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Dipyridamole
Indications
Dipyridamole is a medication with both antiplatelet and vasodilatory properties.
FDA-Approved Indications
Dipyridamole is approved by the US Food and Drug Administration (FDA) for use as an adjunct in thromboembolism prophylaxis in patients undergoing cardiac valve replacement and in thallium nuclear stress testing.[1][2]
Off-Label Uses
Dipyridamole is also used off-label to prevent stroke; however, it is not FDA-approved for this indication. The drug can be administered as a single agent or in combination with aspirin in an extended-release formulation (ASA-ERDP). This combination is FDA-approved for stroke prevention and as an alternative therapy in patients who experience intolerable headaches with other regimens. Off-label uses of aspirin with extended-release dipyridamole combination include the management of symptomatic carotid artery stenosis and maintaining hemodialysis graft patency.[3][4]
Additionally, the American Society of Sleep Medicine conditionally recommends dipyridamole over no treatment for adults with restless legs syndrome, based on low-certainty evidence. Iron studies should be performed, and any deficiencies corrected as needed; however, other medications are generally preferred.[5][6] Please see StatPearls' companion resource, "Dipyridamole Nuclear Stress Test," for more information.
Evidence
Stroke prevention: The indication for stroke prevention is primarily based on data obtained from the European Stroke Prevention Study 2 Trial (ESPS-2).[7] This randomized controlled trial evaluated stroke risk reduction in patients with recent transient ischemic attacks (TIA) or ischemic stroke. The patients meeting the inclusion criteria were categorized into 4 distinct treatment groups: placebo treatment, aspirin 25 mg twice daily, extended-release dipyridamole 200 mg twice daily, or a combination of aspirin 25 mg and extended-release dipyridamole 200 mg twice daily.
The ESPS-2 study concluded that the group that received the combination therapy with aspirin (25 mg) and extended-release dipyridamole (200 mg) showed a reduced risk of stroke compared to the placebo group. Furthermore, the combination treatment group demonstrated the most significant reduction in stroke risk, with an odds ratio (OR) of 0.59, compared to aspirin (OR=0.79) and extended-release dipyridamole (OR=0.81).
Additionally, a 2005 meta-analysis performed by Leonardi-Bee et al compiled data from randomized controlled trials and suggested that dipyridamole alone reduced the risk of recurrent stroke events compared to control arms.[8] However, the exact impact and validity of this finding are debated, as 59% of the data collected from this meta-analysis was derived from the ESPS-2 trial; excluding ESPS-2, the results were no longer statistically significant.
A 2009 study published in the New England Journal of Medicine compared the combination of ASA-ERDP with clopidogrel for preventing the risk of recurrent stroke.[9] This double-blinded study evaluated patients receiving aspirin 25 mg with extended-release dipyridamole 200 mg twice daily versus clopidogrel 75 mg once daily. The study demonstrated comparable outcomes in the primary endpoint of stroke recurrence, with similar rates between groups: 8.8% in the clopidogrel group and 9.0% in the ASA-ERDP group. The results indicated that neither treatment was superior in preventing stroke recurrence.
Further research has shown that, similar to aspirin and clopidogrel, ASA-ERDP is recommended for the secondary, long-term prevention of non-cardioembolic strokes.[10] This combination was also found to be safer and more efficient than aspirin alone in small vessel disease.[11] As per the 2021 guidelines from the American Heart Association and the American Stroke Association, antiplatelet therapy is recommended over oral anticoagulation for patients with non-cardioembolic ischemic stroke or TIA. This approach aims to lower the risk of recurrent ischemic stroke and other cardiovascular issues while also reducing bleeding risk.
