Falls in older adults hospitalized in tertiary centers in Colombia. Clinical description and complications.

OBJECTIVE: The incidence of falls in elderly patients in the hospital environment is three times higher than that in the community. The aim was to determine the characteristics of patients who suffered in-hospital falls and their complications. METHODS: This was a cross-sectional study with patients older than 64 years of age, admitted between 2018 and 2020 to four clinics in Colombia who presented a fall during their stay. Clinical data, reasons for the fall, complications and use of drugs with a known risk for causing falls and with an anticholinergic load were reviewed. RESULTS: A total of 249 patients were included. The mean age was 77.5 ± 7.4 years, and there was a predominance of males (63.9%). The patients were hospitalized mainly for community-acquired pneumonia (12.4%) and heart failure (10.4%). Falls occurred most frequently in hospitalization wards (77.1%) and emergency departments (20.9%). Falls were related to standing alone (34.4%) and on the way to the bathroom (28.9%), with 40.6% (n = 102) of falls resulting in trauma, especially to the head (27.7%); the incidence of fractures was low (3.2%). Ninety-two percent of patients had polypharmacy (≥5 drugs), 88.0% received psychotropic drugs, and 37.3% received drugs with an anticholinergic load ≥3 points. CONCLUSIONS: Hospitalized adults over 65 years of age suffered falls, mainly in hospitalization wards and emergency departments, especially during the process of solitary ambulation. Most had received psychotropic drugs and medications with a high anticholinergic load. These results suggest that it is necessary to improve risk prevention strategies for falls in this population.

Falls in hospitalized older adults and the use of fall risk-increasing drugs and anticholinergic medications in Colombia: a case‒control study.

Introduction: In-hospital falls are multicausal in older hospitalized patients. Drugs with anticholinergic load and psychotropic effects can increase the risk of falling. Objective: This study aimed to determine the associations between fall risk-increasing drugs (FRIDs) and the anticholinergic risk score (ARS) with falls in hospitalized older hospitalized patients. Methods: This was a case‒control study of patients ≥65 years of age of either sex treated in four clinics in Colombia between 2018 and 2020. Each patient who suffered a fall during hospitalization was matched with four hospitalized patients who did not. Sociodemographic, clinical, and pharmacologic variables and the use of the ARS and FRIDs were evaluated. The risk associated with FRIDs was estimated using conditional logistic regression. Results: There were 250 patients and 1,000 controls (ratio of 1:4), with a mean age of 77.4 ± 7.4 years and a predominance of men (n = 800, 64.0%). The majority of falls occurred during hospitalization (n = 192 patients, 76.8%). Polypharmacy, calcium channel blockers, antiepileptics, antipsychotics, sodium-glucose cotransporter type 2 inhibitors, and nonsteroidal anti-inflammatory drugs were associated with falls during hospitalization. With an ARS score of 3, the probability of falling during the hospital stay increased (aOR: 2.34; 95% CI: 1.64-3.32). Conclusion: There is an association between suffering a fall and the use of drugs with anticholinergic load or FRIDs in hospitalized adults more than 65 years of age in Colombia.

The frequency of complications in a cohort of patients diagnosed with hemophilia A and hemophilia B receiving prophylactic treatment in Colombia: A retrospective noninterventional study.

INTRODUCTION: Hemophilia A and B are disorders associated with the deficit of coagulation factors VIII and IX. OBJECTIVE: Was to determine the incidence of complications in a cohort of patients diagnosed with moderate and severe hemophilia A or B under treatment in a specialized institution. METHODS: A retrospective study of a cohort of patients with replacement therapy for hemophilia A or B, evaluating treatment and complications between January/2012 and July/2019. Sociodemographic, clinical and disease management-related variables were extracted from the medical records. Time to inhibitor development and rate associated with bleeding and hospitalizations were evaluated. RESULTS: A total of 159 male patients were identified with hemophilia A (n = 140; 88.1%) and B (n = 19; 11.9%) with a mean follow-up of 5.9±2.3 years. The mean age was 23.6±16.1 years, hemophilia was reported as severe in 125 patients in hemophilia A (89.3%) and 13 patients in hemophilia B (68.4%). Primary prophylaxis was registered in 17.0% of patients, 44.7% secondary, and 38.3% tertiary, with recombinant factors (n = 84; 52.8%) followed by plasma derived factors (n = 75; 47.2%). The incidence of inhibitor development was 0.3 per 100 patients/year, with mean time to event of 509 days. The incidence of bleeding was 192 per 100 patients/year, especially at the joint (n = 99; 62.3%) and muscle (n = 25; 15.7%) level. The incidence of hospitalization was 3.7 per 100 patients/year. CONCLUSIONS: The most common complication was joint bleeding which was expected in this type of patients. Low proportion of patients developed factor inhibitors during the follow up.

Potentially Inappropriate Use of Opioids in the Management of Migraine in Colombia.

