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1.
Int J Clin Pract ; : e13485, 2020 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-32003099

RESUMO

BACKGROUND: Associations of fear of hypoglycemia with prescription of second-line insulin secretagogues (IS) or insulin and subsequent glycemic control in patients with type 2 diabetes were analysed using data from the DISCOVER study-a large, prospective, observational study. METHODS: Patients with type 2 diabetes initiating a second-line treatment after a first-line oral therapy were enrolled. Fear of hypoglycemia was assessed using baseline Hypoglycemia Fear Survey (HFS) worry score. Glycemic control was assessed using glycated haemoglobin (HbA1c) levels at 6-month and 1-year follow-up, and HbA1c change from baseline was analysed. To examine the association of baseline HFS worry scores with second-line use of IS or insulin, a hierarchical logistic model with country as random effect was used. RESULTS: A total of 6217 patients were analysed. The mean HFS worry score was 6.9 ± 11.4, while patients in the upper quartile had an HFS worry score ≥9. We divided patients into three groups according to their baseline HFS worry score (0, 1-8, ≥9). HFS worry score was associated with the use of first-line IS, but not the second-line treatment. Compared to treatments with no IS and insulin, a better HbA1c response to second-line IS or insulin was noted in patients with a baseline HFS worry score of 0 or 1-8, but not in patients with a baseline HFS worry score ≥9. CONCLUSION: HFS worry score was associated with the use of first-line IS and glycemic response to second-line IS or insulin in patients with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02322762. Registered 23 December 2014.

2.
Diabetes Obes Metab ; 22(1): 66-78, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31468637

RESUMO

AIM: To assess glycaemic control and factors associated with poor glycaemic control at initiation of second-line therapy in the DISCOVER programme. MATERIALS AND METHODS: DISCOVER (NCT02322762 and NCT02226822) comprises two similar prospective observational studies of 15 992 people with type 2 diabetes (T2D) initiating second-line glucose-lowering therapy in 38 countries across six regions (Africa, Americas, South-East Asia, Eastern Mediterranean, Europe and Western Pacific). Data were collected using a standardized case report form. Glycated haemoglobin (HbA1c) levels were measured according to standard clinical practice in each country, and factors associated with poor glycaemic control (HbA1c >8.0%) were evaluated using hierarchical regression models. RESULTS: HbA1c levels were available for 80.9% of patients (across-region range [ARR] 57.5%-97.5%); 92.2% (ARR 59.2%-99.1%) of patients had either HbA1c or fasting plasma glucose levels available. The mean HbA1c was 8.3% (ARR 7.9%-8.7%). In total, 26.7% of patients had an HbA1c level ≥9.0%, with the highest proportions in South-East Asia (35.6%). Factors associated with having HbA1c >8.0% at initiation of second-line therapy included low education level, low country income, and longer time since T2D diagnosis. CONCLUSIONS: The poor levels of glycaemic control at initiation of second-line therapy suggest that intensification of glucose-lowering treatment is delayed in many patients with T2D. In some countries, HbA1c levels are not routinely measured. These findings highlight an urgent need for interventions to improve monitoring and management of glycaemic control worldwide, particularly in lower-middle- and upper-middle-income countries.

3.
Circulation ; 140(18): 1463-1476, 2019 10 29.
Artigo em Inglês | MEDLINE | ID: mdl-31524498

RESUMO

BACKGROUND: Outcome trials in patients with type 2 diabetes mellitus have demonstrated reduced hospitalizations for heart failure (HF) with sodium-glucose co-transporter-2 inhibitors. However, few of these patients had HF, and those that did were not well-characterized. Thus, the effects of sodium-glucose co-transporter-2 inhibitors in patients with established HF with reduced ejection fraction, including those with and without type 2 diabetes mellitus, remain unknown. METHODS: DEFINE-HF (Dapagliflozin Effects on Biomarkers, Symptoms and Functional Status in Patients with HF with Reduced Ejection Fraction) was an investigator-initiated, multi-center, randomized controlled trial of HF patients with left ventricular ejection fraction ≤40%, New York Heart Association (NYHA) class II-III, estimated glomerular filtration rate ≥30 mL/min/1.73m2, and elevated natriuretic peptides. In total, 263 patients were randomized to dapagliflozin 10 mg daily or placebo for 12 weeks. Dual primary outcomes were (1) mean NT-proBNP (N-terminal pro b-type natriuretic peptide) and (2) proportion of patients with ≥5-point increase in HF disease-specific health status on the Kansas City Cardiomyopathy Questionnaire overall summary score, or a ≥20% decrease in NT-proBNP. RESULTS: Patient characteristics reflected stable, chronic HF with reduced ejection fraction with high use of optimal medical therapy. There was no significant difference in average 6- and 12-week adjusted NT-proBNP with dapagliflozin versus placebo (1133 pg/dL (95% CI 1036-1238) vs 1191 pg/dL (95% CI 1089-1304), P=0.43). For the second dual-primary outcome of a meaningful improvement in Kansas City Cardiomyopathy Questionnaire overall summary score or NT-proBNP, 61.5% of dapagliflozin-treated patients met this end point versus 50.4% with placebo (adjusted OR 1.8, 95% CI 1.03-3.06, nominal P=0.039). This was attributable to both higher proportions of patients with ≥5-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary score (42.9 vs 32.5%, adjusted OR 1.73, 95% CI 0.98-3.05), and ≥20% reduction in NT-proBNP (44.0 vs 29.4%, adjusted OR 1.9, 95% CI 1.1-3.3) by 12 weeks. Results were consistent among patients with or without type 2 diabetes mellitus, and other prespecified subgroups (all P values for interaction=NS). CONCLUSIONS: In patients with heart failure and reduced ejection fraction, use of dapagliflozin over 12 weeks did not affect mean NT-proBNP but increased the proportion of patients experiencing clinically meaningful improvements in HF-related health status or natriuretic peptides. Benefits of dapagliflozin on clinically meaningful HF measures appear to extend to patients without type 2 diabetes mellitus. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02653482.

