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1.
Int J Mol Sci ; 25(4)2024 Feb 16.
Article in English | MEDLINE | ID: mdl-38397015

ABSTRACT

Diabetes mellitus (DM) is a highly prevalent disease worldwide, estimated to affect 1 in every 11 adults; among them, 90-95% of cases are type 2 diabetes mellitus. This is partly attributed to the surge in the prevalence of obesity, which has reached epidemic proportions since 2008. In these patients, cardiovascular (CV) risk stands as the primary cause of morbidity and mortality, placing a substantial burden on healthcare systems due to the potential for macrovascular and microvascular complications. In this context, leptin, an adipocyte-derived hormone, plays a fundamental role. This hormone is essential for regulating the cellular metabolism and energy balance, controlling inflammatory responses, and maintaining CV system homeostasis. Thus, leptin resistance not only contributes to weight gain but may also lead to increased cardiac inflammation, greater fibrosis, hypertension, and impairment of the cardiac metabolism. Understanding the relationship between leptin resistance and CV risk in obese individuals with type 2 DM (T2DM) could improve the management and prevention of this complication. Therefore, in this narrative review, we will discuss the evidence linking leptin with the presence, severity, and/or prognosis of obesity and T2DM regarding CV disease, aiming to shed light on the potential implications for better management and preventive strategies.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Leptin , Obesity , Adult , Humans , Cardiovascular Diseases/metabolism , Diabetes Mellitus, Type 2/metabolism , Leptin/metabolism , Obesity/metabolism
2.
Clin Investig Arterioscler ; 34(1): 36-55, 2022.
Article in English, Spanish | MEDLINE | ID: mdl-34330545

ABSTRACT

This document is an update to the clinical practice recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. The consensus has been developed by a multidisciplinary team made up of members of the Cardiovascular Risk Group of the Spanish Diabetes Society (SED). The work is a necessary update as, since the last review three years ago, there have been many clinical trials that have studied the cardiovascular outcomes of numerous drugs in the diabetic population. We believe that this guideline update may be of interest to all clinicians treating patients with diabetes.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cardiovascular Diseases/prevention & control , Diabetes Mellitus/therapy , Heart Disease Risk Factors , Humans , Risk Factors
3.
Nutrients ; 13(11)2021 Nov 19.
Article in English | MEDLINE | ID: mdl-34836405

ABSTRACT

Cardiovascular disease (CVD) is the most common cause of morbidity and mortality in developed countries. The prevalence of CVD is much higher in patients with type 2 diabetes mellitus (T2DM), who may benefit from lifestyle changes, which include adapted diets. In this review, we provide the role of different groups of nutrients in patients with T2DM and CVD, as well as dietary approaches that have been associated with better and worse outcomes in those patients. Many different diets and supplements have proved to be beneficial in T2DM and CVD, but further studies, guidelines, and dietary recommendations are particularly required for patients with both diseases.


Subject(s)
Cardiovascular Diseases/diet therapy , Diabetes Mellitus, Type 2/diet therapy , Diabetic Cardiomyopathies/diet therapy , Diet/methods , Nutrition Therapy/methods , Cardiovascular Diseases/complications , Diabetes Mellitus, Type 2/complications , Diabetic Cardiomyopathies/complications , Dietary Supplements , Humans , Nutrients/therapeutic use
4.
Colloids Surf B Biointerfaces ; 193: 111119, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32464356

ABSTRACT

Voriconazole (VCZ) is currently the first-line treatment for invasive aspergillosis, although the doses are limited by its poor solubility and high hepatic toxicity. The aim of this study was to develop a solid self-dispersing micellar system of VCZ to improve the pharmacokinetic/pharmacodynamic (PK/PD) relationship and reduce hepatotoxicity. In this work, solid micellar systems of VCZ are formulated with different polysorbate 80 ratios using mannitol as a hydrophilic carrier. The novel micellar systems were characterized by scanning electron microscopy (SEM), powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC) and dissolution studies. Self-dispersing micellar systems reduced VCZ crystallinity, leading to an improvement in its dissolution rate. The in vitro susceptibility test also revealed that the most common microorganisms in invasive aspergillosis exhibited low minimum inhibitory concentration (MIC) values for micellar systems. Pharmacokinetic studies indicated an improvement in bioavailability for MS-1:3:0.05, and changes in its biodistribution to different organs. MS-1:3:0.05 showed an increased concentration in lungs and a significant decrease in VCZ accumulated in the liver.


