RESUMEN
BACKGROUND: Renal outcomes in patients with type 2 diabetes following treatment with sodium-glucose co-transporter-2 inhibitors (SGLT2is) or glucagon-like peptide-1 receptor agonists (GLP1RAs) have not been directly compared. This study compared the impact of SGLT2i and GLP1RA therapy on renal function and metabolic parameters. METHODS: Patients with type 2 diabetes who initiated SGLT2i or GLP1RA therapy in a tertiary hospital between January 2009 and August 2023 were included to assess composite renal outcomes, such as a 40% decline in estimated glomerular filtration rate (eGFR), onset of end-stage renal disease, renal death, or new-onset macroalbuminuria. Alterations in blood pressure, glucose regulation parameters, lipid profile, and anthropometric parameters, including body fat and muscle masses, were examined over 4-years. RESULTS: A total of 2,112 patients were enrolled using a one-to-three propensity-score matching approach (528 patients for GLP1RAs, 1,584 patients for SGLT2i). SGLT2i treatment was favoured over GLP1RA treatment, though not significantly, for composite renal outcomes (hazard ratio [HR], 0.63; p = 0.097). SGLT2i therapy preserved renal function effectively than GLP1RAs (decrease in eGFR, ≥ 40%; HR, 0.46; p = 0.023), with improving albuminuria regression (HR, 1.72; p = 0.036). SGLT2i therapy decreased blood pressure and body weight to a greater extent. However, more patients attained HbA1c levels < 7.0% with GLP1RAs than with SGLT2is (40.6% vs 31.4%; p < 0.001). GLP1RA therapy enhanced ß-cell function and decreased LDL-cholesterol levels below baseline values. CONCLUSIONS: SGLT2is were superior for preserving renal function and reducing body weight, whereas GLP1RAs were better for managing glucose dysregulation and dyslipidaemia.
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Diabetes Mellitus Tipo 2 , Receptor del Péptido 1 Similar al Glucagón , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Receptor del Péptido 1 Similar al Glucagón/agonistas , Anciano , Resultado del Tratamiento , Hipoglucemiantes/uso terapéutico , Riñón/efectos de los fármacos , Tasa de Filtración Glomerular/efectos de los fármacos , Estudios RetrospectivosRESUMEN
Atherosclerotic cardiovascular disease (ASCVD) stands as the leading global cause of mortality. Addressing this vital and pervasive condition requires a multifaceted approach, in which antiplatelet intervention plays a pivotal role, together with antihypertensive, antidiabetic, and lipid-lowering therapies. Among the antiplatelet agents available currently, cilostazol, a phosphodiesterase-3 inhibitor, offers a spectrum of pharmacological effects. These encompass vasodilation, the impediment of platelet activation and aggregation, thrombosis inhibition, limb blood flow augmentation, lipid profile enhancement through triglyceride reduction and high-density lipoprotein cholesterol elevation, and the suppression of vascular smooth muscle cell proliferation. However, the role of cilostazol has not been clearly documented in many guidelines for ASCVD. We comprehensively reviewed the cardiovascular effects of cilostazol within randomized clinical trials that compared it to control or active agents and involved individuals with previous coronary artery disease or stroke, as well as those with no previous history of such conditions. Our approach demonstrated that the administration of cilostazol effectively reduced adverse cardiovascular events, although there was less evidence regarding its impact on myocardial infarction. Most studies have consistently reported its favorable effects in reducing intermittent claudication and enhancing ambulatory capacity in patients with peripheral arterial disease. Furthermore, cilostazol has shown promise in mitigating restenosis following coronary stent implantation in patients with acute coronary syndrome. While research from more diverse regions is still needed, our findings shed light on the broader implications of cilostazol in the context of atherosclerosis and vascular biology, particularly for individuals at high risk of ASCVD.
