При наличии ингибиторов Xа фактора существование ингибиторов тромбина бессмысленно. У них нет никаких преимуществ, даже ценовых, а потенциальные риски длительного полного ингибирования тромбина никем не изучены. У тромбина полно других функций в организме, помимо участия в образовании фибрина, и подавление даже базального уровня антифизиологично.
Похоже, что над Прадаксой начинают сгущаться тучи. Количество кровотечений на дабигатране в реальной клинической практике намного превышает число кровотечений на варфарине.
Dabigatran (PRADAXA). This drug, which was launched in October 2010 to reduce the risk of stroke in patients with atrial fibrillation, generated hundreds of adverse event reports during the first quarter of 2011. Overall, 932 serious adverse events were linked to this drug, including 120 deaths, 25 cases of permanent disability, and 543 cases requiring hospitalization. Of the 932 events, 505 cases involved hemorrhage, more than any other monitored drug including warfarin, which ranked second with 176 cases of hemorrhage. The total included 120 cases that described the event with terms indicating hemorrhagic stroke, which is particularly problematic given that the drug’s primary indication is to prevent ischemic strokes.
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Похожие проблемы и в Японии.
In August 2011, the Japanese MHLW issued a safety advisory to warn of the potential for serious adverse events with dabigatran (Pradaxa®) which was approved in Japan in January 2011. This was following the death of five patients who were taking the drug. Between January and 11 August 2011, the patient exposure in Japan was about 64,000 people. At the time of publication of the advisory, there were 81 cases of serious side effects associated with dabigatran reported in Japan, including cases of gastrointestinal bleeding .
The five patients who had bleeding events contributory to their death were elderly, aged between 76 and 100 years old. They were prescribed with age-adjusted doses of dabigatran. The events leading to death include haemorrhage of the digestive tract, pulmonary alveolar haemorrhage, respiratory failure and haemorrhagic shock. The time to onset for these events ranged from eight days to 104 days. Two of these patients had taken aspirin concomitantly. Based on limited data available and a post-hoc estimation of creatinine clearance (CLcr), four of the patients were suspected to have severe renal impairment while on dabigatran therapy.
Physicians in Japan were advised to carefully monitor for signs of anaemia and bleeding and the need for immediate response should these side effects develop. They were also recommended to perform renalfunction tests before and during treatment, and to reduce the dose of dabigatran or stop treatment upon signs of renal impairment or bleeding.
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