Estudio comparativo de reacciones adversas sospechosas con fármacos inhibidores de la bomba de protones reportados al programa Mundial de farmacovigilancia de 1984 a 2017
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Vera Ortiz, Lizeth Yuliana | 2018
related to acidity and gastroesophageal reflux. Within this group of medicines we can find Omeprazole, Esomeprazole, Rabeprazole, Lansoprazole and Dexlansoprazole among others. These are generally characterized as very safe drugs that have a high efficacy and safety, however the increase in their consumption and prescription in recent years has caused the appearance of various disorders present both in their short-term and long-term use, being the most worrisome the disorders presented by consuming them in long periods of time.
At the same time and based on different problems that have arisen worldwide with the consumption of medicines, we have the birth of different pharmacovigilance programs, being the pioneer the international pharmacovigilance program of the WHO (World Health Organization), the which, with the help of other entities such as the UMC (Uppsala Monitoring Center), have helped to considerably improve the health of people with their programs for the reporting and control of adverse drug events and thanks to this they have improved more and more, creating better programs and providing information for the whole community in general. Among these programs we have VigiBase and VigiAccess, databases that support each other, being the VigiAccess the one that takes the information that is reported in the VigiBase, and also having the characteristic of stratifying the notifications made by sex, age, geographical location, year of report and classify the reactions according to their symptomatology.
With the help of this database it is that in this study the different analyzes of each of the PPIs mentioned above are carried out and that the purpose is to compare the adverse reactions reported in these databases for each of the aforementioned drugs, evaluating the variables that can be obtained from this interface and in this way establish which factors influence or have influenced over the years that may have increased or decreased the number of adverse reactions reported, addressing issues such as self-medication, self-prescription, safety of the different generations of PPIs, a poor diagnosis, among others.
According to the results obtained and clearly evidencing a problem of duplication of information within the VigiAccess interface for some items, we can establish that the drugs that report the most adverse reactions are Omeprazole and Esomeprazole, as well as the one that presents the least is Dexlansoprazole, in turn in terms of sex reports, there is a clear advantage of male versus female having the latter a greater number of reports. In terms of geographical location, we observed a greater number of reports for the American continent and the lowest for the continent of Africa, by age, people between 44 and 65 are the ones that have presented the most reactions and per year of reports, each PPI has a year in which more events have been presented, however Esomeprazole is the one that presents major peaks in many years different from the other PPIs
From the above it was concluded that Esomeprazole was the drug with the most reports presented during the years from 1984 to 2017 followed by Omeprazole, something curious considering that Omeprazole is the longest PPI on the market, however to take into account that there are data duplication errors that could affect the result. In turn, it was possible to determine, based on the reported events, which PPIs have higher and lower reports according to the year, geographical location, sex and age, which allows determining which population is the most vulnerable, also if it has been improved. the safety of PPIs with the development of different generations, or if factors such as location or gender influence to present more or less adverse reactions, also taking into account pharmacovigilance programs in different parts of the world.
Finally, and with the help of the information obtained, this scientific article was developed, and a brochure was designed with clear and concrete information about the care and proper use when consuming a PPI, making known its main functions as well as complications and This way inform about the importance of reporting the eventualities that may occur when consuming these medications.
LEER