Key result
Extended-release acetylsalicylic acid (ER-ASA) showed a safety profile consistent with immediate-release ASA, with adverse events in 23.4% of ER-ASA patients versus 26.2% of IR-ASA patients.
Why the study?
Does extended-release acetylsalicylic acid have comparable safety and tolerability to immediate-release and enteric-coated formulations in patients with atherosclerosis and healthy volunteers?
Does extended-release acetylsalicylic acid have comparable safety and tolerability to immediate-release and enteric-coated formulations in patients with atherosclerosis and healthy volunteers?
Absolute Event Rate: 23.4% vs 26.2%
Extended-release acetylsalicylic acid demonstrates a safety and tolerability profile consistent with immediate-release and enteric-coated formulations.
ER-ASA offers comparable safety to IR-ASA; extends limited evidence on formulation tolerability in atherosclerosis.
AIM: To evaluate tolerability of a new extended-release acetylsalicylic acid (ER-ASA). MATERIALS & METHODS: Daily ER-ASA (162.5-1300 mg) for up to 6 weeks was evaluated (four studies; n = 565). Safety of ER-ASA, immediate-release (IR; 150-1200 mg) ASA and enteric-coated ASA (75 mg) was assessed. RESULTS: Forty-three out of 184 (23.4%) patients with atherosclerosis (ER-ASA 162.5 mg group) experienced adverse events versus 51/195 (26.2%) patients receiving IR-ASA 150 mg. Overall, 48.7 and 51.3% of patients in the ER-ASA group experienced no gastrointestinal discomfort or any gastrointestinal symptoms, respectively, versus 42.1 and 57.9% of patients in the IR-ASA group, respectively. In healthy volunteers, adverse event incidence was comparable between ER-ASA and IR-ASA and between ER-ASA and enteric-coated ASA. CONCLUSION: Safety of the new ER-ASA formulation was consistent with other ASA formulations.
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Patrick et al. (2016) conducted a review in Atherosclerosis and healthy volunteers (n=565). Extended-release acetylsalicylic acid (ER-ASA) vs. Immediate-release ASA (150-1200 mg) and enteric-coated ASA (75 mg) was evaluated on Adverse events. Extended-release acetylsalicylic acid (ER-ASA) showed a safety profile consistent with immediate-release ASA, with adverse events in 23.4% of ER-ASA patients versus 26.2% of IR-ASA patients.
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