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This study compared dapagliflozin, a sodium-glucose co-transporter 2 inhibitor, and dipeptidyl peptidase-4 inhibitors (DPP-4i) with regard to cardiovascular (CV) event incidence and direct medical costs during type 2 diabetes treatment. A retrospective cohort study was conducted using national health insurance claims data from September 1, 2014, to June 30, 2018, of patients in Korea. Patients who were prescribed dapagliflozin and DPP-4i for the first time were included. The primary outcome was the incidence of a composite of major adverse CV events (MACEs)-nonfatal myocardial infarction, nonfatal stroke, or in-hospital CV death. Proportional hazard models after propensity score weighting were used to determine hazard ratios (HRs) and 95% confidence intervals (CIs) for MACE in the dapagliflozin and DPP-4i groups. A decision analytic model was used to compare direct medical costs between the two treatment groups from a healthcare provider's perspective. Of the 260,336 patients in the cohort, 23,147 and 237,189 received dapagliflozin and DPP-4i, respectively. During the follow-up, 184 patients receiving dapagliflozin and 3,674 receiving DPP-4i (incidence, 6.47 and 11.33 events/1,000 person-years, respectively) had MACE. The adjusted HR of MACE for dapagliflozin compared with that for DPP-4i was 0.69 (95% CI 0.57-0.83). The corresponding HRs were consistent among patients with and without underlying CV disease. The estimated direct medical cost appeared to be lower by $68,452 in the dapagliflozin group than that in the DPP-4i group for 3 years, in 1,000 hypothetical patients. In this population-based cohort study, the use of dapagliflozin instead of DPP-4i was associated with a reduced risk of MACE, which subsequently reduced direct medical costs. These data provide valuable information to patients, practitioners, and authorities regarding the risk of CV events associated with dapagliflozin versus DPP-4i use in clinical practice.
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BACKGROUND: Dapagliflozin is one of the novel glucose-lowering agents, which has recently been reported to reduce the risk of hospitalization for heart failure (hHF). The present study aimed to compare the differences between the risk of hHF after using dapagliflozin and dipeptidyl peptidase-4 inhibitors (DPP-4i) as second-line drugs for the treatment of type 2 diabetes mellitus using the latest nationwide population data in Korea. Additionally, we aimed to examine the impact of clinical outcomes on direct medical costs in the two groups. METHODS: The present population-based, retrospective cohort study was conducted using the nationwide claims data between September 01, 2014 and June 30, 2018. New users of dapagliflozin and DPP-4i were identified from the database and the differences in patients' characteristics between the two groups were analyzed using propensity score-weighted analysis. Cox proportional hazards regression analysis was used to estimate the risk of hHF. A simple model was used for the estimation of direct medical costs for 3 years. RESULTS: In total, 23,147 patients in the dapagliflozin group and 237,187 patients in the DPP-4i group were selected for the analysis. The incidence rates of hHF were 3.86 and 6.79 per 1000 person-years in the dapagliflozin and DPP-4i groups, respectively. In the entire study population, the hazard ratio for hHF in the dapagliflozin group compared to the DPP-4i group was 0.58 (95% confidence interval 0.46-0.74), with 0.55 (95% confidence interval 0.41-0.74) among patients with underlying cardiovascular disease and 0.66 (95% confidence interval 0.46-0.95) among patients without underlying cardiovascular disease. The direct medical costs were $57,787 lower in the dapagliflozin group than in the DPP-4i group for 3 years. CONCLUSIONS: This study showed that dapagliflozin lowers the risk for hHF and subsequently reduces direct medical costs compared to DPP-4i. The protective effect against hHF was more evident among patients with underlying cardiovascular disease.
