New oral anti-coagulants versus vitamin K antagonists in high thromboembolic risk patients.

BACKGROUND: Oral anticoagulant therapy (VKA) is nowadays the mainstay of treatment in primary and secondary stroke prevention in patients with atrial fibrillation. Given the limited risk-benefit ratio of vitamin K antagonists, pharmacological research has been directed towards the development of products that could overcome these limits, new oral anticoagulants were recently introduced: dabigatran, rivaroxaban, apixaban, and edoxaban. AIM: Scope of the present study was to examine patterns of use, effectiveness, safety and mean annual cost per patient of anticoagulant treatment for non-valvular AF in real clinical practice. METHODS: A retrospective observational cohort study, by using administrative databases (drugs, hospitalizations, clinical visits, lab tests, population registry), was conducted in the Local Health Unit (LHU) of Treviso, Italy, from January 1, 2012 to December 31, 2016. RESULTS: 5597 subjects were selected, 2171 of which satisfied all inclusion criteria. In particular 1355 patients were treated with VKA, 577 patients were treated with NOAC, and 239 patients were treated initially with VKA and subsequently switched to NOAC (switch group). NOAC treatment showed to be superior to VKA and this superiority was statistically significant on both end-points: patients in the NOAC group reported less cardiovascular events (9,9%) and less bleeding episodes (5,5%) versus VKA patients (14,6% and 11,4%; p<,0001 and p = 0,0049, respectively). The mean cost per patient per year was respectively € 1323,9 for patients treated with NOAC versus € 1003,3 for patients treated with VKA. Cost difference appears to be largely driven by drug cost (€ 767,9 for NOAC versus € 17,7 for VKA patients) and by specialist visits and laboratory tests (€ 318,4 for NOAC versus € 733,4 for VKA patients). CONCLUSION: In this retrospective real-world study treatment with NOAC showed to be associated with significant reductions of CV events and bleeding events compared to VKA use, albeit at a higher NHS' direct cost per patient/year, mainly due to higher drug therapy cost.

Real-practice thromboprophylaxis in atrial fibrillation.

This retrospective observational study was based on databases of the Local Health Authority of Treviso, Italy. It evaluated the prevalence and the effectiveness of oral anticoagulation treatment (OAT) for the management of nonvalvular atrial fibrillation (NVAF) in everyday clinical practice. Out of 6,138 NVAF patients, only 3,024 received vitamin K antagonist (VKA). Potential barriers decreasing the probability of being treated with VKA were female sex, older age, antiplatelet treatment and history of bleeding. In addition, VKA-treatment was not in line with current ESC and AIAC guidelines, since the patients at high or low risk of stroke were under- or over-treated, resp. Among VKAtreated patients, 73 % of subjects were not at target with anticoagulation. OAT resulted to be effective in reducing stroke risk. However, stroke events were significantly influenced also by previous stroke or transient ischemic attack (hazard ratio, HR = 2.99, p < 0.001) and by previous bleeding events (HR = 1.60, p < 0.001).

Evaluation of the prescription and utilization patterns of statins in an Italian local health unit during the period 1994-2003.

OBJECTIVES: The prescription pattern of statins in the Local Health Unit (LHU) of Treviso (northern Italy) over a 10-year period was evaluated, with the aim of evaluating the persistence with and adherence to therapy. METHODS: Data on 21,393 subjects who received at least one prescription for statins during the period between January 1, 1994 and December 31, 2003 were retrieved from the LHU database in order to track the pharmacological history of individual patients. The data included age, sex, drug formulation, strength, number of drug packages prescribed, and prescription date. The adopted indicators for drug utilization included the Defined Daily Dose (DDD), the Received Daily Dose (RDD), and a surrogated Prescribed Daily Dose (sPDD), extrapolated from available prescription data. An Adherence to Therapy Index (ATI) was calculated from the ratio between the amount of drug actually prescribed and the amount of sPDD. Based on the ATI, patients were grouped into non-adherent, poor-adherent, and good-adherent groups. The distribution of adherence level among patient-age classes and statin-prescribed patients in primary or secondary prevention was evaluated. RESULTS: All drug-utilization indicators showed an increase in statin use over the study period in terms of both the number of prescribed patients and the sPDD. Persistence with and adherence to therapy remained low, with a 50% discontinuation rate in the first year, and persistent patients did not follow the therapy regularly. Patients in secondary prevention were the most adherent to their drug regimen, although only 41% of these had a good compliance. CONCLUSIONS: Our findings suggest an increase in statin use which is, however, accompanied by poor patient persistence with and adherence to statin therapy.