For secondary prevention of ischemic stroke, recommended options include aspirin (50-325 mg) daily, clopidogrel (75 mg) daily, or the combination of aspirin (25 mg) and extended-release dipyridamole (200 mg) twice daily.[12][13] In patients with small subcortical infarction, a network meta-analysis of 19 randomized controlled trials demonstrated that cilostazol significantly reduced the incidence of major adverse cardiovascular events compared with other antiplatelet therapies.[14][13]
Thromboembolism prophylaxis in cardiac valve replacement (adjunct with warfarin): A 1994 meta-analysis by Pouleur and Buyse demonstrated the benefit of dipyridamole in patients with mechanical cardiac valve replacement by reducing the frequency and risk of embolic events.[15] The analysis, which included randomized controlled trials involving 1141 patients, showed a significant reduction in both fatal and nonfatal thromboembolic events when dipyridamole was combined with anticoagulation compared to anticoagulation alone. Overall, thromboembolic events were reduced by 56%, whereas fatal events decreased by 64%, underscoring the substantial role of dipyridamole in reducing thromboembolic complications after valve replacement.[15]
Additionally, a 1983 randomized controlled trial compared warfarin combined with either aspirin, dipyridamole, or no additional agent to evaluate the risk of adverse bleeding events in patients who underwent mechanical valve replacement. The study concluded that substituting aspirin with dipyridamole reduced the risk of adverse bleeding events by approximately 10% when used in combination with warfarin.[16]
Role in Thallium Myocardial Perfusion Imaging
Myocardial perfusion imaging is used to assess blood flow to the heart and evaluate coronary artery disease (CAD). Dipyridamole was the first agent introduced for pharmacological stress testing, which is now also performed using agents such as dobutamine and adenosine.[3][4] Pharmacological stress testing works by inducing coronary steal through dilation of normal coronary vessels, thereby revealing areas of ischemia and hypoperfusion on an electrocardiogram (ECG), echocardiogram, or nuclear scan. Dipyridamole facilitates this process by promoting coronary vasodilation via 2 main mechanisms—the hyperemic effect and the ischemic effect.[17]
Notably, in 2015, a study assessed the diagnostic value of a combined dipyridamole-plus-exercise stress testing protocol for individuals who were unable to achieve their target predicted heart rate. The combined protocol demonstrated higher sensitivity than exercise or dipyridamole alone; however, the difference did not reach statistical significance due to the small sample size.[18]
According to the 2018 American Society of Echocardiography guidelines, dipyridamole-induced vasodilator stress real-time myocardial contrast echocardiography at standard (0.56 mg/kg) or high (0.84 mg/kg) doses should be used to assess both myocardial perfusion and regional wall motion. This combined approach significantly improves the sensitivity for detecting CAD.[19]
Role in Restenosis Reduction Post-Coronary Artery Disease Stenting
Patients who have undergone coronary stenting face an annual 2% risk of complications, primarily due to stent restenosis. Evidence supports the use of dipyridamole as an approved therapeutic agent for its vasculoprotective effects, which help improve vascular patency by reducing neointimal proliferation and promoting stent healing.[20][21]
The American College of Chest Physicians 2012 guidelines recommend long-term antiplatelet therapy for patients with symptomatic carotid stenosis, including those who have recently undergone carotid endarterectomy. Recommended options include clopidogrel once daily, ASA-ERDP, or aspirin alone once daily, with clopidogrel or ASA-ERDP preferred over aspirin monotherapy.[22]
Mechanism of Action
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Mechanism of Action
Dipyridamole acts predominantly by inhibiting the function of phosphodiesterase and adenosine deaminase.[23] Phosphodiesterase is useful for the conversion of cyclic adenosine monophosphate (cAMP) and cyclic guanine monophosphate (cGMP) into their noncyclic equivalent. Inhibition of this enzyme increases the intracellular concentrations of these secondary messengers (cAMP and cGMP).[24][25] Elevated cAMP and cGMP levels reversibly inhibit platelet aggregation and platelet-related thrombosis, providing the basis for dipyridamole’s use in thromboembolism prophylaxis for patients with mechanical valve replacements (as an adjunct to anticoagulants) and in secondary stroke prophylaxis.[26][27]
Furthermore, the accumulation of these secondary messengers, along with the downstream release of prostacyclin (PGD2), promotes vasodilatory effects in the coronary artery vasculature.[25] This vasodilatory effect induces coronary steal in pharmacological stress testing to induce myocardial ischemia in vessels affected by CAD.
Pharmacokinetics
Absorption: Dipyridamole has an onset of action of approximately 24 minutes, with peak plasma concentrations typically achieved within 2 to 2.5 hours, indicating efficient and rapid gastrointestinal absorption.
Distribution: Dipyridamole has a volume of distribution that ranges between 2 and 3 L/kg. The drug is highly protein-bound in plasma, with 91% to 99% of the circulating drug bound to serum proteins, which can affect the availability of free drug and its tissue penetration.
Metabolism: Dipyridamole is primarily metabolized in the liver. Hepatic metabolism has a central role in its biotransformation. The involvement of specific CYP450 isoenzymes appears minimal or is not well-characterized.
Excretion: Dipyridamole is primarily eliminated through the feces, with minimal renal contribution. Total systemic clearance ranges from 2.3 to 3.5 mL/min/kg, and the terminal elimination half-life is approximately 10 to 12 hours. Dipyridamole is not dialyzable; therefore, making hemodialysis ineffective for overdose management.