Subject(s)
Antifungal Agents/pharmacology , Aspergillosis/drug therapy , Aspergillus/drug effects , Voriconazole/pharmacology , Animals , Antifungal Agents/chemistry , Antifungal Agents/toxicity , Drug Compounding , Drug Liberation , Male , Mannitol/chemistry , Microbial Sensitivity Tests , Particle Size , Polysorbates/chemistry , Rats , Rats, Wistar , Surface Properties , Tissue Distribution , Voriconazole/chemistry , Voriconazole/toxicity
5.
Clín. investig. arterioscler. (Ed. impr.) ; 30(3): 137-153, mayo-jun. 2018. tab
Article in Spanish | IBECS | ID: ibc-175429

ABSTRACT

El presente documento es una actualización de las recomendaciones de práctica clínica para el manejo de los factores de riesgo cardiovascular en la diabetes mellitus. Este consenso está elaborado por los miembros del Grupo de Riesgo Cardiovascular de la Sociedad Española de Diabetes (SED). Se han propuesto y actualizado las intervenciones sobre el estilo de vida, tratamiento farmacológico indicado para alcanzar los objetivos terapéuticos según los niveles de HbA1c, grado de obesidad, hipertensión arterial, hiperlipemia, insuficiencia cardiaca, antiagregación plaquetaria, insuficiencia renal y diabetes en el anciano, así como nuevos biomarcadores de interés en la evaluación del riesgo cardiovascular. El trabajo es una actualización de las intervenciones y objetivos terapéuticos; además, se señala la necesidad de la inclusión de los especialistas en Endocrinología, Metabolismo y Nutrición en las Unidades de Rehabilitación Cardiaca para el control y seguimiento de esta población


This document is an update to the clinical practice recommendations for the management of cardiovascular risk factors in diabetes mellitus. The consensus is made by members of the Cardiovascular Risk Group of the Spanish Diabetes Society. We have proposed and updated interventions on lifestyle, pharmacological treatment indicated to achieve therapeutic objectives according to the levels of HbA1c, degree of obesity, hypertension, hyperlipidemia, heart failure, platelet antiagregation, renal insufficiency, and diabetes in the elderly, as well as new biomarkers of interest in the evaluation of cardiovascular risk in individuals with diabetes mellitus. The work is an update of the interventions and therapeutic objectives in addition, it is noted the need for the inclusion of specialists in Endocrinology, Metabolism and Nutrition in Cardiac Rehabilitation Units for the control and monitoring of this population


Subject(s)
Humans , Aged , Diabetes Complications/prevention & control , Cardiovascular Diseases/prevention & control , Diabetes Mellitus/physiopathology , Risk Factors , Life Style , Obesity, Morbid/surgery , Blood Glucose/analysis , Hypertension , Hyperlipidemias/drug therapy , Renal Insufficiency, Chronic/drug therapy , Aged
6.
Clin Investig Arterioscler ; 30(3): 137-153, 2018.
Article in English, Spanish | MEDLINE | ID: mdl-29754804

ABSTRACT

This document is an update to the clinical practice recommendations for the management of cardiovascular risk factors in diabetes mellitus. The consensus is made by members of the Cardiovascular Risk Group of the Spanish Diabetes Society. We have proposed and updated interventions on lifestyle, pharmacological treatment indicated to achieve therapeutic objectives according to the levels of HbA1c, degree of obesity, hypertension, hyperlipidemia, heart failure, platelet antiagregation, renal insufficiency, and diabetes in the elderly, as well as new biomarkers of interest in the evaluation of cardiovascular risk in individuals with diabetes mellitus. The work is an update of the interventions and therapeutic objectives in addition, it is noted the need for the inclusion of specialists in Endocrinology, Metabolism and Nutrition in Cardiac Rehabilitation Units for the control and monitoring of this population.


