The information contained on this page is intended
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The information contained on this page is intended
for US healthcare professionals only.  Patient siteFREE SAMPLES/COUPONS

325 mg Clinical Data

Clinical Study— Pharmacokinetic (PK)/Pharmacodynamic (PD) Comparison: Plain Aspirin, VAZALORE®, Enteric Coated Aspirin1

In a single-center, randomized, active-controlled, single-blind, triple crossover PK and PD study of antiplatelet activity over 3 days, in obese patients with type 2 diabetes.1

Time to Complete
Antiplatelet
Effect

In this study, VAZALORE 325 mg achieved 99% inhibition of thromboxane B2 generation significantly faster (12.5 hours) than enteric coated aspirin 325 mg (48.2 hours) (p<0.0001).1

This study design cannot provide data on cardiovascular outcomes.

Study population: obese patients with type 2 diabetes

Graph showing plain aspirin, VAZALORE and EC aspirin thromboxane B2 inhibition

Plasma
Acetylsalicylic
Acid (ASA) Concentration Versus Time

In this study population, the AUC of plasma concentrations were: VAZALORE (2523 ng x hr/ml), immediate release aspirin (1964 ng x hr/ml), and enteric coated aspirin (456 ng x hr/ml). Thus, absorption with VAZALORE 325 mg was 5X as high as that of enteric coated aspirin 325 mg (p<0.0001).1

AUC = area under curve

This study design cannot provide data on cardiovascular outcomes.

Study population: obese patients with type 2 diabetes

Graph showing 325 mg plain aspirin, VAZALORE and EC aspirin AUC

Inhibition of TXB2
GENERATION by 72 hours

In this study population, by 72 hours, VAZALORE 325 mg provided complete antiplatelet effect (≥99% inhibition of TXB2 generation) for almost twice as many patients as enteric coated aspirin 325 mg.1

This study design cannot provide data on cardiovascular outcomes.

Study population: obese patients with type 2 diabetes

Graph showing plain aspirin, VAZALORE and EC aspirin complete antiplatelet effect over time
Clinical Study—
Upper GI Injury: Plain Aspirin vs VAZALORE2
In a randomized, single-blind, multicenter, active-controlled study of upper GI damage of aspirin in healthy subjects in a 7-day study of oral 325 mg once daily, immediate release aspirin tablets or VAZALORE.2

Upper GI Damage Comparison

In this study, VAZALORE 325 mg caused significantly fewer erosions and ulcers than immediate release aspirin 325 mg after 7 days of therapy2:
• 47% lower risk of erosions or ulcers (NNT=5)
• 71% lower risk of ulcers (NNT=8)

ITT = intent to treat; NNT = number needed to treat

Two graphs showing percentage of subjects with damage after 7 days of therapy

References:

  1. Bhatt DL, Grosser T, Dong J-F, et al. Enteric coating and aspirin nonresponsiveness in patients with type 2 diabetes mellitus. J Am Coll Cardiol. 2017;69(6):603-612.
  2. Cryer B, Bhatt DL, Lanza FL, Dong JF, Lichtenberger LM, Marathi UK. Low-dose aspirin-induced ulceration is attenuated by aspirin–phosphatidylcholine: a randomized clinical trial. Am J Gastroenterol. 2011;106(2):272-277.

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VAZALORE works

 

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Opportunity for innovation in
aspirin delivery