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Aterosclerosis , Enfermedad Arterial Periférica , Humanos , Cilostazol , Inhibidores de Fosfodiesterasa 3 , Inhibidores de Agregación Plaquetaria , HDL-Colesterol , Hidrolasas Diéster Fosfóricas , Biología , Tetrazoles , Quimioterapia CombinadaRESUMEN
BACKGROUND: Recent large clinical trials have demonstrated cardiovascular benefits of similar overall magnitude for sodium-glucose cotransporter-2 inhibitor (SGLT-2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy in subjects with type 2 diabetes. We sought to identify subgroups based on baseline characteristics with a differential response to either SGLT-2i or GLP-1RA. METHODS: PubMed, Cochrane CENTRAL, and EMBASE were searched from 2008 to 2022 for SGLT-2i or GLP-1RA randomized trials that reported 3-point major adverse cardiovascular events (3P-MACE). Baseline clinical and biochemical characteristics included age, sex, body mass index (BMI), HbA1c, estimated glomerular filtration rate (eGFR), albuminuria, preexisting cardiovascular disease (CVD), and heart failure (HF). Absolute and relative risk reductions (ARR and RRR) regarding incidence rates for 3P-MACE with a 95% confidence interval were calculated. The association of average baseline characteristics in each study with the ARR and RRR for 3P-MACE was investigated by meta-regression analyses (random-effects model, assuming inter-study heterogeneity). Meta-analysis was also conducted to investigate whether the efficacy of SGLT-2i or GLP-1RA on 3P-MACE reduction could differ according to the patient's characteristics (e.g., HbA1c above/below cutoff). RESULTS: After a critical assessment of 1,172 articles, 13 cardiovascular outcome trials with a total of 111,565 participants were selected. In meta-regression analysis, the more patients with reduced eGFR in the studies, the greater ARR by SGLT-2i or GLP-1RA therapy. Similarly, in the meta-analysis, SGLT-2i therapy tended to be more effective in reducing 3P-MACE in people with eGFR < 60 ml/min/1.73 m2 than in those with normal renal function (ARR - 0.90 [-1.44 to - 0.37] vs. - 0.17 [-0.34 to - 0.01] events/100 person-years). Furthermore, people with albuminuria tended to respond better to SGLT-2i therapy than those with normoalbuminuria. However, this was not the case for the GLP-1RA treatment. Other factors including age, sex, BMI, HbA1c, and preexisting CVD or HF did not affect the efficacy of either SGLT-2i or GLP-1RA treatment on the ARR or RRR of 3P-MACE. CONCLUSIONS: Because decreased eGFR [significant] and albuminuria [trend] were found to predict a better efficacy for SGLT-2i in 3P-MACE reduction, this class of drug should be preferred in such patients. However, GLP-1RA may be considered for patients with normal eGFR because it showed better efficacy than SGLT-2i in this subgroup [trend].
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Receptor del Péptido 1 Similar al Glucagón , Insuficiencia Cardíaca , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Albuminuria , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Receptor del Péptido 1 Similar al Glucagón/agonistas , Hemoglobina Glucada , Inhibidores del Cotransportador de Sodio-Glucosa 2/efectos adversosRESUMEN
AIM: An important characteristic of glucose-lowering therapies (GLTs) is their ability to prevent cardiovascular complications. We aimed to investigate the cardiorenal efficacy and general safety of GLTs. MATERIALS AND METHODS: Multicentre, randomized, clinical trials that included over 100 participants comparing antidiabetic agents with a placebo or a different antidiabetic agent and reporting major adverse cardiovascular events (MACEs), or primarily reporting heart failure, were searched in the PubMed, Embase and Cochrane databases. Data were extracted independently for random-effects network meta-analyses to calculate the hazard ratio estimates. RESULTS: Forty-three trials that compared nine types of GLTs were included in the present analysis. The risk of three-point MACE was reduced in the presence of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and thiazolidinedione therapy compared with the placebo, dipeptidyl peptidase-4 inhibitors, or insulin therapy. GLP-1 RAs were favourable for cardiovascular and renal outcomes. SGLT-2is reduced renal outcomes by ~40%, which was superior to other GLTs. Thiazolidinedione therapy increased the risks of hospitalization for heart failure and had no benefits on mortality. Adverse events leading to drug discontinuation were higher with GLP-1 RAs and thiazolidinediones than placebo. CONCLUSIONS: GLP-1 RAs, SGLT-2is and thiazolidinediones reduced three-point MACE compared with other GLTs. Each drug class had unique advantages and disadvantages.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Inhibidores de la Dipeptidil-Peptidasa IV , Insuficiencia Cardíaca , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Tiazolidinedionas , Humanos , Hipoglucemiantes/efectos adversos , Metaanálisis en Red , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Tiazolidinedionas/efectos adversos , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Insuficiencia Cardíaca/prevención & control , Insuficiencia Cardíaca/complicaciones , Péptido 1 Similar al Glucagón/uso terapéutico , Glucosa/uso terapéutico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/etiologíaRESUMEN
OBJECTIVE: In patients with type 2 diabetes who were inadequately controlled with metformin and sulphonylurea, we compared the glucose-lowering efficacy, cardiometabolic parameters and safety of two drugs, ipragliflozin, a sodium-glucose cotransporter-2 inhibitor, and sitagliptin, a dipeptidyl peptidase-4 inhibitor. MATERIALS AND METHODS: Patients with 7.5%-9.0% glycated haemoglobin treated with metformin and sulphonylurea were randomly assigned to ipragliflozin (50 mg, n = 70) or sitagliptin (100 mg, n = 70) therapy for 24 weeks. Measures of glycaemic control, fatty liver indices, other metabolic parameters and subclinical atherosclerosis were compared by a paired t-test before and after 24 weeks of treatment. RESULTS: Mean glycated haemoglobin levels decreased from 8.5% to 7.5% in the ipragliflozin group and from 8.5% to 7.8% in the sitagliptin group, resulting in a 0.34% between-group difference (95% confidence interval, 0.10%-0.43%, p = .088). Fasting and postprandial 2-h glucose levels also showed a similar trend, with a greater reduction with ipragliflozin therapy. An increase of over 70% in ketone levels and a decrease in whole body and abdominal fat masses were observed with ipragliflozin treatment. Fatty liver indices also improved with ipragliflozin treatment. Despite no difference in carotid intima-media thickness and ankle-brachial index, ipragliflozin therapy improved flow-mediated vasodilation, reflecting endothelial function, while sitagliptin did not. The safety profile did not differ between the two groups. CONCLUSIONS: Ipragliflozin add-on therapy can be a viable option for better glycaemic control with multiple vascular and metabolic benefits in patients with type 2 diabetes who are inadequately controlled with metformin and sulphonylurea.
