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SGLT-2 inhibitors or GLP-1 receptor agonists for adults with type 2 diabetes: a clinical practice guideline.
Li, S, Vandvik, PO, Lytvyn, L, Guyatt, GH, Palmer, SC, Rodriguez-Gutierrez, R, Foroutan, F, Agoritsas, T, Siemieniuk, RAC, Walsh, M, et al
BMJ (Clinical research ed.). 2021;:n1091
Abstract
CLINICAL QUESTION What are the benefits and harms of sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists when added to usual care (lifestyle interventions and/or other diabetes drugs) in adults with type 2 diabetes at different risk for cardiovascular and kidney outcomes? CURRENT PRACTICE Clinical decisions about treatment of type 2 diabetes have been led by glycaemic control for decades. SGLT-2 inhibitors and GLP-1 receptor agonists are traditionally used in people with elevated glucose level after metformin treatment. This has changed through trials demonstrating atherosclerotic cardiovascular disease (CVD) and chronic kidney disease (CKD) benefits independent of medications' glucose-lowering potential. RECOMMENDATIONS The guideline panel issued risk-stratified recommendations concerning the use of SGLT-2 inhibitors or GLP-1 receptor agonists in adults with type 2 diabetes• Three or fewer cardiovascular risk factors without established CVD or CKD: Weak recommendation against starting SGLT-2 inhibitors or GLP-1 receptor agonists.• More than three cardiovascular risk factors without established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and weak against starting GLP-1 receptor agonists.• Established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and GLP-1 receptor agonists.• Established CVD and CKD: Strong recommendation for starting SGLT-2 inhibitors and weak recommendation for starting GLP-1 receptor agonists.• For those committed to further reducing their risk for CVD and CKD outcomes: Weak recommendation for starting SGLT-2 inhibitors rather than GLP-1 receptor agonists. HOW THIS GUIDELINE WAS CREATED An international panel including patients, clinicians, and methodologists created these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel applied an individual patient perspective. THE EVIDENCE A linked systematic review and network meta-analysis (764 randomised trials included 421 346 participants) of benefits and harms found that SGLT-2 inhibitors and GLP-1 receptor agonists generally reduce overall death, and incidence of myocardial infarctions, and end-stage kidney disease or kidney failure (moderate to high certainty evidence). These medications exert different effects on stroke, hospitalisations for heart failure, and key adverse events in different subgroups. Absolute effects of benefit varied widely based on patients' individual risk (for example, from five fewer deaths in the lowest risk to 48 fewer deaths in the highest risk, for 1000 patients treated over five years). A prognosis review identified 14 eligible risk prediction models, one of which (RECODe) informed most baseline risk estimates in evidence summaries to underpin the risk-stratified recommendations. Concerning patients' values and preferences, the recommendations were supported by evidence from a systematic review of published literature, a patient focus group study, a practical issues summary, and a guideline panel survey. UNDERSTANDING THE RECOMMENDATION We stratified the recommendations by the levels of risk for CVD and CKD and systematically considered the balance of benefits, harms, other considerations, and practical issues for each risk group. The strong recommendation for SGLT-2 inhibitors in patients with CVD and CKD reflects what the panel considered to be a clear benefit. For all other adults with type 2 diabetes, the weak recommendations reflect what the panel considered to be a finer balance between benefits, harms, and burdens of treatment options. Clinicians using the guideline can identify their patient's individual risk for cardiovascular and kidney outcomes using credible risk calculators such as RECODe. Interactive evidence summaries and decision aids may support well informed treatment choices, including shared decision making.
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Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials.
Palmer, SC, Tendal, B, Mustafa, RA, Vandvik, PO, Li, S, Hao, Q, Tunnicliffe, D, Ruospo, M, Natale, P, Saglimbene, V, et al
BMJ (Clinical research ed.). 2021;:m4573
Abstract
OBJECTIVE To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk. DESIGN Network meta-analysis. DATA SOURCES Medline, Embase, and Cochrane CENTRAL up to 11 August 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias. MAIN OUTCOME MEASURES Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review. RESULTS 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agonists might cause severe gastrointestinal events (low certainty). Low certainty evidence suggested that SGLT-2 inhibitors and GLP-1 receptor agonists might lower body weight. Little or no evidence was found for the effect of SGLT-2 inhibitors or GLP-1 receptor agonists on limb amputation, blindness, eye disease, neuropathic pain, or health related quality of life. The absolute benefits of these drugs vary substantially across patients from low to very high risk of cardiovascular and renal outcomes (eg, SGLT-2 inhibitors resulted in 3 to 40 fewer deaths in 1000 patients over five years; see interactive decision support tool (https://magicevidence.org/match-it/200820dist/#!/) for all outcomes. CONCLUSIONS In patients with type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists reduced cardiovascular and renal outcomes, with some differences in benefits and harms. Absolute benefits are determined by individual risk profiles of patients, with clear implications for clinical practice, as reflected in the BMJ Rapid Recommendations directly informed by this systematic review. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42019153180.