RESEARCH OBJECTIVE: To identify the frequency of opioid use in a group of patients diagnosed with migraine in Colombia. METHODS: Study of a retrospective cohort of patients with a diagnosis of migraine and a first prescription of antimigraine drugs from emergency services and a priority outpatient clinic. Sociodemographic, clinical, and pharmacological variables were identified; a 12-month follow-up was carried out to identify the use of a new opioid. RESULTS: A total of 6309 patients with a diagnosis of migraine were identified, with a mean age of 35.5 ± 12.3 years, of which 81.3% were women. Nonsteroidal anti-inflammatory drugs (51.1%) were the most frequently prescribed medications, followed by ergotamine + caffeine (31.3%), acetaminophen (15.05%), and acetaminophen + codeine (14.4%). At the time of the index, 1300 (20.6%) patients received some opioid. During the follow-up, a total of 1437 (22.8%) patients received a new opioid, of which 31.8% belonged to the group that received an initial opioid and 20.4% to the group that did not receive one, which was statistically significant (OR:1.81; 95%CI:1.58-2.07; p < 0.001). CONCLUSIONS: The frequent use of opioids in the management of migraines is potentially inappropriate and can lead to problems of tolerance, abuse and dependence. This combined with the low prescription of triptans, offers an opportunity for improvements in medical practice.

Con qué medicamentos están siendo tratados los pacientes con trastorno afectivo bipolar en Colombia / Which drugs are being treated patients with bipolar affective disorder in Colombia / Com quais medicamentos os pacientes com transtorno afetivo bipolar estão sendo tratados na Colômbia?

Introducción:El trastorno bipolar (TB) es una condición psiquiátrica grave caracterizada por alteraciones progresivas en las funciones sociales y cognitivas. Objetivo:Determinar cuáles son los medicamentos con que se está tratando a un grupo de pacientes con diagnóstico de TB, afiliados al Sistema de Salud de Colombia.Materiales y métodos:Estudio de corte para identificar prescripciones de medicamentos de pacientes ambulatorios de cualquier edad y sexo con TB, a partir de una base de datos poblacional de dispensaciones. Se consideraron variables sociodemográficas, clínicas y farmacológicas buscando medicamentos en indicaciones aprobadas y no aprobadas por agencias reguladoras.Resultados:Se identificaron 1334 pacientes, con edad media de 40,2±18,5 años y 50% eran mujeres. Un total de 809 (60,6%) pacientes eran tratados en monoterapia principalmente con ácido valproico (286/615 pacientes, 46,4%), quetiapina (259/525, 49,3%) y Carbonato de Litio (98/275, 35,6%). Las combinaciones más comunes de fármacos para su tratamiento fueron ácido valproico más quetiapina (n=162, 12,1%), ácido valproico más risperidona (n=73, 5,5%) y carbonato de litio más quetiapina (n=62, 4,6%). El 57,4% (n=766) tenían prescripciones de fármacos con indicaciones no aprobadas.Conclusiones:Los pacientes con TB son tratados principalmente en monoterapia y más de la mitad estaba recibiendo fármacos en indicaciones no aprobadas.

Introduction:Bipolar disorder (BP) is a serious psychiatric condition characterized by progressive changes in social and cognitive functions. Objective: To determine which medications are being used to treat a group of patients diagnosed with BP who receive treatment from the Colombian Health System. Materials and methods: Cross-sectional study to identify medication prescriptions of outpatients (regardless of their age) using a population database. Sociodemographic, clinical, and pharmacological variables were considered, searching for medications that are both approved and not approved by regulatory agencies. Results: 1,334 patients were identified, who had a mean age of 40.2±18.5 years, 50% of which were women. A total of 809 (60.6%) patients followed monotherapy, mainly using valproic acid (286/615 patients, 46.4%), quetiapine (259/525, 49.3%), and lithium carbonate (98/275, 35.6%). The most common combination of medications to treat these patients were valproic acid combined withquetiapine (n=162, 12.1%), valproic acid combined withrisperidone (n=73, 5.5%), and lithium carbonate combined withquetiapine (n=62, 4,6%). 57.4% (n=766) of patients had prescriptions with non-approved medications. Conclusions: BPpatients are mostly treated with monotherapy and more than half of them received drugs that are not approved.

Introdução:O transtorno bipolar (TB) é uma condição psiquiátrica grave caracterizada por alterações progressivas nas funções sociais e cognitivas. Objetivo:Determinar quais medicamentos estão sendo usados para tratar um grupo de pacientes diagnosticados com TB, vinculados ao Sistema de Saúde da Colômbia. Materiais e métodos:Estudo transversal para identificação de prescrições de medicamentos para pacientes ambulatoriais de qualquer idade e sexo com TB, a partir de um banco de dados populacional de dispensações. Foram consideradas variáveis sociodemográficas, clínicas e farmacológicas, buscando medicamentos em indicações aprovadas e não aprovadas pelos órgãos reguladores. Resultados:Foram identificados 1.334 pacientes, com média de idade de 40,2 ± 18,5 anos, sendo 50% mulheres. Um total de 809 (60,6%) pacientes foram tratados em monoterapia principalmente com ácido valpróico (286/615 pacientes, 46,4%), quetiapina (259/525, 49,3%) e carbonato de lítio (98/275, 35,6%). As combinações medicamentosas mais comuns paraseu tratamento foram ácido valpróico mais quetiapina (n=162, 12,1%), ácido valpróico mais risperidona (n=73, 5,5%) e carbonato de lítio mais quetiapina (n=62, 5,5%).4,6 %). 57,4% (n=766) tinham prescrições de medicamentos com indicações não aprovadas. Conclusões:Os pacientes com TB são tratados principalmente com monoterapia e mais da metade estava recebendo medicamentos em indicações não aprovadas.