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Compuestos de Bencidrilo/economía , Compuestos de Bencidrilo/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Inhibidores de la Dipeptidil-Peptidasa IV/economía , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Costos de los Medicamentos , Glucósidos/economía , Glucósidos/uso terapéutico , Insuficiencia Cardíaca/economía , Insuficiencia Cardíaca/prevención & control , Inhibidores del Cotransportador de Sodio-Glucosa 2/economía , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Adulto , Anciano , Compuestos de Bencidrilo/efectos adversos , Ahorro de Costo , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiología , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Femenino , Glucósidos/efectos adversos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Costos de Hospital , Humanos , Incidencia , Masculino , Persona de Mediana Edad , República de Corea/epidemiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Inhibidores del Cotransportador de Sodio-Glucosa 2/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Purpose: To conduct a population-based study to determine whether the use of GnRH agonist and antiandrogens are associated with an increased risk of cardio-cerebrovascular disease (CCVD) in Asian patients with prostate cancer using the National Health Insurance Service-Elderly Cohort Database (NHIS-ECD). Materials and Methods: We included a total of 2,413 men aged 60 years or older with prostate cancer between January 2003 and December 2008. Outcomes of interest included the first occurrence of cardiovascular events [acute myocardial infarction (AMI), ischemic heart disease (IHD)] and cerebrovascular events [ischemic stroke (IS), and cerebrovascular disease (CVD)]. Results: The 5-year AMI-free rates of patients diagnosed with prostate cancer and treated with GnRH agonists, antiandrogens alone, or androgen deprivation therapy (ADT)-naïve interventions were 97.0%, 96.5%, and 98.3%, respectively, while the 5-year IHD-free rates were 93.2%, 92.3%, and 94.5%, respectively. Exposure to GnRH agonists or antiandrogen regimens did not significantly increase the risk of AMI or IHD compared to ADT-naïve treatment in multivariate Cox proportional-hazards models after adjusting for other covariates. Five-year IS-free rates of patients exposed to GnRH agonists, antiandrogens alone, and those with ADT-naïve prostate cancer were 94.8%, 94.7%, and 95.5%, respectively, while the five-year CVD-free rates were 92.9%, 93.3%, and 94.6%, respectively. Cox proportional-hazards models also failed to show that men who received GnRH agonist or antiandrogen treatment alone carried a significantly increased risk for IS or CVD compared to ADT-naïve patients. Conclusions: The current study based on Asian population suggests that treatment with neither GnRH agonist nor antiandrogens increases the risk of cardio-cerebrovascular disease compared to patients with ADT-naïve prostate cancer.
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AIM: We performed a systematic review and meta-analysis to compare the efficacy and safety of ticagrelor and prasugrel with those of clopidogrel in CYP2C19 reduced-metabolizers. METHODS: PubMed, Cochrane and Web of Science were systematically searched for randomized controlled trials or cohort studies up to January 2020. The primary endpoint was major adverse cardiovascular events (MACE), including cardiovascular (CV) death, all-cause death, myocardial infarction (MI), stent thrombosis and stroke. The secondary endpoint was bleeding. Pooled effects were measured by relative risk (RR) with 95% confidence intervals (CIs). Publication bias was evaluated with Egger's regression test and adjusted by trim and fill method. RESULTS: Twelve studies comprising 5829 CV patients with CYP2C19 loss-of-function alleles were included. Patients who received ticagrelor or prasugrel showed a lower risk of MACE than those who received clopidogrel (RR 0.524; 95% CI: 0.375, 0.731). The former also had lower risks of CV death (RR 0.409; 95% CI: 0.177, 0.946), all-cause death (RR 0.441; 95% CI: 0.263, 0.739), MI (RR 0.554; 95% CI: 0.414, 0.741) and stent thrombosis (RR 0.587; 95% CI: 0.348, 0.988) than the latter patient group. The risk of stroke was not significantly different between patients receiving the alternatives and those receiving clopidogrel (RR 0.605; 95% CI: 0.257, 1.425). Major and minor bleeding risk was not significantly different between patients treated with alternatives and clopidogrel (RR 1.019; 95% CI: 0.827, 1.260 and RR 1.235; 95% CI: 0.581, 2.628, respectively). CONCLUSION: CYP2C19 reduced-metabolizers can expect better clinical outcome on using prasugrel or ticagrelor rather than clopidogrel.
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Síndrome Coronario Agudo , Enfermedad de la Arteria Coronaria , Alelos , Clopidogrel/efectos adversos , Citocromo P-450 CYP2C19/genética , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Clorhidrato de Prasugrel/efectos adversos , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Ticagrelor/efectos adversos , Resultado del TratamientoRESUMEN
This prospective, single-blind, randomized study was designed to evaluate the effect of genotype-based warfarin dosing compared with standard warfarin dosing in Korean patients with mechanical cardiac valves. Patients were assigned to either the genotype-based dosing group or the standard dosing group using stratified block randomization. The genotype-based dosing equation was adopted from a previous study which included VKORC1 rs9934438, CYP2C9 rs1057910, CYP4F2 rs2108622, and age. Primary outcomes included the percentage of time in the therapeutic range (pTTR): (i) during the first week following initiation of warfarin therapy, (ii) during hospitalization and (iii) until the first outpatient visit. A total of 91 patients were included in the analysis, 42 treated with genotype-based warfarin dosing and 49 treated with standard warfarin dosing. The genotype frequency differences of the three SNPs included in this study (ie, VKORC1, CYP2C9, CYP4F2), between the genotype-based dosing and standard dosing groups were not different. The genotype-based dosing group trended toward higher pTTR when compared with the standard dosing group, although this difference was not statistically significant. In patients with aortic valve replacement, TTRTraditional and TTRRosendaal were significantly higher in the genotype-based dosing group when compared with the standard dosing group during the first week following treatment initiation [ie, 58.5% vs. 38.1% (p = 0.009) and 64.0% vs. 44.6% (p = 0.012), respectively]. Based on the results, the genotype-guided dosing did not offer a significant clinical advantage, but a possible benefit in patients with aortic valve replacement has been suggested.
