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OBJECTIVE: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). METHODS: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. RESULTS: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. CONCLUSION: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331).
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Diabetes Mellitus , Neuropatias Diabéticas , Plantas Medicinais , Humanos , Neuropatias Diabéticas/tratamento farmacológico , Banhos , Método Duplo-Cego , Extratos Vegetais/uso terapêuticoRESUMO
BACKGROUND: Diabetes is a major public health issue. Because lifetime risk, life expectancy, and years of life lost are meaningful metrics for clinical decision making, we aimed to estimate these measures for type 2 diabetes in the high-income setting. METHODS: For this multinational, population-based study, we sourced data from 24 databases for 23 jurisdictions (either whole countries or regions of a country): Australia; Austria; Canada; Denmark; Finland; France; Germany; Hong Kong; Hungary; Israel; Italy; Japan; Latvia; Lithuania; the Netherlands; Norway; Scotland; Singapore; South Korea; Spain; Taiwan; the UK; and the USA. Our main outcomes were lifetime risk of type 2 diabetes, life expectancy in people with and without type 2 diabetes, and years of life lost to type 2 diabetes. We modelled the incidence and mortality of type 2 diabetes in people with and without type 2 diabetes in sex-stratified, age-adjusted, and calendar year-adjusted Poisson models for each jurisdiction. Using incidence and mortality, we constructed life tables for people of both sexes aged 20-100 years for each jurisdiction and at two timepoints 5 years apart in the period 2005-19 where possible. Life expectancy from a given age was computed as the area under the survival curves and lifetime lost was calculated as the difference between the expected lifetime of people with versus without type 2 diabetes at a given age. Lifetime risk was calculated as the proportion of each cohort who developed type 2 diabetes between the ages of 20 years and 100 years. We estimated 95% CIs using parametric bootstrapping. FINDINGS: Across all study cohorts from the 23 jurisdictions (total person-years 1 577 234 194), there were 5 119 585 incident cases of type 2 diabetes, 4 007 064 deaths in those with type 2 diabetes, and 11 854 043 deaths in those without type 2 diabetes. The lifetime risk of type 2 diabetes ranged from 16·3% (95% CI 15·6-17·0) for Scottish women to 59·6% (58·5-60·8) for Singaporean men. Lifetime risk declined with time in 11 of the 15 jurisdictions for which two timepoints were studied. Among people with type 2 diabetes, the highest life expectancies were found for both sexes in Japan in 2017-18, where life expectancy at age 20 years was 59·2 years (95% CI 59·2-59·3) for men and 64·1 years (64·0-64·2) for women. The lowest life expectancy at age 20 years with type 2 diabetes was observed in 2013-14 in Lithuania (43·7 years [42·7-44·6]) for men and in 2010-11 in Latvia (54·2 years [53·4-54·9]) for women. Life expectancy in people with type 2 diabetes increased with time for both sexes in all jurisdictions, except for Spain and Scotland. The life expectancy gap between those with and without type 2 diabetes declined substantially in Latvia from 2010-11 to 2015-16 and in the USA from 2009-10 to 2014-15. Years of life lost to type 2 diabetes ranged from 2·5 years (Latvia; 2015-16) to 12·9 years (Israel Clalit Health Services; 2015-16) for 20-year-old men and from 3·1 years (Finland; 2011-12) to 11·2 years (Israel Clalit Health Services; 2010-11 and 2015-16) for 20-year-old women. With time, the expected number of years of life lost to type 2 diabetes decreased in some jurisdictions and increased in others. The greatest decrease in years of life lost to type 2 diabetes occurred in the USA between 2009-10 and 2014-15 for 20-year-old men (a decrease of 2·7 years). INTERPRETATION: Despite declining lifetime risk and improvements in life expectancy for those with type 2 diabetes in many high-income jurisdictions, the burden of type 2 diabetes remains substantial. Public health strategies might benefit from tailored approaches to continue to improve health outcomes for people with diabetes. FUNDING: US Centers for Disease Control and Prevention and Diabetes Australia.
