Prescrire international
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Prescrire international · May 2013
ReviewDeep venous thrombosis and pulmonary embolism. Part 2--Prevention of recurrences: warfarin or low-molecular-weight heparin for at least 3 months.
In patients with deep venous thrombosis or pulmonary embolism, initial treatment with low-molecular-weight heparin (LMWH) is primarily aimed at preventing thrombus extension. After this initial phase, the goal of treatment is to prevent recurrences, which can be fatal. Is it better to continue treatment of deep venous thrombosis or pulmonary embolism with LMWH or switch to an oral anticoagulant? What is the optimal duration of treatment? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology. ⋯ Various clinical practice guidelines published since 2006 recommend first-line treatment with a vitamin K antagonist for at least 3 months in patients without cancer, and continuation of LMWH therapy in patients with cancer. Overall, LMWH and warfarin have similar harm-benefit balances. In practice, it is best to choose between these drugs on a case-by-case basis, taking into account patient preferences, monitoring constraints, difficulty controlling the INR, the risk of bleeding and interactions, and the cost of treatment.
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Prescrire international · Apr 2013
Review Comparative StudyDeep venous thrombosis and pulmonary embolism. Part 1. Initial treatment: usually a low-molecular-weight heparin.
Patients with deep venous thrombosis are at a short-term risk of symptomatic or even life-threatening pulmonary embolism, and a long-term risk of post-thrombotic syndrome, characterised by lower-limb pain, varicose veins, oedema, and sometimes skin ulcers. What is the best choice of initial antithrombotic therapy following deep venous thrombosis or pulmonary embolism, in terms of mortality and short-term and long-term complications? How do the harm-benefit balances of the different options compare? To answer these questions, we reviewed the available literature using the standard Prescrire methodology. Unfractionated heparin has documented efficacy in reducing mortality and recurrent thromboembolic events in patients with pulmonary embolism or symptomatic proximal (above-knee) deep venous thrombosis. ⋯ In practice, initial treatment of deep venous thrombosis and pulmonary embolism should be based on LMWH in patients without renal failure. Thrombolytic agents may be useful in case of massive pulmonary embolism, but more evaluation is needed. Bleeding and heparin thrombocytopenia are the main adverse effects of these treatments.
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Common sense dictates that one should choose tried and tested drugs with proven, concrete benefits that outweigh their adverse effects. Many new drugs are approved each year, often despite a lack of solid evidence that they are any better than existing treatments. Worse, some are approved despite being less effective or more harmful than current options. ⋯ These drugs should not be used. Patients and healthcare professionals should reassess ongoing treatments and, if necessary, replace these drugs with proven treatments. Without waiting for the authorities to remove them from the market in a timely manner, as the accumulation of data showing that they are more harmful than beneficial would require.
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More pharmacovigilance data on agomelatine became available in 2012. The main sources of information were surveillance data from the French national monitoring system, EU periodic safety update reports (PSURs), and the European pharmacovigilance database. ⋯ The harms associated with agomelatine, which has no proven efficacy in depression, clearly outweigh the benefits. Until regulatory agencies decide to withdraw agomelatine from the market, it is up to healthcare professionals to protect patients from this unnecessarily dangerous drug.