Certain risk factors result in increased immature platelet production and activation which may cause increases in thrombosis and cardiovascular mortality

  • Diabetes mellitus4
  • Obesity5
  • Smoking6
  • Cardiovascular disease7

Diabetes and ASCVD create a high risk for thrombosis. This is due to platelet differences including increased immature platelet production and high platelet turnover, resulting in highly reactive platelets. Patients with these platelet changes can have 3 times increased risk of CV events.16

Henry et al. Time-dependent aspirin efficacy demonstrating a significant recovery of aggregation by 24 hours with conventional aspirin

Newly formed immature platelets are associated with increased thrombosis and cardiovascular mortality

Immature platelets are more hyperreactive, resulting in:

  • Increased platelet adhesion9
  • Increased platelet sensitivity and activation10
  • Increased blood clotting10

Use immediate-release aspirin, not DURLAZA, in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

DURLAZA provides sustained platelet exposure to aspirin for 24-hour coverage

Mean ASA concentration following single dose of DURLAZA or regular aspirin1

Mean ASA (acetylsalicylic acid) concentration-time profile following single-dose administration of 162.5-mg DURLAZA or 81-mg regular aspirin.1

In contrast to regular aspirin, patients treated with a single dose of DURLAZA had measurable levels of salicylic acid at 24 hours.1

Regular aspirin leaves gaps in platelet inhibition

  • Regular aspirin leaves a substantial window of platelet production without aspirin in the bloodstream. Platelets under regular aspirin treatment are left unexposed for up to 20 hours11,12
  • Over 4 billion new platelets are produced every hour,13 potentially leaving up to 80 billion newly formed platelets without aspirin exposure for 75% of the dosing interval

The short half-life of regular aspirin can leave newly formed platelets uninhibited.

Use immediate-release aspirin, not DURLAZA, in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Important Safety Information

Indications and Usage

DURLAZA® (aspirin) Extended-Release Capsules 162.5 mg is indicated:

  • to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina;
  • to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack.

Limitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Important Safety Information

Contraindications: DURLAZA is contraindicated in patients with a hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. DURLAZA may cause severe urticaria, angioedema, or bronchospasm.

Warnings and precautions:

  • DURLAZA increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk for bleeding.
  • DURLAZA may cause gastric ulceration and bleeding. Avoid DURLAZA in patients with active peptic ulcer disease.
  • DURLAZA can cause fetal harm when administered to a pregnant woman, including low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal death. Avoid DURLAZA in the third trimester of pregnancy.

Adverse reactions: The following adverse reactions have been reported for products containing low dose aspirin:

  • Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, lethargy, seizures;
  • Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis;
  • Gastrointestinal: Dyspepsia, hepatic enzyme elevation, hepatitis, Reye's Syndrome;
  • Renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.

Drug interactions:

  • Alcohol: Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol.
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
  • Anticoagulant and antiplatelets: Increased risk of bleeding.
  • Anticonvulsants: Decreased phenytoin concentration and increased serum valproic acid levels.
  • Methotrexate: Increased risk of bone marrow toxicity.
  • NSAIDs: Increased risk of bleeding. Nonselective NSAIDs may interfere with the antiplatelet effect of DURLAZA.

Use in specific populations:

  • Pregnancy: Avoid use during the third trimester.
  • Hepatic Impairment: Avoid use in patients with severe impairment.
  • Renal Impairment: Avoid use in patients with GFR <10mL/min.

Please see full Prescribing Information for DURLAZA.