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Diabetes Mellitus Tipo 2 , Masculino , Feminino , Humanos , Adulto Jovem , Adulto , Diabetes Mellitus Tipo 2/epidemiologia , Expectativa de Vida , Austrália , Renda , IncidênciaRESUMO
AIMS/HYPOTHESIS: We aimed to investigate the prevalence and incidence of depression, and the interplay of cardiometabolic comorbidities, in the differentiation of depression risk between young-onset diabetes (diagnosis at age <40 years) and usual-onset diabetes (diagnosis at age ≥40 years). METHODS: Using electronic medical records from the UK and USA, retrospective cohorts of adults with incident type 2 diabetes diagnosed between 2006 and 2017 were examined. Trends in the prevalence and incidence of depression, and risk of developing depression, in participants with young-onset type 2 diabetes compared with usual-onset type 2 diabetes were assessed separately by sex and comorbidity status. RESULTS: In total 230,932/1,143,122 people with type 2 diabetes from the UK/USA (mean age 58/60 years, proportion of men 57%/46%) were examined. The prevalence of depression in the UK/USA increased from 29% (95% CI 28, 30)/22% (95% CI 21, 23) in 2006 to 43% (95% CI 42, 44)/29% (95% CI 28, 29) in 2017, with the prevalence being similar across all age groups. A similar increasing trend was observed for incidence rates. In the UK, compared with people aged ≥50 years with or without comorbidity, 18-39-year-old men and women had 23-57% and 20-55% significantly higher risks of depression, respectively. In the USA, compared with those aged ≥60 years with or without comorbidity, 18-39-year-old men and women had 5-17% and 8-37% significantly higher risks of depression, respectively. CONCLUSIONS/INTERPRETATION: Depression risk has been increasing in people with incident type 2 diabetes in the UK and USA, particularly among those with young-onset type 2 diabetes, irrespective of other comorbidities. This suggests that proactive mental health assessment from the time of type 2 diabetes diagnosis in primary care is essential for effective clinical management of people with type 2 diabetes.
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Diabetes Mellitus Tipo 2 , Adulto , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Adolescente , Adulto Jovem , Incidência , Prevalência , Diabetes Mellitus Tipo 2/epidemiologia , Depressão/epidemiologia , Estudos Retrospectivos , Comorbidade , Reino Unido/epidemiologiaRESUMO
Objective: To evaluate the temporal trend in young adult depression, prescription patterns of first- and second-line antidepressants, and factors influencing therapy intensification for depression stratified by sex.Methods: A retrospective cohort of people aged ≥ 18 years with incident depression between 2006 and 2017 was extracted from the Centricity Electronic Medical Records.Results: Among 2,201,086 people with depression (82% on antidepressants), the mean age was 47 years, 29% were male, 40% had cardiometabolic multimorbidity, and 32% were diagnosed at age < 40 years (young adult depression). Prevalence of young adult depression increased significantly from 26% to 36% with a higher proportion in females compared to males (34% vs 26%) between 2006 and 2017. Selective serotonin reuptake inhibitors (SSRIs) were the most prescribed first-line antidepressant (56%), with a prescribing rate increase from 47 per 1,000 person-years to 81 per 1,000 person-years. Among first-line antidepressant recipients, 23% had treatment intensification after a median of 17 months. Compared to those aged 60-70 years, younger males and females had a similar significantly higher treatment intensification risk (range of hazard ratio [HR], 1.09-1.46). Cardiometabolic multimorbidity was associated with a 2% (HR CI, 1.01-1.05) and 7% (HR CI, 1.05-1.09) higher treatment intensification risk in males and females, respectively, while anxiety increased the treatment intensification risk by 63% (HR CI, 1.57-1.68) in males and 57% (HR CI, 1.52-1.62) in females. Non-Whites and SSRI initiators had lower risks of treatment intensification (all HR CI < 1).Conclusions: More than one-third of US adults with depression are aged < 40 years with an increasing trend among females. The temporal antidepressant prescribing rates were similar between sex, while significant ethnic disparity in therapy intensification was observed between sex.
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Doenças Cardiovasculares , Depressão , Adulto , Antidepressivos , Depressão/tratamento farmacológico , Depressão/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prescrições , Estudos Retrospectivos , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Evidence on therapeutic interventions and factors driving treatment intensification (TI) in people with incident depression in UK are scarce. AIMS: To explore antidepressant prescribing patterns and factors influencing TI. DESIGN: and setting: Retrospective cohort study of adults with incident depression diagnosed between 2006 and 2017 using UK primary care database. METHODS: Patterns of antidepressant prescriptions, and factors influencing TI were evaluated by sex. RESULTS: In 931,302 people with depression (90% initiating antidepressants), mean age was 39 years, 41% were male, 14% had cardiometabolic multimorbidity (CMM), and 54% were diagnosed at < 40 years. Being the most prescribed first-line antidepressant (62%), SSRI prescribing rate increased from 66 per 1000 person-years to 170 per 1000 person-years; 24% (2% dose escalation, 4% adding, 18% switching) of first-line antidepressant initiators intensified with 13 months median time to TI. Compared to 60-70 years, younger adults had significantly higher TI risk (range of hazards ratio, HR: 1.08-1.42). CMM and anxiety were associated with 15-24% and 39-49% significantly higher TI risks respectively. First-line antidepressant and deprivation status influenced TI differently by gender. CONCLUSIONS: Men and women with depression in UK have different antidepressant prescription patterns in real-world. Age at diagnosis, deprivation status and cardiometabolic multimorbidity are the major sociodemographic and non-psychiatric risk factors for therapeutic changes.