4.
Diabetes Obes Metab ; 21(11): 2474-2485, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31297947

RESUMO

AIM: To evaluate treatment data from DISCOVER (NCT02322762 and NCT02226822), a global, prospective, observational study programme of patients with type 2 diabetes initiating a second-line glucose-lowering therapy. MATERIALS AND METHODS: Data were collected using a standardized case report form. First- and second-line treatments were assessed in 14 668 patients from 37 countries across six regions. Among patients prescribed first-line metformin monotherapy, Firth logistic regression models were used to assess factors associated with second-line treatment choices. RESULTS: The most common first-line therapies were metformin monotherapy (57.9%) and combinations of metformin with a sulphonylurea (14.6%). The most common second-line therapies were combinations of metformin with other agents (72.2%), including dipeptidyl peptidase-4 (DPP-4) inhibitors (25.1%) or sulphonylureas (21.3%). Among patients prescribed first-line metformin monotherapy, the most common second-line therapies were combinations of metformin with a DPP-4 inhibitor [32.8%; across-region range (ARR): 2.4%-51.3%] or a sulphonylurea (30.0%; ARR: 18.3%-63.6%); only a few patients received combinations of metformin with sodium-glucose co-transporter-2 inhibitors (6.7%; ARR: 0.0%-10.8%) or glucagon-like peptide-1 receptor agonists (1.9%; ARR: 0.1%-4.5%). Both clinical and non-medical factors were associated with choice of second-line therapy after metformin monotherapy. CONCLUSIONS: Fewer patients than expected received metformin monotherapy at first line, and the use of newer therapies at second line was uncommon in some regions of the world. Patients' socioeconomic status was associated with treatment patterns, suggesting that therapy choices are influenced by cost and access.

5.
BMJ Open Diabetes Res Care ; 7(1): e000627, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31114700

RESUMO

Objective: To assess the eligibility of patients participating in DISCOVER (a 3-year, prospective, observational study program of 15 992 patients with type 2 diabetes [T2D] initiating a second-line glucose-lowering therapy across 38 countries) for four cardiovascular outcomes trials (CVOTs) of sodium-glucose cotransporter 2 inhibitors (CANagliflozin cardioVascular Assessment Study [CANVAS], Dapagliflozin effect on CardiovascuLAR Events trial [DECLARE-TIMI 58], EMPAgliflozin cardiovascular OUTCOME event trial [EMPA-REG OUTCOME], and eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial [VERTIS-CV]). Research design and methods: In this cross-sectional analysis, baseline characteristics of DISCOVER patients were compared with the inclusion and exclusion criteria of the CVOTs to assess patient eligibility, overall and in four regions (Asia-Pacific, Europe, Latin America, and Middle East and Africa). Results: Overall, 11 385 patients (71.2%) had sufficient data for the analysis; 56.1% were men. The mean age and time since T2D diagnosis were 57.4 and 5.6 years, respectively. The mean glycated hemoglobin level was 8.3%. DISCOVER patients were younger, and fewer had a history of cardiovascular disease, than those enrolled in the CVOTs. Eligibility varied across the CVOTs; the proportion of eligible DISCOVER patients was highest for DECLARE-TIMI 58 (40.5%), followed by CANVAS (19.9%), VERTIS-CV (7.2%), and EMPA-REG OUTCOME (7.1%); 54.6% of patients were not eligible for any CVOT. Eligibility for each CVOT varied across regions, which was explained by the differing proportions of patients with established cardiovascular disease. Conclusions: In a large, international population of patients with T2D initiating a second-line glucose-lowering therapy, DECLARE-TIMI 58 was the most inclusive CVOT, suggesting that its study population will be more representative of patients encountered in routine clinical practice than those of CANVAS, EMPA-REG OUTCOME, and VERTIS-CV.

