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1.
J Health Care Poor Underserved ; 34(1): 399-424, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37464502

RESUMEN

Hispanic/Latino representation in medical research remains poor. We describe factors affecting rates of recruitment, participation, adherence, and retention of Hispanics/Latinos in clinical studies in the United States and characterize proposed strategies to improve these rates. A targeted literature review was conducted. Relevant studies were identified from Embase, MEDLINE®, and CENTRAL from January 1, 2010 to September 4, 2020. Sixty-eight studies were included. Key facilitators to research involvement were establishing trust between research staff and participants, incorporating familism, and using culturally appropriate language. Common elements of successful strategies for improving research involvement included incorporating community partners, bilingual and culturally competent research staff, continuous engagement and building relationships between participants and staff, and incorporating Hispanic/Latino cultural values. There is no universal strategy to improve research involvement of Hispanics/Latinos. The best strategy is likely a combination of key elements from several strategies, tailored to each unique study population. Further research is needed.


Asunto(s)
Ensayos Clínicos como Asunto , Hispánicos o Latinos , Estudios Observacionales como Asunto , Participación del Paciente , Humanos , Estados Unidos
2.
Rheumatol Ther ; 9(4): 1091-1107, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35604547

RESUMEN

INTRODUCTION: Targeted DMARD (tDMARD) use in patients with rheumatoid arthritis (RA) and type 2 diabetes mellitus (T2DM) may increase whole-body insulin sensitivity. Evidence comparing the T2DM-related clinical and economic impact of abatacept versus other tDMARDs is limited. This study compared differences in T2DM-related healthcare resource utilization (HCRU) and costs in patients with RA and T2DM. METHODS: This retrospective study used 100% Medicare Fee-for-Service claims (parts A/B/D) to identify patients ≥ 65 age, diagnosed with RA and T2DM, and were either TNFi-experienced (switched from a TNFi to another tDMARD) or tDMARD-naïve, initiating their first tDMARD (abatacept, TNFi, or non-TNFi) between 2010 and 2017. Abatacept users were propensity-score (PS) matched to TNFi and other non-TNFi users separately on baseline demographics, comorbidities, medications, T2DM-related HCRU, and costs. Post-index follow-up: until discontinuation of index treatment, disenrollment, death, or end of study period, whichever occurred first. T2DM-related complications and HCRU were assessed. Costs were normalized to per-patient-per-month (PPPM) and inflated to 2019 US$. RESULTS: The TNFi-experienced group included 2169 abatacept/TNFi and 2118 abatacept/other non-TNFi PS-matched pairs; the tDMARD-naïve group included 2667 abatacept/TNFi and 2247 abatacept/other non-TNFi PS-matched pairs. For TNFi-experienced patients, T2DM-related complication rates for inpatient settings PPPM trended lower for abatacept than TNFi (21 vs. 24, p = 0.046) and other non-TNFi groups (21 vs. 26; p < 0.0001). T2DM-related total costs PPPM for TNFi-experienced patients demonstrated lower trends for abatacept than TNFi ($489 vs. $594, p = 0.016) and other non-TNFi users ($493 vs. $606, p = 0.012). CONCLUSIONS: Medicare beneficiaries with RA and T2DM who switch to/initiate abatacept as their first tDMARD have directionally lower rates and costs of T2DM-related complications compared with patients switching to/initiating other tDMARDs. Abatacept treatment may help reduce clinical and economic burdens associated with T2DM in patients with RA.

3.
Artículo en Inglés | MEDLINE | ID: mdl-34262386

RESUMEN

OBJECTIVE: To scope the current published evidence on cardiovascular risk factors in rheumatoid arthritis (RA) focusing on the role of autoantibodies and the effect of antirheumatic agents. METHODS: Two reviews were conducted in parallel: A targeted literature review (TLR) describing the risk factors associated with cardiovascular disease (CVD) in RA patients; and a systematic literature review (SLR) identifying and characterizing the association between autoantibody status and CVD risk in RA. A narrative synthesis of the evidence was carried out. RESULTS: A total of 69 publications (49 in the TLR and 20 in the SLR) were included in the qualitative evidence synthesis. The most prevalent topic related to CVD risks in RA was inflammation as a shared mechanism behind both RA morbidity and atherosclerotic processes. Published evidence indicated that most of RA patients already had significant CV pathologies at the time of diagnosis, suggesting subclinical CVD may be developing before patients become symptomatic. Four types of autoantibodies (rheumatoid factor, anti-citrullinated peptide antibodies, anti-phospholipid autoantibodies, anti-lipoprotein autoantibodies) showed increased risk of specific cardiovascular events, such as higher risk of cardiovascular death in rheumatoid factor positive patients and higher risk of thrombosis in anti-phospholipid autoantibody positive patients. CONCLUSION: Autoantibodies appear to increase CVD risk; however, the magnitude of the increase and the types of CVD outcomes affected are still unclear. Prospective studies with larger populations are required to further understand and quantify the association, including the causal pathway, between specific risk factors and CVD outcomes in RA patients.

