Abstract
A prospective 6-month open, comparative study originally included600patients 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 - 200pa - 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. 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 inseverity of GI symptoms by results of the questionnaire: a significant improvement of compliance by the treatment satisfaction index in group 1and 2; and a 1.7 time decrease in the proportion of ASA-noncompliant patients were observed. According totheresults ofROC 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). 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. Itprovided 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.
Highlights
Predictors for development of major cardiovascular events in elderly patients with severe and extremely severe chronic obstructive pulmonary disease in combination with early stages of chronic kidney disease
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
Safety and compliance to the treatment were evaluated using standard tests and analogue scales; symptoms of dyspepsia were evaluated with a study-specific questionnaire
Summary
В исследование включались пациенты, находящи- по частоте любых острых сердечно-сосудистых собыеся на амбулаторном лечении, имевшие диагноз ИБС, тий (включая ИМ и сердечно-сосудистую смерть). Стабильной стенокардии II–III ФК и / или перенес- Учитывались показатели приверженности к терапии шие не менее 12 месяцев назад ИМ, получавшие анти- при длительном приеме АСК. Нарастание симптоматики по данным анкеты в динамике рассматривалось, наряду с другими ЖК осложнениями, как одна из конечных точек для оценки безопасности терапии препаратами АСК. При этом проведенный на начальном этапе работы ROC-анализ показал, что суммарный балл анкеты ≥3 достоверно предсказывает факт неприверженности и / или недостаточной приверженности с диагностической чувствительностью 58,9 %, специфичностью 56,3 % при площади под кривой 0,602 и р=0,002. Чаще всего перевод на прием Аспирина Кардио осуществляли при наличии в анамнезе ЖК осложнений, при появлении новых ЖК симптомов в период приема АСК или при наличии выраженных диспепсических проявлений на момент обследования (по данным анкеты, суммарный балл ≥3). Для определения порогового суммарного балла выраженности ЖК симптомов, связанного с риском неэффективности терапии, использовали ROC-анализ; Таблица 1. Клинические, демографические и лабораторные показатели у больных страт А, В и С на момент начала исследования
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