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Diabetes Mellitus Tipo 2 , Inhibidores de la Dipeptidil-Peptidasa IV , Hígado Graso , Metformina , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/metabolismo , Fosfato de Sitagliptina/efectos adversos , Metformina/efectos adversos , Hemoglobina Glucada , Grosor Intima-Media Carotídeo , Glucemia/metabolismo , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Resultado del Tratamiento , Hipoglucemiantes/efectos adversos , Inhibidores de la Dipeptidil-Peptidasa IV/efectos adversos , Compuestos de Sulfonilurea/uso terapéutico , Quimioterapia Combinada , Hígado Graso/tratamiento farmacológicoRESUMEN
The opioid epidemic has had a devastating impact on our country, with wide-ranging effects on healthcare, corrections, employment, and social systems. Programs have been put in place for monitoring prescriptions, initiating and expanding medications for opioid use disorder, and harm reduction (i.e., naloxone distribution, needle exchanges). However, opportunities for personalization of opioid therapy based on addiction risk have been limited. The goal of the present study was to develop an objective risk assessment algorithm based on genetic markers that are correlated with opioid use disorder (OUD). A total of 180 single-nucleotide polymorphisms (SNPs) were tested in patients with and without OUD. SNPs selected for testing were associated with opioid metabolism and drug reward pathways based on previous studies. Of the 394 patients recruited, 200 had OUD and 194 served as controls without OUD but with prior opioid exposure. Logistic regression analyses stratified by sex identified ten unique SNPs in females and nine unique SNPs in males that were significantly associated with OUD. A Genetics Opioid Risk Score (GenORs) was calculated by counting the number of OUD risk-associated SNPs/genotypes for each patient. To evaluate the discrimination of the GenORs, a receiver operating characteristic (ROC) curve for each sex was generated and determined to be sensitive and specific. This represents the first published example of a sex-based genetic risk score with potential to predict OUD, and the first OUD algorithm to include opioid-associated pharmacokinetic genes.
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Algoritmos , Trastornos Relacionados con Opioides/genética , Adulto , Anciano , Analgésicos Opioides/farmacocinética , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polimorfismo de Nucleótido Simple , Curva ROC , Medición de Riesgo , Sensibilidad y Especificidad , Factores SexualesRESUMEN
OBJECTIVES: The objectives of this study were (1) to determine the rate of antibiotic prescribing at ambulatory clinics, and (2) to assess the concordance of antibiotic prescriptions with published guidelines and Food and Drug Administration-approved indications in terms of drug choices and dosing regimen. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Patients of all ages receiving at least 1 prescription during ambulatory visits in 2016 to 2017 were observed. OUTCOME MEASURES: For each of the 3 clinic systems included in this study, oral antibiotic prescribing rates were estimated per patient and per ambulatory visit. Then, the concordance of oral antibiotic prescribing was assessed with respect to (1) choice of agent and (2) the dosing regimen by comparing it to the recommended therapeutic regimen (RTR). RESULTS: A total of 284,348 patients receiving at least 1 prescription were included in the analysis. Between clinics, 17.4 to 43.7 per 100 patients received antibiotics. Of the antibiotics prescribed, 48.9% in Clinic A, 48.0% in Clinic B, and 60.7% in Clinic C were considered to be discordant in terms of drug choice. When the dosing regimen was taken into account in addition to the choice of agent, 72.6% in Clinic A, 76.7% in Clinic B, and 81.6% in Clinic C were discordant based on drug choice or dosing regimen. Of the prescriptions written with a discordant dosing regimen, 91.2% in Clinic A, 79.6% in Clinic B, and 91.0% in Clinic C were at a higher dosage than RTR. CONCLUSION: Antibiotic prescribing rates vary by clinics, whereas discordant prescribing is consistently prevalent across clinics. More efforts should be put into ambulatory care to address antibiotic misuse problems, and our method could improve ambulatory antimicrobial stewardship programs.