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Doenças Cardiovasculares , Depressão , Adulto , Antidepressivos/uso terapêutico , Depressão/diagnóstico , Depressão/tratamento farmacológico , Depressão/epidemiologia , Prescrições de Medicamentos , Feminino , Humanos , Masculino , Estudos Retrospectivos , Reino Unido/epidemiologiaRESUMO
OBJECTIVE: To explore risks and associated mediation effects of developing chronic kidney disease (CKD) and heart failure (HF) in young- and usual-onset type 2 diabetes (T2D) between White Americans (WAs) and African Americans (AAs). RESEARCH DESIGN AND METHODS: From U.S. medical records, 1,491,672 WAs and 31,133 AAs were identified and stratified by T2D age of onset (18-39, 40-49, 50-59, 60-70 years). Risks, mediation effects, and time to CKD and HF were evaluated, adjusting for time-varying confounders. RESULTS: In the 18-39, 40-49, 50-59, 60-70 age-groups, the hazard ratios (of developing CKD and HF in AAs versus WAs were 1.21 (95% CI 1.17-1.26) and 2.21 (1.98-2.45), 1.25 (1.22-1.28) and 1.86 (1.75-1.97), 1.21 (1.19-1.24) and 1.54 (1.48-1.60), and 1.10 (1.08-1.12) and 1.11 (1.07-1.15), respectively. In AAs and WAs aged 18-39 years, time in years to CKD (8.7 [95% CI 8.2-9.1] and 9.7 [9.2-10.2]) and HF (10.3 [9.3-11.2] and 12.1 [10.6-13.5]) were, on average, 3.6 and 4.0 and 3.1 and 4.1 years longer compared with those diagnosed at age 60-70 years. Compared with females, AA males aged <60 years had an 11-49% higher CKD risk, while WA males aged <40 years had a 23% higher and those aged ≥50 years a 7-14% lower CKD risk, respectively. The mediation effects of CKD on the HF risk difference between ethnicities across age-groups (range 54-91%) were higher compared with those of HF on CKD risk difference between ethnicities across age-groups (13-39%). CONCLUSIONS: Developing cardiorenal complications within an average of 10 years of young-onset T2DM and high mediation effects of CKD on HF call for revisiting guidelines on early diagnosis and proactive treatment strategies for effective management of cardiometabolic risk.
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Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Insuficiência Renal Crônica , Negro ou Afro-Americano , Idoso , Diabetes Mellitus Tipo 2/complicações , Etnicidade , Feminino , Insuficiência Cardíaca/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/etiologiaRESUMO
PURPOSE: Albumin and C-reactive protein (CRP) are non-specific markers of inflammation, which could affect muscle tissue during acute hospitalization. We investigated the association between albumin and CRP during acute hospitalization with functional and body composition parameters in patients admitted to geriatric rehabilitation. METHODS: The REStORing Health of Acutely Unwell AdulTs (RESORT) cohort includes geriatric rehabilitation patients assessed for change in activities of daily living (ADL, using the Katz index) during acute hospitalization, and subsequently for Katz ADL, gait speed (GS), handgrip strength (HGS) and skeletal muscle mass index (SMI) at geriatric rehabilitation admission. Albumin and CRP average (median), variation (interquartile range), and maximum or minimum were collected from serum samples, and were examined for their association with functional and body composition parameters using multivariable linear regression analysis adjusted for age, sex and length of acute hospital stay. RESULTS: 1769 Inpatients were included for analyses (mean age 82.6 years ± 8.1, 56% female). Median length of acute hospitalization was 7 [IQR 4, 13] days and median number of albumin and CRP measurements was 5 [IQR 3, 12] times. ADL declined in 89% of patients (median - 3 points, IQR - 4, - 2). Lower average albumin, higher albumin variation and lower minimum albumin were associated with larger declines in ADL and with lower ADL, GS, HGS and SMI at geriatric rehabilitation admission. Higher average and maximum CRP were associated with lower GS. CONCLUSION: Inflammation, especially lower albumin concentrations, during acute hospitalization is associated with lower physical function at geriatric rehabilitation admission.
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Proteína C-Reativa , Força da Mão , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Composição Corporal , Proteína C-Reativa/análise , Feminino , Avaliação Geriátrica , Hospitalização , Humanos , Inflamação , Masculino , Estudos ProspectivosRESUMO
AIMS: Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. MATERIALS AND METHODS: We conducted a randomized, multicenter, 2 × 2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. RESULTS: In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. CONCLUSION: In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.