Treatment patterns of antidiabetic and kidney protective therapies among patients with type 2 diabetes mellitus and chronic kidney disease in Colombia. The KDICO descriptive study.

BACKGROUND: Type 2 diabetes mellitus is one of the most common causes of chronic kidney disease (CKD) worldwide and prevalence of 1.75 per 100 inhabitants in Colombia. The aim of this study was to describe the treatment patterns of a group of patients with type 2 diabetes mellitus and CKD in an outpatient setting from Colombia. METHODS: A cross-sectional study in adult patients with type 2 diabetes mellitus and CKD identified in the Audifarma S.A. administrative healthcare database between April 2019 and March 2020 was performed. Sociodemographic, clinical and pharmacological variables were considered and analyzed. RESULTS: A total of 14,722 patients with type 2 diabetes mellitus and CKD were identified, predominantly male (51%), with a mean age of 74.7 years. The most common treatment patterns of type 2 diabetes mellitus included the use of metformin monotherapy (20.5%), followed by the combination of metformin + dipeptidyl peptidase-4 inhibitor (13.4%). Regarding the use of drugs with nephroprotective properties, the most prescribed treatments were angiotensin receptor blockers (67.2%), angiotensin converting enzyme inhibitors (15.8%), sodium glucose cotransporter 2 inhibitors (SGLT2i) (17.0%) and glucagon-like peptide-1 analogs (GLP1a) (5.2%). CONCLUSION: In Colombia, the majority of patients with type 2 diabetes mellitus and CKD identified in this study were treated with antidiabetic and protective medications to ensure adequate metabolic, cardiovascular, and renal control. The management of type 2 diabetes mellitus and CKD may be improved if the beneficial properties of new groups of antidiabetics (SGLT2i, GLP1a), as well as novel mineralocorticoid receptor antagonists, are considered.

Clinical characterization of a cohort of patients treated for systemic lupus erythematosus in Colombia: A retrospective study.

INTRODUCTION: Systemic lupus erythematosus is an autoimmune disease associated with serious complications and high costs. The aim was to describe the clinical characteristics and health care resource utilization of a Colombian systemic lupus erythematosus outpatient cohort. METHODS: This was a retrospective descriptive study. Clinical records and claims data for systemic lupus erythematosus patients from ten specialized care centers in Colombia were reviewed for up to 12 months. Baseline clinical variables, Systemic Lupus Erythematosus Disease Activity Index, drug use, and direct costs were measured. Descriptive statistics were analyzed using SPSS. RESULTS: A total of 413 patients were included; 361 (87.4%) were female, and the mean age was 42 ± 14 years. The mean disease evolution was 8.9 ± 6.0 years; 174 patients (42.1%) had a systemic manifestation at baseline, mostly lupus nephritis (105; 25.4%). A total of 334 patients (80.9%) had at least one comorbidity, mainly antiphospholipid syndrome (90; 21.8%) and hypertension (76; 18.4%). The baseline Systemic Lupus Erythematosus Disease Activity Index score was 0 in 215 patients (52.0%), 1-5 in 154 (37.3%), 6-10 in 41 (9.9%) and 11+ in 3 (0.7%). All patients received pharmacological therapy, and the most common treatment was corticosteroids (293; 70.9%), followed by antimalarials (chloroquine 52.5%, hydroxychloroquine 31.0%), immunosuppressants (azathioprine 45.3%, methotrexate 21.5%, mycophenolate mofetil 20.1%, cyclosporine 8.0%, cyclophosphamide 6.8%, leflunomide 4.8%) and biologicals (10.9%). The mean annual costs were USD1954 per patient/year, USD1555 for antirheumatic drugs (USD10,487 for those with biologicals), USD86 for medical visits, USD235 for drug infusions and USD199 for laboratory tests. CONCLUSIONS: Systemic lupus erythematosus generates an important economic and morbidity burden for the Colombian health system. Systemic lupus erythematosus outpatient attention costs in the observation year were mainly determined by drug therapy (especially biologics), medical visits and laboratory tests. New studies addressing the rate of exacerbations, long-term follow-up or costs related to hospital care are recommended.

Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia.

Purpose: The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs). Patients and Methods: Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out. Results: A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3±10.4 years. Patients were followed for a mean of 2.3±1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA2DS2-VASc Score was 3.6±1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68-2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82-6.52) and persistence events (HR: 4.51; 95% CI: 3.81 -5.33). Conclusion: The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.