4.
Clin Exp Rheumatol ; 39(5): 1108-1118, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33635222

RESUMEN

OBJECTIVES: To summarise the epidemiology, risk and prognostic factors, and treatment landscape of rheumatoid arthritis-associated interstitial lung disease (RA-ILD). METHODS: Targeted and systematic literature reviews were conducted to characterise the epidemiology and treatment landscape associated with RA-ILD, respectively. MEDLINE®, Embase, and CENTRAL were searched via OvidSP in March 2019 and December 2018. The results were narratively summarised. RESULTS: A total of 24 and 20 publications were captured through targeted and systematic literature review, respectively. No randomised controlled trials were identified; publications were observational cohort studies, cross-sectional, or case-control. Unadjusted incidence of interstitial lung disease (ILD) ranged from 1.3/1,000 person-years for interstitial pneumonia-type ILD to 5.0/1,000 person-years for 'probable or definite ILD'. Prevalence of ILD ranged from 1.8% to 67% (median: 24.9%) and varied with case definition and sample size. Few publications identified the same risk and prognostic factors; age, male sex, duration of disease, and antibodies to cyclic citrullinated peptides were the most frequently reported risk factors for development of RA-ILD, and age was the most common predictor of mortality. Despite identification of a variety of pharmacotherapeutic interventions, assessment of the comparative efficacy and safety of the available treatments were difficult due to heterogenous reporting of outcomes and small sample size. CONCLUSIONS: A wide range of estimates were identified for incidence and prevalence of RA-ILD. Further, there was no consensus on risk and prognostic factors. Sufficiently powered clinical trials are needed to confirm the findings of the observational studies with respect to efficacy and safety of current treatments.


Asunto(s)
Artritis Reumatoide , Enfermedades Pulmonares Intersticiales , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Estudios Transversales , Humanos , Enfermedades Pulmonares Intersticiales/diagnóstico , Enfermedades Pulmonares Intersticiales/epidemiología , Enfermedades Pulmonares Intersticiales/terapia , Masculino , Pronóstico , Factores de Riesgo
5.
J Rheumatol ; 48(7): 992-1001, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33262304

RESUMEN

OBJECTIVE: Patients with rheumatoid arthritis (RA) who also have diabetes mellitus (DM) might have worse clinical outcomes and adverse events compared to patients with RA who do not have DM. We evaluated the effects of DM on Health Assessment Questionnaire (HAQ) changes and outpatient infection rates in patients with RA. METHODS: Using the American College of Rheumatology's Rheumatology Informatics System for Effectiveness (RISE) electronic health record-based registry, we identified patients with RA who had ≥ 1 rheumatologist visit with a HAQ measured in 2016 (index visit), ≥ 1 previous visit, and a subsequent outcome visit with the same HAQ measured at 12 months (± 3 months). We identified DM by diagnosis codes, medications, or laboratory values. Outpatient infection was defined by diagnosis codes or antiinfective medications. We calculated mean HAQ change and incidence rate (IR) of outpatient infections among patients with and without DM. Generalized linear models and Cox regression were used to calculate the adjusted mean HAQ change and HRs. RESULTS: We identified 3853 RA patients with DM and 18,487 without DM. The mean HAQ change between index and outcome visit among patients with DM was 0.03 and without DM was 0.002 (P < 0.01). We identified 761 outpatient infections for patients with DM with an IR of 22.6 (95% CI 21.0-24.2) per 100 person-years and 3239 among patients without DM with an IR of 19.8 (95% CI 19.1-20.5). The adjusted HR of outpatient infections among patients with DM was 0.99 (95% CI 0.91-1.07), compared to patients without DM. CONCLUSION: Patients with RA with concomitant DM had greater worsening, or less improvement, in their functional status, suggesting additional interventions may be needed for RA patients with DM to optimize treatment and management of other comorbidities.


