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Pradaxa vs Xarelto
Introduction
For patients who are at risk of stroke due to conditions such as atrial fibrillation or those requiring deep vein thrombosis (DVT) and pulmonary embolism (PE) treatment, certain drugs that help prevent blood clots can be life-saving. Pradaxa and Xarelto are two such medications often prescribed for these purposes. Both of them work by inhibiting the function of specific proteins in the blood that contribute to clot formation - but they do so in different ways. Pradaxa is a direct thrombin inhibitor which works by directly blocking the action of thrombin, an enzyme involved in clotting. On the other hand, Xarelto belongs to a class known as Factor Xa inhibitors, which works by blocking Factor Xa – another enzyme necessary for blood clotting.
Pradaxa vs Xarelto Side By Side
| Attribute | Pradaxa | Xarelto |
|---|---|---|
| Brand Name | Pradaxa | Xarelto |
| Contraindications | Severe kidney disease, liver disease, undergoing spinal anesthesia procedures | Severe kidney disease, liver disease, undergoing spinal anesthesia procedures |
| Cost | $450 for a 30-day supply | $470 for a 30-day supply |
| Generic Name | Dabigatran | Rivaroxaban |
| Most Serious Side Effect | Unexpected bleeding, signs of severe allergic reaction, unusual bruising, coughing up blood or brown material that looks like coffee grounds, pink or brown urine; red or black stools (looks like tar), unexpected pain, swelling, joint pain, headaches and feeling dizzy or weak, symptoms of spinal cord clot | Signs of an allergic reaction, unusual bleeding, headaches, feeling dizzy or weak, blood in your urine or stools, heavy menstrual periods, bruising more easily than usual, coughing up blood or vomit that looks like coffee grounds |
| Severe Drug Interactions | Antifungal drugs such as ketoconazole or itraconazole | Antifungal drugs such as ketoconazole or itraconazole |
| Typical Dose | 150–300 mg/day, with 150 mg/day being sufficient for most indications | 15 mg twice daily for the first 21 days, then 20 mg once daily |
What is Pradaxa?
Dabigatran (the generic name for Pradaxa) was one of the first in a newer class of anticoagulants, marking a major shift from conventional anticoagulant drugs like warfarin. Dabigatran was first approved by the FDA in 2010. It works by directly inhibiting thrombin, an important protein involved in blood clotting, which effectively prevents potential harmful clots from forming within the body's vascular system. It is prescribed for stroke prevention in patients with atrial fibrillation and treatment of deep vein thrombosis or pulmonary embolism.
On the other hand, Rivaroxaban (Xarelto), though also an anticoagulant, operates differently: it selectively inhibits Factor Xa, another crucial enzyme involved in blood coagulation. This difference results in various comparative advantages and side effects. For instance, unlike Pradaxa that requires twice-daily dosing to maintain therapeutic levels due to its shorter half-life, Xarelto generally only needs once-daily administration because of its longer half-life. Both medications have similar risks when it comes to bleeding complications - a common concern with all anticoagulants.
What conditions is Pradaxa approved to treat?
Pradaxa has received approval for the management of several conditions related to blood clotting:
- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), after treatment with a parenteral anticoagulant for 5-10 days
- Risk reduction in recurrent DVT and PE following initial therapy.
How does Pradaxa help with these illnesses?
Pradaxa works to prevent blood clots by inhibiting thrombin, an enzyme necessary for clot formation within the bloodstream. It does this by attaching itself to the active site of thrombin, preventing it from catalyzing reactions that lead to clotting. Thrombin plays a key role in coagulation or blood clotting, which is a crucial mechanism in our bodies used to stop bleeding and repair damaged blood vessels. However, when clots form unnecessarily inside veins or arteries (thrombosis), they can cause serious health issues such as stroke or heart attack.
In certain conditions where there's a higher risk of unwanted clot formation like atrial fibrillation or after hip/knee replacement surgeries, Pradaxa is prescribed as it reduces these risks significantly by its action on thrombin. Thus, by inhibiting thrombin activity, Pradaxa helps manage and limit potential dangerous effects related to abnormal blood clotting and contributes greatly towards maintaining cardiovascular health.