Patrones de uso de anticonceptivos hormonales en una población de Colombia

Objetivo: El uso de anticonceptivos hormonales ha crecido progresivamente en muchos países del mundo. Determinar los patrones de utilización de anticonceptivos hormonales, frecuencia de comorbilidades y medicaciones concomitantes en mujeres mayores de 15 años afiliadas al Sistema de Salud de Colombia. Materiales y métodos: Estudio de corte, que incluyó datos de mujeres mayores de 15 años con prescripciones y dispensaciones de algún anticonceptivo hormonal durante al menos tres meses continuos (abril a junio-2016). Se creó una base de datos con información sociodemográfica, farmacológica (tipo de anticonceptivos, dosis, comedicaciones y comorbilidades. Se realizaron análisis descriptivos y multivariados buscando identificar factores asociados con comedicaciones de riesgo. Resultados: Se identificaron 34309 mujeres que recibieron anticonceptivos hormonales, con edad media de 27,2±7,0 años (rango:13-60,8 años). Los anticonceptivos más utilizados fueron inyectables de aplicación mensual (63,0 %), inyectables de aplicación trimestral (19,1 %), de administración oral (12,1 %), los implantes subdérmicos (7,4 %) y finalmente los dispositivos intrauterinos hormonales con 0,4 %. El 5,7 % de las pacientes (n=1957), estaban recibiendo alguna comedicación, especialmente con antihipertensivos (2,9 %) y antimigrañosos (1,9 %). Ser mayor de 45 años (OR:2,3; IC95 %:1,7-3,0), utilizar dispositivo intrauterino hormonal (OR:2,4; IC95 %:1,4-4,1) y anticonceptivo inyectable trimestral (OR: 1,7; IC95 %:1,3-2,3) se asociaron con mayor probabilidad de recibir comedicaciones. Conclusiones. Las mujeres colombianas que acceden a anticonceptivos hormonales a través del Sistema de Salud están empleando principalmente presentaciones inyectables, con muy baja frecuencia de las orales, y en general tienen pocas comorbilidades que requieran tratamiento farmacológico, pese a que algunas tienen condiciones cardiovasculares que pueden implicar un potencial riesgo de eventos trombóticos.

Objective: The use of hormonal contraceptives has grown progressively in many countries of the world. The aim was to determine the patterns of use of hormonal contraceptives, frequency of comorbidities and concomitant medications in women over 15 years of age affiliated with the Colombian Health System. Methods: Cross-sectional study, which included data on women over 15 years of age with prescriptions and dispensations of a hormonal contraceptive for at least three continuous months (April-June-2016). A database with sociodemographic, pharmacological information (type of contraceptives, doses, comedications and comorbidities) was created. Descriptive and multivariate analyzes were conducted seeking to identify factors associated with risk comedications. Results: 34309 women who received hormonal contraceptives were identified, with a mean age of 27.2 ± 7.0 years (range: 13-60.8 years). The most commonly used contraceptives were injectable of monthly application (63.0 %), injectable of quarterly application (19.1 %), oral administration (12.1 %), subdermal implants (7.4 %) and finally the hormonal intrauterine devices with 0.4 %. 5.7 % of the patients (n = 1957) were receiving some medication, especially with antihypertensives (2.9 %) and anti-migraines (1.9 %). Be over 45 years old (OR:2.3; 95 %CI: 1.7-3.0), use hormonal intrauterine device (OR: 2.4; 95 % CI:1.4-4.1) and quarterly injectable contraceptive (OR:1.7; 95 %CI:1.3-2.3) were associated with a higher probability of receiving comedications. Conclusions: Colombian women who access hormonal contraceptives through the Health System are mainly using injectable presentations, with very low frequency of oral ones, and in general they have few comorbidities that require pharmacological treatment, although some have cardiovascular conditions that may involve potential risk of thrombotic events.

Trends in the Use of Sedative-Hypnotics, Opioids, and Neuromuscular Blockers in Hospitalized Patients During the COVID-19 Pandemic: Observational Retrospective Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has increased the use of drugs administered for mechanical ventilation, leading to shortages in some countries. OBJECTIVE: The aim was to identify trends in the consumption of sedatives, hypnotics, neuromuscular blockers, and opioids used for anesthetic induction and deep sedation in hospitals in Colombia. METHOD: This was a descriptive, longitudinal, and retrospective study with monthly follow-up of sedative, hypnotic, opioid, and neuromuscular blocker dispensing in 20 clinics and hospitals from January to November 2020. The frequencies of use of each drug and variations in the institutions and intensive care units (ICUs) were identified. RESULTS: A total of 1,252,576 units of the analyzed drugs were delivered to 79,094 treated patients, 55.0% of whom were women (n = 43,521). The drugs with the greatest increase in consumption were rocuronium (1058% variation in March-November) and propofol (511%). The consumption of midazolam and vecuronium initially increased, but by the end of the study period, it decreased. Among drugs dispensed only in ICUs, 920,170 units were delivered (73.5% of the drugs dispensed during the study), and the most often dispensed drugs were fentanyl (n = 251,519; 27.3% of the drugs used in the ICU) and midazolam (5 mg/5 mL) solution (n = 188,568; 20.5%). Specifically in the ICU, the drugs with the greatest increase in use were rocuronium (19,709%), propofol (2622%), and ketamine (2591%). CONCLUSION: Rapid changes in the use of drugs were evident, which demonstrates the need for closer cooperation among treating physicians, service providers, pharmaceutical managers, and state institutions to maintain a sufficient and timely supply of critical drugs in this type of contingency.

For what indications are antidepressants being used in adults in Colombia?