Asunto(s)
Artritis Reumatoide , Diabetes Mellitus , Reumatología , Artritis Reumatoide/complicaciones , Artritis Reumatoide/epidemiología , Evaluación de la Discapacidad , Registros Electrónicos de Salud , Humanos , Sistema de Registros
6.
Clin Exp Rheumatol ; 38(5): 1008-1015, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32301430

RESUMEN

OBJECTIVES: This systematic literature review (SLR) and network meta-analysis (NMA) was aimed at comparing the relative efficacy and safety of abatacept (ABA) with other currently recommended therapies for patients with early RA. METHODS: An SLR (January 1998 to June 2018) was conducted including MEDLINE®, Embase, and CENTRAL databases, and grey literature. Population was adults with active RA for ≤2 years treated with biologic DMARDs as monotherapy or in combination with conventional DMARDs. A Bayesian NMA was performed using randomised controlled trials (RCTs) and comparisons for ACR50, DAS28 remission, withdrawal due to adverse events and total withdrawal where reported. RESULTS: Ninety publications pertaining to 69 studies (43 RCTs and 26 observational studies) were identified. Twenty-eight RCTs were eligible to be included in the NMA. ABA as monotherapy was similar to the combination of ABA+methotrexate (MTX) for ACR50 (RR: 0.82 [95% CI 0.51-1.35]), and DAS28 remission (RR: 0.69 [95% CI 0.37-1.3]), as well as for withdrawal due to AEs (RR: 2.35 [95% CI 0.69-7.38]) and all-cause withdrawal (RR: 1.73 [95% CI 0.905-3.35]). ABA as monotherapy and ABA+MTX were both comparable to all other therapies for the main efficacy and safety outcomes. Observational study data reported was congruous with the RCT analysis. CONCLUSIONS: The results of this NMA show similar efficacy and safety between ABA (as monotherapy or in combination with MTX) and other biologics in early RA. Further comparison of different treatment options for early RA is warranted as growing research provides evidence for the application of new novel therapies for RA.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Abatacept/efectos adversos , Adulto , Antirreumáticos/efectos adversos , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/efectos adversos , Quimioterapia Combinada , Humanos , Metotrexato/efectos adversos , Metaanálisis en Red
7.
Am J Dent ; 27(6): 312-7, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-25707085

RESUMEN

PURPOSE: An 18-month randomized, controlled prospective study evaluated, in an intra-individual comparison, the clinical performance of two-step etch-and-rinse adhesives in non-carious cervical lesions (NCCL). METHODS: 35 subjects, with at least two similar sized NCCL participated in this study. After sample size calculation, 70 restorations were placed, according to one of the following groups: Adper Single Bond 2 (SB) and Ambar (AM). The restorations were placed incrementally using a resin composite (Opallis). The restorations were evaluated at baseline and after 6 and 18 months according to the FDI criteria. The differences in the ratings of the two materials after 6 and 18 months were tested with Fisher's exact test (α = 0.05), and the performance of the each material at baseline and after 6 and 18 months was evaluated by Wilcoxon test (α = 0.05). RESULTS: All subjects attended the 18-month recall. No significant differences were observed between the materials for any criteria evaluated. Only four restorations (two from each material) were lost after 18 months. Thus, the retention rates of both materials at 18 months were 94.2% (95% CI 81-98%). Nine restorations (four Ambar and five Adper Single Bond 2) showed marginal discoloration which was solved with a polishing procedure. Both adhesive systems showed acceptable clinical retention rates after 18 months.