Subject(s)
Cardiovascular Diseases/prevention & control , Diabetic Angiopathies/prevention & control , Diabetic Cardiomyopathies/prevention & control , Aged , Biomarkers/metabolism , Cardiovascular Diseases/etiology , Diabetes Mellitus/physiopathology , Diabetes Mellitus/therapy , Humans , Life Style , Risk Factors , Spain
7.
J Ophthalmol ; 2017: 8234186, 2017.
Article in English | MEDLINE | ID: mdl-28695003

ABSTRACT

A group of members of the Spanish Retina and Vitreous Society (SERV) and of the Working Group of Ocular Health of the Spanish Society of Diabetes (SED) updated knowledge regarding the diagnosis and treatment of diabetic retinopathy (DR) based on recent evidence reported in the literature. A synthesis of this consensus forms the basis of the present review, which is intended to inform clinicians on current advances in the field of DR and their clinical applicability to patients with this disease. Aspects presented in this article include screening procedures of DR, new technologies in the early diagnosis of DR, control of risk factors in the different stages of the disease, indications of panretinal laser photocoagulation, efficacy of intravitreal antiangiogenic agents and steroids, and surgical options for treating DR-related complications. Practical information regarding periodicity of screening procedures in patients with type 1 and type 2 diabetes, ophthalmological controls according to the stage of retinopathy and complications, and criteria and degree of urgency for referral of a DR patient to the ophthalmologist are also presented.

8.
Aten. prim. (Barc., Ed. impr.) ; 48(5): 325-336, mayo 2016. tab
Article in Spanish | IBECS | ID: ibc-151919

ABSTRACT

El presente documento actualiza las recomendaciones de práctica clínica del manejo de los factores de riesgo cardiovascular (FRCV) en la diabetes mellitus (DM). Es un consenso médico realizado por un panel de expertos independiente de la Sociedad Española de Diabetes (SED). Se han propuesto y actualizado varios consensos de diferentes sociedades científicas o médicas con el fin de mejorar los resultados terapéuticos. La valoración del RCV en la población general puede carecer de sensibilidad para la evaluación individual en determinados grupos de riesgo como los diabéticos. Se revisan los factores de riesgo tradicionales y no tradicionales, así como las estrategias de intervención para el control de los FRCV en los pacientes diabéticos como la dieta, el control ponderal, el ejercicio físico, los hábitos tóxicos, el control glucémico, tensional y lipídico, así como la antiagregación plaquetaria. Confiamos en que estas pautas ayuden a los médicos en la toma de decisiones en su actividad asistencial. Se expone una actualización de los conceptos más relevantes y de mayor interés clínico-práctico y, a su vez realista, para reducir el RCV de los diabéticos como se venía haciendo regularmente por parte del Grupo de Enfermedad Cardiovascular de la SED


The present paper updates the Clinical Practice Recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. This is a medical consensus agreed by an independent panel of experts from the Spanish Society of Diabetes (SED). Several consensuses have been proposed by scientific and medical Societies to achieve clinical goals. However, the risk score for general population may lack sensitivity for individual assessment or for particular groups at risk, such as diabetics. Traditional risk factors together with non-traditional factors are reviewed throughout this paper. Intervention strategies for managing CVRF in the diabetic patient are reviewed in detail: balanced food intake, weight reduction, physical exercise, smoking cessation, reduction in HbA1c, therapy for high blood pressure, obesity, lipid disorders, and platelet anti-aggregation. It is hoped that these guidelines can help clinicians in the decisions of their clinical activity. This regular update by the SED Cardiovascular Disease Group of the most relevant concepts, and of greater practical and realistic clinical interest, is presented in order to reduce CVR of diabetics