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Glicemia , Hipoglicemiantes/uso terapêutico , Estilo de Vida , Pioglitazona/uso terapêutico , Estado Pré-Diabético/terapia , Adulto , Idoso , China , Feminino , Seguimentos , Teste de Tolerância a Glucose , Humanos , Masculino , Pessoa de Meia-Idade , Estado Pré-Diabético/sangue , Estado Pré-Diabético/tratamento farmacológico , Comportamento de Redução do Risco , Resultado do TratamentoRESUMO
INTRODUCTION: The aim of this study is to evaluate the temporal trends in systolic blood pressure control over 18 months after blood pressureâlowering drug initiation in the U.S. METHODS: From U.S. nationally representative electronic health records, 1,036,775 adults initiating and continuing blood pressureâlowering drugs for ≥18 months during 2006-2018 were identified (January 2021). Prevalence trends of cardiovascular disease, diabetes, and depression at blood pressureâlowering drug initiation, blood pressureâlowering drug therapy intensification over 18 months, and the adjusted probability of achieving systolic blood pressure control 6 months after baseline and sustaining the control for over 18 months were evaluated. RESULTS: At blood pressureâlowering drug initiation, the prevalence of diabetes and depression consistently increased during the study period across all age groups, particularly in those aged 18-49 years, whereas the prevalence of cardiovascular disease was stable. Adjusted probabilities of achieving sustainable systolic blood pressure control by age group were 0.62 (95% CI=0.61, 0.63) for ages 18-39 years, 0.55 (95% CI=0.55, 0.56) for ages 40-49 years, 0.50 (95% CI=0.49, 0.50) for ages 50-59 years, 0.43 (95% CI=0.42, 0.43) for ages 60-69 years, and 0.37 (95% CI=0.37, 0.38) for ages 70-80 years. Those with cardiovascular disease or cardiovascular disease and diabetes had approximately 20% lower adjusted probability of achieving systolic blood pressure control (31%/29%) than those without these conditions (52%, p<0.01). Those with depression had a 4% higher probability of systolic blood pressure control than those without the condition (49% vs 45%, p<0.01). CONCLUSIONS: In the U.S., only 30%-50% of the population are achieving sustainable blood pressure control over 18 months after blood pressureâlowering drug initiation, with no indication of improvement in control over the last decade.
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Doenças Cardiovasculares , Hipertensão , Adulto , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , PrevalênciaRESUMO
Evaluating appropriate methodologies for imputation of missing outcome data from electronic medical records (EMRs) is crucial but lacking for observational studies. Using US EMR in people with type 2 diabetes treated over 12 and 24 months with dipeptidyl peptidase 4 inhibitors (DPP-4i, n = 38,483) and glucagon-like peptide 1 receptor agonists (GLP-1RA, n = 8,977), predictors of missingness of disease biomarker (HbA1c) were explored. Robustness of multiple imputation (MI) by chained equations, two-fold MI (MI-2F) and MI with Monte Carlo Markov Chain were compared to complete case analyses for drawing inferences. Compared to younger people (age quartile Q1), those in age quartile Q3 and Q4 were less likely to have missing HbA1c by 25-32% (range of OR CI: 0.55-0.88) at 6-month follow-up and by 26-39% (range of OR CI: 0.50-0.80) at 12-month follow-up. People with HbA1c ≥ 7.5% at baseline were 12% (OR CI: 0.83, 0.93) and 14% (OR CI: 0.77, 0.97) less likely to have missing data at 6-month follow-up in the DPP-4i and GLP-1RA groups, respectively. All imputation methods provided similar HbA1c distributions during follow-up as observed with complete case analyses. The clinical inferences based on absolute change in HbA1c and by proportion of people reducing HbA1c to a clinically acceptable level (≤ 7%) were also similar between imputed data and complete case analyses. MI-2F method provided marginally smaller mean difference between observed and imputed data with relatively smaller standard error of difference, compared to other methods, while evaluating for consistency through artificial within-sample analyses. The established MI techniques can be reliably employed for missing outcome data imputations in large EMR-based relational databases, leading to efficiently designing and drawing robust clinical inferences in pharmaco-epidemiological studies. Supplementary Information: The online version contains supplementary material available at 10.1007/s41666-022-00119-w.