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Anticoagulantes/uso terapéutico , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Warfarina/uso terapéutico , Adulto , Anciano , Citocromo P-450 CYP2C9/genética , Familia 4 del Citocromo P450/genética , Femenino , Genotipo , Humanos , Masculino , Persona de Mediana Edad , Polimorfismo de Nucleótido Simple/genética , Estudios Prospectivos , Método Simple Ciego , Vitamina K Epóxido Reductasas/genéticaRESUMEN
PURPOSE: Talc slurry (TS) has been commonly used with high success rates in managing spontaneous pneumothroax (SP), but there were concerns of post-procedural complications. Alternatively, doxycycline solution (DS) was used successfully. This retrospective study aims to compare the effectiveness and safety between talc and doxycycline as a sclerosing agent and to investigate risk factors for recurrence in patients with SP. METHODS: The review of medical records between January 2011 and December 2014 was conducted on 83 patients with SP who underwent pleurodesis with either TS (n=16) or DS (n=67). Recurrence and complications were compared between the DS and TS groups. Associations between recurrence after DS treatment and various factors were analysed. RESULTS: Recurrence was significantly higher in the DS group than in the TS group (P=0.033), whereas complications were higher in the TS group than the DS group: fever was significantly higher in the TS group (P=0.001). Recurrences associated with doxycycline use were found significantly more often in patients with recurrent diagnosis of SP, height/weight ≥3.25 cm/kg and weight <55 kg. CONCLUSION: Talc was more effective without recurrence compared with doxycycline. Clinically insignificant fever associated with pleurodesis was more common with talc. Low weight, high height to weight ratio and recurrent diagnosis of SP were associated with higher recurrence after doxycycline treatment.
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BACKGROUND: Although there are several studies on the association between use of proton pump inhibitors (PPIs) and increased Clostridium difficile infection (CDI) risk, detailed studies analyzing the effects of PPI use on CDI risk are lacking. The present study investigated the association of the dose, duration, and types of PPIs with CDI risk. METHODS: A single-center, cohort study was conducted on patients admitted to a hospital. The exposed cohort comprised patients who were prescribed PPIs at least once during the study period, and a control cohort was prepared by randomly assigning an index date to patients who did not use PPIs ensuring the same distribution of index dates as in the exposed cohort and matching sex, age, hospitalization period, and date of admission. RESULTS: PPI use increased the risk of CDI by 1.8-fold [95% confidence interval (CI) 1.5-2.2]. CDI risk increased by 1.8-fold with esomeprazole (95% CI 1.4-2.2) and 2.0-fold with pantoprazole (95% CI 1.5-2.8). Patients who used a high dose had a higher risk than those who used a medium dose [adjusted hazard ratio (HR) 2.0 vs 1.3]. The risk of CDI increased 4.2-fold when the PPI exposure period was 6 days or shorter than 6 days. CONCLUSIONS: Our study showed that PPI use was associated with an increased risk of developing CDI and the risk of CDI was dose dependent. Therefore, PPIs should only be used at proper doses and only for the necessary indications to avoid CDI risk.