What is Xarelto?
Xarelto, also known as rivaroxaban, is an anticoagulant or a blood thinner that prevents the formation of blood clots. It works by directly inhibiting factor Xa in the coagulation cascade, which ultimately reduces the production of thrombin, a key player in blood clotting. Since its FDA approval in 2011, it has been widely used to prevent deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke in patients with atrial fibrillation.
Unlike Pradaxa which requires two doses per day for most indications, Xarelto's main advantage is its once-daily dosing regimen. This can make it more convenient for some patients and may improve medication compliance. In terms of side effects though, both drugs are similar; bleeding is the most common side effect due to their inherent action on preventing clot formation. While there are minor differences between them such as how they're metabolized and eliminated from the body - factors that might influence drug choice depending on patient-specific characteristics - both anticoagulants have proven effective at reducing risk of thromboembolic events when compared to older therapies like warfarin.
What conditions is Xarelto approved to treat?
Xarelto is an anticoagulant medication that has been approved by the FDA for treating and preventing several health conditions, including:
- Deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism)
- After hip or knee replacement surgery to prevent DVT and pulmonary embolism
- Atrial fibrillation, a heart condition that increases the risk of stroke.
How does Xarelto help with these illnesses?
Xarelto, like Pradaxa, plays a critical role in blood clot prevention by inhibiting the coagulation cascade. Specifically, Xarelto is an inhibitor of Factor Xa, a key enzyme required for blood clots to form. By blocking this factor's action, Xarelto helps decrease the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation or those undergoing hip or knee replacement surgery. Its unique once-daily dosing regimen offers convenience over multiple daily doses required by some other anticoagulants like Pradaxa. Moreover, unlike Pradaxa which requires regular monitoring of renal function due to its elimination pathway through kidneys; Xarelto has fewer such requirements making it a preferred option amongst certain patient demographics.
How effective are both Pradaxa and Xarelto?
Both dabigatran (Pradaxa) and rivaroxaban (Xarelto) are novel oral anticoagulants that have been successfully used for the prevention of stroke in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of venous thromboembolism. They were approved by the FDA within a couple of years apart, Pradaxa in 2010 and Xarelto in 2011.
The effectiveness of these two drugs was directly compared in several trials; both exhibited similar efficacy profiles but acted on different parts of the coagulation cascade. Pradaxa is a direct thrombin inhibitor while Xarelto is a factor Xa inhibitor.
In terms of safety profile, both medications do not require regular blood monitoring like warfarin does, which adds to their convenience. However, bleeding risk remains an important concern when using either drug. A meta-analysis published in 2020 found that major bleeding rates were somewhat lower with dabigatran than with rivaroxaban.
A review from 2019 reported that among novel oral anticoagulants, Pradaxa has shown evidence suggesting it might be more effective at preventing strokes versus other treatments including warfarin or aspirin alone. This finding though needs to be balanced against potential side-effects such as gastrointestinal issues which some patients may find troublesome.
On the other hand, data from a large scale study known as ROCKET-AF pointed out that although no significant difference was observed between rivaroxaban and warfarin concerning reducing stroke risk or systemic embolism rate; however its ease-of-use gives it an advantage over traditional therapies such as Warfarin especially since routine coagulation monitoring isn't required.
Despite having different mechanisms within anticoagulant pathways—dabigatran acting upon thrombin whereas rivaroxaban inhibits Factor Xa—the choice between them often comes down to individual patient characteristics including renal function (both medicines are substantially excreted by kidney), cost considerations and physicians' experience.
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At what dose is Pradaxa typically prescribed?
Oral dosages of Pradaxa range from 150–300 mg/day, but studies have indicated that 150 mg/day is sufficient for treating and preventing deep vein thrombosis (DVT) and pulmonary embolism in most people. Patients with renal impairment may be started on a lower dose of 110mg twice daily. In either population, dosage can be adjusted based on kidney function. The maximum dosage that should not be exceeded in any case is 300 mg/day.
On the other hand, Xarelto's standard oral dose for DVT treatment and prevention ranges from 10-20 mg once per day. It may also need to be adjusted according to kidney function or if taken alongside certain medications. As always, follow your doctor's advice closely when starting new medication.