Administration
Available Dosage Forms and Strengths
Dipyridamole is available in oral tablet strengths of 25 mg, 50 mg, and 75 mg, including generic formulations. The drug is also available as an intravenous (IV) solution in various concentrations, primarily used as an adjunct during pharmacological stress testing and typically administered over a period of 4 minutes.
Indication-Specific Dosing
Thromboembolism prophylaxis in post-cardiac valve replacement: The recommended dosage is 5 to 100 mg PO 4 times daily, administered as an adjunct to warfarin.
Myocardial perfusion scan: Dipyridamole is administered as an IV infusion at a rate of 0.142 mg/kg/min IV over a period of 4 minutes. The maximal allowed total dose is 60 mg.
Specific Patient Populations
Hepatic impairment: Elevated hepatic enzymes and rare cases of hepatic failure have been reported with dipyridamole use. Caution is advised when prescribing to patients with liver impairment.
Renal impairment: The manufacturer provides no specific dosage adjustment recommendations for patients with renal impairment.
Pregnancy considerations: Animal reproduction studies in mice, rabbits, and rats at oral doses up to approximately 1.5, 2, and 25 times the maximum recommended daily human oral dose (on a mg/m2 basis), respectively, have shown no evidence of fetal harm. However, due to the absence of well-controlled studies in pregnant women and the limitations of animal data in predicting human response, dipyridamole should be used during pregnancy only when clearly necessary.
Breastfeeding considerations: Currently, there are no published data regarding the use of dipyridamole during breastfeeding. However, the label indicates that it is excreted in human milk. Until further information is available, dipyridamole should be used cautiously while breastfeeding, particularly when nursing a newborn or preterm infant. If a lactating mother is prescribed dipyridamole, infants should be monitored for signs of bruising or bleeding.[28]
Pediatric patients: The safety and efficacy of dipyridamole in children aged 12 or younger have not been established. Limited data support the use of this medication in pediatric patients; however, an off-label dose of 2 to 5 mg/kg/d is recommended for its antiplatelet effect in the prevention of thromboembolism as an adjunct to warfarin or aspirin, particularly in association with cardiac valve conditions. Given the limited data, dipyridamole is not considered a first-line agent for antiplatelet therapy in pediatric and adolescent patients.[29]
Older patients: According to the 2023 American Geriatrics Society Beers Criteria, dipyridamole may cause orthostatic hypotension and should generally be avoided in the geriatric population. However, the IV formulation is considered acceptable for use during cardiac stress testing.[30]
Adverse Effects
The most frequently reported adverse effects include:
- Chest pain (20%)
- Angina exacerbation, with IV administration (19.7%)
- Abnormal ECG findings (15.9%)
- Headache associated with IV use (12.2%)
- Dizziness (12%) [31]
Adverse Reactions by System Organ Classification
Generalized system effects: Diaphoresis, fatigue, increased appetite and thirst, malaise, and weakness.
Cardiopulmonary effects: Arrhythmia, bronchospasm, cough, chest pain, cardiomyopathy, flushing, myocardial infarction, hypotension, ischemic changes on ECG, orthostatic hypotension, labile blood pressure, tachycardia, palpitations, and shortness of breath.
Central nervous system effects: Ataxia, changes in vision, dizziness, generalized weakness, headache, hypertonia, numbness/tingling, tinnitus, tremor, and vertigo.
Dermatological system effects: Hypersensitivity reactions, flushing, injection site reactions, pruritus, skin rash, and urticaria.
Gastrointestinal system effects: Abdominal pain, dyspepsia, dysphagia, nausea, eructation, flatulence, diarrhea, tenesmus, and vomiting.
Psychiatric effects: Depersonalization.
Lymphatic system effects: Edema.
Musculoskeletal effects: Arthralgia, back pain, claudication, generalized weakness, myalgia, and muscle rigidity.
Drug-Drug Interactions
- Combination of aspirin and dipyridamole with other antiplatelet agents or anticoagulants increases the risk of bleeding; therefore, a detailed risk-benefit evaluation should be considered.[32][33]
- For patients taking dipyridamole tablets who require pharmacological stress testing with IV dipyridamole or other adenosinergic agents, such as adenosine, clinicians should discontinue dipyridamole tablets 48 hours before stress testing.
-
Dipyridamole has been reported to increase the plasma levels and enhance the cardiovascular effects of adenosine. Therefore, dosage adjustment of adenosine may be necessary. If dipyridamole is not discontinued at least 48 hours before stress testing, the potential risk of cardiovascular adverse events with IV adenosinergic agents may be significantly increased.
