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.

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.

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.

PREVALENCE OF ANXIETY SYMPTOMS AMONG HEALTH CARE WORKERS IN COLOMBIA DURING THE COVID-19 PANDEMIC.

OBJECTIVE: This study aimed to determine the prevalence of anxiety symptoms in a Colombian HCW sample during the COVID-19 pandemic. METHODS: A cross-sectional study was carried out by means of an online survey (May-June 2020). Respondents were HCWs in Colombia reached by a nonprobability sample. Zung's self-rating anxiety scale allowed the estimation of prevalence and classification of anxiety symptoms. RESULTS: A total of 568 HCWs answered the questionnaire, 66.0% were women, the mean age was 38.6±11.4 years. 28.9% presented with anxiety symptoms, of whom 9.2% were moderate-severe. Characteristics such as living with relatives at higher risk of mortality from COVID-19 infection (OR:1.90; 95% CI: 1.308-2.762), female sex (OR:2.16; 95% CI: 1.422-3.277), and personal history of psychiatric illness (OR:3.41; 95% CI: 2.08-5.57) were associated with higher levels of anxiety. Access to sufficient personal protective equipment (OR:0.45; 95% CI: 0.318-0.903) and age >40 years (OR:0.53; 95% CI: 0.358-0.789) were associated with lower anxiety levels. CONCLUSIONS: Anxious symptoms are common in the population of HCWs faced with patient care during the COVID-19 pandemic. Different strategies are required to intervene with subgroups at risk of developing higher levels of anxiety during the pandemic.[[[es]]]ResumenObjetivo: Determinar la prevalencia de síntomas de ansiedad en una muestra de personal de salud (PDS) colombianos durante la pandemia por COVID-19-.Métodos: Se llevó a cabo un estudio de corte transversal, mediante una encuesta en línea (mayo a junio 2020). Los encuestados fueron PDS en Colombia reclutados mediante una muestra no probabilística. La escala de autoevaluación de ansiedad de Zung permitió la estimación de la prevalencia y clasificación de los síntomas de ansiedad. RESULTS: Un total de 568 PDS respondieron el cuestionario, 66.0% fueron mujeres, la edad promedio fue 38.6±11.4 años. 28.9% presentaron síntomas de ansiedad, de los cuales 9.2% fueron moderados-severos. Características como vivir con familiares con mayor riesgo de mortalidad por infección por COVID-19 (OR:1.90; 95% IC: 1.308-2.762), sexo femenino (OR:2.16; 95% IC: 1.422-3.277), y la presencia de historia personal de patología psiquiátrica (OR:3.41; 95% IC: 2.08-5.57) se asociaron con mayores niveles de ansiedad. El acceso a elementos de protección personal suficientes (OR:0.45; 95% IC: 0.318-0.903) y las edades >40 años (OR:0.53; 95% IC: 0.358-0.789) se correlacionaron con menores niveles de ansiedad. CONCLUSIONES: Los síntomas ansiosos son comunes en la población de PDS enfrentados al cuidado de pacientes durante la pandemia por COVID-19. Diferentes estrategias se requieren para intervenir los subgrupos en riesgo de desarrollar mayores niveles de ansiedad durante la pandemia.

Treatment patterns in fibromyalgia including the use of opioids.

OBJECTIVE: Opioids (except for tramadol) have not been shown to be effective in patients with fibromyalgia, but they can increase the risk of adverse drug reactions. The aim was to determine the treatment patterns of a group of patients with fibromyalgia and to identify the factors associated with the use of opioids in Colombia. METHODS: This was a cross-sectional study of a group of patients with fibromyalgia from a pain clinic in Colombia. Sociodemographic, clinical and pharmacological variables were identified. Descriptive, bivariate, and multivariate analyses were performed. RESULTS: A total of 559 patients were analysed, 88.6% of whom were women, and the mean age was 53.4 ± 12.6 years. A total of 40.6% received nonpharmacological management, and the majority were treated with acetaminophen (96.1%) and pregabalin (62.8%). A total of 69.6% received opioids, the most common of which was hydrocodone (36.3%). The average morphine equivalent milligrammes was 36.9 ± 91.2 (range: 2.3-750 mg), and 43.8% had intermediate/high doses. Being male (OR: 3.12; 95% CI: 1.40-6.91), having arterial hypertension (OR: 1.67; 95% CI: 1.04-2.69), obesity (OR: 2.23; 95% CI: 1.18-4.24), degenerative disease of vertebral discs (OR: 2.32; 95% CI: 1.10-4.88) and comedication with gabapentinoids (OR: 1.75; 95% CI: 1,15-2.65) were associated with a higher probability of receiving opioids, while patients treated with muscle relaxants had a lower risk of opioid treatment (OR: 0.64; 95% CI: 0.41-0.98). CONCLUSIONS: A significant proportion of patients were treated with opioids, the most common of which was hydrocodone, which goes against the recommendations of clinical practice guidelines.