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Clostridioides difficile/aislamiento & purificación , Infecciones por Clostridium/epidemiología , Hospitalización/estadística & datos numéricos , Inhibidores de la Bomba de Protones/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Infecciones por Clostridium/etiología , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de la Bomba de Protones/efectos adversos , Estudios Retrospectivos , Riesgo , Adulto JovenRESUMEN
AIMS: To evaluate the real-world effect of dipeptidyl peptidase-4 inhibitor (DPP4i) on the incidence of autoimmune diseases (AD), including rheumatoid arthritis (RA), inflammatory bowel diseases, multiple sclerosis and systemic lupus erythematosus. METHODS: We identified new users of DPP4i (n = 497 619) or non-DPP4i (n = 643 165) oral combination therapy between 1 January 2011 and 30 June 2015 among patients with type 2 diabetes mellitus in the Korean national health insurance claims database. Patients were followed from the date of initiation of combination therapy until AD outcome, censoring for treatment discontinuation or switching, death or end of study (31 August 2016). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) for RA, inflammatory bowel diseases, other AD (multiple sclerosis and systemic lupus erythematosus), and the composite of all outcomes were estimated using propensity score (PS)-adjusted Cox model. RESULTS: In the PS-weighted and PS-matched analysis, the risk of incident RA was decreased for DPP4i initiators compared with non-DPP4i initiators (aHR 0.67 [95% CI 0.49-0.92] and aHR 0.72 [95% CI 0.51-1.01], respectively). In both analyses, the risk of incident composite AD was also decreased for DPP4i initiators compared with non-DPP4i initiators (aHR 0.82 [95% CI 0.68-0.99] and aHR 0.76 [95% CI 0.62-0.93], respectively). CONCLUSIONS: In this large population-based cohort study, upfront DPP4i combination therapy was associated with a lower risk of composite AD compared with initial non-DPP4i combination therapy.
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Enfermedades Autoinmunes/epidemiología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Administración Oral , Adolescente , Adulto , Anciano , Enfermedades Autoinmunes/prevención & control , Estudios de Cohortes , Bases de Datos Factuales/estadística & datos numéricos , Quimioterapia Combinada , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , República de Corea/epidemiología , Factores de Riesgo , Factores Sexuales , Adulto JovenRESUMEN
AIM: Smartphone overuse can cause not only mobility problems in the wrists, fingers and neck but also interference with sleep habits. However, research on smartphone addiction and sleep disturbances is scarce. Therefore, we aimed to investigate daytime sleepiness in association with smartphone addiction risk in Korean adolescents. METHODS: A cross-sectional survey method was used in this study. The Pediatric Daytime Sleepiness Scale was used to assess daytime sleepiness, and the Korean Smartphone Addiction Proneness Scale index was used to evaluate the degree of risk for smartphone addiction. RESULTS: The analyses were performed in 1796 adolescents using smartphones, including 820 boys and 976 girls. The at-risk smartphone users made up 15.1% of boys and 23.9% of girls. Our multivariate analyses demonstrated that students who were female, consumed alcohol, had lower academic performance, did not feel refreshed in the morning and initiated sleep after 12 am were at a significantly higher risk of smartphone addiction. The at-risk smartphone user group was independently associated with the upper quartile Pediatric Daytime Sleepiness Scale score in students with the following factors: Female gender, alcohol consumption, poor self-perceived health level, initiating sleep after 12 am, longer time taken to fall asleep and duration of night sleep less than 6 h. CONCLUSIONS: The quality of sleep in adolescence affects growth, emotional stability and learning skills. Therefore, the management of smartphone addiction seems to be essential for proper sleeping habits. There is a critical need to develop a means of preventing smartphone addiction on a social level.
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Conducta Adictiva/fisiopatología , Trastornos del Sueño-Vigilia/etiología , Somnolencia , Teléfono Inteligente , Adolescente , Conducta Adictiva/diagnóstico , Conducta Adictiva/psicología , Estudios Transversales , Femenino , Encuestas Epidemiológicas , Humanos , Modelos Logísticos , Masculino , República de Corea , Medición de Riesgo , Factores de Riesgo , Trastornos del Sueño-Vigilia/diagnóstico , Trastornos del Sueño-Vigilia/fisiopatología , Trastornos del Sueño-Vigilia/psicologíaRESUMEN
PURPOSE: Results of a meta-analysis of data from clinical studies comparing patient outcomes and hospital length of stay (LOS) in surgical patients receiving fish oil (FO)-containing i.v. fat emulsions (IVFEs) versus non-FO-containing IVFEs are presented. METHODS: Computerized searches of the MEDLINE, Embase, and Coch rane CENTRAL databases were performed in August 2014 to identify English-language articles on randomized controlled trials (RCTs) comparing FO-containing and non-FO-containing IVFEs in adult surgical patients receiving parenteral nutrition. Selected articles were analyzed for methodological and publication bias and study heterogeneity (I2 statistic). RESULTS: Data from 19 RCTs (total n = 1,167) were included in the meta-analysis. Compared with use of non-FO-containing IVFEs (products based in soybean oil [SO], medium-chain triglycerides, or olive oil), use of FO-containing IVFEs was associated with reduced infectious morbidity (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.30-0.65; p < 0.0001; I2 = 0%); the effect size was greatest for FO-containing versus SO-based IVFEs. Relative to use of SO-based IVFEs, use of FO-containing IVFEs was associated with a significant reduction in hospital LOS (weighted mean difference, -2.70 days; 95% CI, -3.60 to -1.79 days; p < 0.00001; I2 = 0%). CONCLUSION: The results of the meta-analysis indicated that FO-containing IVFEs could improve infectious morbidity and LOS. The overall effect of reducing infectious morbidity and LOS was found to be the greatest in comparison with the SO-based IVFEs.