Asunto(s)
Grabado Ácido Dental , Cementos Dentales , Diente , Humanos , Estudios Prospectivos
8.
Clín. int. j. braz. dent ; 8(2): 188-196, abr.-jun. 2012. ilus
Artículo en Portugués | LILACS, BBO - Odontología | ID: lil-716624

RESUMEN

A técnica de clareamento dental vem sendo considerada pela literatura científica como um dos métodos mais seguros e eficazes para clarear os dentes e recuperar a estética sem envolver desgaste da estrutura dental. Diante disso, o clareamento dental tem sido amplamente difundido e é considerado o protocolo de eleição para os pacientes previamente ao início do tratamento restaurador. Evidências científicas têm demostrado resultados satisfatórios de clareamento dental em dentes com diversas etiologias, desde escurecimento fisiológico até casos em que, tradicionalmente, algumas alterações de cor eram tratadas somente com técnicas restauradoras. Este trabalho apresenta um caso clínico de alteração de cor do incisivo central superior com diagnóstico de calcificação pulpar, em que se obteve resultado satisfatório com a técnica de clareamento dental


Tooth bleaching therapy is being considered by the scientific literature as one of the most secure, simple and effective way of whitening teeth and restore esthetics without involving wear of the tooth structure. Thus, bleaching has been widely used is considered the treatment of choice for patients, previous to restorative treatment. Scientific evidence has shown satisfactory results fter whitening teeth discolored from several etiologies, ranging from physiological darkening to cases where, traditionally, some color changes were only treated with restorative techniques. This paper showed a case report of a discolored maxillary right central incisor which presented calcification of the coronary pulp after radiographic examination. The chosen treatment was the association of two bleaching techniques


Asunto(s)
Humanos , Femenino , Adulto Joven , Calcificaciones de la Pulpa Dental , Estética Dental , Blanqueamiento de Dientes
9.
São Paulo; s.n; 2009. [165] p. ilus, tab, graf.
Tesis en Portugués | LILACS | ID: lil-554440

RESUMEN

Os polimorfismos do gene da paraoxonase 1 (PON1) estão relacionados ao metabolismo lipídico conferindo efeito marginal e modesto nas concentrações séricas das lipropoteínas e sobre o risco de desenvolvimento de doença arterial coronária (DAC). O objetivo primário deste estudo é avaliar se há associação entre os polimorfismos da PON1: R192Q- rs662, R160G: rs13306698, Leu55Met: rs854560, Promoter_161: rs705381 e rs3917464 e eventos cardiovasculares em 5 anos numa sub-população com DAC estável do estudo MASS II (Medical, Angioplasty or Surgery Study II). Como objetivos secundários, investigamos a influência destes polimorfismos nas concentrações lipídicas iniciais e após 5 anos de acompanhamento, e também a sua relação com os desfechos cardiovasculares combinados no grupo randomizado para tratamento clínico exclusivo. Foram randomizados 611 pacientes para o MASS II. A população alvo deste estudo foi constituída por 518 pacientes que tiveram material genético coletado (MASS II Genético). Os polimorfismos avaliados, apesar de estarem associados ao metabolismo do HDL-c, apresentaram baixa associação com os níveis lipídicos e com o seu comportamento ao longo de 5 anos. Houve diferença nas concentrações médias de HDL-c entre os genótipos do Promoter_161, o alelo T associado a concentrações mais baixas de HDL-c (p=0,0369). Análise univariada mostrou que houve associação entre o raro alelo G do polimorfismo R160G (5 pacientes) e aumento da mortalidade, porém quando incluído no modelo ajustado por regressão logística multivariada não se mostrou preditor independente de óbito nesta população. Na análise do grupo randomizado para o tratamento médico, o polimorfismo R192Q está associado de forma independente ao novo infarto agudo do miocárdio, óbito, e eventos combinados. Genótipo GG aumentou o risco de óbito em 7,69 vezes (IC: 1.65- 35.76) e de IAM em 6,58 vezes (IC: 1.39- 30.46) quando comparado ao genótipo AA. Alelo A estava independentemente associado...