Utilization Patterns and Trends in the Use of Medications for Asthma in a Cohort of Colombian Patients.

Purpose: Asthma affects approximately 358 million people worldwide. This study aimed to determine the trend for the use of medications intended to treat asthma in a group of patients affiliated with the Colombian health system. Patients and Methods: This was a retrospective study on prescription patterns of medications used to treat asthma in patients over 5 years of age between 2017 and 2019. Sociodemographic variables, medications used and combinations, the persistence of use, and prescribing physicians were considered. Data were obtained from a drug-dispensing database from Colombia. Results: A total of 10,706 people diagnosed with asthma were identified, including predominantly females (56.8%), with a mean age of 32.2 ± 26.1 years. At the beginning of the follow-up, 53.2% of patients aged 5-11 years were receiving monotherapy, with a mean of 1.5 ± 0.6 drugs/patient, especially inhaled corticosteroids (ICSs; 55.9%) and short-acting ß-agonists (SABAs; 55.6%). Moreover, in patients older than 12 years, 53.5% were treated with monotherapy, with a mean of 1.6 ± 0.7 drugs/patient, 45.9% of whom were on SABAs, while 37.1% were on ICSs. Between 63.0% and 83.6% of patients were treated by a general practitioner. 12.5% of patients (n = 495) received triple therapy (ICS/LABA + LAMA [long-acting antimuscarinic]), particularly fluticasone/salmeterol + tiotropium. Conclusion: The identification of treatment patterns will allow physicians and decision makers to implement strategies in order to promote adherence to treatment and improve asthma medication use.

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.

Prescription profile of antiarrhythmic drugs in a group of patients in Colombia / Perfil de prescripción de fármacos antiarrítmicos en un grupo de pacientes en Colombia

Abstract Objective: To determine the prescription patterns of antiarrhythmic drugs and variables associated with their use in a population of patients affiliated with the Colombian Health System. Methods: A cross-sectional study was performed on a population database with patients who received antiarrhythmics from March to May 2016. Sociodemographic, pharmacological and comedication variables were included. SPSS-24 was used for data analysis using X2 tests and multivariate analyses. Results: In total, 2772 patients were treated with antiarrhythmics in the evaluated period. The mean age was 70.1 ± 13.1 years, and 51.2% were women. In total, 79.4% used a β-blocker, 58.5% amiodarone and 2.9% a calcium channel blocker. Moreover, 1192 (43.0%) patients were prescribed a single antiarrhythmic, and 1580 (57.0%) received two or more. There were 2603 patients (93.9%) with comedication, including lipid-lowering drugs (62.6%), inhibitors of the renin angiotensin aldosterone system (62.6%) and antiplatelet drugs (42.0%). Age older than 65 years increased the probability of comedication (odds ratio [OR]: 2.48; 95% confidence interval [95% CI]: 1.59-3.85), and the risk was proportional to age. We identified 1364 patients treated with conditional risk medications for QT prolongation (49.2%), 68 with a possible risk (2.5%) and 171 (6.2%) with a known risk. Conclusion: Antiarrhythmic drugs recommended by clinical practice guidelines are mainly used; however, risk interactions interactions of QT prolongation were identified and should be taken into account by physicians to avoid adverse events or complications.