6.
Circ Heart Fail ; 12(6): e005855, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31129998

RESUMO

Background Thiazolidinediones (rosiglitazone, pioglitazone) are oral insulin-sensitizing medications used in type 2 diabetes mellitus that reduce glucose with minimal risk of hypoglycemia and potential benefits on atherosclerosis. However, thiazolidinediones can cause fluid retention thereby increasing the risk of heart failure-a common complication of type 2 diabetes mellitus. Methods and Results Data were analyzed from the Diabetes Collaborative Registry, a US outpatient registry of patients with type 2 diabetes mellitus that currently encompasses 203 cardiology, endocrinology, and primary care practices and 3074 providers. Among 424 061 US adults enrolled in Diabetes Collaborative Registry who had type 2 diabetes mellitus and were taking ≥1 glucose-lowering medication, 35 018 patients (8.3%) were on a thiazolidinedione, which has remained stable over time. Patients on thiazolidinediones tended to be old (mean age, 69.2±10.7 years), 61.9% had coronary disease, and 17.2% had class 3 obesity. In total, 40.3% of patients on a thiazolidinedione had either a clinical diagnosis of heart failure (23.7%), had an ejection fraction of <40% (7.7%), or were on a loop diuretic (29.9%). Conclusions Although thiazolidinediones lost significant market share after 2007 when concerns arose regarding their safety, thiazolidinediones are still commonly used. At least a quarter, and up to two-fifths, of patients currently treated with thiazolidinediones have some evidence of heart failure and therefore should not be candidates for this therapy. Accordingly, heart failure concerns with thiazolidinediones may be under-recognized.

7.
Diabetes Obes Metab ; 21(8): 1985-1989, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30968543

RESUMO

Generalizability of findings from cardiovascular outcomes trials (CVOTs) to patients with type 2 diabetes (T2D) in clinical practice is unknown. We assessed the proportions of patients in the Diabetes Collaborative Registry who would have met enrolment criteria for pivotal CVOTs of sodium-glucose co-transporter-2 inhibitors (SGLT-2is): EMPA-REG OUTCOME, CANVAS, DECLARE and VERTIS CV. In 172 643 patients, mean [standard deviation (SD)] age and HbA1c were 68.1 (11.8) years and 7.8% (2.2), respectively; 56.8% of patients were men and SGLT-2i use was 4.4%. Atherosclerotic cardiovascular disease (ASCVD) prevalence was 64.3% and mean 10-year ASCVD risk was 28.6% in patients without ASCVD. Proportions of patients eligible for CVOTs ranged from 26% (EMPA-REG OUTCOME) to 44% (DECLARE); 48% of patients were ineligible for all CVOTs. Mean (SD) ASCVD risk was 25.4% (22.6), 32.1% (20.6) and 37.7% (19.4) in patients eligible for no, one or two CVOTs, respectively. SGLT-2i use was low in patients eligible for no CVOTs (3.5%) and at least one CVOT (5.2%). In conclusion, applicability of CVOT results to patients with T2D in clinical practice varies based on trial eligibility criteria.

8.
Diabetes Res Clin Pract ; 151: 20-32, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30904743

RESUMO

AIMS: To describe the characteristics and treatment of patients with type 2 diabetes mellitus initiating a second-line glucose-lowering therapy in the global DISCOVER study programme. METHODS: DISCOVER comprises two similar 3-year prospective observational studies (NCT02322762 and NCT02226822), involving 15,992 patients initiating a second-line glucose-lowering therapy in 38 countries across six regions (Africa, Americas, South-East Asia, Eastern Mediterranean, Europe and Western Pacific). RESULTS: Overall, 54.2% of patients were male (across region range [ARR]: 37.7-58.6%). At baseline, mean age and time since diagnosis of type 2 diabetes mellitus were 57.2 (ARR: 53.1-61.9)and 5.6 (ARR: 4.6-6.9) years, respectively. Median glycated haemoglobin (HbA1c) was 63.9 mmol/mol (8.0%; ARR: 7.6-8.3%). Microvascular and macrovascular complications were reported in 18.9% (ARR: 14.5-23.5%) and 12.7% (ARR: 5.0-26.6%) of patients, respectively. First-line treatments were mostly metformin monotherapy (55.6%; ARR: 42.5-83.6%) and combinations of metformin with a sulfonylurea (14.4%; ARR: 5.8-31.1%). The most commonly prescribed second-line therapies were combinations of metformin with a dipeptidyl peptidase-4 inhibitor (23.5%; ARR: 2.2-29.6%) or a sulfonylurea (20.9%; ARR: 13.6-57.1%). CONCLUSIONS: DISCOVER demonstrates considerable global variation in the treatment of type 2 diabetes mellitus, and a need for more aggressive risk factor control.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Saúde Global , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
9.
J Am Heart Assoc ; 8(3): e010855, 2019 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-30691334