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Emulsiones Grasas Intravenosas/administración & dosificación , Ácidos Grasos Omega-3/administración & dosificación , Atención Perioperativa/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Humanos , Tiempo de Internación/tendencias , Atención Perioperativa/tendencias , Infección de la Herida Quirúrgica/diagnóstico , Infección de la Herida Quirúrgica/tratamiento farmacológico , Resultado del TratamientoRESUMEN
The objective of this study was to carry out a large population-based study to understand the factors associated with hypoglycemia-related hospitalizations among older Korean adults with diabetes mellitus.This study analyzed data from a subset of the 2013 Health Insurance and Review and Assessment service-Adult Patient Sample. A total of 307,170 subjects, comprising 41.7% men and 58.3% women, had diabetes mellitus. Hypertension (80.8%) was the most common comorbidity, and dyslipidemia (59.0%) and ischemic heart disease (21.3%) were also prevalent. Approximately half of the patients with diabetes had >2 comorbidities, and two-thirds of the patients had >3 comorbidities. The proportion of patients taking insulin or sulfonylureas was 54.9%, and 23.2% of the patients were taking other medications. About 21.9% of the patients were treated nonpharmacologically. A total of 2867 hypoglycemia-related admission occurred, the incident rate was 9.33 per 1000 person. The risk was higher among female patients and older patients with several comorbidities, including cardiovascular disease, cerebrovascular disease, chronic liver disease, chronic kidney disease, dementia, and malignancies. Treatment modalities, including insulin and sulfonylureas, were associated with a high risk of hypoglycemia. After adjustments for age, sex, the different comorbidities, and the treatment modalities, we determined that chronic kidney disease and dementia were associated with a high risk of hypoglycemia-related hospitalization (odds ratio [OR]â=â2.52 and ORâ=â1.93, respectively). Furthermore, patients with chronic kidney disease or dementia who were treated with sulfonylureas and insulin had very high risks of hypoglycemia, and the incident rate was 66.6 and 63.75 per 1000 person, respectively.In conclusion, the presence of comorbidities, especially chronic kidney disease and dementia, increased the risk of hypoglycemia-associated hospitalization within this population of older patients with diabetes. The impact of the treatment modality, for example, insulin or sulfonylureas, on hypoglycemia was much greater among these patients.
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Glucemia/metabolismo , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hospitalización/tendencias , Hipoglucemia/epidemiología , Hipoglucemiantes/efectos adversos , Vigilancia de la Población , Distribución por Edad , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad/tendencias , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Hipoglucemia/sangre , Hipoglucemia/inducido químicamente , Hipoglucemiantes/uso terapéutico , Incidencia , Masculino , Pronóstico , República de Corea/epidemiología , Estudios Retrospectivos , Medición de RiesgoRESUMEN
BACKGROUND: Bleeding complications have been frequently reported in East Asian patients on warfarin with a target international normalized ratio (INR) of 2.0-3.0. OBJECTIVE: This study aimed to identify the optimal therapeutic range of the INR in Korean patients with non-valvular atrial fibrillation (NVAF). Setting Cardiovascular department of a 1320 inpatient bed Korean hospital. METHOD: Retrospective chart review was conducted on 1014 patients for a total follow-up period of 2249.2 patient years. Major thromboembolic and bleeding complications were evaluated. The INR incidence of complication curve was plotted, and the optimal therapeutic range of INR was determined from the intersection of curves to ensure the lowest incidences of both thromboembolic and bleeding complications. For subgroup analysis, all patients were stratified by the following factors: age (above 75), disease (presence of hypertension, diabetes, congestive heart failure, and a history of stroke or thromboembolism), rhythm control procedure, and concurrent aspirin therapy. Main outcome measure Optimal therapeutic ranges of INR according to the risk factors. RESULTS: A total of 41 thromboembolic and 91 bleeding events occurred during the follow-up period. The complication rates were the lowest at an INR of 1.9 and the optimal therapeutic range was estimated to be 1.7-2.2 for the overall patients. The optimal therapeutic ranges of INR in the stratified patients were determined as follows: 1.3-1.8 in the patients ≥75 years of age; 1.5-2.0 in patients with hypertension, diabetes and concurrent aspirin therapy; 1.8-2.3 in patients with congestive heart failure; 1.9-2.4 in patients with previous stroke or thromboembolism; 1.7-2.2 in patients who had undergone rhythm control procedures. It has been shown that, by keeping the INR within these ranges, complication risks could be significantly reduced by up to 81 %. CONCLUSION: The intensity of anticoagulation therapy for Korean patients with NVAF is optimal when INR is between 1.7 and 2.2.
