Mapping Adverse Drug Reactions burden in Mono- and Dual-Antiplatelet Therapy: A Prospective Hospital-Based Study in CAD Patients

Background

Antiplatelet therapy is central to managing Coronary Artery Disease (CAD), but benefits are offset by Adverse Drug Reactions (ADRs), particularly bleeding.

Objectives

To compare the causality, severity, and preventability of ADRs associated with mono- and dual-antiplatelet therapy among hospitalized CAD patients.

Materials and Methods

A six-month prospective observational study in a tertiary care hospital included adult CAD patients on MAPT or DAPT. ADRs were identified via interviews and record reviews, then assessed using WHO-UMC, Hartwig-Siegel, and standard preventability tools. Data were analyzed using SPSS 26.0.

Results

Of 252 patients, 179 ADRs were found (125 in DAPT; 54 in MAPT). Gastrointestinal bleeding was most common. Intracranial hemorrhage and ticagrelor-induced dyspnea were more frequent with DAPT. DAPT ADRs more often required drug withdrawal or dose modification.

Conclusion

DAPT has a significantly higher ADR burden than monotherapy. Many ADRs are preventable, highlighting the need for individualized selection and vigilant monitoring.