RESUMO

Background Although admission heart rate predicts higher mortality after acute myocardial infarction ( AMI ), less is known about discharge heart rate. We tested the hypothesis that higher discharge heart rate after AMI is related to increased long-term mortality independent of admission heart rate, and assessed whether ß blockers modify this relationship. Methods and Results In 2 prospective US multicenter registries of AMI , we evaluated the associations of discharge and admission heart rate with 3-year mortality using Cox models. Among 6576 patients with AMI , discharge heart rate was modestly associated with initial heart rate ( r=0.28), comorbidities, and infarct severity. In this cohort, 10.7% did not receive ß blockers at discharge. After full adjustment for demographic, psychosocial, and clinical covariates, discharge heart rate (hazard ratio [HR]=1.14 per 10 beats per minute [bpm]; 95% CI =1.07-1.21 per 10 bpm) was more strongly associated with risk of death than admission heart rate (HR=1.05 per 10 bpm; 95% CI=1.02-1.09 per 10 bpm) when both were entered in the same model ( P=0.043 for comparison). There was a significant interaction between discharge heart rate and ß-blocker use ( P=0.004) on mortality, wherein risk of death was markedly higher among those with high discharge heart rate and not on ß blockers (HR=1.35 per 10 bpm; 95% CI=1.19-1.53 per 10 bpm) versus those with a high discharge heart rate and on ß blockers at discharge (HR=1.10 per 10 bpm; 95% CI=1.03-1.17 per 10 bpm). Conclusions Higher discharge heart rate after AMI was more strongly associated with 3-year mortality than admission heart rate, and the risk associated with higher discharge heart rate was modified by ß blockers at discharge. These findings highlight opportunities for risk stratification and intervention that will require further investigation.


Assuntos
Frequência Cardíaca/fisiologia , Infarto do Miocárdio/mortalidade , Alta do Paciente/tendências , Sistema de Registros , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Estados Unidos/epidemiologia
10.
Diabetes Obes Metab ; 21(2): 261-266, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30136348

RESUMO

AIMS: To compare the management of patients with diabetes and heart failure with reduced ejection fraction (HFrEF) in the United States and Asia to understand variations in treatment patterns across different healthcare systems. MATERIALS AND METHODS: Our cohort included patients with diabetes and HFrEF (ejection fraction <40%) from a US-based registry of adults with diabetes (2013-2016, electronic health records) and a multi-national Asian registry of adults with heart failure (2010-2016, prospective registry). Asian countries were categorized as high income (HI) or low income (LI), according to the United Nations classification. Rates of use of guideline-directed medical therapies (determined through review of active medication lists) were compared across regions. RESULTS: Patients with diabetes and HFrEF in the United States (n = 28 877) were older, had higher body mass indices, and were more likely to have coronary disease than those in Asia (n = 2235). Compared with US patients, the use of guideline-directed medical therapy for HFrEF was lower in patients in LI Asian countries (angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers: patients in the United States, 77% vs. patients in HI Asian countries, 76% vs patients in LI Asian countries, 69%; ß-blockers: patients in the United States, 91% vs. patients in HI Asian countries, 87% vs. patients in LI Asian countries, 69%; P < 0.001 for both). Insulin was used more commonly in the United States (44% vs. 24% vs. 25%, respectively; P < 0.001), whereas sulphonylureas were more often prescribed in Asian countries (42% vs. 52% vs. 54%; respectively, P < 0.001). Thiazolidinediones were prescribed in 6% of US patients compared with <1% of patients in Asia. The use of newer diabetes medications was <5% in all. CONCLUSION: In both the United States and Asia, opportunities for improvement in the use of evidence-based therapies exist for patients with both diabetes and HFrEF. Effective tools to guide medication choices for these complex, high-risk patients could have substantial impact on quality and outcomes.


Assuntos
Diabetes Mellitus/terapia , Angiopatias Diabéticas/terapia , Insuficiência Cardíaca/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Ásia/epidemiologia , Estudos de Coortes , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/fisiopatologia , Angiopatias Diabéticas/epidemiologia , Angiopatias Diabéticas/fisiopatologia , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Volume Sistólico/fisiologia , Estados Unidos/epidemiologia
11.
Diabetes Obes Metab ; 21(2): 393-396, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30136353

RESUMO

The 1245.29 Trial recently showed that empaglifozin improved both blood pressure and glucose control in African American (AA) patients with type 2 diabetes (T2D) and hypertension. Using the Diabetes Collaborative Registry, a large-scale US registry of outpatients with diabetes recruited from primary care, cardiology and endocrinology practices, we sought to understand the potential impact of these observations in routine clinical practice. Among 74 290 AA patients with T2D from 368 US clinics, 60.4% had hypertension, of whom 34.5% had systolic blood pressure ≥ 140 mm Hg (20.8% of the total AA T2D population). Only 1.7% of this eligible population had been prescribed a sodium-glucose co-transporter two inhibitor. The mean estimated 5-year risk of cardiovascular death was 7.7%, which could be reduced to 6.2% when modelling the antihypertensive effect of empagliflozin across the eligible population (based on an 8-mm Hg blood pressure reduction). These findings may represent a potential opportunity for better management of cardiovascular risk factors and improved outcomes in this vulnerable cohort.