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Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Fibrilación Atrial/sangre , Fibrilación Atrial/tratamiento farmacológico , Relación Normalizada Internacional , Accidente Cerebrovascular/sangre , Factores de Edad , Anciano , Anciano de 80 o más Años , Pueblo Asiatico , Aspirina/efectos adversos , Aspirina/uso terapéutico , Femenino , Hemorragia/complicaciones , Hemorragia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Retrospectivos , Factores de Riesgo , Tromboembolia/complicaciones , Tromboembolia/epidemiologíaRESUMEN
BACKGROUND: The concomitant use of cytochrome P450 3A4 (CYP3A4) metabolized statins (simvastatin, lovastatin, and atorvastatin) with CYP3A4 inhibitors has been shown to increase the rate of adverse events. OBJECTIVE: This study was performed to describe the co-medication prevalence of CYP3A4-metabolized statins with contraindicated drugs. METHODS: The patients aged 40 or older receiving CYP3A4-metabolized statin prescriptions in 2009 were identified using the national patient sample from a Korea Health Insurance Review and Assessment Service database. Contraindicated co-medication was defined as prescription periods of statins and contraindicated drugs overlapping by at least one day. Co-medication patterns were classified into 3 categories as follows: co-medication in the same prescription, co-medication by the same medical institution, and co-medication by different medical institutions. The proportion of co-medication was analyzed by age, gender, co-morbidities, and the statin's generic name. RESULTS: A total of 2,119,401 patients received CYP3A4-metabolized statins and 60,254 (2.84%) patients were co-medicated with contraindicated drugs. The proportion of co-medication was 4.6%, 2.2%, and 1.8% in simvastatin, lovastatin, and atorvastatin users, respectively. The most frequent combination was atorvastatin-itraconazole, followed by simvastatin-clarithromycin and simvastatin-itraconazole. Among the co-medicated patients, 85.3% were prescribed two drugs by different medical institutions. CONCLUSION: The proportion of co-medication of statins with contraindicated drugs was relatively lower than that of previous studies; however, the co-medication occurring by different medical institutions was not managed appropriately. There is a need to develop an effective system and to conduct outcomes research confirming the association between co-medication and the risk of unfavorable clinical outcomes.
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Inhibidores del Citocromo P-450 CYP3A/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Contraindicaciones , Demografía , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , República de CoreaRESUMEN
BACKGROUND/OBJECTIVES: Data on the comparative effectiveness of oral antidiabetics on cardiovascular outcomes in a clinical practice setting are limited. This study sought to determine whether a differential risk of cardiovascular disease (CVD) exists for the combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor plus metformin versus a sulfonylurea derivative plus metformin or pioglitazone plus metformin. METHODS: We conducted a cohort study of 349,476 patients who received treatment with a DPP-4 inhibitor, sulfonylurea, or pioglitazone plus metformin for type 2 diabetes using the Korean national health insurance claims database. The incidence of total CVD and individual outcomes of myocardial infarction (MI), heart failure (HF), and ischemic stroke (IS) were assessed using the hazard ratios (HRs) estimated from a Cox proportional-hazards model weighted for a propensity score. RESULTS: During follow-up, 3,881 patients developed a CVD, including 428 MIs, 212 HFs, and 1,487 ISs. The adjusted HR with 95% confidence interval (CI) for a sulfonylurea derivative plus metformin compared with a DPP-4 inhibitor plus metformin was 1.20 (1.09-1.32) for total CVD; 1.14 (1.04-1.91) for MI; 1.07 (0.71-1.62) for HF; and 1.51 (1.28-1.79) for IS. The HRs with 95% CI for total CVD, MI, HF, and IS for pioglitazone plus metformin were 0.89 (0.81-0.99), 1.05 (0.76-1.46), 4.81 (3.53-6.56), and 0.81 (0.67-0.99), respectively. CONCLUSIONS: Compared with a DPP-4 inhibitor plus metformin, treatment with a sulfonylurea drug plus metformin was associated with increased risks of total CVD, MI, and IS, whereas the use of pioglitazone plus metformin was associated with decreased total CVD and IS risks.