Paraoxonase 1 (PON1) gene polymorphisms have a known relation with lipid metabolism, conferring a marginal and modest effect on serum lipoprotein concentrations and also on development of coronary artery disease (CAD). The primary objective of this study is to investigate the association between PON1 polymorphisms: R192Q- rs662, R160G: rs13306698, Leu55Met: rs854560, Promoter_161: rs705381, and rs3917464 and 5-year follow-up cardiovascular events in a subpopulation with stable CAD from MASS II (Medical, Angioplasty or Surgery Study II). Secondary objectives will be to evaluate the influence of these polymorphisms on baseline and 5-year follow-up lipid concentrations and also its association with combined cardiovascular events in the MASS II group randomized for medical treatment. MASS II had 611 patients randomized. Target population comprises 518 patients who had genetic material sampled. Even though the polymorphisms were linked to HDL-c metabolism, there was a low association with lipid levels and changes over the 5-year follow-up. HDL-c mean concentrations were different in the Promoter_161 genotypes, T-allele was associated with lower levels (p=0.0369). Univariate analysis showed association between the rare G-allele of polymorphism R160G (5 patients) and increased mortality, but when adjusted in the multivariate logistic regression model this variable was not independent predictor of mortality in this population. In the medical treatment group, r192Q is associated with new myocardium infarction (MI), combined events and death. When compared to AA genotype, GG genotype increased the risk of death by 7.69 (CI: 1.65- 35.76) and of MI by 6.58 (CI: 1.39- 30.46). A-allele is independently associated with combined cardiovascular events with a OR of 3.03 (CI: 1.29- 7.07). In conclusion, this study showed association between G-allele on R160G position with increased mortality in patients with stable CAD. ...


Asunto(s)
Humanos , Masculino , Adulto , Persona de Mediana Edad , Enfermedades Cardiovasculares , Enfermedad Coronaria , Marcadores Genéticos , Lípidos , Polimorfismo Genético , Pronóstico
10.
Arq Bras Endocrinol Metabol ; 52(3): 465-72, 2008 Apr.
Artículo en Portugués | MEDLINE | ID: mdl-18506271

RESUMEN

OBJECTIVES: To evaluate in our population the real prevalence of diabetes (DM) and stress hyperglycemia (HE) in patients with myocardial infarction (IAM) admitted in a cardiologic emergency unit. METHODS: A retrospective analysis of 2262 patients with AMI evaluating the prevalence of DM (referred and diagnosed) and stress hyperglycemia. RESULTS: Besides 12.1% of subjects were previously referred to be diabetic (men: 10.7% and women: 15.8%), diabetes was effectively diagnosed in 24.8% (M: 22.9%, W: 29.7%) and stress hyperglycemia in 13.6% HE of the patients (M: 14.3%, W: 11,7%) indicating that glycemic alterations were effectively observed in 37.2.% of the patients with IAM (M: 37.2%, W: 41.4%). In DM subjects IAM events occurred earlier, total intra-hospital mortality was higher (DM: 20.7%, ND: 13.8%, HE: 13.4%) and less surgical procedures were performed (ND 33.8%, DM: 21.7%, HE: 18.0%). CONCLUSION: The elevated DM and stress hyperglycemia prevalence observed in our study indicates that glycemic alterations is one of the most important risk factors for IAM.


Asunto(s)
Glucemia/metabolismo , Complicaciones de la Diabetes/epidemiología , Hiperglucemia/epidemiología , Infarto del Miocardio/metabolismo , Estrés Fisiológico/fisiología , Adulto , Distribución por Edad , Factores de Edad , Anciano , Anciano de 80 o más Años , Brasil/epidemiología , Complicaciones de la Diabetes/metabolismo , Femenino , Intolerancia a la Glucosa/epidemiología , Intolerancia a la Glucosa/metabolismo , Hospitalización/estadística & datos numéricos , Humanos , Hiperglucemia/metabolismo , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Estado Prediabético/epidemiología , Estado Prediabético/metabolismo , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Distribución por Sexo , Factores Sexuales
11.
Arq. bras. endocrinol. metab ; 52(3): 465-472, abr. 2008. ilus, tab
Artículo en Portugués | LILACS | ID: lil-482575

RESUMEN

OBJETIVOS: Determinar a prevalência do diabetes melito (DM) e da hiperglicemia de estresse (HE) em pacientes com infarto agudo do miocárdio (IAM) admitidos em unidade de emergência cardiológica. MÉTODOS: Análise retrospectiva de 2.262 pacientes com IAM, avaliando, além da prevalência de diabetes referido, o diagnosticado e a hiperglicemia de estresse. RESULTADOS: Apesar de referido em 12,1 por cento dos pacientes (H: 10,7 por cento, M: 15,8 por cento), o DM ocorria efetivamente em 24,8 por cento (H: 22,9 por cento, M: 29,7 por cento) e a HE em 13,6 por cento (H: 14,3 por cento, M: 11,7 por cento) dos indivíduos dessa população. Portanto, alterações glicêmicas ocorreram em 37,4 por cento dos indivíduos com IAM (H: 37,2 por cento, M: 41,4 por cento). Nos pacientes com DM, observou-se maior precocidade etária do IAM, maior prevalência de óbitos (DM: 20,7 por cento, ND:13,8 por cento, HE: 13,4 por cento) e de procedimentos cirúrgicos (ND: 33,8 por cento, HE: 18,0 por cento, DM: 21,7 por cento). CONCLUSÃO: A elevada prevalência de DM e hiperglicemia de estresse observada em nosso estudo indica que as alterações glicêmicas constituem um dos mais importantes fatores de risco para o IAM.