Assuntos
Afro-Americanos , Compostos Benzidrílicos/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucosídeos/uso terapêutico , Hipertensão/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Afro-Americanos/estatística & dados numéricos , Idoso , Pressão Sanguínea/efeitos dos fármacos , Determinação da Pressão Arterial , Complicações do Diabetes/tratamento farmacológico , Complicações do Diabetes/etnologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/fisiopatologia , Feminino , Humanos , Hipertensão/complicações , Hipertensão/etnologia , Colaboração Intersetorial , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Pesquisa Médica Translacional , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
Cardiovasc Diabetol ; 17(1): 150, 2018 11 28.
Artigo em Inglês | MEDLINE | ID: mdl-30486889

RESUMO

BACKGROUND: The global prevalence of type 2 diabetes-related complications is not well described. We assessed prevalence of vascular complications at baseline in DISCOVER (NCT02322762; NCT02226822), a global, prospective, observational study program of 15,992 patients with type 2 diabetes initiating second-line therapy, conducted across 38 countries. METHODS: Patients were recruited from primary and specialist healthcare settings. Data were collected using a standardized case report form. Prevalence estimates of microvascular and macrovascular complications at baseline were assessed overall and by country and region, and were standardized for age and sex. Modified Poisson regression was used to assess factors associated with the prevalence of complications. RESULTS: The median duration of type 2 diabetes was 4.1 years (interquartile range [IQR]: 1.9-7.9 years), and the median glycated hemoglobin (HbA1c) level was 8.0% (IQR: 7.2-9.1%). The crude prevalences of microvascular and macrovascular complications were 18.8% and 12.7%, respectively. Common microvascular complications were peripheral neuropathy (7.7%), chronic kidney disease (5.0%), and albuminuria (4.3%). Common macrovascular complications were coronary artery disease (8.2%), heart failure (3.3%) and stroke (2.2%). The age- and sex-standardized prevalence of microvascular complications was 17.9% (95% confidence interval [CI] 17.3-18.6%), ranging from 14.2% in the Americas to 20.4% in Europe. The age- and sex-standardized prevalence of macrovascular complications was 9.2% (95% CI 8.7-9.7%), ranging from 4.1% in South-East Asia to 18.8% in Europe. Factors positively associated with vascular complications included age (per 10-year increment), male sex, diabetes duration (per 1-year increment), and history of hypoglycemia, with rate ratios (95% CIs) for microvascular complications of 1.14 (1.09-1.19), 1.30 (1.20-1.42), 1.03 (1.02-1.04) and 1.45 (1.25-1.69), respectively, and for macrovascular complications of 1.41 (1.34-1.48), 1.29 (1.16-1.45), 1.02 (1.01-1.02) and 1.24 (1.04-1.48), respectively. HbA1c levels (per 1.0% increment) were positively associated with microvascular (1.05 [1.02-1.08]) but not macrovascular (1.00 [0.97-1.04]) complications. CONCLUSIONS: The global burden of microvascular and macrovascular complications is substantial in these patients with type 2 diabetes who are relatively early in the disease process. These findings highlight an opportunity for aggressive early risk factor modification, particularly in regions with a high prevalence of complications. Trial registration ClinicalTrials.gov; NCT02322762. Registered 23 December 2014. https://clinicaltrials.gov/ct2/show/NCT02322762 . ClinicalTrials.gov; NCT02226822. Registered 27 August 2014. https://clinicaltrials.gov/ct2/show/NCT02226822.


Assuntos
Diabetes Mellitus Tipo 2/epidemiologia , Angiopatias Diabéticas/epidemiologia , Adulto , Distribuição por Idade , Idoso , Biomarcadores/sangue , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Angiopatias Diabéticas/sangue , Angiopatias Diabéticas/diagnóstico , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Estudos Prospectivos , Fatores de Risco , Distribuição por Sexo , Fatores de Tempo
13.
J Diabetes Complications ; 32(11): 1035-1039, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30177468