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Patient-perceived service needs and health care utilization in people with type 2 diabetes: A multicenter cross-sectional study.
Ni, Y, Liu, S, Li, J, Li, S, Dong, T
Medicine. 2020;(21):e20322
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Abstract
The aim of this study was to investigate service needs and health care utilization among people with type 2 diabetes, further to identify the relationship between service needs and health care utilization.We used a self-reported questionnaire to collect data regarding demographic and diabetes characteristics, service needs toward self-management and follow-up care, and 4 health care utilizations during past year. Multiple linear regression and binary logistic regression were used to test the impacts of demographic and diabetes characteristics on service needs and health care utilizations, respectively. Spearman rank correlations were used to explore correlation between service needs and health care utilization.We recruited 1796 participants with type 2 diabetes from 20 community health centers across 12 cities of Sichuan Province in China. Needs of self-management and follow-up had significant positive correlations with health care utilization. Participants rated that nutrition was the most needed aspects of self-management (78.5%), and out-patient visit was the most popular type of follow-up (66.8%). Educational level and treatment modality were predictors of self-management needs. Low educational level (elementary school or blow, β = 0.11, P = .008; middle school, β = 0.10, P = .015) and insulin treatment (β = 0.08, P = .007) were positive factors of self-management needs. Younger age (age < 45 years old, β = 0.07, P = .046), being employed (β = 0.14, P < .001), and underdeveloped region (β = 0.16, P < .001) were positive factors of follow-up care needs. Elementary educational level (OR: 0.53; CI: 0.30-0.96) and underdevelopment region (OR: 0.01; CI: 0.01-0.07) were protective factors of general practitioner visit, in contrast, those factors were risk factors of specialist visit (elementary educational level, OR: 1.69; CI: 1.13-2.5; underdevelopment region, OR: 2.93; CI: 2.06-4.16) and emergency room visit (elementary educational level, OR: 2.97; CI: 1.09, 8.08; underdevelopment region, OR: 6.83; CI: 2.37-14.65).The significant positive relationship between service needs and health care utilization demonstrated the role of service needs in influencing health care utilization. When self-management education is provided, age, educational level, employment status, treatment modality, and region should be considered to offer more appropriate education and to improve health care utilization.
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Analysis of Lipoprotein Subfractions in 920 Patients With and Without Type 2 Diabetes.
Zhao, X, Zhang, HW, Zhang, Y, Li, S, Xu, RX, Sun, J, Zhu, CG, Wu, NQ, Gao, Y, Guo, YL, et al
Heart, lung & circulation. 2017;(3):211-218
Abstract
BACKGROUND It has been demonstrated that diabetic dyslipidaemia is the chief bridge between diabetes and incremental risk of cardiovascular disease in patients with diabetes. However, the characteristics of lipoprotein subfractions distribution in patients with type 2 diabetes (T2D) have not been fully investigated. The aim of present study was to evaluate the distributions of lipoprotein subfractions in T2D patients. METHODS A total of 920 patients, who have not received lipid-lowering drug treatment previously, were consecutively enrolled in this study. Based on the evidence of diabetes, patients were divided into T2D group (n=204) and non-T2D group (n=716). Both low- and high-density lipoprotein cholesterol (LDL- and HDL-C) subfractions were analysed using the Quantimetrix Lipoprint System. The distributions of lipoprotein subfractions were evaluated in patients with and without T2D. RESULTS Compared with non-T2D individuals, the T2D group manifested significantly lower large HDL-C concentration/HDL subfraction percentage, smaller mean LDL particle size but higher small HDL-C and LDL-C concentrations as well as small HDL and LDL subfraction percentages. Moreover, the data indicated that the small HDL-C/ LDL-C concentrations, the small and large HDL subfraction percentages along with the mean LDL particle size were independently related to the existence of T2D (95% CI=1.009-1.067, p=0.009; 95% CI=0.938-0.983, p=0.001; 95% CI=1.023-1.135, p=0.005; 95% CI= 1.005-1.048, p=0.014; 95% CI=0.940-0.999, p=0.040; respectively) assessed by logistic regression analysis. CONCLUSIONS The present study indicated that the changes of lipid profile in patients with T2D are characterised by abnormal distributions of lipoprotein subfractions apart from clinically atherogenic dyslipidaemia.
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Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies.
