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Luca Degli Esposti,1 Stefania Saragoni,1 Valentina Perrone,1 Stefania Sella,2 Margherita Andretta,3 Maurizio Rossini,4 Sandro Giannini2 1CliCon S.r.l. Health, Economics & Outcomes Research, Ravenna, Italy; 2Clinica Medica 1, Department of Medicine, University of Padova and Regional Center for Osteoporosis, Padova, Italy; 3UOC HTA, Azienda Zero, Padova, Italy; 4Rheumatology Unit, Azienda Ospedaliera Universitaria Integrata di Verona and Regional Center for Osteoporosis, Verona, ItalyCorrespondence: Luca Degli EspostiCliCon S.r.l. Health, Economics & Outcomes Research, Via Salara, 36, Ravenna 48121, ItalyTel +39 0544 38393Fax +39 0544 212699Email luca.degliesposti@clicon.itBackground: Fractures represent the most important complication of osteoporosis, in terms of loss of independency, chronic pain, increased risk of mortality, but also high healthcare costs.Objective: To assess healthcare costs in an Italian cohort of osteoporotic patients with a fracture with and without specific osteoporosis treatment and supplementation with calcium/vitamin D.Methods: This retrospective observational study used data from administrative databases of five Local Health Units in Italy. Patients ≥ 50 years of age and hospitalized for vertebral or hip fracture occurring from 01/01/2011 to 31/12/2015 were included. Patients were then classified as “untreated” and “treated” if they had been treated or not with drugs for fracture prevention after the index fracture. We also identified subjects that were only treated with drugs for fracture prevention, “osteoporosis drug only” group, compared to the “osteoporosis drug plus calcium/vitamin D” group, in which calcium and/or vitamin D were also in combination. Healthcare cost analysis included drug expenditure, hospitalization costs (excluding costs related to the hospitalization for the index fracture) and outpatient service costs.Results: Three thousand four hundred and seventy-five patients were included in the present study, most of whom (58.5%) had received specific osteoporosis treatment after index fracture. Among treated patients, the vast majority (83.6%) received supplementation with calcium/vitamin D. Mean annual healthcare cost per patient was € 9,289.85 in the untreated group and € 4,428.26 for treated subjects (p < 0.001); mean annual healthcare cost for the osteoporosis drug-only group was higher compared to the osteoporosis drug plus calcium/vitamin D group (€ 5,976.88 vs € 4,124.74, respectively, p < 0.001). Hospitalization costs accounted for the majority of total costs in all groups of patients.Conclusion: Healthcare costs in patients with osteoporotic fractures were significantly lower in those receiving osteoporosis treatment compared to untreated patients with even lower costs observed in patients that were also receiving calcium/vitamin D supplements.Keywords: healthcare costs, calcium/vitamin D supplementation, osteoporosis, fracture, hospitalization

Alberto Migliore,1 Silvana Giannini,2 Emanuele Bizzi,1 Umberto Massafra,1 Maurizio Cassol,3 Martin Jose Michael Abilius,1 Giovanni Boni4 1Operative Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 2Department of Radiology, Villa Stuart Sport Clinic, Rome 00136, Italy; 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 4ANTIAGE Sportive Medicine Ambulatory Department (Ambulatorio di Medicina dello Sport Antiage), Foligno, Italy Objective: The aim of this study is to investigate the effect of intra-articular hyaluronic acid administration in active football players complaining of knee pain after sports activity. Efficacy and safety profiles of intra-articular hyaluronic acid and time needed for football players to recover and restart sports activity were examined.Methods: Clinical data of active football players reporting knee pain after sports activity were included in this retrospective study. All patients who received an intra-articular injection at time 0 and after 2 weeks were included in the study. Patients underwent laboratory examination, knee X-ray, ultrasound, and clinical examination before receiving the intra-articular injection. Effusions or cysts were drained before injections. Lequesne index score, pain visual analog scale (VAS) score, and patient’s global assessment score were recorded at time 0 (day of the first injection), 1 and 2 days after the first injection, at 2 weeks (day of the second injection), and at follow-up visits. Only data from patients completing the follow-up were analyzed.Results: Data from 17 patients were analyzed: 16 males and one female, of which three were professional players (two males and one female) and 14 were nonprofessional players. The mean age of patients was 39.8±11.8 years. Two patients (one male and one female) showed joint effusion. Two patients reported relevant joint pain after injection that regressed without any medication. At the first week, all parameters examined indicated improvement that was maintained until the end of follow-up. One day after the first and second injection, patients reported a slight increase in pain VAS score, which was not statistically significant, and the pain resolved after 1 day. All patients successfully restarted playing after the first injection within 3.1±2.0 days and kept playing after the second injection following our indication (1 day of break).Conclusion: The use of a medium-molecular weight hyaluronic acid in football players affected by knee osteoarthritis seems efficacious and safe and resulted, in our experience, a stable improvement of symptoms; moreover, it allowed a rapid restart of sports activity. Larger studies on larger populations are needed to confirm these findings. Keywords: sports, hyaluronic acid, intra-articular, injection, football, trauma

Migliore A, Giannini S, Bizzi E, Massafra U, Cassol M, Abilius MJ, Boni G. Open Access Journal of Sports Medicine. 2019;10:11–15.Following publication, the authors of this article discovered an error on page 12, in Methods section, 3rd paragraph, 4th row regarding name and affiliation of hyaluronic acid applied in this study. Correct name and provenance is SINOVIAL 8 mg/mL (IBSA Farmaceutici, Italy).Read the original article

Edoardo Mannucci,1 Stefano Giannini,2 Ilaria Dicembrini1 1Diabetes Agency, Careggi Teaching Hospital, Florence, 2Section of Endocrinology, Department of Biomedical Clinical and Experimental Sciences, University of Florence and Careggi University Hospital, Florence, Italy Abstract: Basal insulin is an important component of treatment for both type 1 and type 2 diabetes. One of the principal aims of treatment in patients with diabetes is the prevention of diabetic complications, including cardiovascular disease. There is some evidence, although controversial, that attainment of good glycemic control reduces long-term cardiovascular risk in both type 1 and type 2 diabetes. The aim of this review is to provide an overview of the potential cardiovascular safety of the different available preparations of basal insulin. Current basal insulin (neutral protamine Hagedorn [NPH], or isophane) and basal insulin analogs (glargine, detemir, and the more recent degludec) differ essentially by various measures of pharmacokinetic and pharmacodynamic effects in the bloodstream, presence and persistence of peak action, and within-subject variability in the glucose-lowering response. The currently available data show that basal insulin analogs have a lower risk of hypoglycemia than NPH human insulin, in both type 1 and type 2 diabetes, then excluding additional harmful effects on the cardiovascular system mediated by activation of the adrenergic system. Given that no biological rationale for a possible difference in cardiovascular effect of basal insulins has been proposed so far, available meta-analyses of publicly disclosed randomized controlled trials do not show any signal of increased risk of major cardiovascular events between the different basal insulin analogs. However, the number of available cardiovascular events in these trials is very small, preventing any clear-cut conclusion. The results of an ongoing clinical trial comparing glargine and degludec with regard to cardiovascular safety will provide definitive evidence. Keywords: basal insulin, cardiovascular effects, long-acting insulin analog, cardiovascular risk