RESUMO

BACKGROUND: Although practice guidelines stress individualization of glucose management in patients with type 2 diabetes (T2D), the extent to which providers take patient factors into account when selecting medications is not well known. METHODS: Diabetes Collaborative Registry (DCR) is an outpatient diabetes registry including primary care, cardiology, and endocrinology practices. T2D medications were grouped as those which may be suboptimal for key patient subgroups, and we examined patient factors associated with use of these agents using hierarchical, multivariable Poisson models. RESULTS: In DCR, 157,551 patients from 374 US practices were prescribed a glucose-lowering medication. Patients with morbid obesity were more likely treated with medications prone to cause weight gain (relative rate [RR] 1.09, 95% CI 1.07-1.11). Older patients were more likely to be treated with medications with increased risk of hypoglycemia (RR 1.04 per 5 years, 95% CI 1.04-1.05). Patients with CKD 4/5 were less likely to be treated with agents with known risk in patients with advanced CKD (RR 0.74, 95% CI 0.71-0.77). Patients with coronary artery disease were no more or less likely to be treated with medications with potential cardiovascular safety issues (RR 0.99, 95% CI 0.96-1.01). CONCLUSIONS: We observed some targeted use of glucose-lowering therapies in certain subgroups but also identified potential opportunities for better personalization of treatment. Data sources such as the DCR can highlight potential areas for improving targeted approaches to pharmacologic therapy in order to optimize selection of patients most likely to benefit (and least likely to be harmed) from treatments.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Uso de Medicamentos , Hipoglicemiantes/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Medicina de Precisão/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Comportamento Cooperativo , Diabetes Mellitus Tipo 2/epidemiologia , Uso de Medicamentos/normas , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/normas , Medicina de Precisão/métodos , Melhoria de Qualidade , Sistema de Registros , Estados Unidos/epidemiologia
14.
Am Heart J ; 203: 25-29, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30015065

RESUMO

BACKGROUND: Optimal glucose-lowering strategies in patients with both heart failure (HF) and type 2 diabetes mellitus (T2D) are not well defined, particularly as novel medication classes emerge.We sought to evaluate current patterns of glucose-lowering medication use in adults with T2D with and without HF. METHODS: The DCR is a US-based outpatient registry of adults with diabetes; currently includes 3074 providers in 203 practices. We used hierarchical, modified Poisson regression models to examine the relationship between concomitant HF with use of each glucose-lowering medication class, adjusting for other factors that could impact selection of one medication class over another: age, chronic kidney disease (CKD), coronary artery disease (CAD), number of glucose-lowering medications, and insurance. RESULTS: Among 456,106 adults with T2D, 125,161 (27%) had a diagnosis of HF (30% HFrEF, 15%HFmrEF, 55% HFpEF). Patients with T2D and HF were more likely to be older and male, and to have CAD, atrial fibrillation, and CKD. In the multivariable models, HF was associated with a greater use of insulin (RR 1.39, 95% CI 1.36-1.42) and lower use of thiazolidinediones (RR 0.79, 95% CI 0.74-0.83), SGLT2 inhibitors (RR 0.83, 95% CI 0.79-0.89), and metformin (RR 0.84, 95% CI 0.82-0.86). Among the subgroup of patients with HF, thiazolidinediones, GLP-1 receptor agonists, and SGLT2 inhibitors were used even less often in patients with lower ejection fraction, indicating that both the diagnosis of clinical HF and ejection fraction may influence the choice of glucose-lowering medications. CONCLUSION: In a large US-based outpatient registry, we found that a quarter of adults with T2D had a diagnosis of HF, which was predominantly HFpEF. Although certain T2D medication use in patients with HF appeared consistent with evidence (less use of thiazolidinediones), others appeared contrary to evidence (less use of metformin and SGLT2 inhibitors).


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insuficiência Cardíaca/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Sistema de Registros , Idoso , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Feminino , Seguimentos , Insuficiência Cardíaca/sangue , Insuficiência Cardíaca/complicações , Humanos , Masculino , Pacientes Ambulatoriais/estatística & dados numéricos , Estudos Retrospectivos , Resultado do Tratamento
15.
BMC Cardiovasc Disord ; 18(1): 80, 2018 05 03.
Artigo em Inglês | MEDLINE | ID: mdl-29724164

RESUMO

BACKGROUND: Due to a relative lack of outpatient heart failure (HF) clinical registries, we aimed to describe symptoms, signs, and medication treatment among ambulatory patients with heart failure (HF) over time. METHODS: Using health records from 234 PINNACLE (Practice Innovation and Clinical Excellence) U.S. cardiology practices (2008-2014), serial visits for patients with HF were characterized. Symptoms, signs, and HF medications (angiotensin-converting enzyme inhibitors [ACEI], angiotensin receptor blockers [ARB], beta blockers [BB], and diuretics) were compared between visits. RESULTS: Among 763,331 patients with HF, 550,581 had ≥2 clinic visits < 1 year apart, with 2,998,444 visit pairs. In the 12 months following an index visit, patients had a mean of 2.5 ± 2.3 additional visits. Recorded index visit symptoms ranged from dyspnea (53.6%) to orthopnea (23.1%); signs ranged from peripheral edema (52.2%) to hepatomegaly (0.6%). Of those with ejection fraction < 40%, ACEI was prescribed in 58.6%, ARB in 18.5%, BB in 85.2%, and diuretics in 70.0%. Between-visit recorded changes were infrequent: dyspnea appeared in 3.8%, resolved in 2.7%; NYHA class increased in 2.9%, decreased in 2.9%; number of signs increased in 6.0%, decreased in 5.1%; ACEI/ARB or BB added in 6.4%, removed in 6.2%; diuretic added in 3.7%, removed in 3.8%. Changes in recorded symptoms were rarely associated with initiation or discontinuation in HF medication classes. CONCLUSIONS: Ambulatory HF care in U.S. cardiology practices seldom recorded changes in symptoms, signs, and medication class. Although templated medical records and absence of medication dosing likely underestimated the degree to which clinical changes occur over serial visits for HF, these PINNACLE data suggest opportunities for greater symptom-based and therapy-focused visits.