Resumen Objetivo: determinar los patrones de prescripción de fármacos antiarrítmicos y variables asociadas a su utilización en una población de pacientes afiliados al sistema de salud de Colombia. Métodos: estudio de corte transversal sobre una base de datos poblacional con pacientes que recibieron antiarrítmicos entre marzo y mayo de 2016. Se incluyeron variables sociodemográficas, farmacológicas y de comedicación. Para el análisis de datos se utilizó SPSS-24, realizando pruebas X2 y análisis multivariado. Resultados: se encontraron 2 772 pacientes en tratamiento con antiarrítmicos en el periodo evaluado, la edad promedio fue 70,1 ± 13,1 años, 51,2 % eran mujeres. El 79,4% utilizó algún β-bloqueador, 58,5% amiodarona y 2,9 % algún bloqueante de canales de calcio. Al 43 % se les prescribió un solo antiarrítmico y 57 % recibieron dos o más. El 93,9 % tenía con alguna comedicación, especialmente hipolipemiantes (62,6 %), inhibidores del sistema renina angiotensina aldosterona (62,6 %) y antiagregantes (42 %). Ser mayor de 65 años aumentó la probabilidad de comedicación (OR:2,48; IC95 %:1,59-3,85) y el riesgo fue proporcional al incremento de la edad. El 49,2 % (n=1364) estaban tratados con medicamentos de riesgo condicional de prolongación del QT, 2,5 % (n=68) con riesgo posible y 6,2% (n=171) de riesgo conocido. Conclusión: se están utilizando los mismos fármacos recomendados por las guías de práctica clínica; sin embargo, se encontraron interacciones de riesgo de prolongación del intervalo QT que deben ser tenidas en cuenta para evitar eventos o complicaciones en los pacientes.

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.

Prescription patterns of riluzole in a population of patients with motor neuron disease / Patrón de prescripción de riluzol en una población de pacientes con enfermedad de neurona motora

SUMMARY OBJECTIVE: To determine the prescription pattern of riluzol and the variables associated to its use in a population of patients with motor neuron disease affiliated to the Colombian General Social Security Health System (SGSSS) in 2017. METHOD: Descriptive cross-sectional study. Through a systemized data base of approximately 3,5 million members to the Colombian SGSSS; patients who had been given riluzol uninterruptedly between April 1 and June 30 of 2017, were selected. Sociodemographic, pharmacological variables and comorbidities were analyzed. Defined daily dose (DDD) was estimated for 1.000 inhabitants/day and its costs. RESULTS: There were found 81 patients with motor neuron disease receiving riluzol, with an average age of 60,8+12,6 years. 48.1% were male. The prevalence of motor neuron disease was 29/100.000 individuals. Patients received riluzol in 50 mg tablets and the doses was estimated in 0,016 DDD for 1.000 inhabitants/day 63% were receiving medicines that reflect comorbidity or could interact with riluzol. The total cost of riluzol dispensed in 2017 was USD 85.348 and per prescribed daily dose on average was USD 2,3. CONCLUSIONS: The use of riluzol in patients with motor neuron disease in Colombia was carried by the recommended doses by the WHO and with a direct cost lower than reported in other countries. Studies are recommended in order to determine the effectiveness of riluzol in real-life conditions.

RESUMEN OBJETIVOS: Determinar el patrón de prescripción de riluzol y las variables asociadas a su utilización en una población de pacientes con enfermedad de neurona motora afiliados al Sistema General de Seguridad Social en Salud de Colombia (SGSSS) en 2017. METODOLOGÍA: Estudio descriptivo de corte transversal. Mediante una base de datos sistematizada de aproximadamente 3,5 millones de afiliados al SGSSS de Colombia; se seleccionaron pacientes a quienes se les haya dispensado riluzol de manera ininterrumpida entre 1 abril y 30 junio de 2017. Se analizaron variables socio-demográficas, farmacológicas y las comorbilidades. Se estimaron la dosis diaria definida (DDD) por 1.000 habitantes/día y los costos. RESULTADOS: Se encontraron 81 pacientes con enfermedad de neurona motora recibiendo riluzol, con edad promedio de 60,8+12,6 años. El 48,1% eran hombres. La prevalencia de enfermedad de neurona motora fue 2,29/100.000 personas. Los pacientes recibieron riluzol en tabletas de 50 mg y se estimó la dosis en 0,016 DDD por 1.000 habitantes/día. El 63% recibían medicamentos que reflejan comorbilidad o pudieran tener interacción con riluzol. El costo total del riluzol dispensado en 2017 fue USD 85.348 y por dosis diaria prescrita en promedio fue USD 2,3. CONCLUSIONES: El uso de riluzol en pacientes con enfermedad de neurona motora en Colombia se realizó a las dosis recomendadas por la OMS y con un costo directo menor al reportado en otros países. Se recomienda realizar estudios que permitan determinar la efectividad del riluzol en condiciones de la vida real.

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.

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.

Trends in Opioid Use in a Cohort of Patients with Rheumatoid Arthritis.