Subject(s)
Humans , Male , Female , Diabetes Mellitus/diagnosis , Diabetes Mellitus/prevention & control , Diabetes Mellitus/therapy , Cardiovascular Diseases/complications , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/therapy , Risk Factors , Life Style , Motor Activity/physiology , Diet, Mediterranean , Disease Prevention , Epidemiologic Studies , Exercise/physiology , Medication Adherence , Prospective Studies , Practice Guidelines as Topic/standards , Consensus , Spain
9.
Aten Primaria ; 48(5): 325-36, 2016 May.
Article in Spanish | MEDLINE | ID: mdl-26031458

ABSTRACT

The present paper updates the Clinical Practice Recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. This is a medical consensus agreed by an independent panel of experts from the Spanish Society of Diabetes (SED). Several consensuses have been proposed by scientific and medical Societies to achieve clinical goals. However, the risk score for general population may lack sensitivity for individual assessment or for particular groups at risk, such as diabetics. Traditional risk factors together with non-traditional factors are reviewed throughout this paper. Intervention strategies for managing CVRF in the diabetic patient are reviewed in detail: balanced food intake, weight reduction, physical exercise, smoking cessation, reduction in HbA1c, therapy for high blood pressure, obesity, lipid disorders, and platelet anti-aggregation. It is hoped that these guidelines can help clinicians in the decisions of their clinical activity. This regular update by the SED Cardiovascular Disease Group of the most relevant concepts, and of greater practical and realistic clinical interest, is presented in order to reduce CVR of diabetics.


Subject(s)
Cardiovascular Diseases/prevention & control , Diabetic Angiopathies/prevention & control , Diabetic Cardiomyopathies/prevention & control , Cardiovascular Diseases/etiology , Diabetic Angiopathies/etiology , Diabetic Cardiomyopathies/etiology , Diet, Healthy , Exercise , Humans , Hyperlipidemias/complications , Life Style , Obesity, Morbid/complications , Obesity, Morbid/surgery , Risk Factors , Smoking Prevention
10.
Clín. investig. arterioscler. (Ed. impr.) ; 27(4): 181-192, jul.-ago. 2015. tab
Article in Spanish | IBECS | ID: ibc-142015

ABSTRACT

El presente documento actualiza las recomendaciones de práctica clínica del manejo de los factores de riesgo cardiovascular (FRCV) en la diabetes mellitus (DM). Es un consenso médico realizado por un panel de expertos independiente de la Sociedad Española de Diabetes (SED). Se han propuesto y actualizado varios consensos de diferentes sociedades científicas o médicas con el fin de mejorar los resultados terapéuticos. La valoración del RCV en la población general puede carecer de sensibilidad para la evaluación individual en determinados grupos de riesgo como los diabéticos. Se revisan los factores de riesgo tradicionales y no tradicionales, así como las estrategias de intervención para el control de los FRCV en los pacientes diabéticos como la dieta, el control ponderal, el ejercicio físico, los hábitos tóxicos, el control glucémico, tensional y lipídico, así como la antiagregación plaquetaria. Confiamos en que estas pautas ayuden a los médicos en la toma de decisiones en su actividad asistencial. Se expone una actualización de los conceptos más relevantes y de mayor interés clínico-práctico y, a su vez realista, para reducir el RCV de los diabéticos como se venía haciendo regularmente por parte del Grupo de Enfermedad Cardiovascular de la SED