Assuntos
Assistência Ambulatorial , Cardiologia , Fármacos Cardiovasculares/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Estudos Transversais , Diuréticos/uso terapêutico , Substituição de Medicamentos , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Registros Médicos , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Sistema de Registros , Volume Sistólico/efeitos dos fármacos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Função Ventricular Esquerda/efeitos dos fármacos
16.
Resuscitation ; 123: 58-64, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29102470

RESUMO

BACKGROUND: Although rates of survival to hospital discharge after in-hospital cardiac arrest (IHCA) have improved over the last decade, it is unknown if these survival gains are sustained after hospital discharge. OBJECTIVE: To examine 1-year survival trends overall and by rhythm after IHCA. METHODS: Using Medicare beneficiaries (age≥65years) with IHCA occurring between 2000 and 2011 at Get With The Guidelines®-Resuscitation Registry participating hospitals we used multivariable regression, to examine temporal trends in risk-adjusted rates of 1-year survival. RESULTS: Among 45,567 patients with IHCA, the unadjusted 1-year survival was 9.4%. Unadjusted 1-year survival was 21.8% among the 9,223 (20.2%) of patients with Ventricular Fibrillation or Pulseless Ventricular Tachycardia (VF/VT) and 6.2% among the 36,344 (79.8%) of patients with Pulseless Electrical Activity or asystole (PEA/asystole). After adjustment for patient and arrest characteristics, 1-year survival increased over time for all IHCA from 8.9% in 2000-2001 to 15.2% in 2011 (adjusted rate ratio [RR] per year, 1.05; 95% CI, 1.03-1.06; P<0.001 for trend). Improvements in 1-year risk adjusted survival were also observed for VF/VT (19.4% in 2000-2001 to 25.6% in 2011 [RR per year, 1.02; 95% CI, 1.01-1.04; P 0.004 for trend]) and PEA/asystole arrests (4.7% in 2000-2001 to 10.2% in 2011 [RR per year, 1.07; 95% CI, 1.05-1.08; P<0.001 for trend]). CONCLUSION: Among Medicare beneficiaries in the GWTG-Resuscitation registry, 1-year survival after IHCA has increased for over the past decade. Temporal improvements in survival were noted for both shockable and non-shockable presenting arrest rhythms.


Assuntos
Parada Cardíaca/mortalidade , Idoso , Reanimação Cardiopulmonar/mortalidade , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Medicare , Alta do Paciente/estatística & dados numéricos , Estudos Prospectivos , Sistema de Registros , Risco Ajustado , Análise de Sobrevida , Fatores de Tempo , Estados Unidos/epidemiologia
17.
J Cardiovasc Nurs ; 33(3): 255-260, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-28816774

RESUMO

BACKGROUND: Some studies suggest that female practitioners are more likely to provide guideline-concordant care than male practitioners; however, little is known about the role of practitioner gender in cardiology. OBJECTIVE: The aim of the study was to measure the association between practitioner gender and adherence to the cardiovascular performance measures in the American College of Cardiology's ambulatory Practice Innovation and Clinical Excellence Registry. METHODS: Patients with at least 1 outpatient visit with a unique practitioner were included. Among eligible patients, adherence to 7 guideline-supported performance measures for coronary artery disease, heart failure, and atrial fibrillation over 12 months after registry entry was compared by practitioner gender using hierarchical models adjusting for practitioner type (physicians vs advance practice practitioners) and number of visits. RESULTS: The study cohort included 1493 individual practitioners who saw 769 139 patients; 80% of practitioners were men. Male practitioners were more often physicians compared with female practitioners (98.2% vs 43.7%, P < .01). Accounting for practitioner category and visit frequency, guideline adherence rates were similar by practitioner gender for all measures with the exception of marginally higher rates for coronary artery disease performance measures for male practitioners compared with female practitioners (antiplatelet: rate ratio [RR] = 1.06; 95% confidence interval [CI], 1.03-1.09; ß-blockers: RR = 1.06; 95% CI, 1.01-1.10; and lipid-lowering drug: RR = 1.07; 95% CI, 1.04-1.10) and atrial fibrillation (oral anticoagulants: RR = 1.05; 95% CI, 1.01-1.09). CONCLUSION: Male practitioners marginally outperformed their female counterparts in ambulatory practices enrolled in a voluntary cardiovascular performance improvement registry program. Overall low adherence to some performance measures suggests room for improvement among all practitioners.


