second drug, according to the treating physician's choice, resulted in three groups, PIO + MET, PIO + SU and MET + SU, followed for twelve months, while efficacy and safety parameters were measured at baseline, at six and at twelve months. RESULTS: A total of 2116 (88.6%) patients completed the study. Diabetic control and lipid profile improved in all three groups, but the improvement was always greater in the two PIO groups. At 12 months PIO + SU and PIO + MET groups compared to SU + MET showed greater increase in HDL cholesterol (8.3% and 9.2 versus 4.3% p < 0.001) and greater decrease in HbA1c (1.53% and 1.46% versus 0.97%, p < 0.001 for both), in triglycerides (20.7% and 21.5% versus 15.2%, p < 0.001) and in LDL cholesterol (15.2% and 14.6% versus 11.3%, p < 0.001 and p < 0.01, respectively). All changes were greater in patients already taking hypolipidaemic drugs. As ECLA was an observational study, the major limitation is the introduction of confounding bias which, however, was accounted for in the statistical analysis. CONCLUSIONS: Since improvement of both glycaemic control and lipid profile are considered main targets in the management of the diabetic patient, the results of the present study, conducted under conditions of everyday clinical practice, show that pioglitazone may be considered a potential choice for the treatment of type 2 diabetes, when lifestyle and metformin fail.