The objective was to determine the trend in the use of opioid analgesics in a cohort of patients diagnosed with and treated for rheumatoid arthritis (RA) in 24 cities in Colombia. This retrospective cohort study included adult patients diagnosed with RA, which was managed in a specialized institution in Colombia between January 2011 and December 2012. The first rheumatology visit was recorded as an index date, and monthly monitoring of the analgesic medication received was performed until December 2017. Sociodemographic variables, the use of opioids, and concomitant prescriptions were evaluated. A total of 1,329 patients diagnosed with and treated for RA were included; they had a mean age of 61.2 ± 11.8 years and were predominantly females (n = 936; 82.9%). A total of 1,129 (84.9%) subjects used opioids for at least one month, and a growing trend, from 13.5% to 21.4%, was observed in patients who received opioids every month throughout a 7-year follow-up of the cohort. In total, 46.7% of the cases used opioids for more than 12 months. The most commonly used opioids were codeine (76.3%) and tramadol (71.1%). All patients received conventional disease-modifying antirheumatic drugs (DMARDs), 85.6% received systemic corticosteroids, 73.9% received nonsteroidal anti-inflammatory drugs, and 15.9% received biological DMARDs. A high proportion of opioid use was shown for pain management in patients with RA, in many cases for more than 12 months, in whom the efficacy and especially safety, related to the risk of dependence, should be monitored.

Adherence to levothyroxine prescription in patients with hypothyroidism / Adherencia al uso de levotiroxina en pacientes con hipotiroidismo

ABSTRACT Background: Hypothyroidism occurs in 1-2% of the general population, is associated with significant morbidity and requires continuous treatment with levothyroxine. Aim: To determine the effectiveness, adherence and safety of levothyroxine therapy in patients with hypothyroidism. Material and Methods: The Morisky-Green adherence test was applied, and effectiveness was determined by measuring thyroid-stimulating hormone (TSH) in 330 patients with with hypothyroidism; the mean age was 64+-15 years and 76% was women. Results: Median TSH was 2.09 mIU/L (interquartile range: 1.16-3.61 mIU/L). Two hundred thirty-five (71%) patients had TSH levels in the euthyroid range, 64 (19%) in the hypothyroid range and 31 (9%) in the hyperthyroid range. Complete, moderate and lack of adherence with levothyroxine was reported in 283 (86%), 29 (9%) and 18 (5%) of patients, respectively. The presence of anemia (odds ratio (OR): 0.37, 95% confidence intervals (CI): 0.15-0.98) or the need of doses over 100 µg/day (OR: 0.47, 95%CI: 0.28-0.80) increased the probability of having an abnormal TSH level. Conclusions: In a large proportion of these patients, TSH levels were controlled, and most patients were adherent to levothyroxine therapy.

Antecedentes: El hipotiroidismo se presenta entre el 1-2% de la población general, genera importante morbilidad y requiere tratamiento con levotiroxina de manera continua. Objetivo: Determinar la efectividad, adherencia y seguridad de la terapia con levotiroxina en pacientes con hipotiroidismo. Material y Métodos: Se aplicó test de adherencia de Morisky-Green y se determinó efectividad mediante medición de TSH en 330 pacientes con edad promedio 63 ± 15 años (76% mujeres). Resultados: La mediana de TSH fue 2,09 mUI/l, (rango intercuartílico: 1,16mUI/l-3,61mUI/l). Un total de 235 (71,2%) tenían cifras de TSH en rango de estado eutiroideo, 64 (19,4%) se catalogaron hipotiroideos y 31 (9,4%) hipertiroideos. El 86% (n = 283) manifestó tener adherencia completa al medicamento, 29 (9%) moderada y 18 (5%) se clasificaron poco adherentes. Tener diagnóstico de anemia (razón de riesgo (RR): 0,37; intervalos de confianza (IC) 95%: 0,15-0,98) o necesitar dosis mayores de 100 µg/día (RR: 0,47; IC95%: 0,28-0,80) elevaron la probabilidad de no controlar el hipotiroidismo. Conclusiones. Una alta proporción de pacientes se encuentran controlados y con mucha frecuencia son adherentes a la terapia con levotiroxina.

Evaluation of Treatment Patterns and Direct Costs Associated with the Management of Neuropathic Pain.

