Tackling potentially inappropriate prescriptions in older adults: development of deprescribing criteria by consensus from experts in Colombia, Argentina, and Spain.

BACKGROUND: Potentially inappropriate medication use is prevalent among older adults in primary care, leading to increased morbidity, adverse drug reactions, hospitalizations, and mortality. This study aimed to develop and validate a tool for identifying PIMs in older adults within the primary care setting. The tool is composed of a list of criteria and was created based on consensus among experts from three Spanish-speaking countries, including two from Latin America. METHODS: A literature review was conducted to identify existing tools, and prescription patterns were evaluated in a cohort of 36,111 older adults. An electronic Delphi method, consisting of two rounds, was used to reach a formal expert consensus. The panel included 18 experts from Spain, Colombia, and Argentina. The content validity index, validity of each content item, and Kappa Fleiss statistical measure were used to establish reliability. RESULTS: Round one did not yield a consensus, but a definitive consensus was reached in round two. The resulting tool consisted of a list of 5 general recommendations per disease, along with 33 criteria related to potential problems, recommendations, and alternative therapeutic options. The overall content validity of the tool was 0.87, with a Kappa value of 0.69 (95% CI 0.64-0.73; Substantial). CONCLUSIONS: The developed criteria provide a novel list that allows for a comprehensive approach to pharmacotherapy in older adults, intending to reduce inappropriate medication use, ineffective treatments, prophylactic therapies, and treatments with an unfavorable risk-benefit ratio for the given condition. Further studies are necessary to evaluate the impact of these criteria on health outcomes.

Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019

Abstract Hepatic injury has been documented in patients with coronavirus disease 2019 (COVID-19). However, pharmacotherapy can frequently impact liver alterations, given the known hepatotoxic potential of drugs not effective to treat COVID-19. The objective of the present study was to evaluate reports of suspected liver reactions to drugs used for treating COVID-19, compare their use for other indications among patients with COVID-19, and assess possible interactions between them. We obtained reports on drugs used to treat COVID-19 (tocilizumab, remdesivir, hydroxychloroquine, and/or lopinavir/ritonavir), registered on June 30, 2020, from the Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard. We then analyzed the risk of developing liver events with these drugs by calculating the reported odds ratios (ROR). We identified 662, 744, and 1381 reports related to tocilizumab, lopinavir/ ritonavir, and hydroxychloroquine use, respectively. The RORs (95% confidence intervals) were 6.32 (5.28-7.56), 6.12 (5.22-7.17), and 9.07 (8.00-10.29), respectively, demonstrating an increased risk of liver events among patients with COVID-19 when compared with uninfected patients. The elevated risk of reporting adverse liver events in patients with COVID-19 who receive these drugs, alone or in combination, highlights the need for careful drug selection and efforts to reduce drug combinations without notable benefits. Similar to any other condition, the use of drugs without established efficacy should be avoided.

Bleeding associated with self-medication in warfarin users: A prospective observational study in Ijuí (Brazil)

Abstract Warfarin has been associated with bleeding and venous thromboembolism. Objective: This study aimed to estimate the association between bleeding and concomitant self-medication, and the incidence of adverse drug reactions in patients using warfarin. Setting: the public health network of Ijuí, a municipality in southern Brazil. This was an open prospective cohort, conducted for a period of 18 months with users of warfarin, treated at the public health service. The association between bleeding and self-medication was evaluated by means of the Cox Model with left truncation, using the time variable. Main outcome measurement: bleeding reported in the follow-up. Cases of thromboembolism and death were also registered. All patients treated with warfarin in the public health system of the municipality (98) were identified. Sixty-eight were interviewed and followed up, of whom 63 completed follow-up and five died during the study. Bleeding rates of 37.7 /100 patients/year, thromboembolism of 4.8/100 patients / year and deaths of 4.8 /100 patients / year were observed. The results showed that patients, who take warfarin and self-medicated present a two-fold increased bleeding, compared with those who do not self-medicate. The bleeding risk associated with self-medication ranged from 2.001 to 2.685; those values maintained their significance even when adjusted for number of interactions, CYP polymorphism, TTR and age in COX analysis. These results greatly suggest the need for providing greater assistance to patients who take anticoagulant medications with the purpose of reducing self-medication and consequently, adverse reactions.

Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database.

The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.

Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database / Potencial nefropatia associada ao uso do remdesivir para COVID-19: análise de uma base de dados de farmacovigilância / Potenciales lesiones renales asociadas con el uso de remdesivir para la COVID-19: análisis de una base de datos de farmacovigilancia

Abstract: The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.

Resumo: De acordo com a Agência de Controle de Alimentos e Medicamentos dos Estados Unidos (FDA), a prescrição do remdesivir deve ser feita com cautela em pacientes com taxa de filtração glomerular estimada (TFGe) < 30, sendo que diversos estudos relatam risco de eventos adversos renais. São limitados os dados disponíveis sobre o perfil de segurança renal do remdesivir. Assim, analisamos as reações adversas renais e urinárias atribuídas ao remdesivir e notificadas em um grande base de dados abertos de farmacovigilância. Obtivemos notificações sobre remdesivir e outros medicamentos usados para tratar a COVID-19 (tocilizumabe, hidroxicloroquina, lopinavir/ritonavir) registradas até 30 de setembro de 2020 do Sistema de Notificação de Eventos Adversos da FDA (FAERS). Analisamos as razões de chances de notificação (RORs) para notificações de eventos adversos renais e urinários referentes ao remdesivir e outros medicamentos. Encontramos 2.922 notificações sobre remdesivir registradas no FAERS para COVID-19. Entre esses casos, foram notificados 493 efeitos adversos renais e urinários (16,9%). Os eventos mais frequentes foram lesão renal aguda (338; 11,6%), comprometimento renal (86; 2,9%) e insuficiência renal (53; 1,8%). Comparado com a hidroxicloroquina, lopinavir/ritonavir ou tocilizumabe, o uso do remdesivir esteve associado com um aumento das chances de notificação de transtornos renais e urinários, independentemente do sexo e idade dos pacientes (2,53; IC95%: 2,10-3,06). A ROR permaneceu significativo quando limitamos a análise à hidroxicloroquina (4,31; IC95%: 3,25-5,71) ou ao tocilizumabe (3,92; IC95%: 2,51-6,12). Nossos resultados corroboram outros estudos e destacam a utilidade para profissionais da saúde que usam esse novo antiviral para tratar a COVID-19, sobretudo em função de sua baixa eficácia.

Resumen: La Agencia Americana de Control de Alimentos y Medicamentos (FDA) ha destacado que la prescripción de remdesivir debe ser prudente con pacientes con tasa de filtración glomerular estimada (TGFe) < 30; además, algunos estudios informaron del riesgo de reacciones adversas renales. La información disponible sobre el perfil de seguridad renal, en el caso del remdesivir, es limitada. Por ello, analizamos las reacciones adversas renales y urinarias atribuidas al remdesivir e notificadas en una extensa base de datos abierta de farmacovigilancia. Obtuvimos las notificaciones de remdesivir y otros medicamentos usados para tratar la COVID-19 (tocilizumab, hidroxicloroquina, lopinavir/ritonavir) registrados el 30 de septiembre de 2020 por el Sistema de Notificación de Eventos Adversos de la FDA (FAERS). Analizamos las odds ratios informadas (RORs) en el caso de informes de eventos adversos renales y urinarios adversos relacionados con el remdesivir y otros medicamentos. En el FAERS, encontramos 2.922 notificaciones de remdesivir registradas como medicament sospechoso usado en COVID-19. De estos, habían 493 con efectos renales y urinarios adversos (16,9%). Los efectos adversos más frecuentes fueron lesiones renales agudas (338; 11,6%), insuficiencia renal (86; 2,9%), y fallo renal (53; 1,8%). Frente a hidroxicloroquina, lopinavir/ritonavir, o tocilizumab, el uso de remdesivir se asoció con un riesgo mayor de notificar alteraciones renales y urinarios, independientemente del género y edad de los pacientes (2,53; IC95%: 2,10-3,06). La ROR permaneció significativo al restringir el análisis a la hidroxicloroquina (4,31; IC95%: 3,25-5,71) o tocilizumab (3,92; IC95%: 2,51-6,12). Nuestros resultados corroboran datos previos, algo que podría ser extremadamente útil para los profesionales de la salud que decidan usar este nuevo antiviral para tratar la COVID-19, sobre todo conociendo su baja eficacia.