INTRODUCTION: Antidepressants are useful in the pharmacological treatment of different depressive and anxiety disorders, as well as being potentially useful in other indications. The aim of the study was to determine the indications for which antidepressants are being prescribed in patients over 18 years of age registered with the Colombian Health System. METHODS: Retrospective study with data from patients over 18 years old, of either sex, registered with the Colombian Health System, who are prescribed antidepressants. Medical records were reviewed, looking for indications approved and not approved by regulatory agencies. Patients were identified randomly, as well as the sociodemographic, clinical and pharmacological variables that could be associated with prescriptions for unapproved indications. RESULTS: 351 patients were evaluated, with a mean age of 60.4 ± 15.3 years, of whom 72.6% were women. They were attended in 34 cities, with prescriptions mainly by general practitioners (n = 276; 78.6%), and psychiatrists (n = 42; 12.0%). Selective serotonin reuptake inhibitors were the most widely prescribed antidepressants (n = 204; 58.1%), followed by atypicals (n = 76; 21.7%). The most frequent indications were for depression (n = 169; 48.1%), anxiety (n = 48; 13.7%), pain (n = 22; 6.3%) and sleep disorders (n = 17; 4.8%). A total of 188 prescriptions (53.6%) were made for approved indications, and the remaining 163 (46.4%) were classified as unapproved. CONCLUSIONS: Antidepressants are being prescribed for the treatment of depression, anxiety, pain and sleep disorders, especially in older adult women, but almost half of the formulations were for unapproved indications.

Para qué indicaciones se están utilizando los antidepresivos en adultos de Colombia / For What Indications are Antidepressants Being Used in Adults in Colombia?

RESUMEN Introducción: Los antidepresivos son útiles en el tratamiento farmacológico de diferentes trastornos depresivos y de ansiedad, además de su potencial utilidad para otras indicaciones. El objetivo del estudio es determinar las indicaciones para las que se están prescribiendo los antidepresivos a pacientes mayores de 18 años afiliados al Sistema de Salud de Colombia. Métodos: Estudio retrospectivo con datos de pacientes mayores de 18 años, de cualquier sexo, afiliados al Sistema de Salud de Colombia, a los que se prescriben antidepresivos; se revisaron las historias clínicas buscando indicaciones aprobadas y no aprobadas por agencias reguladoras. Se identificó a los pacientes aleatoriamente, así como las variables sociodemográficas, clínicas y farmacológicas que se pudieran asociar con prescripciones para indicaciones no aprobadas. Resultados: Se evaluó a 351 pacientes, con una media de edad de 60,4 ± 15,3 años; el 72,6% eran mujeres; se atendieron en 34 ciudades, y los prescriptores principalmente fueron médico general (n = 276; 78,6%) y psiquiatra (n = 42; 12,0%). Los inhibidores selectivos de la recaptación de serotonina fueron los antidepresivos más prescritos (n = 204; 58,1%), seguidos de los atípicos (n = 76; 21,7%). Las indicaciones más frecuentes fueron depresión (n = 169; 48,1%), ansiedad (n = 48; 13,7%), dolor (n = 22; 6,3%) y trastornos del sueño (n = 17; 4,8%). Un total de 188 prescripciones (53,6%) se hicieron para indicaciones aprobadas y las 163 (46,4%) restantes se catalogaron como no aprobadas. Conclusiones: Los antidepresivos se están prescribiendo para tratar depresión, ansiedad, analgesia y trastornos del sueño, especialmente a mujeres adultas mayores, pero casi la mitad de las formulaciones fueron para indicaciones no aprobadas.

ABSTRACT Introduction: Antidepressants are useful in the pharmacological treatment of different depressive and anxiety disorders, as well as being potentially useful in other indications. The aim of the study was to determine the indications for which antidepressants are being prescribed in patients over 18 years of age registered with the Colombian Health System. Methods: Retrospective study with data from patients over 18 years old, of either sex, registered with the Colombian Health System, who are prescribed antidepressants. Medical records were reviewed, looking for indications approved and not approved by regulatory agencies. Patients were identified randomly, as well as the sociodemographic, clinical and pharmacological variables that could be associated with prescriptions for unapproved indications. Results: 351 patients were evaluated, with a mean age of 60.4 ± 15.3 years, of whom 72.6% were women. They were attended in 34 cities, with prescriptions mainly by general practitioners (n = 276; 78.6%), and psychiatrists (n = 42; 12.0%). Selective serotonin reuptake inhibitors were the most widely prescribed antidepressants (n = 204; 58.1%), followed by atypicals (n = 76; 21.7%). The most frequent indications were for depression (n = 169; 48.1%), anxiety (n = 48; 13.7%), pain (n = 22; 6.3%) and sleep disorders (n = 17; 4.8%). A total of 188 prescriptions (53.6%) were made for approved indications, and the remaining 163 (46.4%) were classified as unapproved. Conclusions: Antidepressants are being prescribed for the treatment of depression, anxiety, pain and sleep disorders, especially in older adult women, but almost half of the formulations were for unapproved indications.

Antibiotic Prescriptions for Respiratory Tract Viral Infections in the Colombian Population.

Antimicrobials are frequently inappropriately prescribed for the management of upper respiratory tract infections (URTIs); therefore, the frequency of antibiotic prescriptions for patients with viral URTIs was assessed in this study. A cross-sectional study, including ambulatory patients diagnosed with viral URTI, was conducted, and records of antimicrobial prescriptions were obtained. Sociodemographic, clinical (diagnostic), and pharmacological (antimicrobial) variables were assessed. Through multivariate analysis, variables associated with the use of antibiotics for viral infections were identified. A total of 341,182 patients with viral URTIs were identified. The patients, who were from 26 different departments of Colombia, had a mean age of 29.7 ± 23.5 years and a female predominance of 58.7% (n = 200,195). The most frequent viral infections were as follows: acute rhinopharyngitis (common cold) (n = 206,211; 60.4%); unspecified acute tonsillitis (n = 27,432; 8.0%); and acute pharyngitis (n = 26,411; 7.7%). A total of 24.8% of the patients (n = 84,453) received a prescription for antibiotics, predominantly penicillins (n = 61,871; 18.1%) and cephalosporins (n = 10,926; 3.2%). Patients treated in Atlántico, Valle, and Risaralda departments, along with those older than 5 years, were more likely to receive antibiotics for the treatment of viral infections. Antibiotics are frequently prescribed for the management of URTIs, which is considered an inappropriate practice due to a lack of clinical benefits, increased generation of antimicrobial resistance, and a risk of adverse reactions due to the use of medications that patients do not require. Drug utilization studies are a great tool for monitoring how antibiotics are being used and planning interventions to improve their use.

