9th International Conference and Exhibition on Pharmacovigilance & Drug Safety
Jorge I Gonzalez Borroto
Grupo Ferrer Internacional, Spain
Title: Impact of the polypill approach in the efficacy and safety of trinomia®: Post-marketing pharmacovigilance data after three-years
Biography: Jorge I Gonzalez Borroto
Statement of the Problem: Fixed dose combination therapy including acetylsalicylic acid, beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors, and statins have been advocated by the World Health Organization (WHO) for Cardiovascular Disease (CVD) secondary prevention since 2001 due to better efficacy, adherence, scalability, and cost-effectiveness. Trinomia is a fixed dose combination therapy for CVD secondary prevention with demonstrated similar bioequivalence with respect to the reference drugs. The expected patient´s efficacy of this cardiovascular-polypill show similar/greater reduction in risk factors as well as a greater increase in adherence compared with usual treatments in CVD secondary prevention. The 2012 European Society of Cardiology Guidelines on cardiovascular disease prevention in clinical practice states that reducing dosage demands is the most effective single approach toward enhancing adherence. Trinomia will cover the requirements to reduce dosage demands in adult patients.
Methodology: Polypill project (trinomia) is the European new fixed-drug combination developed as a therapy for secondary CVD prevention through a public-private strategic partnership between the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Spain and Ferrer Internacional S.A., Spain to help overcome the unmet clinical need in CVD prevention.
Findings: Trinomia is currently an approved new fixed dose combination and constitute a galenic-innovation combining several active ingredients that concomitantly reduce risk factors or pathological mechanisms of CVD in a single capsule. Multi-treatments schedules are frequent after cardiovascular events and represent health issues, such as adverse drug-drug interactions, medication errors and treatment non-adherence.
Conclusion & Significance: The CNIC-Ferrer polypill strategy has recently progressed in the CVD field, reducing complex-medication regimen, helping to solve additional risks associated with poly-medicated patients. Trinomia’s pharmacovigilance post-marketing data after three-years demonstrate as expected, that is a well-tolerated drug with good safety profile representing a valuable alternative for secondary prevention of CVD.