In high-risk patients with Diabetes and Cardiovascular Disease PLATELETS AND RISKS ARE DIFFERENT

DURLAZA® to reduce the risk of heart attacks, strokes, or death in high-risk patients such as those with diabetes and cardiovascular disease

Patients with diabetes suffer from the highest rate of CVD EVENTS

Data from the REACH registry, an international prospective cohort, illustrating the cumulative incidence of cardiovascular death, MI, or CVA over a 4-year period in patients with and without DM2 CVA= cerebrovascular accident.3

Cardiovascular Disease IN PATIENTS WITH DIABETES Creates a Highly Thrombotic Disease State

In high risk patients, platelet production and turnover may be increased due to several factors:

  • Diabetes mellitus
  • Elevated BMI
  • Coronary Artery Disease

Immature platelets are more hyperactive, resulting in:

  • Increased platelet adhesion
  • Increased platelet sensitivity and activation
  • Increased blood clotting

PATIENTS WITH CVD AND DIABETES produce a substantial number of platelets after regular aspirin is cleared from the blood

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 hours,11,12 potentially leaving up to 80 billion newly formed platelets without aspirin exposure for 75% of the dosing interval.

DURLAZA, A PROVEN ER TECHNOLOGY formulation that provides 24-hour aspirin release.

Characteristic diffusion-based dissolution profile based on Fick's second law.

Platelet Inhibition in Patients with DIABETES MELLITUS AND CVD

Platelet Aggregation (blood clotting) assessed by LTA, Multiplatelet Analyzer© and VerifyNow© Aspirin Assay. Blood clotting was assessed after days 10-14 of treatment.15

Most patients can fill a DURLAZA prescription WITH LITTLE OUT-OF-POCKET COSTS

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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.