Prevalence of the Use of Aspirin and Statins for Preventing Cardiovascular Events in the Colombian Population with Type 2 Diabetes Mellitus: Comparison of 2008 and 2018.

BACKGROUND: Type 2 diabetes mellitus (T2DM) greatly increases cardiovascular risk. Primary and secondary cardiovascular prevention lead to lower cardiovascular events, improved quality of life and lower costs related to complications. OBJECTIVE: To estimate the proportion of patients with T2DM undergoing drug therapy for cardiovascular prevention (aspirin and statins) in Colombia and to describe the change in patterns of use between 2008 and 2018. METHODS: This was a cross-sectional study comparing prescriptions for aspirin and statins in 2008 and in 2018 in outpatients diagnosed with T2DM. Records were obtained from a national drug claim database. The proportion of use of cardiovascular prevention drugs and antidiabetic drugs, medications for comorbidities and sociodemographic variables were analyzed for both periods. RESULTS: In total, 26 742 patients in 2008 and 188 321 in 2018 with a diagnosis of T2DM treated with antidiabetic drugs were identified, among whom 57.5% and 44.2% received aspirin and 44.9% and 60.2% received statins, respectively. The use of high-intensity statins increased from 1.1% in 2008 to 95.2% in 2018. The probabilities of receiving drugs in 2008 and in 2018 were higher for men (OR: 1.12, 95% CI: 1.06-1.17 and OR: 1.26, 95% CI: 1.23-1.28, respectively), for those persons over 75 years of age (OR: 6.5, 95% CI: 5.3-7.9 and OR: 5.8, 95% CI: 5.4-6.2) and for those who also received clopidogrel (OR: 5.8, 95% CI: 4.4-7.6 and OR: 2.2, 95% CI: 2.1-2.4). CONCLUSIONS: The use of high-intensity statins in patients with T2DM has increased significantly in the last decade, which should reduce cardiovascular events, morbidity and mortality.

Estudio de utilización de fármacos antigotosos en población colombiana, 2016 / Patterns of anti-gout drug use in a Colombian population: 2016

RESUMEN Objetivo: Identificar las características clínicas de los pacientes con gota y la forma de utilización de los medicamentos antigotosos en Colombia. Métodos: Estudio de corte transversal en el que se analizaron 310 historias clínicas de pacientes atendidos en el último trimestre del 2016 y que recibieron un medicamento antigotoso. Se identificaron variables sociodemográficas, clínicas, farmacológicas, comorbilidades y paraclínicas. Para cada medicamento antigotoso se determinó si el uso fue según las recomendaciones aprobadas por la Federal Drug Administration (FDA). Se realizaron análisis descriptivos, bivariados y multivariados. Resultados: Se evaluaron pacientes de 14 diferentes ciudades de Colombia, con un predominio masculino del 70,3% (n = 218) y una mediana de edad de 64 arios (RIC: 26-94 arios). El antigotoso más frecuentemente utilizado fue alopurinol (n = 255; 82,3%), seguido de colchicina (n = 54; 17,4%). Los diagnósticos hallados como indicación fueron: hiperuricemia (n = 181; 58,4%), gota (n = 34; 11%), artritis gotosa (n = 28; 9%). El 74,5% (n = 231) de las prescripciones tenía un uso aprobado según la FDA, especialmente alopurinol en el manejo de gota e hiperuricemias, mientras que colchicina se encontró siendo utilizada en indicaciones no aprobadas (n = 44; 81,4%). Las comorbilidades más frecuentes fueron hipertensión (68,4%) y dislipidemia (55,8%). Conclusiones: Los pacientes con gota en tratamiento farmacológico tienen una elevada frecuencia de comorbilidades cardiovasculares, y están siendo tratados con alopurinol para la prevención a largo plazo, mientras que una menor proporción recibe colchicina que comúnmente es utilizada para indicaciones no aprobadas por las agencias reguladoras.

ABSTRACT Objective: To identify the clinical characteristics of patients with gout, and the prescription patterns of anti-gout medications in Colombia. Methods: Cross-sectional study, that analysed the data from 310 medical records of patients treated in the last quarter of 2016, and who received an anti-gout medication. Sociodemographic, clinical, pharmacological, comorbidities, and paraclinical variables were identified. For each anti-gout drug used, it was determined whether the use was in accordance with Federal Drug Administration (FDA) approved recommendations. Descriptive, bivariate and multivariate analyses were performed. Results: Patients from 14 different cities in Colombia were evaluated, with a male predominance of 70.3% (n = 218) and a median age of 64 years (RIC: 26-94 years). The most frequently used anti-gout medication was allopurinol (n = 255; 82.3%), followed by colchicine (n = 54; 17.4%). The main diagnoses found as an indication were: hyperuricaemia (n=181, 58.4%), gout (n = 34; 11.0%), and gouty arthritis (n = 28; 9.0%). Almost three-quarters (74.5%; n = 231) of the prescriptions had an approved use according to the FDA, especially allopurinol in the management of gout and hyperuricaemia, while colchicine was found to be used in unapproved indications (n = 44, 81.4%). The most frequent comorbidities were hypertension (68.4%) and dyslipidaemia (55.8%). Conclusions: Patients with gout who are under pharmacological treatment have a high frequency of cardiovascular comorbidities. They were being treated with allopurinol for long-term prevention, while a smaller proportion received colchicine, which is often used for indications not approved by regulatory agencies.

