We have carried out an open randomized study of metoprolol tartrate´s protracted form safety (Metocard® Retard, production of «Polpharma», Poland) and metoprolol tartrate´s unprotracted form safety (Metocard®, production of «Polpharma», Poland) in patients with CHD and GERD association.
Materials and methods. 60 patients were examined. They were randomized into 2 groups of 30 persons in each one. The inclusion criteria: CHD. Exertional angina of 2-3 functional class and /or CHD. Old myocardial infarction combined with endoscopically positive form of GERD, acceptability of beta-blockers. The GERD was diagnosed on the data of fibroesophagogastroduodenoscopy (FEGDS). The exclusion criteria: acute forms of CHD, noncoronarogenic forms of the cardiac muscle damage, acute infectious diseases, chronic illnesses in decompensation stage, cardiac failures, cardiac decompensation of IV functional class according to NYHA, malignant neoplasms, well-known contraindications to metoprolol application. The patients of both groups were commeasuered according to their sex, age (the average age - 65±5) and comorbidity. The investigation duration was 30 days. The first group patients got 200 mg of Metocard® Retard per day; the second group got Metocard® in daily dose of 200 mg. Besides the specified preparations all the patients got ACE inhibitors, antiaggregants and inhibitors of protonic pomp in standard doses. For the purpose of estimation of the total GER episode number per day and daily average factor of intraesophageal pH (IP pH) the daily IP pH-monitoring with the application of "Gastroscan-24" unit was used, and it was carried out right after the randomizing and in 30 days from the starting moment of the investigation.
Results. The initial examination data in the selected groups didn´t differ. At the administration of the protracted preparation the IP pH-metria factors authentically didn´t change, while in the patients, who got unprotracted metoprolol, the last some deteriorated. In the patients, who got Metocard®, the daily average IP pH factor after the treatment made 3,31±0,12, while in the patients, who got Metocard® Retard, - 3,61±0,11 (<0,05). At the investigation of the total number of GER episodes per day authentic differences (<0,05) were obtained: the minimal number of GER episodes was registered in the patients, who got Metocard® Retard, and the maximal one - in the patients, who got Metocard®. Thus, according to the data of IP pH-metria, the GER intensity was authentically more (<0,05) in the patients, who got the treatment with Metocard®, than in the patients, who got Metocard® Retard.
Conclusions. The findings allow supposing a more unfavourable run of GERD, and accordingly, a more risk of myocardium electrical instability development in patients with combined pathology at unprotracted metoprolol form application. Thus, Metocard® Retard is the agent of choice in patients with coronary heart disease synthropy and gastroesophageal reflux disease.
The article is admitted to the International Scientific Conference "Fundamental and applied problems of medicine and biology"; Italy (Sicily), July 15-22, 2007.; came to the editorial office on 25.06.07