Development of a stepwise tool to aide primary health care professionals in the process of deprescribing in older persons.

OBJECTIVE: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons. METHODS: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications. A 2-round electronic Delphi method was conducted to establish consensus. Eighteen experts from different countries (Colombia, Spain and Argentina) accepted to be part of the panel representing geriatricians, internists, endocrinologist, general practitioners, pharmacologists, clinical pharmacists, family physicians and nurses. Panel members were asked to mark a Likert Scale from 1 to 9 points (1= strongly disagree, 9= strongly agree). The content validity ratio, item-level content validity, and Fleiss' Kappa statistics was measured to establish reliability. The same voting method was used for round 2. RESULTS: A 7-question algorithm was proposed. Each question was part of a domain and conduct into a decision. In round 1, a consensus was not reached but statements were grouped and organized. In round 2, the tool met consensus. The inter-rater reliability was between substantial and almost perfect for questions with Kappa=0.77 (95% CI 0.60-0.93), for domains with Kappa= 0.73 (95%CI 0.60-0.86) and for decisions with Kappa= 0.97 (95%CI 0.90-1.00). CONCLUSIONS: This is a novel tool that captures and supports healthcare professionals in clinical decision-making for deprescribing potentially inappropriate medication. This includes patient's and caregiver's preferences about medication. This tool will help to standardize care and provide guidance on the prescribing/deprescribing process of older persons' medications. Also, it provides a holistic way to reduce polypharmacy and inappropriate medications in clinical practice.

Nonadherence to treatment recommendations is a factor contributing to the clinical failure of daptomycin: Cohort study in Brazil

To evaluate the clinical outcomes of daptomycin therapy and adherence to treatment recommendations, a retrospective cohort study was conducted with patients that received daptomycin during the period of the study. The adherence and nonadherence to clinical guidelines were assessed through organism identification, dose and time of treatment, management of bacteremia, and vancomycin treatment failure. A multiple logistic regression model analyzed the association between independent variables and clinical success (dependent variable), considering 5% of statistical significance. The study presented 52 patients who received daptomycin for the treatment of bacteremia (21.1%) or infections (osteomyelitis [63.5%], synovial fluid [15.4%]). Most patients (86.5%) received daptomycin as the second line of treatment, and 51.9% achieved clinical success. The patients had a better chance of clinical success when they followed the guideline indications (OR = 16.86; 95% CI = 1.45-195.88) and the medication was prescribed by a specialist in infectious diseases (OR = 4.84; 95% CI = 1.11-21.09). The study demonstrated lower clinical success than that described in the literature because of patients who were not eligible according to the clinical guidelines. Adherence to recommendations and appropriate prescription of reserve antibiotics is important in limiting early resistance, and avoiding clinical failure and unnecessary expenditure.

Prevalence of potential drug-drug interactions in bone marrow transplant patients.