Assuntos
Assistência Ambulatorial , Cardiologia/normas , Fidelidade a Diretrizes , Guias de Prática Clínica como Assunto , Qualidade da Assistência à Saúde , Antagonistas Adrenérgicos beta/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Auditoria Clínica , Doença da Artéria Coronariana/tratamento farmacológico , Feminino , Pessoal de Saúde , Humanos , Masculino , Sistema de Registros , Fatores Sexuais , Estados Unidos
18.
Artigo em Inglês | MEDLINE | ID: mdl-29237746

RESUMO

BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.


Assuntos
Nível de Saúde , Insuficiência Cardíaca/terapia , Autocuidado , Telemedicina/métodos , Idoso , Distribuição de Qui-Quadrado , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/psicologia , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Comportamento Social , Inquéritos e Questionários , Telefone , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
19.
Medicine (Baltimore) ; 96(44): e8401, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29095269

RESUMO

The purpose of the study is to evaluate the feasibility of blood oxygenation level-dependent MRI (BOLD-MRI) to early detect the femoral head osteonecrosis (FHON). One hundred twelve patients were recruited who had received steroid treatment. The normal control group included 10 volunteers with 20 hips. MRI examinations were performed in all patients following up at 1, 4 to 5, 7 to 8, and 12 to 13 months after steroid therapy. With the section cross as the biggest lesion in coronal images, we set 6 regions of interest (ROIs) per section to analyze the morphological performance of routine MRI sequences and the differences of R2* values and their dynamic changes of BOLD-MRI between the control and the FHON group. A total of 15 hip joints were diagnosed with FHON. Seven right hips and 8 left hips were affected. In the first and second MRI examinations, the area of the lesion for both conventional MRI and BOLD-MRI R2* mapping was difficult to distinguish the lesion border. However, at the third and the fourth MRI examinations, some of the affected regions for R2* mapping were larger than those in conventional sequences for the same patient. BOLD-MRI has some significant advantages in early detecting FHON over conventional MRI techniques and it can be feasible noninvasive tool for detecting and evaluating FHON after steroid therapy.


Assuntos
Necrose da Cabeça do Fêmur/induzido quimicamente , Necrose da Cabeça do Fêmur/diagnóstico por imagem , Glucocorticoides/efeitos adversos , Imagem por Ressonância Magnética/métodos , Adolescente , Adulto , Diagnóstico Precoce , Estudos de Viabilidade , Humanos , Masculino , Pessoa de Meia-Idade , Prednisolona/efeitos adversos , Estudos Retrospectivos , Adulto Jovem
20.
J Am Heart Assoc ; 6(10)2017 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-29054844

RESUMO

BACKGROUND: Antianginal medications (AAMs) can be perceived to be less important after percutaneous coronary intervention (PCI) and may be de-escalated after revascularization. We examined the frequency of AAM de-escalation at discharge post-PCI and its association with follow-up health status. METHODS AND RESULTS: In a 10-center PCI registry, the Seattle Angina Questionnaire was assessed before and 6 months post-PCI. AAM de-escalation was defined as fewer AAMs at discharge versus admission or >25% absolute dose decrease. Of 2743 PCI patients (70% male), AAM were de-escalated, escalated, and unchanged in 299 (11%), 714 (26%), and 1730 (63%) patients, respectively. Patients whose AAM were de-escalated were more likely to report angina at 6 months, compared with unchanged or escalated AAM (34% versus 24% versus 21%; P<0.001). The association of AAM de-escalation with health status was examined using multivariable models adjusting for the predicted risk of post-PCI angina, completeness of revascularization, and the interaction of AAM de-escalation×completeness of revascularization. There was a significant interaction between AAM de-escalation and completeness of revascularization (P<0.001), suggesting that AAM de-escalation was associated with greater impairment of health status among patients with incomplete revascularization. In patients with incomplete revascularization, de-escalation of AAM at discharge was associated with 43% increased angina risk (relative risk, 1.43; 95% confidence interval, 1.26-1.63) and worse angina-related health status at 6 months post-PCI. CONCLUSIONS: De-escalation of AAM occurs in 1 in 10 patients post-PCI, and it is associated with an increased risk of angina and worse health status, particularly among those with incomplete revascularization.


Assuntos
Angina Pectoris/terapia , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Nível de Saúde , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Idoso , Angina Pectoris/diagnóstico , Angina Pectoris/fisiopatologia , Angina Instável/fisiopatologia , Angina Instável/terapia , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/fisiopatologia , Alta do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Qualidade de Vida , Sistema de Registros , Fatores de Risco , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
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