The aim of the study was to evaluate efficacy, safety and treatment compliance for different ASA forms (Aspirin Cardio, Cardiomagnyl and Trombo Ass) in a 6-month study.
Materials and methods: A prospective 6-month open, comparative study originally included 600 patients with IHD and stable angina who received chronic therapy with different forms of aspirin. In the prospective part of the study, these patients were subdivided into four groups: group 1 consisted of 200 patients switched to Aspirin Cardio; group 2 - 200 pa - tients receiving chronic therapy with this drug; group 3 - 100 patients continuing on the Trombo Ass treatment; and group 4 - 100 pa - tients who had been treated with Cardiomagnyl for a long time. Efficacy, safety and compliance to the treatment were evaluated using standard tests and analogue scales; symptoms of dyspepsia were evaluated with a study-specific questionnaire. Switching to Aspirin Cardio (group 1) was on discretion of the physician in charge based on the history of gastrointestinal (GI) complications or significant manifestations of dyspepsia.
Results: The efficacy in prevention of cardiovascular events was similar in all groups. No "major" or "minor, clinically significant" bleeding (ISTH) were observed. Proportions of patients with "minor" bleeding were similar in all groups with a tendency towards their decrease under the Aspirin Cardio treatment. After switching to Aspirin Cardio, positive changes in severity of GI symptoms by results of the questionnaire: a significant improvement of compliance by the treatment satisfaction index in group 1 and 2; and a 1.7 time decrease in the proportion of ASA-noncompliant patients were observed. According to the results of ROC analysis an average GI symptom score ≥3 predicted an improvement of compliance in case of switching to Aspirin Cardio with a diagnostic sensitivity of 72.3% and specificity of 51.1% (р=0.012) as well as alleviation of GI symptoms (sensitivity, 74.5%; specificity, 63.8%, р=0.001).
Conclusions: Different dosage forms of ASA are characterized with similar efficacy in prevention of cardiovascular events and effects on the risk of bleeding. Aspirin Cardio showed a better tolerability due to a less effect on GI symptoms. It provided a better compliance to chronic treatment. This study confirmed advisability of using the proposed questionnaire to evaluate GI symptoms for specification of prediction and modification of therapy.