At what dose is Xarelto typically prescribed?
Xarelto treatment is typically initiated at a dosage of 15 mg taken orally twice daily with food, for the first 21 days. After this initial period, the dose can be reduced to 20 mg once daily with food. It's crucial to take Xarelto around the same time each day. For patients with renal impairment or taking certain other medications, your doctor may recommend adjusting the dose appropriately. Always follow your healthcare provider's instructions and never exceed their recommended dosage without discussing it with them first.
What are the most common side effects for Pradaxa?
Common side effects of Pradaxa and Xarelto can include:
- Easy bruising or minor bleeding, such as a nosebleed or bleeding from the gums
- Coughing up blood or vomit that looks like coffee grounds
- Severe headache, dizziness, fainting
- Weakness and swelling in your arms or legs
- Pain, discomfort or heaviness in your chest
- Shortness of breath
- Nausea and possibly vomiting
- Diarrhea (more common with Pradaxa)
Remember to seek immediate medical attention if you experience any signs of severe bleeding while taking these medications.
Are there any potential serious side effects for Pradaxa?
While both Pradaxa and Xarelto are used to prevent blood clots, they can carry some serious side effects. Here are the potential adverse reactions that you need to be aware of when taking these medications:
- Unexpected bleeding or bleeding that lasts a long time, such as frequent nose bleeds, unusual bleeding from the gums, heavier than normal menstrual or vaginal bleeding
- Signs of severe allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue or throat
- Unusual bruising (bruises that develop without known cause or grow in size)
- Coughing up blood or brown material that looks like coffee grounds
- Pink or brown urine; red or black stools (looks like tar)
- Unexpected pain, swelling, joint pain
- Headaches and feeling dizzy or weak
- Any symptoms of spinal cord clot: back pain; numbness/tingling/weakness/muscle paralysis in lower body
Remember it is important to seek immediate medical attention if you experience any of these symptoms while on either medication.
What are the most common side effects for Xarelto?
When taking Xarelto, the following side effects may be experienced:
- Bleeding gums
- Blood in the urine or stools
- Bowel or bladder dysfunction
- Coughing up blood
- Increased menstrual flow or vaginal bleeding
- Nosebleeds
- Paralysis on one side of the body.
- Dizziness, severe headache and sudden loss of coordination are also possible. Remember these symptoms as they could indicate serious conditions such as internal bleeding. It's important to note that unlike Pradaxa, there is no readily available reversal agent for Xarelto should major bleeding occur.
Are there any potential serious side effects for Xarelto?
While Xarelto is generally well-tolerated, it can sometimes cause serious side effects. If you are taking this medication and experience any of the following symptoms, you should seek immediate medical attention:
- Signs of an allergic reaction: hives; difficult breathing; swelling in your face or throat.
- Unusual bleeding (nose, mouth, vagina, rectum), bleeding from wounds or needle injections that doesn't stop.
- Headaches, feeling dizzy or weak
- Blood in your urine or stools,
- Heavy menstrual periods
- Bruising more easily than usual
- Coughing up blood or vomit that looks like coffee grounds Remember that Xarelto is a potent blood thinner and these signs may indicate complications related to its use. Therefore if they occur promptly contact healthcare provider.
Contraindications for Pradaxa and Xarelto?
Both Pradaxa and Xarelto, like all anticoagulant medications, may amplify the risk of bleeding in some people. If you observe any unusual bruising or bleeding that lasts for a prolonged period, please seek immediate medical attention.
Neither Pradaxa nor Xarelto can be taken if you are taking or have been taking antifungal drugs such as ketoconazole or itraconazole. Always inform your physician which medications you are currently using; these antifungal drugs may interact adversely with Pradaxa and Xarelto leading to increased risks.
Furthermore, both of these blood thinners should not be used by individuals with severe kidney disease, liver disease or those undergoing spinal anesthesia procedures due to the potential for serious complications like spinal/epidural hematoma. It's crucial to discuss all health conditions and current medication regimen with your healthcare provider before starting treatment with either Pradaxa or Xarelto.
