Safety and Tolerability of extended-release Acetylsalicylic Acid Capsules: A Summary of double-blind Comparative Studies

Abstract

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.

KEYWORDS :

• antiplatelet
• aspirin
• secondary prevention

Author contributions

All of the authors report making equal contributions to the writing of the manuscript and analyzing of the data.

Financial & competing interests disclosure

J Patrick, A Johnson, L Dillaha and AT Pennell were employees of New Haven Pharmaceuticals, Inc., at the time the study was conducted. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Technical editorial and medical writing assistance, under direction of the authors, was provided by MB Moncrief, and L Nelson, Synchrony Medical Communications, LLC, West Chester, PA, USA. New Haven Pharmaceuticals funded the writing assistance.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.