Assessment of the safety profile of the product EGIRAMLON® in patients with hypertension Original article

Abstract

Introduction: The product EGIRAMLON® has been introduced to the market after proving similar to the original drugs (ramipril and amlodipine) pharmacokinetic profile. No clinical trial evaluating safety and tolerability profile of the product prior to registration has been conducted. The aim of this observational study was to assess the safety profile of the product EGIRAMLON® in the therapy of hypertensive patients previously receiving ramipril and amlodipine separately.

Patients and methods: Adverse reactions associated with the use of EGIRAMLON® were recorded in post-marketing, open, non-interventional, non-randomized, multicenter observation study.

Results: The study included 24 240 patients with hypertension using product EGIRAMLON® for 25 (± 14) days. During 57 (± 29) days of observation, a total of 110 adverse events that could be related to the product EGIRAMLON® in 84 patients (0.35%) were recorded, none of them was sever. All reported adverse events were previously described for the original drugs. The percentage of patients evaluated tolerability of EGIRAMLON® as a very good increased during the follow-up period from 74.5% to 87.1%. Systolic blood pressure and diastolic blood pressures decreased from 144.5 (± 14.2) to 131.3 (± 8.8) mmHg and from 87.3 (± 8.8) to 80.3 (± 6.2) mmHg, respectively. The proportion of patients with good blood pressure control increased from 32.8% to 76.5%.

Conclusion: The obtained results confirm the safety of EGIRAMLON® and indicate its good tolerability in patients treated for hypertension previously receiving ramipril and amlodipine separately. The combine therapy results in more efficient treatment of hypertension than separately prescribed drugs.