The present paper updates the Clinical Practice Recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. This is a medical consensus agreed by an independent panel of experts from the Spanish Society of Diabetes (SED). Several consensuses have been proposed by scientific and medical Societies to achieve clinical goals. However, the risk score for general population may lack sensitivity for individual assessment or for particular groups at risk, such as diabetics. Traditional risk factors together with non-traditional factors are reviewed throughout this paper. Intervention strategies for managing CVRF in the diabetic patient are reviewed in detail: balanced food intake, weight reduction, physical exercise, smoking cessation, reduction in HbA1c, therapy for high blood pressure, obesity, lipid disorders, and platelet anti-aggregation. It is hoped that these guidelines can help clinicians in the decisions of their clinical activity. This regular update by the SED Cardiovascular Disease Group of the most relevant concepts, and of greater practical and realistic clinical interest, is presented in order to reduce CVR of diabetics


Subject(s)
Female , Humans , Male , Diabetes Mellitus/blood , Diabetes Mellitus/pathology , Cardiovascular Abnormalities/genetics , Cardiovascular Abnormalities/metabolism , Diet, Diabetic/classification , Diet, Diabetic/methods , Arterial Pressure/genetics , Pharmaceutical Preparations/administration & dosage , Diabetes Mellitus/genetics , Diabetes Mellitus/metabolism , Cardiovascular Abnormalities/complications , Cardiovascular Abnormalities/pathology , /standards , Diet, Diabetic/instrumentation , Diet, Diabetic , Arterial Pressure/physiology , Pharmaceutical Preparations/supply & distribution
11.
Clin Investig Arterioscler ; 27(4): 181-92, 2015.
Article in Spanish | MEDLINE | ID: mdl-25825221

ABSTRACT

The present paper updates the Clinical Practice Recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. This is a medical consensus agreed by an independent panel of experts from the Spanish Society of Diabetes (SED). Several consensuses have been proposed by scientific and medical Societies to achieve clinical goals. However, the risk score for general population may lack sensitivity for individual assessment or for particular groups at risk, such as diabetics. Traditional risk factors together with non-traditional factors are reviewed throughout this paper. Intervention strategies for managing CVRF in the diabetic patient are reviewed in detail: balanced food intake, weight reduction, physical exercise, smoking cessation, reduction in HbA1c, therapy for high blood pressure, obesity, lipid disorders, and platelet anti-aggregation. It is hoped that these guidelines can help clinicians in the decisions of their clinical activity. This regular update by the SED Cardiovascular Disease Group of the most relevant concepts, and of greater practical and realistic clinical interest, is presented in order to reduce CVR of diabetics.


Subject(s)
Cardiovascular Diseases/prevention & control , Diabetes Mellitus/epidemiology , Cardiovascular Diseases/etiology , Humans , Risk Factors , Smoking Cessation/methods , Spain
12.
Fetal Diagn Ther ; 29(2): 178-80, 2011.
Article in English | MEDLINE | ID: mdl-20962514

ABSTRACT

We report a case of fetal goiter in a pregnant woman with Graves-Basedow disease. It was diagnosed in the third trimester by a routine ultrasound, and the cordocentesis verified increased levels of thyroxine (T4) and increased autoantibodies (antithyroperoxidase antibodies) that were also increased in maternal blood. Fetal goiter got smaller on the follow-up scans, and the newborn presented hypothyroidism. Current notions on the diagnosis and management of fetal goiter are briefly discussed.


Subject(s)
Autoantibodies/blood , Fetal Diseases/immunology , Goiter/immunology , Graves Disease/immunology , Adult , Female , Fetal Diseases/diagnostic imaging , Goiter/diagnostic imaging , Humans , Placental Circulation , Pregnancy , Ultrasonography
13.
Hepatology ; 50(6): 1702-8, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19845037