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Antibacterianos , Programas de Optimización del Uso de los Antimicrobianos , Instituciones de Atención Ambulatoria , Antibacterianos/uso terapéutico , Estudios Transversales , Humanos , Pautas de la Práctica en MedicinaRESUMEN
PURPOSE: To describe opioid prescribing practice patterns and trends in emergency department visits (EDs) by provider type: physicians and advanced practice providers (APPs), which include nurse practitioners (NPs) and physician assistants (PAs). METHODS: The data source was the ED visit files of the 2005-2015 National Hospital Ambulatory Care Survey. The study sample was opioid prescription-related ED visits. Descriptive and multinomial logistic regression analyses were conducted to assess the proportion of opioid prescription-related visits by provider type over time in total and by patient age group. We then characterized opioid prescribing practices of NPs, PAs, and physicians according to type of opioid and pain-related diagnosis. RESULTS: From 2005 to 2015, there was a 116.7% increase in the proportion of the opioid prescription-related visits seen by NPs and a 61.2% increase seen by both APPs and physicians. In contrast, the proportion of the physician-only visits decreased (-8.3%). When stratified by age group, the growth was particularly notable among the visits with patients aged 65 and older seen by both APPs and physicians (AORâ¯=â¯2.35, 95% CIâ¯=â¯1.69, 3.25). Proportionally less hydromorphone and morphine was prescribed by APPs than by physicians. Opioids were prescribed more often by APPs in visits involving dental and injury-related pain, whereas physicians prescribed opioids more in abdominal and chest pain-related visits. CONCLUSIONS: From 2005 to 2015, APPs, particularly NPs played an increasing role in opioid prescribing in EDs. Opioid prescribing practices of APPs and physicians varied by patient condition as well as by opioid type.
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Analgésicos Opioides/uso terapéutico , Servicio de Urgencia en Hospital/estadística & datos numéricos , Dolor/tratamiento farmacológico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Pautas de la Práctica en Medicina/tendencias , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Encuestas de Atención de la Salud , Humanos , Hidromorfona/uso terapéutico , Lactante , Recién Nacido , Modelos Logísticos , Masculino , Persona de Mediana Edad , Morfina/uso terapéutico , Enfermeras Practicantes/estadística & datos numéricos , Asistentes Médicos/estadística & datos numéricos , Médicos/estadística & datos numéricos , Estados Unidos , Adulto JovenRESUMEN
OBJECTIVE: As uncontrolled hyperuricemia has been associated with an increased risk of cardiovascular disease and the progression of chronic kidney disease (CKD), management of serum uric acid levels is important. The aim of this study was to evaluate the effectiveness of febuxostat in regulating uncontrolled hyperuricemia in patients with renal dysfunction. MATERIALS AND METHODS: We included patients with CKD and persistent uncontrolled hyperuricemia despite treatment with allopurinol. The primary outcome of the study, which was the overall response rate of febuxostat, was defined as the proportion of patients that achieved a serum uric acid level < 7.0 mg/dL. The secondary outcomes included the change in renal function and factors that might influence treatment outcomes. The safety outcome was evaluated based on the incidence of adverse reactions. RESULTS: A total of 111 patients who switched medication to febuxostat were included. Febuxostat treatment significantly lowered serum uric acid level and the response rates were above 70% at all the time points for 1 year. Febuxostat-treated patients demonstrated no significant change in renal function during the study period. A history of gout attack decreased the response rate of febuxostat (odds ratio (OR): 3.13, 95% confidence interval (CI): 1.08 - 9.06), whereas low-dose aspirin use significantly increased response rate (OR: 0.29, 95% CI: 0.09 - 0.92) in the first month. No patients experienced any severe adverse events. CONCLUSIONS: Febuxostat effectively lowered serum uric acid levels and was well tolerated in patients with CKD and allopurinol-refractory hyperuricemia.â©.