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Enfermedades Cardiovasculares/epidemiología , Sistema Cardiovascular/efectos de los fármacos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Quimioterapia Combinada/efectos adversos , Hipoglucemiantes/efectos adversos , Adulto , Anciano , Estudios de Cohortes , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Femenino , Insuficiencia Cardíaca/epidemiología , Humanos , Hipoglucemiantes/uso terapéutico , Incidencia , Masculino , Metformina/efectos adversos , Metformina/uso terapéutico , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Pioglitazona , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Accidente Cerebrovascular/epidemiología , Compuestos de Sulfonilurea/efectos adversos , Compuestos de Sulfonilurea/uso terapéutico , Tiazolidinedionas/efectos adversos , Tiazolidinedionas/uso terapéutico , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: Strong concerns have been raised about whether the risk of ischemic stroke differs between conventional antipsychotics (CAPs) and atypical antipsychotics (AAPs). This study compared the risk of ischemic stroke in elderly patients taking CAPs and AAPs. METHOD: We conducted a retrospective cohort study of 71,584 elderly patients who were newly prescribed the CAPs (haloperidol or chlorpromazine) and those prescribed the AAPs (risperidone, quetiapine, or olanzapine). We used the National Claims Database from the Health Insurance Review and Assessment Service (HIRA) from January 1, 2006 to December 31, 2009. Incident cases for ischemic stroke (ICD-10, I63) were identified. The hazard ratios (HR) for AAPs, CAPs, and for each antipsychotic were calculated using multivariable Cox regression models, with risperidone as a reference. RESULTS: Among a total of 71,584 patients, 24,668 patients were on risperidone, 15,860 patients on quetiapine, 3,888 patients on olanzapine, 19,564 patients on haloperidol, and 7,604 patients on chlorpromazine. A substantially higher risk was observed with chlorpromazine (HR = 3.47, 95% CI, 1.97-5.38), which was followed by haloperidol (HR = 2.43, 95% CI, 1.18-3.14), quetiapine (HR = 1.23, 95% CI, 0.78-2.12), and olanzapine (HR = 1.12, 95% CI, 0.59-2.75). Patients who were prescribed chlorpromazine for longer than 150 days showed a higher risk (HR = 3.60, 95% CI, 1.83-6.02) than those who took it for a shorter period of time. CONCLUSIONS: A much greater risk of ischemic stroke was observed in patients who used chlorpromazine and haloperidol compared to risperidone. The evidence suggested that there is a strong need to exercise caution while prescribing these agents to the elderly in light of severe adverse events with atypical antipsychotics.
Asunto(s)
Antipsicóticos/uso terapéutico , Accidente Cerebrovascular/etiología , Anciano , Antipsicóticos/efectos adversos , Benzodiazepinas/efectos adversos , Benzodiazepinas/uso terapéutico , Clorpromazina/efectos adversos , Clorpromazina/uso terapéutico , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Femenino , Haloperidol/efectos adversos , Haloperidol/uso terapéutico , Humanos , Masculino , Olanzapina , Modelos de Riesgos Proporcionales , Fumarato de Quetiapina/efectos adversos , Fumarato de Quetiapina/uso terapéutico , República de Corea , Estudios Retrospectivos , Riesgo , Accidente Cerebrovascular/patología , Factores de TiempoRESUMEN
BACKGROUND: Low-dose aspirin is recommended to reduce the risk of cardiovascular disease. However, the questions with regard to primary prevention have been raised among patients with diabetes. We evaluated low-dose aspirin use for preventing ischemic stroke in patients with diabetes using a national health insurance database. METHODS: Using data from the Korean Health Insurance Review and Assessment Service database from January 1, 2005, through December 31, 2009, a population-based retrospective cohort study was conducted with incident patients with diabetes aged 40 to 99 years old with the initial use of low-dose aspirin during the index period from January 1, 2006 to December 31, 2007. We matched each low-dose aspirin user to one non-user using a propensity score. The Cox proportional hazards model was used to compare the risk of hospitalization for ischemic stroke in users and nonusers of low-dose aspirin until December 31, 2009. RESULTS: Out of 261,065 incident patients with diabetes, 15,849 (6.2%) were low-dose aspirin users. Compared to non-users, the adjusted hazard ratio (95% confidence interval) of low-dose aspirin users for hospitalization due to ischemic stroke was 1.73 (95% CI; 1.41-2.12). In a sensitivity analysis of study subjects with more than 1 year follow-up periods, slightly higher adjusted hazard ratio (1.97, 95% CI; 1.51-2.62) was observed. In the subgroup analyses, there were no significant changes in the risk of hospitalization for ischemic stroke irrespective of gender, age, or comorbidity. CONCLUSIONS: In this study of patients with diabetes, the use of low-dose aspirin showed an increased risk of hospitalization for ischemic stroke. These results suggest that low-dose aspirin use for the primary prevention of ischemic stroke should be reconsidered in patients with diabetes.