ABSTRACT

UNLABELLED: Insulin resistance affects sustained virological response (SVR) in chronic hepatitis C. To know whether adding metformin to standard antiviral treatment improves SVR, we conducted a prospective, multicentered, randomized, double-blinded, placebo-controlled trial in 19 Spanish hospitals, including 123 consecutive patients with genotype 1 chronic hepatitis C and insulin resistance. Patients were randomized to receive either metformin (arm A; n = 59) or placebo (arm B; n = 64) in addition to peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). The primary end point was SVR, and secondary endpoints were viral clearance at weeks 12, 24, and 48, and changes in the homeostasis model assessment (HOMA) index over the first 24 weeks. There were no differences between arms at baseline. In the intent-to-treat analysis, SVR was observed in 53% versus 42% in arm A and arm B, respectively (P = NS). In the subgroup analyses, SVR was higher in females (n = 54) receiving metformin: arm A, 58% (15/26) versus 29% (8/28) arm B (P = 0.03). In the per protocol analysis (PPA; n = 101), SVR was 67% in arm A and 49% in arm B (P = 0.06). Viral decline during the first 12 weeks was greater in females receiving metformin: -4.88 (1.18) versus -4.0 (1.44) (P = 0.021), whereas no differences were seen in males. The triple therapy was well tolerated, but diarrhea was more often seen in arm A (34% versus 11%; P < 0.05). CONCLUSION: Adding metformin to peginterferon and ribavirin was safe and improved insulin sensitivity. Although the study failed to show a statistically significant difference between arms, it did show an improved SVR in females.


Subject(s)
Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Insulin Resistance , Interferon-alpha/administration & dosage , Metformin/therapeutic use , Polyethylene Glycols/administration & dosage , Ribavirin/administration & dosage , Adult , Double-Blind Method , Drug Therapy, Combination , Female , Genotype , Hepatitis C, Chronic/virology , Humans , Interferon alpha-2 , Interferon-alpha/adverse effects , Male , Middle Aged , PPAR gamma/agonists , Polyethylene Glycols/adverse effects , Recombinant Proteins , Ribavirin/adverse effects
14.
J Hepatol ; 48(5): 721-7, 2008 May.
Article in English | MEDLINE | ID: mdl-18308416

ABSTRACT

BACKGROUND/AIMS: To investigate the effect of sustained virological response (SVR) on impaired fasting glucose (IFG) and/or type 2 diabetes (T2DM); to assess the influence of glucose abnormalities on the SVR rate. METHODS: 1059 patients with chronic HCV; normal glucose (< 100 mg/dl) in 734, IFG (between 100 and 125 mg/dl) in 218, and T2DM (126 mg/dl) in 107 cases, were treated with interferon plus ribavirin over 24 or 48 weeks, depending on viral genotype. RESULTS: The SVR rate was lower in patients with IFG and/or T2DM than in patients with normal glucose concentrations [143/325 (44%) vs. 432/734 (58.8%); P=0.002]. In the follow-up, abnormal glucose concentrations were observed in 74 of 304 (24.3%) non-responders and in 49 of 430 (11.4%) sustained responders (log-rank: 13.8; P=0.00002). Reverse stepwise logistic regression analysis identified the independent variables predictive of IFG or T2DM development as: sustained response (OR: 0.44; 95%CI=0.20-0.97; P=0.004) and fibrosis stage (OR: 1.46; 95%CI=1.06-2.01;P=0.02). Family history of DM, steatosis, gender, HCV viral load, genotype, triglycerides, cholesterol and BMI did not enter the multivariate analysis equation. CONCLUSIONS: SVR reduces the risk of IFG and/or T2DM development in patients with chronic hepatitis C while altered glucose metabolism impairs sustained response to viral treatment.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 2/etiology , Hepatitis C, Chronic/drug therapy , Adult , Alanine Transaminase/blood , Drug Therapy, Combination , Female , Hepatitis C, Chronic/blood , Hepatitis C, Chronic/virology , Humans , Interferons/administration & dosage , Male , Middle Aged , Ribavirin/administration & dosage , Viral Load
15.
Diabetes Care ; 30(4): 771-6, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17392539