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Alopurinol/uso terapéutico , Resistencia a Medicamentos , Sustitución de Medicamentos , Febuxostat/uso terapéutico , Supresores de la Gota/uso terapéutico , Hiperuricemia/tratamiento farmacológico , Insuficiencia Renal Crónica/complicaciones , Ácido Úrico/sangre , Adulto , Anciano , Anciano de 80 o más Años , Alopurinol/efectos adversos , Biomarcadores/sangre , Regulación hacia Abajo , Febuxostat/efectos adversos , Femenino , Supresores de la Gota/efectos adversos , Humanos , Hiperuricemia/sangre , Hiperuricemia/complicaciones , Hiperuricemia/diagnóstico , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Insuficiencia Renal Crónica/diagnóstico , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
Fenofibrate activates not only peroxisome proliferator-activated receptor-α (PPARα) but also adenosine monophosphate-activated protein kinase (AMPK). AMPK-mediated cellular responses protect kidney from high-fat diet (HFD)-induced injury, and autophagy resulting from AMPK activation has been regarded as a stress-response mechanism. Thus the present study examined the role of AMPK and autophagy in the renotherapeutic effects of fenofibrate. C57BL/6J mice were divided into three groups: normal diet (ND), HFD, and HFD + fenofibrate (HFD + FF). Fenofibrate was administered 4 wk after the initiation of the HFD when renal injury was initiated. Mouse proximal tubule cells (mProx24) were used to clarify the role of AMPK. Feeding mice with HFD for 12 wk induced insulin resistance and kidney injury such as albuminuria, glomerulosclerosis, tubular injury, and inflammation, which were effectively inhibited by fenofibrate. In addition, fenofibrate treatment resulted in the activation of renal AMPK, upregulation of fatty acid oxidation (FAO) enzymes and antioxidants, and induction of autophagy in the HFD mice. In mProx24 cells, fenofibrate activated AMPK in a concentration-dependent manner, upregulated FAO enzymes and antioxidants, and induced autophagy, all of which were inhibited by treatment of compound C, an AMPK inhibitor. Fenofibrate-induced autophagy was also significantly blocked by AMPKα1 siRNA but not by PPARα siRNA. Collectively, these results demonstrate that delayed treatment with fenofibrate has a therapeutic effect on HFD-induced kidney injury, at least in part, through the activation of AMPK and induction of subsequent downstream effectors: autophagy, FAO enzymes, and antioxidants.
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Proteínas Quinasas Activadas por AMP/metabolismo , Albuminuria/tratamiento farmacológico , Autofagia/efectos de los fármacos , Nefropatías Diabéticas/tratamiento farmacológico , Dieta Alta en Grasa , Fenofibrato/uso terapéutico , Hipolipemiantes/uso terapéutico , Albuminuria/metabolismo , Animales , Nefropatías Diabéticas/metabolismo , Relación Dosis-Respuesta a Droga , Fenofibrato/farmacología , Hipolipemiantes/farmacología , Resistencia a la Insulina/fisiología , Túbulos Renales Proximales/metabolismo , Ratones , Fosforilación/efectos de los fármacos , Sustancias Protectoras/farmacología , Sustancias Protectoras/uso terapéutico , Transducción de Señal/efectos de los fármacosAsunto(s)
Diabetes Mellitus Tipo 2 , Metformina , Compuestos de Bencidrilo/efectos adversos , Diabetes Mellitus Tipo 2/metabolismo , Quimioterapia Combinada , Glucósidos/efectos adversos , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemiantes/efectos adversos , Metformina/efectos adversos , Fosfato de Sitagliptina/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVES: To construct a database of published clinical drug trials suitable for use 1) as a research tool in accessing clinical trial information and 2) in evidence-based decision-making by regulatory professionals, clinical research investigators, and medical practitioners. MATERIALS: Comprehensive information obtained from a search of design elements and results of clinical trials in peer reviewed journals using PubMed (http://www.ncbi.nlm.ih.gov/pubmed). METHOD: The methodology to develop a structured database was devised by a panel composed of experts in medical, pharmaceutical, information technology, and members of Ministry of Food and Drug Safety (MFDS) using a step by step approach. A double-sided system consisting of user mode and manager mode served as the framework for the database; elements of interest from each trial were entered via secure manager mode enabling the input information to be accessed in a user-friendly manner (user mode). Information regarding methodology used and results of drug treatment were extracted as detail elements of each data set and then inputted into the web-based database system. RESULTS: Comprehensive information comprising 2,326 clinical trial records, 90 disease states, and 939 drugs entities and concerning study objectives, background, methods used, results, and conclusion could be extracted from published information on phase II/III drug intervention clinical trials appearing in SCI journals within the last 10 years. The extracted data was successfully assembled into a clinical drug trial database with easy access suitable for use as a research tool. The clinically most important therapeutic categories, i.e., cancer, cardiovascular, respiratory, neurological, metabolic, urogenital, gastrointestinal, psychological, and infectious diseases were covered by the database. Names of test and control drugs, details on primary and secondary outcomes and indexed keywords could also be retrieved and built into the database. The construction used in the database enables the user to sort and download targeted information as a Microsoft Excel spreadsheet. CONCLUSION: Because of the comprehensive and standardized nature of the clinical drug trial database and its ease of access it should serve as valuable information repository and research tool for accessing clinical trial information and making evidence-based decisions by regulatory professionals, clinical research investigators, and medical practitioners.