OBJECTIVE: To assess the prevalence of potential drug-drug interactions (DDIs) in bone marrow transplantation (BMT) patients at the time of pre-infusion (day -1), to describe the potential DDIs and assess their frequency and severity. SETTING: The study was developed in a tertiary care hospital in São Paulo, Brazil. METHOD: Cross-sectional study based on examining the medical prescriptions from the pre-infusion day (day -1) of 70 BMT patients. Potential DDIs were analyzed using Drug-Reax(®) and categorized according to levels of severity, evidence, and onset (rapid and delayed). Only interactions of major or moderate severity were included in the potential DDI analysis. MAIN OUTCOME MEASURE: Prevalence of potential DDIs in patients during the preinfusion phase of BMT. RESULTS: Data were analysed for 70 BMT patients. The median age was 36.5 years; 52.9% (37) of the patients were male, and 65.7% (46) were undergoing autologous BMT. The patients received a median of 8 drugs each. Up to 128 potential DDIs were detected, 60.0% (42) of patients had at least 1 potential DDI and 21.4% (15) were exposed to at least 1 major potential DDI. The most commonly involved drugs were cyclosporine (9, 28.1%), phenytoin (8, 25%) and fluconazole (5, 15.6%). Most potential DDIs had moderate severity (110, 85.9%), a pharmacokinetic mechanism (67, 52.3%), and were classified as delayed onset (106, 82.8%). For major interactions, fluconazole + sulfamethoxazole/trimethoprim, diazepam + fentanyl, fluconazole + levofloxacin and fentanyl + fluconazole were the most frequent. CONCLUSIONS: The prevalence of potential DDIs during the conditioning period of BMT was high as a consequence of the therapeutic complexity of the procedure. Most potential DDIs identified in the study may result in clinically relevant consequences as they could lead to nephrotoxicity, cardiotoxicity, and other undesirable adverse effects. Careful monitoring of clinical and laboratory parameters is essential to ensure a successful BMT and to avoid adverse drug events related to DDI.

The medical consumption of opioids in Colombia, 1997-2007.

The World Health Organization classifies opioid analgesics as essential medicines in the treatment of severe pain and recommends their increased availability. The combination of availability, training of professionals, and a legal framework granting access to these medicines has led to a sharp increase in the consumption of morphine and other opioids in developed countries. However, in Colombia, consumption of opioid analgesics appears to fail to meet patient needs. To analyze the current trends in medical consumption of opioids in Colombia, the numbers of defined daily doses of opioid analgesics for total inhabitants and the population that died of cancer between 1997 and 2007 were calculated and compared. The import of raw materials and medicines varied greatly every year. However, from 2003, a trend toward the increased consumption of morphine, hydromorphone, and methadone was observed. Availability was inconsistent and opioid consumption showed an increase when calculated for total inhabitants and for cancer deaths. The unreliable availability of opioid analgesics may be responsible for their limited consumption. Chronic underuse and a trend toward increased consumption have been confirmed. Monitoring of consumption to promote rational use is recommended.

Risk of potential drug-drug interactions among Brazilian elderly: a population-based, cross-sectional study.