ABSTRACT

OBJECTIVE: To assess the safety and efficacy of insulin aspart (IAsp) versus regular human insulin (HI) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS: Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study. Subjects had A1C < or =8% at confirmation of pregnancy. Insulin doses were titrated toward predefined glucose targets and A1C <6.5%. Outcomes assessed included risk of major maternal hypoglycemia, A1C, plasma glucose profiles, and maternal safety outcomes. RESULTS: Major hypoglycemia occurred at a rate of 1.4 vs. 2.1 episodes/year exposure with IAsp and HI, respectively (relative risk 0.720 [95% CI 0.36-1.46]). Risk of major/major nocturnal hypoglycemia was 52% (RR 0.48 [0.20-1.143]; P = NS) lower with IAsp compared with HI. A1C was comparable with human insulin in second (IAsp-HI -0.04 [-0.18 to 0.11]) and third (-0.08 [-0.23 to 0.06]) trimesters. A total of 80% of subjects achieved an A1C < or =6.5%. At the end of first and third trimesters, average postprandial plasma glucose increments were significantly lower with IAsp than HI (P = 0.003 and P = 0.044, respectively), as were mean plasma glucose levels 90 min after breakfast (P = 0.044 and P = 0.001, respectively). Maternal safety profiles and pregnancy outcomes were similar between treatments. CONCLUSIONS: IAsp is at least as safe and effective as HI when used in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes and may potentially offer some benefits in terms of postprandial glucose control and preventing severe hypoglycemia.


Subject(s)
Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Insulin, Isophane/therapeutic use , Insulin/analogs & derivatives , Insulin/therapeutic use , Pregnancy Complications/blood , Adult , Body Mass Index , Drug Administration Schedule , Europe , Female , Gestational Age , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/epidemiology , Hypoglycemic Agents/therapeutic use , Insulin Aspart , Pregnancy , Pregnancy Complications/drug therapy , Pregnancy Outcome , Quality of Life
16.
Clin Ther ; 27(5): 554-67, 2005 May.
Article in English | MEDLINE | ID: mdl-15978304

ABSTRACT

BACKGROUND: Type 2 diabetes mellitus (DM) is a progressive disease. Initial therapy begins with dietary and lifestyle modifications. However, as the disease progresses, glycemic control becomes more difficult to attain, often requiring > or =1 oral antihyperglycemic medication (OAM), and finally the addition of insulin to the OAMs and insulin monotherapy. OBJECTIVE: This study was designed to determine the effect of pioglitazone 30 mg plus insulin (PIO + INS) versus placebo plus insulin (PLB + INS) on glycemic control, the serum lipid profile, and selected cardiovascular risk factors in patients with type 2 DM whose disease was inadequately controlled with insulin therapy alone despite efforts to intensify such treatment. METHODS: This was a 6-month, randomized, double-blind, prospective, multicenter, placebo-controlled, parallel-group study. Patients with type 2 DM and a glycosylated hemoglobin (HbA(1c)) value > or =7.5% who were using insulin (with or without OAMs) entered a 3-month insulin intensification phase to achieve blood glucose targets with insulin monotherapy. After insulin intensification, those patients with HbA(1c) values > or =7.0% were randomized to PIO + INS or PLB + INS. The primary end point was the change in HbA(1c) from baseline. Cardiovascular risk markers (highly sensitive C-reactive protein [hs CRP] and plasminogen activator inhibitor-1 [PAI-1]) were measured at baseline and end point. RESULTS: Of the 289 patients randomized to treatment (mean [SD] age, 58.9 [7.1] years; 164 women, 125 men), 142 received PIO + INS and 147 received PLB + INS. A total of 263 patients completed the study. After 6 months, PIO + INS reduced mean HbA(1c) (-0.69%; P < 0.002) and mean fasting plasma glucose ([FPG] -1.45 mmol/L; P < 0.002) from baseline. PLB + INS produced no significant changes in HbA(1c) or FPG. The between-treatment differences for HbA(1c) (-0.55%; P < 0.002) and FPG (-1.80 mmol/L; P < 0.002) occurred despite a reduction of insulin dose in the PIO + INS group from baseline (-0.16 U/d . kg; P < 0.002). Significant between-group differences were observed for high-density lipoprotein cholesterol (0.13 mM; P < 0.002), triglycerides (ratio of geometric mean [PIO/PLB], 0.871; P < 0.01), atherogenic index of plasma (-0.11; P < 0.002), PAI-1 (-5.10 U/mL; P < 0.001), and hs CRP (-1.47 mg/L; P < 0.05). The rate of clinical and biochemical hypoglycemia (blood glucose <2.8 mmol/L) did not differ statistically between treatment groups, but reported incidences of subjective hypoglycemia occurred more often with PIO + INS than with PLB + INS (90 vs 75; P < 0.05). Edema was more common with PIO + INS than with PLB + INS (20 vs 5 instances, respectively), as was gain (mean [SEM]) in body weight (4.05 [4.03] vs 0.20 [2.92] kg, respectively). CONCLUSION: Adding pioglitazone to insulin in these study patients with type 2 DM whose disease was inadequately controlled with insulin monotherapy further improved their glycemic control.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Thiazolidinediones/therapeutic use , C-Reactive Protein/analysis , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/etiology , Diabetes Mellitus, Type 2/complications , Double-Blind Method , Drug Therapy, Combination , Female , Glycated Hemoglobin/analysis , Humans , Lipoproteins/blood , Male , Middle Aged , Pioglitazone , Plasminogen Activator Inhibitor 1/blood , Prospective Studies , Risk Factors
17.
Clin Ther ; 25(4): 1074-95, 2003 Apr.
Article in English | MEDLINE | ID: mdl-12809958

