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Published on 16 June 2011

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Boehringer Ingelheim launches low-dose alteplase

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A thrombolytic solution to the problem of occluded central venous access devices was today launched by Boehringer Ingelheim in the United Kingdom. Actilyse® Cathflo® 2mg is a low-dose vial of the thrombolytic alteplase. It is used to restore the patency of central venous access devices (CVADs), including those used in haemodialysis.

The active ingredient of Actilyse® Cathflo® 2mg is alteplase, a recombinant human tissue-type plasminogen activator (rt-pa), which activates plasminogen directly to plasmin. When administered intravenously, alteplase remains relatively inactive in the circulatory system. Once bound to fibrin, it is activated, inducing the conversion of plasminogen to plasmin leading to the dissolution of the fibrin clot and breaking down the thrombus and restoring function to the CVAD. Once the clot has broken down, any debris can be aspirated from the CVAD. The CVAD remains in situ during the process and can be re-used once clear.

Central venous catheterisation is a key component of the treatment of patients who are undergoing procedures such as haemodialysis. Over 20,000 patients are currently receiving dialysis in the United Kingdom. It is estimated that up to 25 percent of CVADs become occluded and it is estimated that 58 per cent of CVAD blockages are caused by blood clots.

When CVADs become occluded, administration of critical therapies may be delayed until the blockage is cleared or the CVAD is replaced. Current treatments for CVAD occlusion include removing and replacing the CVAD. Salvaging the CVAD is the preferred method of managing occlusions as this results in limited interruptions to therapy, reduced risk of complications, reduced trauma for patients and decreased costs.

The safety and efficacy of Actilyse® Cathflo® 2mg in restoration of function to CVADs has been confirmed in three pivotal studies, which enrolled more than 1,400 patients of all ages including 310 children and adolescents in the age of two weeks up to 17 years.  In the COOL and COOL-2 (Cardiovascular thrombolytic to Open Occluded Lines) trials, 74–77 % of patients with occlusions had restored function after one dose and 87–90%  had function restored after two doses of alteplase 2mg using a 120 minute dwell time for each dose. The Cathflo Activase Pediatric Study (CAPS) studied the use of Actilyse® Cathflo® 2mg in paediatric patients and reported restoration rates after one and two doses, each with a maximum dwell time of 120 minutes, of 75% and 83% respectively.

The safety profile of Actilyse® Cathflo® 2mg has also been found to be favourable in this patient cohort. Serious adverse events observed in the COOL and COOL-2 clinical trials included intracranial haemorrhage (0.0%), embolic events (0.0%), gastrointestinal bleeding (0.3%), thrombosis (0.3%), and sepsis (0.4%). The overall safety and efficacy of Actilyse® Cathflo® 2mg appeared similar in children as in adults.

Boehringer Ingelheim



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