BACKGROUND: Drug-drug interactions (DDIs) are one of the main causes of adverse reactions related to medications, being responsible for up to 23% of hospital admissions. However, only a few studies have evaluated this problem in elderly Brazilians. OBJECTIVES: To determine the prevalence of potential DDIs (PDDIs) in community-dwelling elderly people in Brazil, analyse these interactions with regard to severity and clinical implications, and identify associated factors. METHODS: A population-based cross-sectional study was carried out involving 2143 elderly (aged >or=60 years) residents of the metropolitan area of Sao Paulo, Brazil. Data were obtained from the SABE (Saúde, Bem estar e Envelhecimento [Health, Well-Being, and Aging]) survey, which is a multicentre study carried out in seven countries of Latin America and the Caribbean, coordinated by the Pan-American Health Organization. PDDIs were analysed using a computerized program and categorized according to level of severity, onset, mechanism and documentation in the literature. The STATA software statistical package was used for data analysis, and logistic regression was conducted to determine whether variables were associated with PDDIs. RESULTS: Analysis revealed that 568 (26.5%) of the elderly population included in the study were taking medications that could lead to a DDI. Almost two-thirds (64.4%) of the elderly population exposed to PDDIs were women, 50.7% were aged >or=75 years, 71.7% reported having fair or poor health and 65.8% took 2-5 medications. A total of 125 different PDDIs were identified; the treatment combination of an ACE inhibitor with a thiazide or loop diuretic (associated with hypotension) was the most frequent cause of PDDIs (n = 322 patients; 56.7% of individuals with PDDIs). Analysis of the PDDIs revealed that 70.4% were of moderate severity, 64.8% were supported by good quality evidence and 56.8% were considered of delayed onset. The multivariate analysis showed that the risk of a PDDI was significantly increased among elderly individuals using six or more medications (odds ratio [OR] 3.37) and in patients with hypertension (OR 2.56), diabetes mellitus (OR 1.73) or heart problems (OR 3.36). CONCLUSIONS: Approximately one-quarter of the elderly population living in Sao Paulo could be taking two or more potentially interacting medicines. Polypharmacy predisposes elderly individuals to PDDIs. More than half of these drug combinations (57.6%, n = 72) were part of commonly employed treatment regimens and may be responsible for adverse reactions that compromise the safety of elderly individuals, especially at home. Educational initiatives are needed to avoid unnecessary risks.

Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil / A análise das evidências de eficácia e segurança de medicamentos da tosse sem prescrição registrados no Brasil

The objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC) cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, meta-analyses, and studies on safety were searched on the Medline baseline, the Cochrane Library and SIETES (System of Essential Information in Therapeutics and Health; database in Spanish). Most drugs (62.5 percent) were sold as a fixed-dose combination of two or more drugs. Randomized clinical trials were found for only three drugs: bromhexine, dextromethorphan and guaifenesin. No clinical trials were found for fixed-dose combinations. Systematic reviews on Cochrane did not report any evidence in favor of or against the effectiveness of cough drugs. Efficacy is also unclear, especially regarding fixed-dose combinations. The evidence for the efficacy of OTC cough medications available in Brazil is poor due to the lack of quality studies. Pharmacovigilance of OTC cough medications should be encouraged.

O objetivo deste trabalho foi analisar o nível de evidências sobre a eficácia, a efetividade e a segurança dos medicamentos para tosse registrados no Brasil. A base de dados da Agência Nacional de Vigilância Sanitária foi empregada para identificar os medicamentos. Os ensaios clínicos, as revisões sistemáticas, as metanálises e os estudos de segurança foram pesquisados no Medline, the Cochrane Library e SIETES (Sistema de Informações Essenciais em Terapêutica e Saúde, base de dados em espanhol). A maioria dos medicamentos (62,5 por cento) eram comercializados como associação em dose fixa com dois ou mais fármacos. Ensaios clínicos randomizados foram encontrados apenas para três fármacos: bromexina, dextrometorfano e guaifenesina; para associações a dose fixa não foram encontrados ensaios clínicos. Revisões sistemáticas publicadas pela Cochrane não encontraram evidências favoráveis ou contrárias à efetividade dos medicamentos para tosse. Essa eficácia não é clara, especialmente a das associações a dose fixa. As evidências sobre a eficácia dos medicamentos para tosse isentos de prescrição disponíveis no mercado brasileiro são fracas, devido à falta de pesquisas de boa qualidade. A farmacovigilância de medicamentos para tosse isentos de prescrição deve ser incentivada.

Dificultades para el uso racional de medicamentos / Difficulties for rational drug use

A punto de cumplirse los 25 años de la definición del concepto de uso racional de los medicamentos en Nairobi, elautor reflexiona sobre cómo es posible lograr un mejor uso de los medicamentos en la Comunidad Andina a partir de la discusión de tres puntos fundamentales: (1) no siempre se requieren medicamentos para tratar una dolencia; (2) prescribir es algo más que extender una receta con un nombre comercial, y (3) es necesario implicar al paciente en su propio tratamiento.