Background: Neuropathic pain has a prevalence of 2-17% in the general population. Diagnosis and treatment of neuropathic pain are not fully described in different populations. The aim was to determine the treatment patterns and direct costs of care associated with the management of neuropathic pain from the onset of the first symptom to up to two years after diagnosis. Methods: From a drug-claim database, a cohort of randomly selected outpatients diagnosed with neuropathic pain was obtained from an insurer in Colombia and followed up for two years after diagnosis. The clinical records were reviewed individually to identify the study variables, including the time needed to make the diagnosis, the medical and paraclinical resources used, the pharmacological therapy for pain management, and the direct costs associated with care. Results: We identified 624 patients in 49 cities, with a mean age of 50.3 ± 14.1 years, of which 324 were men (51.9%). An average of 90 days passed from the initial consultation until the diagnosis of neuropathic pain, the most frequent being lumbosacral radiculopathy (57.9%). 34.5% of the cohort had at least one diagnostic imaging procedure, and 16% had an electromyography. On average, they were treated by a general practitioner twice. 91.7% received initial treatment with tramadol, carbamazepine, amitriptyline, imipramine, or pregabalin, and 60.4% received combined therapy. The mean cost of care for two years for each patient was US$246.3. Conclusions: Patients with neuropathic pain in Colombia are being diagnosed late, are using therapeutic agents not recommended as first-line treatment by clinical practice guidelines, and are being treated for short periods of time.

Identification of potentially inappropriate cardiovascular prescriptions in the elderly using Beers criteria / Criterios de Beers en la identificación de prescripciones de uso cardiovascular potencialmente inapropiadas en ancianos

Abstract Introduction: improper use of medication is becoming more frequent and can cause physical or physiological damage. Objective: to determine the frequency of potentially inappropriate prescriptions of cardiovascular drugs according to Beers' criteria in a population of colombian patients. Method: cross-sectional study conducted during november 2016 using a population database of 326,192 adults over 65 years of age who were eligible to receive drugs included in the cardiovascular system category according to the Beers' criteria. The frequency of potentially inappropriate prescriptions was determined and investigated in relation to sociodemographic variables. Results: the mean subject age was 74.6±7.6 years (range:65-100 years). It was found that 11.3% (n=36894) of the elderly presented at least one potentially inappropriate prescription for cardiovascular conditions. The most frequent finding was the use of aspirin in patients older than 80 years of age followed by the use of prazosin for hypertension in patients over 65 years of age or in patients who consulted emergency services for syncope. The other criteria were present in less than 1% of patients, and in 16 out of 33 treatment drugs, no patients exposed to potentially inappropriate prescriptions were found. Within the criteria based on drug-drug interactions, the most frequent were loop diuretics along with prazosin (6.4%). Conclusions: the prevalence of potentially inappropriate prescriptions in an elderly population of patients in Colombia is lower than that reported worldwide. In addition, there is a need to re-evaluate the Beers' criteria in this population and adjust the guidelines according to results of pharmacovigilance of active pharmaceutical substances available in Colombia.

Resumen Introducción: el uso incorrecto de medicamentos es cada vez más frecuente y puede causar daños físicos o fisiológicos. Objetivo: determinar la frecuencia de las prescripciones de medicamentos de uso cardiovascular potencialmente inapropiadas según criterios de Beers en una población de pacientes colombianos. Métodos: estudio de corte transversal, a partir de una base de datos de una población de 326.192 adultos mayores de 65 años, durante el mes de noviembre de 2016, susceptibles de recibir medicamentos incluidos en los criterios de Beers en la categoría de sistema cardiovascular, determinando la frecuencia de prescripciones potencialmente inapropiadas, así como la identificación de variables sociodemográficas. Resultados: la edad promedio fue de 74,6±7,6 años (rango 65-100 años). Se halló que el 11,3% (n=36894) de los ancianos tuvo al menos una prescripción potencialmente inapropiada para condiciones cardiovasculares. El criterio más frecuente fue el uso de aspirina en mayores de 80 años, seguido del empleo de prazosín para la hipertensión arterial en mayores de 65 años, o en pacientes que consultaron por síncope a los servicios de urgencias. Los demás criterios se presentaban en menos del 1% de pacientes y en 16 de 33 fármacos de cuidado no se halló ningún paciente expuesto. Entre los criterios basados en interacciones fármaco-fármaco, el más frecuente fue diuréticos de asa junto con prazosín (6,4%). Conclusiones: la prevalencia de prescripciones potencialmente inapropiadas en una población de ancianos colombianos es menor a la reportada en el mundo. Además, se plantea la necesidad de reevaluar los criterios de Beers en dicha población y ajustarlos de acuerdo con los informes de farmacovigilancia y principios activos disponibles en Colombia.