ALERTA CARDIACA SOBRE DROGA USADA PARA LA OSTEOPOROSIS

Europe's drug watchdog has moved to restrict the use of osteoporosis drug strontium ranelate (Protos), citing an increased risk of myocardial infarction compared with placebo. A European Medicines Agency committee said data on the drug "were of concern", and would be evaluated further in an expedited, in-depth review. In the meantime, the committee recommended avoiding strontium ranelate in people with current or previous ischaemic heart disease, peripheral arterial disease or cerebrovascular disease and those with inadequately controlled hypertension. The drug should be used only for treatment of severe osteoporosis, the EMA's Pharmacovigilance Risk Assessment Committee said. "The data from clinical studies showed that there was an increased risk of a heart attack in post-menopausal women taking [Protos] compared with those taking placebo, although there was no increase in deaths," the EMA said in a statement released Friday. "On the whole, the data were of concern given other serious risks (blood clots and rare serious skin reactions) that were identified in a previous EMA review in 2012." Some 350,000 strontium ranelate scripts were dispensed through the PBS in 2012 and there have been 60,000 in 2013 to date, figures show. The Australian product information lists current or previous VTE as a contraindication, but does not mention cardiovascular disease or hypertension. Final recommendations from the EMA's in-depth review will be made public following another meeting on 22-25 April and review by the European Commission. The current findings emerged as part of a routine risk-benefit assessment, which included data on 7,500 patients. Protos manufacturer Servier Australia said the company was aware of the recommendations and had provided all relevant information to the Therapeutic Goods Administration. "We will communicate any changes to the Protos Product Information to healthcare professionals," Servier said in a statement.

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ATORVASTATINA BAJA DOSIS Y EFECTOS PLEIOTROPICOS

Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Kanaki AI, et al. Show all Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28. Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital, Thessaloniki, Greece. Abstract BACKGROUND Experimental and clinical data suggest that statins exert anti-inflammatory and antiproliferative actions on vasculature beyond their lipid-lowering properties. Whether these pleiotropic effects of statins translate into a beneficial effect on arterial stiffness is not clear. This study aimed to evaluate the potential effects of low-dose atorvastatin treatment on arterial stiffness and central arterial pressure waveforms in patients with mild hypertension and hypercholesterolemia. METHODS In a double-blind, randomized, placebo-controlled fashion, 50 hypertensive and hypercholesterolemic patients were allocated to receive 10mg of atorvastatin or placebo for 26 weeks. Arterial stiffness was assessed by aortic pulse-wave velocity (PWV) using a Sphygmocor device. Central arterial pressure waveform parameters were estimated by radial artery applanation tonometry. Heart rate-adjusted augmentation index (AIx(75)) was used as measure of wave reflections. RESULTS At study end, aortic PWV (9.0±1.5 vs. 10.9±2.6 m/sec; P<0.001) and AIx(75) (24.9% ± 9.7% vs 28.8% ± 11.8%; P < 0.001) were significantly lower in the atorvastatin group than that placebo group. Furthermore, decreases in central aortic systolic blood pressure and pulse pressure were evident at study-end with atorvastatin but not with placebo (130±8 vs. 138±6mm Hg, P < 0.001; 48±7 vs. 53±6mm Hg, P < 0.05, respectively). Atorvastatin-induced reductions in aortic PWV during follow-up showed significant associations with changes in AIx(75) and central aortic systolic blood pressure and pulse pressure. CONCLUSIONS This study shows that low-dose atorvastatin treatment improves arterial stiffness and exerts a reduction on central aortic pressures. These effects may represent a potential mechanism of cardiovascular risk reduction observed with statin use. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Database Identifier Number: NCT01126684

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