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OBJECTIVE: To explore possible associations of treatment with biological disease-modifying antirheumatic drugs (bDMARDs), including T-cell-based and interleukin-6 inhibition (IL-6i)-based therapies, and the risk for type 2 diabetes mellitus (T2DM) in patients with rheumatoid arthritis (RA). STUDY DESIGN, SETTING AND PARTICIPANTS: Five treatment groups were selected from a United States Electronic Medical Records database of 283 756 patients with RA (mean follow-up, 5 years): never received bDMARD (No bDMARD, n=125 337), tumour necrosis factor inhibitors (TNFi, n=34 873), IL-6i (n=1884), T-cell inhibitors (n=5935) and IL-6i+T cell inhibitor abatacept (n=1213). Probability and risk for T2DM were estimated with adjustment for relevant confounders. RESULTS: In the cohort of 169 242 patients with a mean 4.5 years of follow-up and a mean 641 200 person years of follow-up, the adjusted probability of developing T2DM was significantly lower in the IL-6i (probability, 1%; 95% CI 0.6 to 2.0), T-cell inhibitor (probability, 3%; 95% CI 2.3 to 3.3) and IL-6i+T cell inhibitor (probability, 2%; 95% CI 0.1 to 2.9) groups than in the No bDMARD (probability, 5%; 95% CI 4.6 to 4.9) and TNFi (probability, 4%; 95% CI 3.7 to 4.7) groups. Compared with No bDMARD, the IL-6i and IL-6i+T cell inhibitor groups had 37% (95% CI of HR 0.42 to 0.96) and 34% (95% CI of HR 0.46 to 0.93) significantly lower risk for T2DM, respectively; there was no significant difference in risk in the TNFi (HR 0.99; 95% CI 0.93 to 1.06) and T-cell inhibitor (HR 0.96; 95% CI 0.82 to 1.12) groups. CONCLUSIONS: Treatment with IL-6i, with or without T-cell inhibitors, was associated with reduced risk for T2DM compared with TNFi or No bDMARDs; a less pronounced association was observed for the T-cell inhibitor abatacept.
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Antirreumáticos , Artrite Reumatoide , Diabetes Mellitus Tipo 2 , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Estudos de Coortes , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Estudos Retrospectivos , Fator de Necrose Tumoral alfa , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: To investigate trends in the prevalence of hypertension and dyslipidaemia in incident type 2 diabetes (T2DM), time to antihypertensive (AHT) and lipid-lowering therapy (LLT), and the association with systolic blood pressure (SBP) and lipid control. RESEARCH DESIGN AND METHODS: Using The Health Improvement Network UK primary care database, 254 925 people with incident T2DM and existing dyslipidaemia or hypertension were identified. Among those without atherosclerotic cardiovascular disease (ASCVD) history and not on AHT or LLT at diagnosis, the adjusted median months to initiating an AHT or an LLT, and the probabilities of high SBP or lipid levels over 2 years in people initiating therapy within or after 1 year were evaluated according to high and low ASCVD risk status. RESULTS: At diabetes diagnosis, 66% and 66% had dyslipidaemia and hypertension, respectively. During 2005 to 2016, dyslipidaemia prevalence increased by 10% in people aged <60 years, while hypertension prevalence remained stable in all age groups. Among those with high ASCVD risk status in the age groups 18 to 39, 40 to 49, and 50 to 59 years, the median number of months to initiation of therapy were 20.4 (95% confidence interval [CI] 20.3-20.5), 10.9 (95% CI 10.8-11.0), and 9.5 (95% CI 9.4-9.6) in the dyslipidaemia subcohort, and 28.1 (95% CI 28.0-28.2), 19.2 (95% CI 19.1-19.3), and 19.9 (95% CI 19.8-20.0) in the hypertension subcohort. Among people with high and low ASCVD risk status, respectively, compared to early LLT initiators, those who initiated LLT after 1 year had a 65.3% to 85.3% and a 65.0% to 85.3% significantly higher probability of failing lipid control at 2 years of follow-up, while late AHT initiators had a 46.5% to 57.9% and a 40.0% to 58.7% significantly higher probability of failing SBP control. CONCLUSIONS: Significant delay in initiating cardioprotective therapies was observed, and time to first prescription was similar in the primary prevention setting, irrespective of ASCVD risk status across all T2DM diagnosis age groups, resulting in poor risk factor control at 2 years of follow-up.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Dislipidemias , Hipertensão , Adolescente , Adulto , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Pré-Escolar , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Dislipidemias/complicações , Dislipidemias/tratamento farmacológico , Dislipidemias/epidemiologia , Humanos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Atenção Primária à Saúde , Fatores de Risco , Adulto JovemRESUMO