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Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Bases de Datos Factuales , Humanos , Conocimiento , Factores de TiempoRESUMEN
PURPOSE: To estimate the risk of type II diabetes (T2DM) in children and adolescents initiating atypical antipsychotic (AAP) therapy. METHODS: We conducted a retrospective cohort study using a new user design approach. Medical and pharmacy claims data between 1 January 2007 and 31 December 2009 for dependents ages 4 to 18 from an employed, commercially insured population from across the USA were included. AAP exposure was defined in the presence of a pharmacy claim preceded by at least six months of AAP-free history. We used propensity score (PS) methodology to identify and match incident AAP users and non-users. New-onset T2DM, was defined based on medical and pharmacy claims. Follow-up was extended until the date of new-onset T2DM or the end of the study period. The risk of T2DM was evaluated in an intent to treat fashion using the Kaplan-Meier estimator and Cox proportional hazard regression that provided hazard ratio (HR) and associated 95% confidence interval (CI). RESULTS: Our study population included 6236 new AAP users and 22 080 non-users. In this PS-matched sample, the estimated risk of T2DM was twice as high in AAP users as non-users (HR 2.18, 95% CI 1.45-3.29). Noticeable risk differences between AAP-treated and control groups materialized within four months of AAP initiation and became constant after six months until the end of the follow-up. CONCLUSIONS: Children and adolescents who were prescribed an AAP medication had a two times higher risk of developing T2DM; our study raises questions about continued AAP use in children and adolescents.
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Antipsicóticos/efectos adversos , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Adolescente , Niño , Servicios de Salud del Niño , Preescolar , Estudios de Cohortes , Bases de Datos Factuales , Diabetes Mellitus Tipo 2/etiología , Femenino , Humanos , Revisión de Utilización de Seguros , Masculino , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
Kentucky Department for Behavioral Health Developmental and Intellectual Disabilities conducted a survey to evaluate consumers' satisfaction with services delivered at the Community Mental Health Centers (CMHCs) in Kentucky. The survey was administered at outpatient clinics operated by fourteen CMHCs in 2010. The purpose of this study was to identify factors that predict whether clients will respond that they were "generally satisfied" with services received from CMHCs. A logistic regression model was developed using respondents' characteristics and their responses to survey questions. Survey questions were grouped into seven core domains: general satisfaction, access, quality, participation in treatment planning, outcomes, functioning, and social connectedness. In result, responses to domains of access, quality and participation in treatment planning significantly affected clients' perception of general satisfaction. Respondents who positively assessed those domains of services were more likely to answer that they were generally satisfied with services. Based on the analysis in this report, improvement in certain domains of services, especially access, quality and participation in treatment planning could increase the level of positive responses in general satisfaction.
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Actitud Frente a la Salud , Servicios Comunitarios de Salud Mental , Satisfacción del Paciente , Adolescente , Adulto , Instituciones de Atención Ambulatoria , Centros Comunitarios de Salud Mental , Comportamiento del Consumidor , Femenino , Encuestas de Atención de la Salud , Accesibilidad a los Servicios de Salud , Humanos , Kentucky , Modelos Logísticos , Masculino , Trastornos Mentales/terapia , Persona de Mediana Edad , Participación del Paciente , Calidad de la Atención de Salud , Adulto JovenRESUMEN
BACKGRUOUND: We investigated the long-term efficacy and safety of initial triple therapy using metformin, a dipeptidyl peptidase-4 inhibitor, and a sodium-glucose cotransporter-2 inhibitor, in patients with type 2 diabetes mellitus. METHODS: We enrolled 170 drug-naïve patients with glycosylated hemoglobin (HbA1c) level >7.5% who had started triple therapy (metformin, sitagliptin, and empagliflozin). Glycemic, metabolic, and urinary parameters were measured for 24 months. RESULTS: After 24 months, HbA1c level decreased significantly from 11.0%±1.8% to 7.0%±1.7%. At 12 and 24 months, the rates of achievement of the glycemic target goal (HbA1c <7.0%) were 72.5% and 61.7%, respectively, and homeostasis model assessment of ß-cell function and insulin resistance indices improved. Whole-body fat percentage decreased by 1.08%, and whole-body muscle percentage increased by 0.97% after 24 months. Fatty liver indices and albuminuria improved significantly. The concentration of ketone bodies was elevated at the baseline but decreased after 24 months. There were no serious adverse events, including ketoacidosis. CONCLUSION: Initial triple combination therapy with metformin, sitagliptin, and empagliflozin led to achievement of the glycemic target goal, which was maintained for 24 months without severe hypoglycemia but with improved metabolic function and albuminuria. This combination therapy may be a good strategy for drug-naïve patients with type 2 diabetes mellitus.
