Pat Hicks
Member
Does anyone know if there is a possibility that some anti-coagulation drug, such as the two now on the market, will be approved for mechanical heart valves in the near future?
New drugs on the horizon?
- Thread starter Pat Hicks
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Dodger Fan
Well-known member
Which two drugs are you referring to? You are already required to take anti-coagulation drugs when you have a mechanical valve. You need to take warfarin (brand name Coumadin) with a mechanical valve.
W. Carter
Well-known member
I doubt that there will be any drugs to take the place of warfarin for mechanical valves in the near future. No matter what kind of anticoagulation medicine there is they are all dangerous. They get just as many internal bleeding incidents from all of the different brands of anticoagulants that are on the market. Warfarin and Pradaxa are the only 2 (that I know of) that can be reversed for emergency surgery. Warfarin gets a bad rap but its no worse than any of them.
My limited research has found the same. For example: "The use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefit and an excess risk. " - see http://www.nejm.org/doi/full/10.1056/NEJMoa1300615
But as I self-manage my Warfarin (Coumadin) at home, testing weekly, I am not unduly worried about switching to one of the new ones. If something comes along in the future then great, once its got established and benefits confirmed I would probably switch, but no rush.
But as I self-manage my Warfarin (Coumadin) at home, testing weekly, I am not unduly worried about switching to one of the new ones. If something comes along in the future then great, once its got established and benefits confirmed I would probably switch, but no rush.
LondonAndy;n860182 said:
Amen to this. Just this past week I played golf with a young man who was an RN in a local hospital CC unit. During our "chit chat" we talked about warfarin use and his comment was that the majority of accidents with the drug are due to patient misuse, often accidental overdosing, causing bleeding issues. He also said that the numbers of patients "overdosing" on the newer drugs is increasing. Proper management of warfarin IS the key to successfully living with it and with home testing the management of warfarin is pretty simple.
pellicle
Professional Dingbat, Guru and Merkintologist
dick0236;n860186 said:
And amen to this too
I was unaware that Pradaxa was reversible without dialysis. It will take sound arguments with solid evidence to swing me around to the view that companies are spending million oof dollars researching warfarin ( which is as cheap as chips) alternatives because they seek better outcomes for patients. They only seek better bottom lines.
Worth watching is is video presentation where an ER specialist discusses their problems with new anticoagulants.
http://vimeo.com/24204720
There is a new drug in clinical trials that has a seven fold reduction in thromboembolic events with minimal increase in bleeding versus people not on any anticoagulation treatment. The company has indicated it intends to target artificial valves as a future indication after total knee replacements. In the study, patients began taking IONIS-FXIrx six weeks BEFORE surgery and continued on the drug after surgery.
[h=3]Description/Summary:[/h] IONIS-FXIRx is an antisense drug designed to reduce the production of Factor XI. Factor XI is a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis, which is the formation of a blood clot inside blood vessels. Thrombosis can cause heart attacks and strokes. People who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk. Although currently available anticoagulants reduce the risk of thrombosis, physicians associate these anticoagulants with increased bleeding, which can be fatal. Given the mechanism of Factor XI inhibition, we believe that our drug has the potential, if data warrant, to be used broadly as an anti-thrombotic in many different therapeutic settings for which additional safe and well tolerated anti-thrombotic drugs are needed. [h=3]Clinical Data[/h] We presented positive data from a Phase 2 comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients undergoing total knee replacement surgery, or total knee arthroplasty (TKA). In this study, patients treated with 300 mg/week of IONIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin, a commonly used anti-coagulant. In addition, IONIS-FXIRx-treated patients experienced numerically fewer bleeding events compared to patients treated with enoxaparin. The safety and tolerability profile of IONIS-FXIRx supports continued development.
[h=3]Study Description[/h] The Phase 2 study of IONIS-FXIRx in approximately 300 patients was a global, multi-center, open-label, comparator-controlled study in patients undergoing TKA. The study compared the safety and activity of IONIS-FXIRx to enoxaparin. Patients in the IONIS-FXIRx-treated cohorts received either 200 mg or 300 mg of IONIS-FXIRx for six weeks prior to TKA surgery and a dose six hours and three days after surgery. Patients in the enoxaparin cohort received 40 mg of enoxaparin the evening before TKA surgery, six to eight hours after surgery and daily for at least eight days after surgery.