OBJECTIVES: To evaluate in our population the real prevalence of diabetes (DM) and stress hyperglycemia (HE) in patients with myocardial infarction (IAM) admitted in a cardiologic emergency unit. METHODS: A retrospective analysis of 2262 patients with AMI evaluating the prevalence of DM (referred and diagnosed) and stress hyperglycemia. RESULTS: Besides 12,1 percent of subjects were previously referred to be diabetic (men: 10.7 percent and women: 15.8 percent), diabetes was effectively diagnosed in 24,8 percent (M: 22,9 percent, W: 29,7 percent) and stress hyperglycemia in 13,6 percent HE of the patients (M: 14,3 percent, W: 11,7 percent) indicating that glycemic alterations were effectively observed in 37.2. percent of the patients with IAM (M: 37,2 percent, W: 41,4 percent). In DM subjects IAM events occurred earlier, total intra-hospital mortality was higher (DM: 20.7 percent, ND: 13,8 percent, HE: 13,4 percent) and less surgical procedures were performed (ND 33.8 percent, DM: 21.7 percent, HE: 18.0 percent). CONCLUSION: The elevated DM and stress hyperglycemia prevalence observed in our study indicates that glycemic alterations is one of the most important risk factors for IAM.


Asunto(s)
Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Glucemia/metabolismo , Complicaciones de la Diabetes/epidemiología , Hiperglucemia/epidemiología , Infarto del Miocardio/metabolismo , Estrés Fisiológico/fisiología , Distribución por Edad , Factores de Edad , Brasil/epidemiología , Complicaciones de la Diabetes/metabolismo , Intolerancia a la Glucosa/epidemiología , Intolerancia a la Glucosa/metabolismo , Hospitalización/estadística & datos numéricos , Hiperglucemia/metabolismo , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Prevalencia , Estado Prediabético/epidemiología , Estado Prediabético/metabolismo , Estudios Retrospectivos , Factores de Riesgo , Distribución por Sexo , Factores Sexuales
12.
Braz. arch. biol. technol ; 49(4): 583-587, July 2006. tab
Artículo en Inglés | LILACS | ID: lil-448924

RESUMEN

The tolerability of stevioside (2.75 mg/kg/day) obtained from leaves of Stevia rebaudiana (Bert) Bertoni (Compositae) was investigated in hyperlipidemic patients. For this purpose a placebo controlled double blind study was performed. The patients were randomized in two groups: the first group received capsules containing placebo and the second group received capsules containing stevioside (50 mg) during 90 days. All capsules were ingested twice daily, i.e., 2 capsules before lunch and 2 capsules before dinner. After the selection of the patients and each 30 days body mass index and laboratory tests (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, total cholesterol, high density lipoprotein, low density lipoprotein, very low density lipoprotein, triglycerides and glucose) were performed. Stevioside did not show any clinical relevant modification in all parameters investigated. Moreover the patients did not report severe adverse effect. Thus, we can concluded that stevioside, at least in the doses employed in this study was safe.


A tolerabilidade do esteviosideo (2.75 mg/kg/dia) obtido a partir de folhas de Stevia rebaudiana (Bert) Bertoni (Compositae) foi investigada em pacientes hiperlipidêmicos. Para alcançar este objetivo realizamos estudo clínico do tipo duplo cego. Os pacientes foram randomizados em 2 grupos: o primeiro recebeu cápsulas contendo placebo e o segundo recebeu cápsulas contendo esteviosídeo (50 mg). Foram ingeridas duas cápsulas antes do almoço e duas cápsulas antes do jantar durante 90 dias. Após a seleção dos pacientes e a cada 30 dias o índice de massa corpórea e exames laboratoriais (alanina aminotransferase, aspartato aminotransferase, gama-glutamiltransferase, colesterol total, lipoproteína de alta densidade, lipoproteína de baixa densidade, lipoproteína de muito baixa densidade, trigliceridemia e glicemia) foram realizados. O esteviosídeo não acarretou qualquer alteração clinicamente relevante nos parâmetros investigados. Além disso, os pacientes não relataram efeitos adversos severos. Assim, podemos concluir que o esteviosídeo, na dose empregada neste estudo é seguro, embora não apresente efeito hipolipemiante.

