Once-monthly (50/50, 100, and 150 mg) and daily (2.5 mg; 3-year vertebral fracture risk reduction: 52%) oral ibandronate regimens were compared in 1609 women with postmenopausal osteoporosis. At least equivalent efficacy and similar safety and tolerability were shown after 1 year.Introduction: Suboptimal adherence to daily and weekly oral bisphosphonates can potentially compromise therapeutic outcomes in postmenopausal osteoporosis. Although yet to be prospectively shown in osteoporosis, evidence from randomized clinical trials in several other chronic conditions shows that reducing dosing frequency enhances therapeutic adherence. Ibandronate is a new and potent bisphosphonate with antifracture efficacy proven for daily administration and also intermittent administration with a dose-free interval of >2 months. This report presents comparative data on the efficacy and safety of monthly and daily oral ibandronate regimens. Materials and Methods: MOBILE is a 2-year, randomized, double-blind, phase III, noninferiority trial. A total of 1609 women with postmenopausal osteoporosis were assigned to one of four oral ibandronate regimens: 2.5 mg daily, 50 mg/50 mg monthly (single doses, consecutive days), 100 mg monthly, or 150 mg monthly. Results: After 1 year, lumbar spine BMD increased by 3.9%, 4.3%, 4.1%, and 4.9% in the 2.5, 50 /50, 100, and 150 mg arms, respectively. All monthly regimens were proven noninferior, and the 150 mg regimen superior, to the daily regimen. All monthly regimens produced similar hip BMD gains, which were larger than those with the daily regimen. All regimens similarly decreased serum levels of C-telopeptide, a biochemical marker of bone resorption. Compared with the daily regimen, a significantly larger proportion of women receiving the 100 and 150 mg monthly regimens achieved predefined threshold levels for percent change from baseline in lumbar spine (6%) or total hip BMD (3%). All regimens were similarly well tolerated. Conclusions:Monthly ibandronate is at least as effective and well tolerated as the currently approved daily ibandronate regimen in postmenopausal osteoporosis.
(Cardiol J 2015; 22, 4: 467-474)
Tuberculosis (TB) is a major concern in patients receiving TNF inhibitors (TNFi). This study aimed to assess the incidence of active TB and the efficacy of TB prevention measures used over the years, and to determine risk factors for developing TB, in a single-centre cohort of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) receiving TNFi. Data of all patients in whom treatment with TNFi was initiated in our rheumatology clinic until December 1st 2014 have been retrospectively analysed. The cohort was divided into 3 groups per the mandatory LTBI screening method at baseline: tuberculin skin test (TST) with a positive threshold of either 10 mm (group TST1), or 5 mm (group TST2), and QuantiFERON®-TB Gold test (group QFT). The incidence of active TB was analysed for each group and compared to TB incidence data in general population. Five hundred fifty patients were included (305 RA, 42 PsA, 203 AS); 97 patients belonged to the TST1, 229 to the TST2 and 224 to the QFT group. The number of active TB cases/time of exposure to TNFi (person-years, PY) was 8/593.5, 9/1044.0 and 3/555.3, respectively, accounting for an incidence of 1348.0, 862.1 and 540.2 cases per 10 PY. Active TB cases occurring in the first year of TNFi treatment (early TB) per total TB cases were only 3/8, 1/9 and 1/3, respectively, too few to identify statistically significant differences between the 3 LTBI screening protocols. However, less TB cases per total observation time were registered in the QFT group, probably due to the reduced duration of exposure to TNFi. All cases of active TB were registered among patients receiving monoclonal antibodies TNFi agents. We have found no significant risk factors for developing active TB. In our cohort, TB occurring after 1 year of TNFi treatment exceeds 'early TB', suggesting the necessity of further TB prevention measures besides baseline screening for LTBI.
The present study aimed to explore the correlations between clinical, biological, imagistic and procedural factors with the risk of intra-stent restenosis (ISR) in coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI). An observational cross-sectional study was conducted in a high-volume PCI center over a period of 2 years. A total of 235 consecutive patients diagnosed with angina or acute coronary syndrome treated by PCI were included in the study. Diagnosis of ISR was documented by coronary angiography in patients with suggestive coronary symptoms and ischemic changes in non-invasive or invasive paraclinical investigations. Thus, they were assigned to two groups: With or without ISR. All patients underwent clinical and laboratory examination, providing clinical and paraclinical variables that could be considered risk factors for ISR. Current smokers [risk ratio (RR)=1.63; 95% confidence interval (95% CI): 1.25-2.13], arterial hypertension (RR=1.86; 95% CI: 1.41-2.45), diabetes (RR=1.83; 95% CI: 1.42-2.36), high C-reactive protein (CRP) levels (RR=1.44; 95% CI: 0.93-2.24), chronic kidney disease (CKD) (RR=1.90; 95% CI: 1.53-2.36) and thrombolysis in myocardial infarction (TIMI) score were found to have a significant role in estimating the risk for ISR. Moreover, the ISR group (119 patients) presented with a lower stent inflation pressure when compared to the control group (116 patients) (14.47 vs. 16.14 mmHg, P=0.004). An increased mean stent diameter used for PCI was not associated with a high ISR incidence (P=0.810) as well as complex coronary treated lesions with longer stents (mean length of 24.98 mm in patients without ISR vs. 25.22 mm in patients with ISR; P=0.311). There was an estimated two times higher risk (RR=2.13; 95% CI: 1.17-3.88) concerning multi-stenting and restenosis degree >70%. To conclude, smoking, hypertension, diabetes mellitus, high CRP levels, CKD, TIMI score, stent type, low pressure for stent implantation and multi-stenting were found to be associated with ISR in patients following PCI. Therefore, a close follow-up should be targeted in such patients.
Objectives. Cardiovascular risk assessment is continuously improving due to a better understanding of the atherosclerotic pathomechanism by investigating new risk factors. Microalbuminuria is known as a predictor of renal, as well as cardiovascular morbidity and mortality in patients with hypertension. The aim of this study was to determine the clinical relevance of microalbuminuria and its relationship with traditional
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