How much do Pradaxa and Xarelto cost?
For the brand name versions of these drugs:
- The price for a 30-day supply of Xarelto (20 mg) averages around $470, which works out to approximately $15.67/day.
- Pradaxa (150 mg), on the other hand, costs about $450 for a 30-day supply, working out to roughly $15/day.
Therefore, if you are comparing prices at equivalent doses, Pradaxa is slightly less expensive than Xarelto. Please remember that cost should not be your main consideration in determining which of these anticoagulant medications is right for you.
It's important to note that there are currently no generic versions available for either Xarelto or Pradaxa in most markets due to patent protections. Therefore, costs remain high compared with many other classes of medication where generic options exist. As always consult with your healthcare provider before making any decisions based on cost alone as clinical effectiveness and side effect profiles differ between patients and medications.
Popularity of Pradaxa and Xarelto
Dabigatran, sold under the brand name Pradaxa, was estimated to have been prescribed to about 1.7 million people in the US in 2020. Dabigatran accounted for just over 13% of anticoagulant prescriptions in the US. However, it appears to be one of the commonly used non-vitamin K antagonist oral anticoagulants (NOACs). The prevalence of dabigatran has been generally increasing since its approval by FDA in 2010.
Rivaroxaban, including brand versions such as Xarelto, was prescribed to approximately 3.6 million people in the USA in 2020. In the US, rivaroxaban accounts for just under 40% of NOAC prescriptions and a significant percentage of overall anticoagulant prescriptions. The prevalence of rivaroxaban has increased significantly since its introduction into clinical practice due to its convenience and efficacy with lower incidences of major bleeding compared to traditional vitamin K antagonists.
Conclusion
Both Pradaxa (dabigatran) and Xarelto (rivaroxaban) are anticoagulants used to prevent blood clots in patients with atrial fibrillation, deep vein thrombosis, or pulmonary embolism. They have been widely studied and proven to be effective alternatives to warfarin, a traditional medication for these conditions. Both drugs target specific steps in the coagulation pathway: Pradaxa inhibits thrombin, while Xarelto blocks factor Xa.
Although there may be circumstances where one drug is preferred over the other due to individual patient factors, both medications are generally considered first-line options for most indications. An important distinction between them lies in their dosing schedules; dabigatran requires twice-daily administration compared with once-daily for rivaroxaban.
Both drugs come as branded products; however generic versions of these medications might become available soon which could significantly reduce costs. The effects of these anticoagulants kick-in quickly but require regular monitoring of kidney function.
The side effect profile is comparable between the two drugs. However, incidents like bleeding events need prompt medical attention as they can potentially lead to serious complications if not managed timely.
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Refrences
- Laux, V., Perzborn, E., Kubitza, D., & Misselwitz, F. (2007, July). Preclinical and Clinical Characteristics of Rivaroxaban: A Novel, Oral, Direct Factor Xa Inhibitor. Seminars in Thrombosis and Hemostasis. Georg Thieme Verlag KG.http://doi.org/10.1055/s-2007-982083
- Ganetsky, M., Babu, K. M., Salhanick, S. D., Brown, R. S., & Boyer, E. W. (2011, September 2). Dabigatran: Review of Pharmacology and Management of Bleeding Complications of This Novel Oral Anticoagulant. Journal of Medical Toxicology. Springer Science and Business Media LLC.http://doi.org/10.1007/s13181-011-0178-y
- Sarich, T. C., Peters, G., Berkowitz, S. D., Misselwitz, F., Nessel, C. C., Burton, P., … DiBattiste, P. M. (2013, May 23). Rivaroxaban: a novel oral anticoagulant for the prevention and treatment of several thrombosis‐mediated conditions. Annals of the New York Academy of Sciences. Wiley.http://doi.org/10.1111/nyas.12136
- FENGER‐ERIKSEN, C., MÜNSTER, A. ‐M ., & GROVE, E. L. (2014, April 9). New oral anticoagulants: clinical indications, monitoring and treatment of acute bleeding complications. Acta Anaesthesiologica Scandinavica. Wiley.http://doi.org/10.1111/aas.12319