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Compuestos de Bencidrilo , Diabetes Mellitus Tipo 2 , Glucósidos , Metformina , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/metabolismo , Metformina/efectos adversos , Fosfato de Sitagliptina/efectos adversos , Hemoglobina Glucada , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Albuminuria , Glucemia/metabolismo , Resultado del TratamientoRESUMEN
OBJECTIVE: Describe how receiving tobacco education within the PharmD curriculum affects 1) students' perceptions and knowledge of electronic nicotine delivery systems (ENDS) and 2) willingness to counsel on cessation. METHODS: Eight institutions used a 29-item questionnaire to assess P1-P4 students' tobacco use, ENDS knowledge, cessation education, and perceptions in the fall of 2020. Students were divided into those who had received tobacco cessation education and those who had not. RESULTS: 832 pharmacy students participated in the study with a 28% response rate. 56% of respondents were reported as receiving at least some tobacco education in the pharmacy curriculum. Quitting other forms of tobacco was the only perceived benefit of ENDS that was statistically different between groups. Tobacco education was associated with a greater likelihood of identifying localized harms of ENDS, including explosion/burns and mouth/throat irritation. Those with tobacco education were more likely to agree they received enough education to counsel on smoking cessation and were more likely to agree they are willing to counsel patients on quitting. Tobacco education was associated with an increased willingness to offer smoking cessation (OR 1.56; 95% CI 1.14-2.13) but not more willing to offer ENDS cessation (0.85; 0.58-1.24). Personal history of combustible cigarette use was associated with increased willingness to counsel on both smoking (2.45; 1.27-4.73) and ENDS (2.79; 1.38-5.64) cessation. CONCLUSION: Tobacco education in the pharmacy curriculum was associated with an increased likelihood of recognizing localized harms of ENDS and willingness to offer smoking cessation counseling but did not increase willingness to offer ENDS cessation counseling.
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South Korea is a unique country in many aspects in terms of its strategy against the COVID-19 pandemic. From February 2020, the South Korean government adopted active epidemiological investigations, strict isolation of affected patients, and extensive public lockdowns, which were helpful in controlling spread until the end of 2021. This stable situation in South Korea has changed dramatically since the Omicron variant-reportedly less severe but more infective than the original strain-became dominant from January 2022. From mid-February to mid-April 2022, daily cases of COVID-19 in South Korea increased steeply, reaching > 600,000 cases/day: the highest incidence rate in the world at that time. Despite this rapid increase, the South Korean government has eased its preventive strategies progressively, based on the belief in the efficacy of >80% of vaccine coverage in the population. Now, in June 2022, the COVID-19 situation in South Korea is improving. The mortality rate is 0·13%: the lowest among the 30 countries with the highest case counts. High vaccine coverage rate (87·7%), the efficient healthcare system, and active co-operation between private sectors and the central government seem to have contributed to this. However, it should also be noted that the COVID-19 pandemic and its preventive measures have had a negative influence on cardiometabolic profiles in the country. Considering the likelihood of another novel variant of SARS-CoV-2 or new infectious disease emerging in the future, understanding the situation in South Korea and the strategies flexibly adopted by its government could be beneficial for many countries.
