[Evaluation of efficacy and safety of hypertension treatment with original angiotensin-converting enzyme inhibitors: the comparison of original and generic formulations].

UNLABELLED: The hypertension is a civilization disease, slowly destroying the cardio-vascular system and leading to serious complications, which may result in patient death. Critical factors enhancing the proper functioning of the body are: properly selected pharmacotherapy and the self-control of the blood pressure.

THE AIM OF THIS STUDY: was to evaluate the effectiveness and safety of the hypertension treatment with generic and original formulations of angiotensin converting enzyme (ACE) inhibitors.

MATERIAL AND

METHODS

To the study, which consisted of an interview and completed a joint survey were enrolled 120 patients with hypertension therapy based on formulations of ACE inhibitors group. Data for the analysis were obtained from surveys conducted in: Department of Angiology, Hypertension and Diabetology, Department and Clinic of Endocrinology, Diabetology and Isotope Therapy and its Clinic for Diabetic Outpatients, in the period from 03/02/2011 to 20/04/2011.

RESULTS

Out of 120 surveyed hypertensive patients treated with ACEI, 79 persons (66%) received the original preparations and 41 (34%) generic medications. Most preparations contained ramipril: 78 patients, of whom 50 received the original formulations and 28 a generic one. In this population no differences were found in the reduction of the systolic and the diastolic blood pressure between groups of patients receiving original and generic formulations. The most common adverse effects (AE) reported by patients were cough (n = 16), hypotension (n = 7), paresthesia (n = 6), skin lesions (n = 6), weakness (n = 5), headache and dizziness (n = 5). Some of these, i.e.: cough, weakness, headaches and dizziness, occurred more frequently in patients receiving therapy with generic preparations.

CONCLUSIONS

Both the reference and generic preparations showed similar efficacy in reducing systolic and diastolic pressure. The therapy with original drugs leads less frequently to adverse effects such as cough, weakness, headaches and dizziness.