BACKGROUND: Diabetes prevalence is increasing in most places in the world, but prevalence is affected by both risk of developing diabetes and survival of those with diabetes. Diabetes incidence is a better metric to understand the trends in population risk of diabetes. Using a multicountry analysis, we aimed to ascertain whether the incidence of clinically diagnosed diabetes has changed over time. METHODS: In this multicountry data analysis, we assembled aggregated data describing trends in diagnosed total or type 2 diabetes incidence from 24 population-based data sources in 21 countries or jurisdictions. Data were from administrative sources, health insurance records, registries, and a health survey. We modelled incidence rates with Poisson regression, using age and calendar time (1995-2018) as variables, describing the effects with restricted cubic splines with six knots for age and calendar time. FINDINGS: Our data included about 22 million diabetes diagnoses from 5 billion person-years of follow-up. Data were from 19 high-income and two middle-income countries or jurisdictions. 23 data sources had data from 2010 onwards, among which 19 had a downward or stable trend, with an annual estimated change in incidence ranging from -1·1% to -10·8%. Among the four data sources with an increasing trend from 2010 onwards, the annual estimated change ranged from 0·9% to 5·6%. The findings were robust to sensitivity analyses excluding data sources in which the data quality was lower and were consistent in analyses stratified by different diabetes definitions. INTERPRETATION: The incidence of diagnosed diabetes is stabilising or declining in many high-income countries. The reasons for the declines in the incidence of diagnosed diabetes warrant further investigation with appropriate data sources. FUNDING: US Centers for Disease Control and Prevention, Diabetes Australia Research Program, and Victoria State Government Operational Infrastructure Support Program.
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Agregação de Dados , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/economia , Saúde Global/tendências , Renda/tendências , Internacionalidade , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , IncidênciaRESUMO
AIM: To evaluate temporal patterns in co-morbidities, cardiometabolic risk factors and a high atherosclerotic cardiovascular disease (ASCVD) risk population at type 2 diabetes (T2D) diagnosis by age groups and sex. MATERIALS AND METHODS: From the UK primary care database, 248,619 people with a new diagnosis of T2D during 2005-2016 were identified. Among people without ASCVD, high ASCVD risk was defined as two or more of current smoker, grade 2+ obesity, hypertension, dyslipidaemia or microvascular disease. Cardiometabolic multimorbidity (CMM) was defined as two or more of cardiovascular disease, microvascular disease, hypertension, dyslipidaemia, grade 2+ obesity or cancer. Temporal patterns in the distribution of cardiometabolic risk factors were evaluated. RESULTS: While the prevalence of ASCVD was stable over time (approximately 18%), 50% were identified to have a high ASCVD risk (26% and 38% in the 18-39 and 40-49 years age groups, respectively), with an increasing trend across all age groups. Overall, 51% had CMM at diagnosis, increasing during 2005-2016 for the 18-39 years age group by 14%-17%, for the 40-49 years age group by 27%-33%, for the 50-59 years age group by 41%-50%, for the 60-69 years age group by 56%-65%, and for the 70-79 years age group by 65%-80%. People with young-onset T2D had significantly higher HbA1c, body mass index and lipids at diagnosis (all p < .01). The proportions with an HbA1c of 7.5% or higher in the 18-39 and 40-49 years age groups were 58% and 54%, respectively, significantly and consistently higher over the last decade compared with those aged 50 years or older, with males having higher proportions of 15-26 and 10-18 percentage points, respectively, compared with females. CONCLUSIONS: CMM and high ASCVD risk have been increasing consistently across all age groups and in both sex, in particular CMM in those aged younger than 50 years. Our findings indicate that the European Society of Cardiology-European Association for the Study of Diabetes recommendations need to change to consider people with young-onset T2D as a high-risk group, as recommended in the Primary Care Diabetes Europe position statement.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Adulto , Idoso , Fatores de Risco Cardiometabólico , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Reino Unido/epidemiologiaRESUMO
We determined the efficacy of tocilizumab (TCZ) in preventing grade 2-4 acute graft-versus-host disease (aGVHD) in patients with acute leukemia or myelodysplasia undergoing matched sibling donor (MSD) or volunteer unrelated donor (VUD) allogeneic stem cell transplantation after myeloablative or reduced-intensity conditioning across 5 Australian centers. A total of 145 patients (50 MSD, 95 VUD) were randomly assigned to placebo or TCZ on day -1. All patients received T-cell-replete peripheral blood stem cell grafts and graft-versus-host disease (GVHD) prophylaxis with cyclosporin/methotrexate. A planned substudy analyzed the VUD cohort. With a median follow-up of 746 days, the incidence of grade 2-4 aGVHD at day 100 for the entire cohort was 36% for placebo vs 27% for TCZ (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.38-1.26; P = .23) and 45% vs 32% (HR, 0.61; 95% CI, 0.31-1.22; P = .16) for the VUD subgroup. The incidence of grade 2-4 aGVHD at day 180 for the entire cohort was 40% for placebo vs 29% for TCZ (HR, 0.68; 95% CI, 0.38-1.22; P = .19) and 48% vs 32% (HR, 0.59; 95% CI, 0.30-1.16; P = .13) for the VUD subgroup. Reductions in aGVHD were predominantly in grade 2 disease. For the entire cohort, transplant-related mortality occurred in 8% vs 11% of placebo-treated vs TCZ-treated patients, respectively (P = .56), and overall survival was 79% vs 71% (P = .27). Median day to neutrophil and platelet engraftment was delayed by 2 to 3 days in TCZ-treated patients, whereas liver toxicity and infectious complications were similar between groups. In this phase 3 randomized double-blind trial, TCZ showed nonsignificant trends toward reduced incidence of grade 2-4 aGVHD in recipients from HLA-matched VUDs but no improvements in long term-survival.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Ciclosporina/uso terapêutico , Doença Enxerto-Hospedeiro/prevenção & controle , Transplante de Células-Tronco Hematopoéticas , Imunossupressores/uso terapêutico , Metotrexato/uso terapêutico , Adulto , Método Duplo-Cego , Feminino , Humanos , Leucemia/terapia , Masculino , Pessoa de Meia-Idade , Síndromes Mielodisplásicas/terapia , Efeito Placebo , Transplante Homólogo , Resultado do TratamentoRESUMO
Background: The need for healthcare workers (HCWs) to have skills and knowledge in non-cancer palliative care has been recognised. Simulation is increasingly being used for palliative care training, offering participants the opportunity to learn in a realistic environment and fully interactive way. Objective: The aim of this systematic review was to summarise and critically appraise controlled studies on simulation training in non-cancer palliative care for HCWs. Selection: Medline, CINAHL, PubMed and Cochrane Library databases were searched using palliative care and simulation terms. Randomised controlled trials (RCTs), non-randomised RCTs and controlled before-and-after (CBA) studies were included. Two reviewers independently screened titles and abstracts and undertook full article review using predefined selection criteria. Studies that met the inclusion criteria had data extracted and risk of bias assessed using the Cochrane Effective Practice and Organisation of Care risk of bias criteria. Findings: Five articles were included: three RCTs and two CBA studies. All studies assessed learners' palliative care communication skills, most studies evaluated learners' perception of change in skills and one study assessed impact on patient outcomes and learners' change in behaviour when applied in practice. There was variation in intervention content, intensity and duration, outcome measures and study design, making it difficult to compare and synthesise results. Conclusion: There is a paucity of evidence to support simulation training to improve non-cancer palliative care. This review highlights the need for more robust research, including multicentre studies that use standardised outcome measures to assess clinician skills, changes in clinical practice and patient-related outcomes.
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OBJECTIVE: To evaluate the temporal patterns of cardiometabolic multimorbidity (CM) and depression in White Caucasians (WCs) and African Americans (AAs) with early-onset type 2 diabetes and their impact on long-term atherosclerotic cardiovascular disease (ASCVD). RESEARCH DESIGN AND METHODS: From U.S. electronic medical records, 101,104 AA and 505,336 WC subjects with type 2 diabetes diagnosed between 2000 and 2017 were identified (mean follow-up 5.3 years). Among those without ASCVD at diagnosis, risk of ASCVD and three-point major adverse cardiovascular events (MACE-3) (heart failure, myocardial infarction, or stroke) was evaluated between ethnicities by age-groups. RESULTS: The proportion of patients diagnosed at <50 years of age increased during 2012-2017 (AA 34-38%, WC 26-29%). Depression prevalence increased during 2000-2017 (AA 15-23%, WC 20-34%), with an increasing trend for CM at diagnosis in both groups. Compared with WC, the adjusted MACE-3 risk was significantly higher in AA across all age-groups, more pronounced in the 18-39-year age-group (hazard ratio 95% CI 1.42, 1.88), and in patients with and without depression. AAs had a 17% (1.05, 1.31) significantly higher adjusted ASCVD risk in the 18-39-year age-group only. Depression was independently associated with ASCVD and MACE-3 risk in both ethnic groups across all age-groups. Other comorbidities were independently associated with ASCVD and MACE-3 risk only among WCs. CONCLUSIONS: AAs have higher cardiovascular risk compared with WCs, particularly in early-onset type 2 diabetes. CM and depression at diabetes diagnosis have been increasing over the past two decades in both ethnic groups. Strategies for screening and optimal management of CM and depression, particularly in early-onset type 2 diabetes, may result in a lower cardiovascular risk.