ABSTRACT

OBJECTIVE: The goal of this study was to compare the effects of 2 doses of pioglitazone hydrochloride (a thiazolidinedione insulin sensitizer) with placebo on glycated hemoglobin (HbA(1c)), insulin sensitivity, and lipid profiles in patients with type 2 diabetes mellitus who had suboptimal glycemic control and mild dyslipidemia. METHODS: Patients with type 2 diabetes mellitus (HbA(1c) >/=6.5% and /=7% to <8%) or high (>/=8% to

Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hyperlipidemias/complications , Hypoglycemic Agents/therapeutic use , Thiazoles/therapeutic use , Thiazolidinediones , Adult , Aged , Aged, 80 and over , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/metabolism , Dose-Response Relationship, Drug , Double-Blind Method , Female , Glycated Hemoglobin/metabolism , Humans , Hyperlipidemias/blood , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Insulin/blood , Lipids/blood , Male , Middle Aged , Pioglitazone , Thiazoles/administration & dosage , Thiazoles/adverse effects , Treatment Outcome
18.
Arch. venez. farmacol. ter ; 10(1): 12-5, 1991. tab
Article in Spanish | LILACS | ID: lil-159535

ABSTRACT

Se evaluó la eficacia y la tolerancia del Florestor (Saccharomyces boulardii, dosis diaria oral 400 mg) en el síndrome de diarrea aguda, mediante un estudio clínico abierto y multicéntrico, donde se incluyeron 230 niños con edades comprendidas entre 3 meses y 5 años. La evaluación del total diario de puntos antes y después de tratamiento con Florestor mostró una diferencia estadísticamente significante (p<0,001). Esta cuantificación de la eficacia reflejó indirectamente porcentajes de curación de 91,7 por ciento a los tres días de tratamiento. Al tercer día de tratamiento, la eficacia clínica fue considerada como muy eficaz o eficaz en un 99,1 por ciento del total de pacientes. En un 96 por ciento del universo de los 230 pacientes, la tolerancia fue expresada como excelente o buena. Se concluye que florestor es un producto seguro y eficaz para el tratamiento de la diarrea aguda, no complicada, asociado a la rehidratación oral en niños ambulatorios con edades entre 3 meses y 5 años


Subject(s)
Infant , Child, Preschool , Humans , Male , Female , Diarrhea/therapy , Multicenter Studies as Topic/statistics & numerical data , Saccharomyces/therapeutic use
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