Prevalence of lipid-lowering drug use / Prevalencia de uso de fármacos hipolipemiantes

Abstract Introduction: Among the main causes of death in Colombia, Latin America, and the general population are pathologies of cardiovascular origin, which have an important relationship with dyslipidemias. Objective: The objective of the study was to establish the prevalence of the use of lipid-lowering drugs in a Colombian population during 2016. Material and methods: A cross-sectional study was conducted using a population database of the Colombian Health System between January and June 2016. Site: outpatients of Colombia. Participants. Researchers considered all patients who had received this class of drug to establish the prevalence of the use of lipid-lowering drugs. Main measurements. Prevalence of use of lipid-lowering drugs. Results: From a population of 4,328,688 patients, a total of 282,002 were prescribed a lipid-lowering drug; the mean age was 64.2 ± 13.3 years and women comprised 50.4% of the users. The estimated prevalence of lipid-lowering drug use was 6.5%. Statins (86.3%) were the most commonly used lipid-lowering drugs (atorvastatin: 81.0%, lovastatina: 14.4%) followed by fibrates (13.1%) and ezetimibe (0.6%). Conclusions: A low proportion of people are being treated with lipid-lowering drugs, according to the estimated prevalence of dyslipidemia.

Resumen Introducción: Las patologías de origen cardiovascular son la primera causa de muerte en Colombia y América Latina, y la dislipidemia tiene una importante relación. Objetivo: El objetivo fue establecer la prevalencia o proporción de uso de hipolipemiantes en una población colombiana durante el año 2016. Materiales y métodos: Estudio de corte transversal a partir de una base de datos poblacional de pacientes afiliados al Sistema de Salud de Colombia entre enero y junio de 2016. Sitio. Pacientes ambulatorios de Colombia. Participantes. Se consideraron todos los pacientes que recibieron algún hipolipemiante, de cualquier sexo y mayores de 18 años. Mediciones principales: prevalencia de uso de hipolipemiantes. Resultados: A partir de una población de 4328688 pacientes, se prescribieron hipolipemiantes a 282002, con una edad media de 64,2 13,3 años y el 50,4% eran mujeres. La prevalencia estimada de uso fue de 6,5%. Las estatinas (86,3%) fueron los hipolipemiantes más comúnmente utilizados (atorvastatina: 81,0%, locastatina: 14,4%) seguido de los fibratos (13,1%) y ezetimibe (0,6%). Conclusiones: Una baja proporción de personas están siendo tratados con hipolipemiantes de acuerdo a la prevalencia estimada de dislipidemia para la población del país.

Use of healthcare resources in a cohort of rheumatoid arthritis patients treated with biological disease-modifying antirheumatic drugs or tofacitinib.

INTRODUCTION/OBJECTIVES: The objective of this study is to describe the treatment patterns and use of healthcare resources in a cohort of Colombian patients with rheumatoid arthritis (RA) treated with biological disease-modifying antirheumatic drugs (bDMARDs) or tofacitinib. METHOD: This is a descriptive study from a retrospective cohort of patients diagnosed with RA who were treated with bDMARDs or tofacitinib after failure of conventional DMARDs (cDMARDs) or first bDMARD. Patients who were receiving pharmacological treatment between 01 January 2014 and 30 June 2018 were included. The analysis is through the revision of claim database and electronical medical records. Demographic and clinical data were collected. The costs of healthcare resources were estimated from the billing expense of healthcare service provider. RESULTS: We evaluated 588 RA patients on treatment with bDMARDs (n = 505) or tofacitinib (n = 83), most of them were in combination with cDMARDs (85.4%). The 88.1% were females and mean age was 57.3 ± 12.5 years. The median evolution of RA since diagnosis was 9 years (IQR:4-17.2). The mean duration of use during follow-up of the bDMARDs or tofacitinib was similar, with a mean of 9.8 ± 1.9 months. It was identified that 394 (67.0%) discontinued therapy. The average annual direct cost of care per patient was USD 8997 ± 2172, where 97.2% was due to drug costs. The average annual cost of treatment per patient with bDMARDs was USD 8604 and tofacitinib was USD 6377. CONCLUSIONS: In the face of a first failure of cDMARD, bDMARDs are frequently added. A high frequency of patients do not persist treatment during the first year of follow-up. The pharmacological treatment is the most representative cause of healthcare costs. Key Points • Rheumatoid arthritis is a disease with a high burden of comorbidities, complications, and worse health-related quality of life and is associated with elevated healthcare costs. • The biological disease-modifying antirheumatic drugs or tofacitinib medications are indicated for those with significant progression of the disease and when there is a need for alternatives to achieve low levels of activity and remission. • Patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs or tofacitinib represent a significant economic burden to the health system, especially in the costs derived from pharmacological treatment.