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Aterosclerose , Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Adulto , Doenças Cardiovasculares/epidemiologia , Depressão/epidemiologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Multimorbidade , Medição de Risco , Fatores de RiscoRESUMO
AIMS: The aim of this study was to evaluate the temporal pattern of amputations in patients with type 2 diabetes mellitus (T2DM), the risk of amputations by new and older anti-diabetic drugs (ADDs), and the interplay of peripheral artery disease (PAD) with therapy and amputation risk. METHODS AND RESULTS: Using Centricity Electronic Medical Records from USA, 3 293 983 patients with T2DM were identified: 169 739 received sodium-glucose cotransporter type-2 inhibitors (SGLT-2i; no exposure to incretins); 149 826 received glucagon-like peptide 1 receptor agonists [GLP-1RA, no SGLT-2i or dipeptidyl peptidase-4 inhibitor (DPP-4i) exposure]; 448 225 received DPP-4i (no exposure to GLP-1RA or SGLT-2i); and 1 954 353 received other ADDs. The proportion of incident amputations per 10 000 adults ranged between 4.7 and 6.8 during 2000-08 and significantly increased to 12.3 in 2017. Over 17 211 719 person-years follow-up post T2DM diagnosis, the rates per 1000 person-years of any and lower limb amputations (LLAs) were similar between SGLT-2i and incretins [95% confidence interval (CI) range: 1.06-1.67], and significantly higher in other groups (95% CI range: 1.96-2.29). In propensity score-adjusted pairwise analyses, the risk of LLA was not higher in SGLT-2i vs. GLP1-RA [hazard ratio (HR) (95% CI): 0.88 (0.73, 1.05)], and lower in SGLT-2i vs. DPP-4i/other ADD [HR (95% CI): 0.65 (0.56, 0.75)/0.43 (0.37, 0.49)]. The rate of LLA was similar in patients treated with canagliflozin, empagliflozin, or dapagliflozin. Patients with PAD had more than four-fold higher LLA risk (range of 95% CI of HR: 3.6-6.0). CONCLUSION: The risk of amputation in patients treated with SGLT-2i and incretins was not higher compared with other ADDs. Pre-existing PAD was the greatest driver of amputation risk.
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Diabetes Mellitus Tipo 2 , Inibidores da Dipeptidil Peptidase IV , Doença Arterial Periférica , Inibidores do Transportador 2 de Sódio-Glicose , Adulto , Amputação Cirúrgica , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Glucose , Humanos , Hipoglicemiantes/uso terapêutico , Doença Arterial Periférica/epidemiologia , Sódio , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêuticoRESUMO
AIMS: To explore cardiometabolic risk profiles, the probability of sustainable control, and the effectiveness of treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors in black and white adults in the United States with type 2 diabetes. MATERIALS AND METHODS: Using nationally representative US electronic medical records, 72 690 white and 10 004 black adults diagnosed with type 2 diabetes initiating SGLT2 inhibitors during the period 2013 to 2018, continuing it for ≥6 months, and with follow-up of ≥12 months, were identified. Glycated haemoglobin (HbA1c), body weight, systolic blood pressure (SBP) and lipid changes at 6 months, and sustainability of control over 18 months post SGLT2 inhibitor initiation were explored, separately in those with and without atherosclerotic cardiovascular disease (ASCVD). RESULTS: The white group was older (58 years) with lower mean HbA1c (8.5%), compared to the black group (age 54 years, HbA1c 9.0%). Body mass index distribution was similar. The proportions of people with uncontrolled SBP, LDL cholesterol, non-HDL cholesterol and triglyceride levels were 24%, 42%, 51% and 62%, respectively, in white patients, and 31%, 51%, 49% and 32%, respectively, in black patients. At 6-month follow-up white and black patients had similar adjusted reductions in HbA1c (1.1%), SBP (8-10 mmHg), LDL cholesterol (0.26 - 0.34 mmol / L) and body weight (1.1-1.4 kg). However, over 18 months' follow-up, compared to white patients, black patients were significantly less likely to achieve sustainable control in HbA1c (odds ratio [OR] 0.67, 95% confidence interval [CI] 0.63-0.72), body weight (OR 0.81, 95% CI 0.72-0.91), SBP (OR 0.67, 95% CI 0.61-0.74) and LDL cholesterol (OR 0.77, 95% CI 0.67-0.89). Triglyceride control was significantly better among black patients. Black patients had a significantly higher risk factor burden, irrespective of ASCVD status. CONCLUSIONS: While the effectiveness of SGLT2 inhibitors was similar among black and white patients, irrespective of ASCVD status, black patients continued to have worse cardiometabolic risk factor burden after SGLT2 inhibitor initiation.