[h=3]Description/Summary:[/h] IONIS-FXIRx is an antisense drug designed to reduce the production of Factor XI. Factor XI is a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis, which is the formation of a blood clot inside blood vessels. Thrombosis can cause heart attacks and strokes. People who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk. Although currently available anticoagulants reduce the risk of thrombosis, physicians associate these anticoagulants with increased bleeding, which can be fatal. Given the mechanism of Factor XI inhibition, we believe that our drug has the potential, if data warrant, to be used broadly as an anti-thrombotic in many different therapeutic settings for which additional safe and well tolerated anti-thrombotic drugs are needed. [h=3]Clinical Data[/h] We presented positive data from a Phase 2 comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients undergoing total knee replacement surgery, or total knee arthroplasty (TKA). In this study, patients treated with 300 mg/week of IONIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin, a commonly used anti-coagulant. In addition, IONIS-FXIRx-treated patients experienced numerically fewer bleeding events compared to patients treated with enoxaparin. The safety and tolerability profile of IONIS-FXIRx supports continued development.
[h=3]Study Description[/h] The Phase 2 study of IONIS-FXIRx in approximately 300 patients was a global, multi-center, open-label, comparator-controlled study in patients undergoing TKA. The study compared the safety and activity of IONIS-FXIRx to enoxaparin. Patients in the IONIS-FXIRx-treated cohorts received either 200 mg or 300 mg of IONIS-FXIRx for six weeks prior to TKA surgery and a dose six hours and three days after surgery. Patients in the enoxaparin cohort received 40 mg of enoxaparin the evening before TKA surgery, six to eight hours after surgery and daily for at least eight days after surgery.
There is a new drug in clinical trials that has a seven fold reduction in thromboembolic events with minimal increase in bleeding versus people not on any anticoagulation treatment. The company has indicated it intends to target artificial valves as a future indication after total knee replacements. In the study, patients began taking IONIS-FXIrx six weeks BEFORE surgery and continued on the drug after surgery.
[h=3]Description/Summary:[/h] IONIS-FXIRx is an antisense drug designed to reduce the production of Factor XI. Factor XI is a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis, which is the formation of a blood clot inside blood vessels. Thrombosis can cause heart attacks and strokes. People who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk. Although currently available anticoagulants reduce the risk of thrombosis, physicians associate these anticoagulants with increased bleeding, which can be fatal. Given the mechanism of Factor XI inhibition, we believe that our drug has the potential, if data warrant, to be used broadly as an anti-thrombotic in many different therapeutic settings for which additional safe and well tolerated anti-thrombotic drugs are needed. [h=3]Clinical Data[/h] We presented positive data from a Phase 2 comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients undergoing total knee replacement surgery, or total knee arthroplasty (TKA). In this study, patients treated with 300 mg/week of IONIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin, a commonly used anti-coagulant. In addition, IONIS-FXIRx-treated patients experienced numerically fewer bleeding events compared to patients treated with enoxaparin. The safety and tolerability profile of IONIS-FXIRx supports continued development.
[h=3]Study Description[/h] The Phase 2 study of IONIS-FXIRx in approximately 300 patients was a global, multi-center, open-label, comparator-controlled study in patients undergoing TKA. The study compared the safety and activity of IONIS-FXIRx to enoxaparin. Patients in the IONIS-FXIRx-treated cohorts received either 200 mg or 300 mg of IONIS-FXIRx for six weeks prior to TKA surgery and a dose six hours and three days after surgery. Patients in the enoxaparin cohort received 40 mg of enoxaparin the evening before TKA surgery, six to eight hours after surgery and daily for at least eight days after surgery.
[h=3]Description/Summary:[/h] IONIS-FXIRx is an antisense drug designed to reduce the production of Factor XI. Factor XI is a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis, which is the formation of a blood clot inside blood vessels. Thrombosis can cause heart attacks and strokes. People who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk. Although currently available anticoagulants reduce the risk of thrombosis, physicians associate these anticoagulants with increased bleeding, which can be fatal. Given the mechanism of Factor XI inhibition, we believe that our drug has the potential, if data warrant, to be used broadly as an anti-thrombotic in many different therapeutic settings for which additional safe and well tolerated anti-thrombotic drugs are needed. [h=3]Clinical Data[/h] We presented positive data from a Phase 2 comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients undergoing total knee replacement surgery, or total knee arthroplasty (TKA). In this study, patients treated with 300 mg/week of IONIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin, a commonly used anti-coagulant. In addition, IONIS-FXIRx-treated patients experienced numerically fewer bleeding events compared to patients treated with enoxaparin. The safety and tolerability profile of IONIS-FXIRx supports continued development.
[h=3]Study Description[/h] The Phase 2 study of IONIS-FXIRx in approximately 300 patients was a global, multi-center, open-label, comparator-controlled study in patients undergoing TKA. The study compared the safety and activity of IONIS-FXIRx to enoxaparin. Patients in the IONIS-FXIRx-treated cohorts received either 200 mg or 300 mg of IONIS-FXIRx for six weeks prior to TKA surgery and a dose six hours and three days after surgery. Patients in the enoxaparin cohort received 40 mg of enoxaparin the evening before TKA surgery, six to eight hours after surgery and daily for at least eight days after surgery.