-
Dipyridamole may antagonize the anticholinesterase action of cholinesterase inhibitors, potentially worsening myasthenia gravis.
- Dipyridamole injection should not be combined with other medications in the same syringe or infusion container.
Contraindications
According to the product labeling, dipyridamole is contraindicated in patients with a history of hypersensitivity reactions to the drug.[34]
Warning and Precautions
Contraindications for stress test: The American Society of Nuclear Cardiology (ASNC) recommends that dipyridamole stress testing should not be performed in patients with active wheezing or a documented history of significant reactive airway disease. The use of this drug is contraindicated in individuals with systolic blood pressure below 90 mm Hg due to the risk of severe hypotension, particularly in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, valvular heart disease, pericardial effusion, or significant carotid artery stenosis associated with cerebrovascular insufficiency. Additionally, uncontrolled hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) warrants avoidance of the test.
Patients should refrain from consuming caffeine-containing substances for at least 12 hours before testing. Additional absolute contraindications include unstable angina and recent acute coronary syndrome.
Relative contraindications of dipyridamole include sinus bradycardia (<40 bpm/min), Mobitz I second-degree AV block (Wenckebach), or severe aortic stenosis.[35]
Intravenous formulation: Severe adverse reactions have been reported infrequently with IV administration. The IV formulation should be used with caution in patients with bronchospastic disease or unstable angina. Aminophylline should be readily available for use in urgent or emergency situations, particularly when administered via the IV dosage form.
Hepatic impairment: Caution is advised in patients with hepatic impairment, as they may have an increased risk of bleeding.
Aortic stenosis: Vasodilator stress myocardial perfusion imaging is generally not preferred in patients with clinically significant aortic stenosis. In symptomatic individuals, surgical aortic valve replacement is the treatment of choice, and diagnostic evaluation typically involves invasive coronary angiography rather than noninvasive functional imaging.[35]
Monitoring
Current guidelines do not recommend routine laboratory testing for therapeutic monitoring of dipyridamole, and no scheduled laboratory evaluations are required for associated toxicities. The ASNC recommends monitoring patients for toxicity during perfusion testing, with particular attention to signs of hypoperfusion, including extremity cyanosis, pallor, or decreased temperature.[36]
In addition to these physical signs, clinicians should closely observe changes in heart rate, blood pressure, and respiration while using dipyridamole for pharmacological stress testing.[31][35] Furthermore, according to the American Society of Interventional Pain Physicians, antiplatelet agents such as dipyridamole, cilostazol, and the combination product dipyridamole plus aspirin may be continued for low- and intermediate-risk procedures. For high-risk interventions, dipyridamole and cilostazol may either be continued or withheld for 2 days.[37]
Toxicity
Signs and Symptoms of Overdose
Due to its hemodynamic effects, dipyridamole overdose may present with symptoms such as facial flushing, sweating, agitation, weakness, and dizziness. Hypotension and tachycardia can also be observed.[38]
Management of Overdose
Aminophylline (50-250 mg IV push over 30-60 seconds) should be readily available for use in the event of urgent or emergent complications or adverse effects of dipyridamole. Administration should occur no earlier than 1 minute after the radiotracer injection is administered.[35] This intervention is particularly indicated for adverse reactions during pharmacological stress testing. Additionally, the Poison Control Center should be contacted at 800-222-1222.
Enhancing Healthcare Team Outcomes
When using dipyridamole for pharmacological stress testing, vigilant monitoring for clinical signs of adverse reactions is essential. In particular, vigilant observation for evidence of hypoperfusion during diagnostic testing is essential to help prevent severe adverse events. The entire interprofessional stress-testing team, including the cardiologists, nurses, ultrasound technicians, and other assisting personnel, must be knowledgeable about and actively assess for both hypoperfusion and dipyridamole-related toxicity.
Pharmacists play a key role by reviewing the patient’s medication profile for potential drug-drug interactions and promptly alerting the team of any findings that may raise concerns. In addition to active monitoring, it is essential to have the necessary resources readily available to reverse induced hypoperfusion and prevent adverse sequelae. Maintaining an adequate supply of aminophylline, along with appropriate syringes, is essential to ensure timely reversal of adverse effects when needed.[35]
Effective interprofessional collaboration among physicians, nurse practitioners, physician assistants, nurses, technicians, and pharmacists is crucial for optimizing patient safety, improving outcomes, and minimizing adverse events.
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Level 3 (low-level) evidence