13.
Phytother Res ; 20(9): 732-6, 2006 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-16775813

RESUMEN

The antihypertensive effect of crude stevioside obtained from the leaves of Stevia rebaudiana (Bertoni) Bertoni (Compositae) on previously untreated mild hypertensive patients was examined. Patients with essential hypertension were submitted to a placebo phase for 4 weeks. The volunteers selected in this phase were randomly assigned to receive either capsules containing placebo during 24 weeks or crude stevioside 3.75 mg/kg/day (7 weeks), 7.5 mg/kg/day (11 weeks) and 15.0 mg/kg/day (6 weeks). All capsules were prescribed twice a daily (b.i.d.), i.e. before lunch and before dinner. After the placebo phase and after each dose of crude stevioside, body mass index, electrocardiogram and laboratory tests were performed. During the investigation blood pressure (BP) was measured biweekly and the remaining data were collected at the end of each stevioside dose step. All adverse events were prospectively recorded but no major adverse clinical effects were observed during the trial. Systolic and diastolic BP decreased (p < 0.05) during the treatment with crude stevioside, but a similar effect was observed in the placebo group. Therefore, crude stevioside up to 15.0 mg/kg/day did not show an antihypertensive effect. Moreover, the results suggest that oral crude stevioside is safe and supports the well-established tolerability during long term use as a sweetener in Brazil.


Asunto(s)
Antihipertensivos/uso terapéutico , Diterpenos de Tipo Kaurano/uso terapéutico , Glucósidos/uso terapéutico , Hipertensión/tratamiento farmacológico , Fitoterapia , Adulto , Antihipertensivos/análisis , Diterpenos de Tipo Kaurano/efectos adversos , Método Doble Ciego , Femenino , Glucósidos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Stevia/efectos adversos , Stevia/química
14.
Planta Med ; 72(8): 691-6, 2006 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-16732523

RESUMEN

The purpose of the present study was to compare the effect of the oral treatment (gavage) with Stevia rebaudiana (Bert.) Bertoni (SRB) and stevioside (STV) on glycaemia and gluconeogenesis of 15-h fasted rats. For this purpose, the rats received SRB (20 mg/kg x day), STV (5.5 mg/kg x day) or an equal volume of water (controls) during 15 days. To measure hepatic gluconeogenesis, liver perfusion and isolated hepatocytes were used. Glycaemia and gluconeogenesis from L-alanine (5 mM), L-glutamine (5 mM) and L-lactate (2 mM) were decreased (P < 0.05) after pre-treatment with SRB. However, the treatment with STV did not influence glycaemia and gluconeogenesis. Moreover, to get further information about the mechanism by which SRB leaves inhibit gluconeogenesis their potential role as a PPARgamma agonist was investigated. The data showed absence of activation of PPARgamma receptors. In summary, our results showed that the reduction of glycaemia promoted by the treatment with SRB leaves was mediated, at least in part, by an inhibition of hepatic gluconeogenesis. However, this effect did not involve stevioside and the activation of PPARgamma receptors.


Asunto(s)
Diterpenos de Tipo Kaurano/farmacología , Glucósidos/farmacología , Hipoglucemiantes/farmacología , Fitoterapia , Extractos Vegetales/farmacología , Stevia , Administración Oral , Animales , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diterpenos de Tipo Kaurano/administración & dosificación , Diterpenos de Tipo Kaurano/uso terapéutico , Gluconeogénesis/efectos de los fármacos , Glucosa/metabolismo , Glucósidos/administración & dosificación , Glucósidos/uso terapéutico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Hígado/efectos de los fármacos , Hígado/metabolismo , Masculino , Extractos Vegetales/administración & dosificación , Extractos Vegetales/uso terapéutico , Hojas de la Planta , Ratas , Ratas Wistar
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