Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS).

BACKGROUND: The Extended Forsteo Observational Study (ExFOS) is a multinational, non-interventional, prospective, observational study that aims to provide real-life data on patients with osteoporosis treated with teriparatide for up to 24 months. It includes the new indications of osteoporosis in men and glucocorticoid-induced osteoporosis (GIOP). We describe the Greek subpopulation enrolled in this study and compare it with a similar cohort from the previous European Forsteo Observational Study (EFOS). METHODS: Baseline data were collected from the Greek cohort of ExFOS. Data included demographic characteristics, medical and osteoporosis history, disease status, prior use of medications, back pain and quality of life. RESULTS: Baseline data for 439 patients, enrolled at 31 sites, indicated the majority of patients were females (92.3%), elderly [mean (standard deviation; SD) age 70.1 (9.8) years] and slightly overweight [mean (SD) body mass index 26.7 (4.3) kg/m(2)], with very low bone mineral density (mean T-score <-3 in lumbar spine or total hip) and at least one previous fracture (55.1% of patients). Of the 439 patients, 19.8% were osteoporosis treatment naïve, 88.4% had experienced back pain during the previous 12 months, 68.1% had experienced back pain at least fairly often during the previous month and 50.9% reported moderate to severe limitation of activities due to back pain, with a mean (SD) of 4.2 (7.7) days spent in bed because of back pain during the previous month. Most baseline characteristics were numerically similar between the female ExFOS and EFOS cohorts; however, the rate of enrolment was faster in ExFOS (by approximately 45%) and a history of fracture was recorded in 53.8% of female patients in ExFOS versus 74.5% in EFOS. CONCLUSIONS: Greek patients prescribed teriparatide in ExFOS had severe osteoporosis with a high risk of fractures and back pain. Female patients shared similarities with EFOS counterparts, reflecting a constant prescribing profile for use of teriparatide, although a noticeable difference in fracture history between the two study cohorts may indicate a change towards prescribing in less severely affected patients. The economic crisis in Greece did not appear to affect patient enrolment. Data are interpreted in the context of an observational setting.

Current management and quality of life of patients with acute coronary syndrome undergoing percutaneous coronary intervention in Greece: 12-Month results from antiplatelet therapy observational study II (APTOR II).

INTRODUCTION: We describe the current management of patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) over 12 months in Greece. METHODS: This was a prospective observational study in ACS patients undergoing PCI from September 2008 to April 2009, capturing practices over 12 months at 22 sites that enrolled 558 eligible patients. RESULTS: A total of 351 patients suffered from unstable angina or non-ST elevation myocardial infarction (UA/ NSTEMI), while 207 patients suffered from ST-elevation myocardial infarction (STEMI). For the UA/NSTEMI group, the median age was 64 years (interquartile range: 55-73), while for the STEMI group the median age was 56 years (interquartile range: 49-66). Stents were placed in 96.4% of patients: bare-metal stents alone were placed in 19% of patients, drug-eluting stents alone in 77.5% of patients, and both types of stent in 3.5% of patients. 74% of UA/NSTEMI patients and 87% of STEMI patients received the first antiplatelet loading dose within 1 day of the episode. 76% of UA/NSTEMI patients underwent PCI within 3 days following the initial ACS symptoms, while 67% of STEMI patients underwent PCI within 1 day of the ACS symptoms. Follow-up data were available for 540 (96.8%) patients. The percentages of patients on antiplatelet therapy and on other medications at the time of hospital discharge and at 12 months post-PCI were as follows: aspirin 98%, 97%; clopidogrel 99%, 96%; statins 81%, 79%; beta-blockers 73%, 72%; calcium blockers 11%, 11%; angiotensin II receptor blockers/angiotensin-converting enzyme inhibitors 64%, 62%; proton-pump inhibitors 39%, 35%. CONCLUSIONS: In ACS patients treated with PCI in Greece, dual antiplatelet treatment is maintained in a very high percentage through 1 year post-procedure, and drug-eluting stent use is also high.

Clinical outcomes and costs for patients with type 2 diabetes mellitus initiating insulin therapy in Greece: two-year experience from the INSTIGATE study.

AIMS: To evaluate the quality of metabolic control, clinical outcomes, resource costs, and quality of life among patients with type 2 diabetes mellitus (T2DM), who initiated insulin for the first time as part of routine clinical practice. METHODS: The INSTIGATE study is a prospective, multicentric, observational study of patients initiating insulin treatment. This sub-cohort analysis focuses on Hellenic outcomes. RESULTS: At baseline, 263 Greek patients were enrolled just before initiating insulin for the first time. At the 6-month visit, 237 patients (90.1%) remained and consented to an additional 18-month observation period. In these 237 extension patients, over the 24-month post-initiation period, HbA1c (mean(SD)) decreased from 9.7%(1.6%) to 7.1%(0.9%) and body weight and BMI increased (+3(6)kg and +1.1(2.2)kg/m(2), respectively). At each post-baseline visit approximately one in five patients reported ≥1 episodes of hypoglycaemia in the preceding 3-6 months. Median total costs fluctuated from 438€ at baseline to 538€ up to 6 months and 451€ at 24 months; mean costs were 496(383)€, 573(276)€ and 485(247)€, respectively. CONCLUSIONS: In this cohort, insulin treatment seems to be effective with little long-term impact on cost. Findings should be interpreted in the context of an observational study.

Management of cardiovascular risk factors with pioglitazone combination therapies in type 2 diabetes: an observational cohort study.

BACKGROUND: Type 2 diabetes (T2D) is strongly associated with cardiovascular risk and requires medications that improve glycemic control and other cardiovascular risk factors. The authors aimed to assess the relative effectiveness of pioglitazone (Pio), metformin (Met) and any sulfonylurea (SU) combinations in non-insulin-treated T2D patients who were failing previous hypoglycemic therapy. METHODS: Over a 1-year period, two multicenter, open-labeled, controlled, 1-year, prospective, observational studies evaluated patients with T2D (n = 4585) from routine clinical practice in Spain and Greece with the same protocol. Patients were eligible if they had been prescribed Pio + SU, Pio + Met or SU + Met serving as a control cohort, once they had failed with previous therapy. Anthropometric measurements, lipid and glycemic profiles, blood pressure, and the proportions of patients at microvascular and macrovascular risk were assessed. RESULTS: All study treatment combinations rendered progressive 6-month and 12-month lipid, glycemic, and blood pressure improvements. Pio combinations, especially Pio + Met, were associated with increases in HDL-cholesterol and decreases in triglycerides and in the atherogenic index of plasma. The proportion of patients at high risk decreased after 12 months in all study cohorts. Minor weight changes (gain or loss) and no treatment-related fractures occurred during the study. The safety profile was good and proved similar among treatments, except for more hypoglycemic episodes in patients receiving SU and for the occurrence of edema in patients using Pio combinations. Serious cardiovascular events were rarely reported. CONCLUSIONS: In patients with T2D failing prior hypoglycemic therapies, Pio combinations with SU or Met (especially Pio + Met) improved blood lipid and glycemic profiles, decreasing the proportion of patients with a high microvascular or macrovascular risk. The combination of Pio with SU or Met may therefore be recommended for T2D second-line therapy in the routine clinical practice, particularly in patients with dyslipidemia.