Use of non-vitamin K antagonist oral anticoagulants in Colombia: A descriptive study using a national administrative healthcare database.

PURPOSE: We aimed to describe time-trends in the use of NOACs among a group of ambulatory patients with nonvalvular atrial fibrillation (NVAF) in Colombia and to describe treatment patterns and user characteristics. METHODS: Using the Audifarma S.A administrative healthcare database in Colombia, we identified 10 528 patients with NVAF aged at least 18 years between July 2009 and June 2017 with a first prescription (index date) for apixaban, dabigatran or rivaroxaban (index NOAC) and followed them for at least year (max, 8.0 years, mean 2.2 years). We described patient characteristics, NOAC use over time, and the dose of the first NOAC prescription. RESULTS: A total of 2153 (20.5%) patients started on apixaban, 3089 (29.3%) on dabigatran and 5286 (50.2%) on rivaroxaban. The incidence of new users of apixaban and rivaroxaban increased over study years while for dabigatran it decreased. Mean age at the index date was: 78.5 years (apixaban), 76.5 years (dabigatran), 76.0 years (rivaroxaban). The percentage of patients started NOAC therapy on the standard dose was: apixaban 38.0%, dabigatran 30.9%, rivaroxaban 56.9%. The percentage still prescribed their index NOAC at 6 months was apixaban 44.6%, dabigatran 51.4%, rivaroxaban 52.7%. Hypertension was the most common comorbidity (>80% in each NOAC cohort). CONCLUSION: During the last decade, the incidence of NOAC use in patients with NVAF affiliated with a private healthcare regime in Colombia has markedly increased. Future studies should evaluate whether the large number of patients with NVAF starting NOAC treatment on a reduced dose are done so appropriately.

Real-World Effectiveness of Therapy With Rosuvastatin Combined With Fenofibric Acid in a Sample of Colombian Patients With Mixed Dyslipidemia.

BACKGROUND: Ischemic heart disease is the leading cause of death in the world and is associated with dyslipidemia, high blood pressure, diabetes mellitus, and other factors. OBJECTIVE: To determine the clinical effectiveness on the lipid profile of the rosuvastatin + fenofibric acid combination in Colombian patients with high cardiovascular risk and mixed dyslipidemia. METHODS: Longitudinal observational study in a random sample of patients with a diagnosis of mixed dyslipidemia and moderate, high, or very high cardiovascular risk who were treated with rosuvastatin + fenofibric acid. Anthropometric, clinical, laboratory, comorbidity, and pharmacological variables were identified. Effectiveness on the lipid profile was determined. RESULTS: A total of 386 patients were analyzed. They had a mean age of 60.8 ± 11.4 years, 53.1% were female, and 75.6% had high/very high cardiovascular risk. The initial evaluation showed a mean LDL cholesterol of 138.4 ± 67.1 mg/dL and triglycerides of 679.7 ± 573.6 mg/dL. At the end of follow-up, mean LDL cholesterol was 87.5 ± 41.2 mg/dL (reduced by 43.3%; P < .001), and triglycerides were 243.5 ± 170.5 mg/dL (reduced by 64.2%; P < .001). Only 35.4% (n = 73) of patients with very high risk reached the goal of metabolic control, compared to 61.6% (n = 53) with high risk and 55.4% (n = 46) with moderate risk. Belonging to the very high-risk group was associated with a lower probability of achieving the control goal (OR: 0.32; 95%CI: 0.192-0.539). CONCLUSION: The combination of rosuvastatin + fenofibric acid is an effective option in patients with mixed dyslipidemia and high cardiovascular risk, providing a therapeutic alternative for those conditions that require it.

Factors Involved in the Development of Inhibitory Antibodies in Patients with Hemophilia in Colombia: A Case-Control Study.

BACKGROUND: The appearance of inhibitory antibodies against antihemophilic factors is one of the most serious complications related to hemophilia. OBJECTIVE: The objective of this study was to identify variables and factors related to the development of inhibitory antibodies in a group of patients undergoing antihemophilic therapy in Colombia. METHODS: A case-control study in patients with hemophilia treated in Specialized Healthcare Provider Institutions (IPS-E) in 21 cities of Colombia of any age and with a diagnosis of inhibitory antibodies against factor VIII or IX during 2016. Four controls per case paired by age and type of hemophilia were used. Sociodemographic, clinical, and pharmacological variables were identified and analyzed. RESULTS: Seventeen patients with inhibitory antibodies and 68 controls with hemophilia were identified. The mean age was 28.3 ± 17.8 years. A total of 94.1% had hemophilia A, and 88.2% of the cases and 50.0% of the controls had severe hemophilia; 47.1% of the cases and 54.4% of the controls were receiving prophylaxis with coagulation factors. Multivariate analysis showed that having severe hemophilia (OR:17.0, 95%CI:1.32-219.60) and lack of knowledge of the coagulation factor with which the patient was treated before entering the care program in the IPS-E (OR:8.9, 95%CI:1.82-43.75) were significantly associated with a higher probability of developing inhibitory antibodies. CONCLUSION AND RELEVANCE: Coagulation factors associated with the development of inhibitory antibodies were severe hemophilia and lack of knowledge of the type of factor used prior to entering the follow-up cohort.