RESUMEN
This study examined 1-year persistency with cholinesterase inhibitors (ChEIs) for the treatment of elderly Alzheimer's dementia (AD) patients in Korea. Korean Health Insurance Review & Assessment Service database from January 2005 to June 2006 was used. Patients aged 65 or older with AD diagnosis who were first prescribed a ChEI were included. The 1-year persistence, persistency rate, and switching patterns during the follow-up period were identified. Mean time to drug discontinuation was analyzed, and persistency rates between different patient factors were compared. The 1-year persistency rate of newly treated 6,461 AD patients was 24.0%, while 50% of study patients discontinued treatment by 91 days from initiation. Persistency rates of female patients (22.8%), patients in rural areas (12.7%), and primary care (10.2%) were relatively low (p < 0.001). Persistency rate differed between age groups (p < 0.001). Overall proportion of switching was 6.6%. The 1-year persistency rate of ChEIs for AD patients in Korea did not reach those of previous researches in other countries. Patients less likely to remain on therapy should be especially monitored to optimize treatment persistence.
Asunto(s)
Enfermedad de Alzheimer/tratamiento farmacológico , Inhibidores de la Colinesterasa/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Factores de Edad , Anciano , Anciano de 80 o más Años , Enfermedad de Alzheimer/epidemiología , Femenino , Humanos , Masculino , Farmacoepidemiología , Atención Primaria de Salud/estadística & datos numéricos , República de Corea/epidemiología , Población Rural , Factores Sexuales , Análisis de Supervivencia , Población UrbanaRESUMEN
PURPOSE: Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS. METHODS: In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications. RESULTS: Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance. CONCLUSIONS: The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information.
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Sistemas de Registro de Reacción Adversa a Medicamentos/organización & administración , Farmacovigilancia , Sistemas de Registro de Reacción Adversa a Medicamentos/legislación & jurisprudencia , Causalidad , Revisión de la Utilización de Medicamentos , Educación en Salud/organización & administración , Promoción de la Salud/organización & administración , Humanos , Prescripción Inadecuada , Revisión de Utilización de Seguros/organización & administración , República de Corea , Gestión de RiesgosRESUMEN
This study was conducted to investigate disease-modifying antirheumatic drug (DMARD) utilization in Korean elderly patients with rheumatoid arthritis (RA). We used data from January 1, 2005 to June 30, 2006 from the Health Insurance Review and Assessment Service claims database. The study subjects were defined as patients aged 65 yr or older with at least two claims with a diagnosis of RA. DMARD use was compared by the patients' age-group, gender, medical service, and geographic divisions. The patterns of DMARD use in mono- and combination therapy were calculated. RA medication use was calculated by the number of defined daily doses (DDD)/1,000 patients/day. A total of 166,388 patients were identified during the study period. DMARD use in RA patients was 12.0%. The proportion of DMARD use was higher in the younger elderly, females, and patients treated in big cities. Hydroxychloroquine was the most commonly used DMARD in monotherapy, and most of the combination therapies prescribed it with methotrexate. DMARD use in elderly RA patients was noticeably low, although drug prescriptions showed an increasing trend during the study period, clinicians may need to pay more attention to elderly RA patients.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Factores de Edad , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Quimioterapia Combinada , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Masculino , Metotrexato/uso terapéutico , Programas Nacionales de Salud , Estudios Retrospectivos , Factores SexualesRESUMEN
The objective of this study was to evaluate the annual incidence of upper tract urolithiasis based on a large population-based study in Korea. This study used a subset of the 2009 Health Insurance and Review and Assessment service-National Patient Sample (HIRA-NPS). The 2009 HIRA-NPS contains data for 1,115,721 patients (711,285 inpatients and 404,436 outpatients) from January 2009 to December 2009. Based on these data, we selected patients who had been diagnosed with urolithiasis using the ICD code and calculated the incidence of urolithiasis. The total number of estimated urolithiasis patients was 219,328. The annual incidence of upper tract urolithiasis was estimated to be 457.02 per 100,000 in the overall population, with 589.09 per 100,000 men and 326.64 per 100,000 women. The male-to-female ratio was about 1.8:1. The annual incidence of urolithiasis in Korea was 457 per 100,000. It is higher than that previously reported in Japan, but lower than that in Western countries.