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The efficacy and safety of medications can be affected by alterations in gut microbiota in human beings. Among antidiabetic medications, incretin-based therapy such as dipeptidyl peptidase 4 inhibitors might affect gut microbiomes, which are related to glucose metabolism. This was a randomized, controlled, active-competitor study that aimed to compare the effects of combinations of gemigliptin−metformin vs. glimepiride−metformin as initial therapies on gut microbiota and glucose homeostasis in drug-naïve patients with type 2 diabetes. Seventy drug-naïve patients with type 2 diabetes (mean age, 52.2 years) with a glycated hemoglobin (HbA1c) level ≥7.5% were assigned to either gemigliptin−metformin or glimepiride−metformin combination therapies for 24 weeks. Changes in gut microbiota, biomarkers linked to glucose regulation, body composition, and amino acid blood levels were investigated. Although both treatments decreased the HbA1c levels significantly, the gemigliptin−metformin group achieved HbA1c ≤ 7.0% without hypoglycemia or weight gain more effectively than did the glimepiride−metformin group (59% vs. 24%; p < 0.05). At the phylum level, the Firmicutes/Bacteroidetes ratio tended to decrease after gemigliptin−metformin therapy (p = 0.065), with a notable depletion of taxa belonging to Firmicutes, including Lactobacillus, Ruminococcus torques, and Streptococcus (all p < 0.05). However, regardless of the treatment modality, a distinct difference in the overall gut microbiome composition was noted between patients who reached the HbA1c target goal and those who did not (p < 0.001). Treatment with gemigliptin−metformin resulted in a higher achievement of the glycemic target without hypoglycemia or weight gain, better than with glimepiride−metformin; these improvements might be related to beneficial changes in gut microbiota.
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Diabetes Mellitus Tipo 2 , Microbioma Gastrointestinal , Hipoglucemia , Metformina , Humanos , Persona de Mediana Edad , Metformina/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hemoglobina Glucada , Glucosa/uso terapéutico , Glucemia/metabolismo , Resultado del Tratamiento , Hipoglucemiantes/uso terapéutico , Hipoglucemia/tratamiento farmacológico , Obesidad/complicaciones , Obesidad/tratamiento farmacológico , Intestinos , Aumento de Peso , Quimioterapia CombinadaRESUMEN
BACKGROUND: We investigated whether Lactobacillus plantarum strain LMT1-48, isolated from Korean fermented foods and newborn feces, is a suitable probiotic supplement to treat overweight subjects. METHODS: In this randomized, double-blind, placebo-controlled clinical trial, 100 volunteers with a body mass index of 25 to 30 kg/m2 were assigned randomly (1:1) to receive 2×1010 colony forming units of LMT1-48 or to a placebo treatment group. Body composition was measured by dual-energy X-ray absorptiometry, and abdominal visceral fat area (VFA) and subcutaneous fat area were measured by computed tomography scanning. Changes in body fat, VFA, anthropometric parameters, and biomarkers were compared between the two treatment groups (ClinicalTrials.gov number: NCT03759743). RESULTS: After 12 weeks of treatment, the body weight decreased significantly from 76.6±9.4 to 75.7±9.2 kg in the LMT1-48 group but did not change in the placebo group (P=0.022 between groups). A similar pattern was found in abdominal VFA between the two groups (P=0.041). Serum insulin levels, the corresponding homeostasis model assessment of insulin resistance, and leptin levels decreased in the LMT1-48 group but increased in the placebo group (all P<0.05). Decrease in body weight and body mass index by treatment with LMT1-48 was correlated with increase in Lactobacillus levels significantly. LMT1-48 also increased Oscillibacter levels significantly, which were negatively correlated with triglyceride and alanine transaminase levels. CONCLUSION: Administration of LMT1-48 decreased body weight, abdominal VFA, insulin resistance, and leptin levels in these subjects with overweight, suggesting its anti-obesogenic therapeutic potential.
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Resistencia a la Insulina , Lactobacillus plantarum , Humanos , Tejido Adiposo , Peso Corporal , Leptina/uso terapéutico , Sobrepeso/tratamiento farmacológicoRESUMEN
In the United States, 18.6% of college students between 19-and 22-years old report e-cigarette use in the last 30 days. Information regarding e-cigarette use and perceptions in this age group may assist in understanding how to decrease initiation of e-cigarettes in a population that may otherwise not use nicotine. The purpose of this survey was to determine current e-cigarette use and how e-cigarette use history relates to a college student's perceptions of health risks associated with e-cigarettes. A 33-item questionnaire was sent to students at a Midwestern university in Fall 2018. Overall, 3754 students completed the questionnaire. More than half of the respondents (55.2%) had used e-cigarettes and 23.2% identified as current users of e-cigarettes. Current e-cigarette users were more likely to agree that e-cigarettes are a safe and effective option to quit smoking, while never users were more likely to disagree (safe P < .001, effective P < .001). Current users were less likely to agree that e-cigarettes may harm a person's overall health than never users (P < .001). Young adults continue to be frequent users of e-cigarettes. There are significant differences in perceptions of e-cigarettes associated with use history. Additional research is needed to see how perceptions and use of e-cigarettes have changed considering lung injury reports and increased regulations in the U.S.