Approaching the 25th anniversary of the definition of the concept of the rational drug use in Nairobi, the author makes areflection about how it is possible to achieve a better use of them in the Andean Community from the discussion of three main issues: (1) drugs are not always needed to treat a disease; (2) to treat is more than to handle a written prescription with a brand name; and (3) it is necessary to involve the patient in his own treatment.

Drug treatment of hypertension: compliance and adverse reactions in a cohort of hypertensive patients in a primary care setting / Tratamiento farmacológico antihipertensivo: Cumplimiento y reacciones adversas en una cohorte de pacientes hipertensos en atención primaria

Objectives. The primary was to assess the frequency of therapeutic non-compliance due to ADRs in a cohort of patients with recently diagnosed systemic hypertension. The secondary objectives were to evaluate the blood pressure control during the follow-up in the whole cohort and in patients who received non-steroidal anti-inflammatory drugs (NSAIDs). Methods. A cohort of 73 recently diagnosed ambulatory hypertensive patients was followed-up for 6 months. Validated questionnaires for identification of therapeutic scheme changes and ADRs were applied monthly, during each medical visit. Results. Family physicians selected monotherapy in 79% of patients. The frequency of therapeutic non-compliance was 44%; non-compliance secondary to ADR was 7%. Systolic and diastolic blood pressure at the beginning of the study were 140 ± 15/90 ± 15 mm Hg for the whole cohort. At the end of the study the figures were 130 ± 11/85 ± 6 (p < 0.001). Patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) had higher blood pressure levels than the groups of patients not receiving such kind of drugs (134 ± 10 vs. 128 ± 8 mm Hg, p = 0.025 and 88 ± 7 vs. 83 ± 5 mm Hg, p = 0.05). Conclusions. The drugs used in the present study as monotherapy are considered acceptable choices for hypertension treatment. The frequency of therapeutic non-compliance was within the limits reported in the literature and the frequency of therapeutic non-compliance secondary to ADRs in this cohort was lower than that reported in the literature. Higher blood pressure was found in the group of patients receiving NSAIDs.

Objetivos. El objetivo primario fue evaluar la frecuencia de falta de cumplimiento terapéutico debido a la presencia de reacciones adversas a medicamentos (RAMs) con el uso de antihipertensivos; los objetivos secundarios fueron evaluar el control de la presión arterial durante el seguimiento y en aquellos pacientes que recibieron fármacos antiinflamatorios no esteroideos. Métodos. Se integró una cohorte de 73 pacientes hipertensos de reciente diagnóstico, a los que se les vigiló durante seis meses. En cada visita médica mensual se les aplicaron cuestionarios validados, para identificar cambios en el esquema terapéutico y RAMs. Resultados. Los médicos familiares emplearon monoterapia en 79% de los pacientes. La falta de cumplimiento terapéutico se presentó en 44%; el incumplimiento terapéutico secundario a RAMs se observó en 7% de los casos. En todos los pacientes la presión arterial sistólica y diastólica al inicio del estudio fue 140 ± 15/90 ± 15 mm Hg y al final del estudio las cifras fueron 130 ± 11 / 85 ± 6 (p < 0.001). Los pacientes que recibieron fármacos antiinflamatorios no esteroideos (AINEs) tuvieron cifras de presión arterial más elevadas que pacientes que no recibieron este tipo de fármacos (134 ± 10 vs. 128 ± 8, p = 0.025 y 88 ±7 vs. 83 ± 5 mm Hg, p - 0.05). Conclusiones. Los fármacos empleados en este estudio como monoterapia son fármacos aceptados para el tratamiento de la hipertensión. La frecuencia de falta de cumplimiento terapéutico se ubicó dentro de los límites descritos en la literatura y la falta de cumplimiento terapéutico secundario a RAMs fue menor que lo informado en la literatura. Se observaron cifras de presión arterial elevadas en pacientes que recibieron AINEs.