Li, L, Li, S, Deng, K, Liu, J, Vandvik, PO, Zhao, P, Zhang, L, Shen, J, Bala, MM, Sohani, ZN, et al
BMJ (Clinical research ed.). 2016;:i610
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Abstract
OBJECTIVES To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. DESIGN Systematic review and meta-analysis of randomised and observational studies. DATA SOURCES Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. ELIGIBILITY CRITERIA Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. DATA COLLECTION AND ANALYSIS Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. RESULTS Eligible studies included 43 trials (n=68,775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1,777,358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15,701 v 33/12,591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18,554 v 552/18,474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. CONCLUSIONS The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use.
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Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial.
Li, S, Chen, X, Li, Q, Du, J, Liu, Z, Peng, Y, Xu, M, Li, Q, Lei, M, Wang, C, et al
Journal of diabetes investigation. 2016;(5):777-85
Abstract
AIMS/INTRODUCTION To assess the efficacy and safety of acetyl-L-carnitine (ALC) on diabetic peripheral neuropathy compared with methylcobalamin (MC). MATERIALS AND METHODS This was a multicenter, randomized, parallel-group, double-blind, double-dummy, positive-controlled, non-inferior phase II clinical trial. Diabetic patients with abnormal nerve conduction test results were randomized in a 1:1 ratio to receive oral ALC 500 mg t.i.d. or MC 0.5 mg t.i.d. for 24 weeks. The neuropathy symptom score, neuropathy disability score and neurophysiological parameters were measured during follow up. RESULTS A total of 232 patients were randomized (ALC n = 117, MC n = 115), 88% of which completed the trial. At week 24, patients from both groups had significant reductions in both neuropathy symptom score and neuropathy disability score with no significant difference between two groups (neuropathy symptom score reduction: ALC vs MC 2.35 ± 2.23, P < 0.0001 vs 2.11 ± 2.48, P < 0.0001, intergroup P = 0.38; neuropathy disability score reduction ALC vs MC 1.66 ± 1.90, P < 0.0001 vs 1.35 ± 1.65, P < 0.0001, intergroup P = 0.23). Neurophysiological parameters were also improved in both groups. No significant difference was found between groups in the development of adverse events. CONCLUSIONS ALC is as effective as MC in improving clinical symptoms and neurophysiological parameters for patients with diabetic peripheral neuropathy over a 24-week period with good tolerance.
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Fruit intake decreases risk of incident type 2 diabetes: an updated meta-analysis.
Li, S, Miao, S, Huang, Y, Liu, Z, Tian, H, Yin, X, Tang, W, Steffen, LM, Xi, B
Endocrine. 2015;(2):454-60
Abstract
Association between fruit intake and risk of type 2 diabetes is inconsistent. In this study, we performed a meta-analysis of all prospective cohort studies to clarify the association between fruit intake and risk of type 2 diabetes. Relevant studies were identified by searches of the PubMed and Embase databases up to November 2013. The summary relative risks of association were obtained using a fixed- or random-effects model. A total of nine prospective studies (403,259 participants, including 27,940 with incident type 2 diabetes) from seven publications were included in the meta-analysis of fruit intake and risk of type 2 diabetes. We found that individuals in the highest category of fruit intake had a reduced risk of type 2 diabetes (relative risk 0.92, 95 % confidence interval 0.86-0.97, p = 0.003) compared to those in the lowest category, with moderate evidence of between-study heterogeneity (I (2) = 37.6 %, p = 0.12). There was an evident non-linear association of fruit intake with type 2 diabetes (P for nonlinearity <0.001). A non-linear threshold of 200 g/day of fruit intake was identified and the risk of type 2 diabetes reduced by about 13 % at this cut-off. Our findings are consistent with diet recommendations to consume about 200 g/day of fruits to prevent type 2 diabetes.
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Intake of fruit juice and incidence of type 2 diabetes: a systematic review and meta-analysis.
Xi, B, Li, S, Liu, Z, Tian, H, Yin, X, Huai, P, Tang, W, Zhou, D, Steffen, LM
PloS one. 2014;(3):e93471
Abstract
BACKGROUND Several prospective studies have been conducted to examine the relationship between fruit juice intake and risk of incident type 2 diabetes, but results have been mixed. In the present study, we aimed to estimate the association between fruit juice intake and risk of type 2 diabetes. METHODS PubMed and Embase databases were searched up to December 2013. All prospective cohort studies of fruit juice intake with risk of type 2 diabetes were included. The pooled relative risks (RRs) with 95% confidence intervals (CIs) for highest vs. lowest category of fruit juice intake were estimated using a random-effects model. RESULTS A total of four studies (191,686 participants, including 12,375 with type 2 diabetes) investigated the association between sugar-sweetened fruit juice and risk of incident type 2 diabetes, and four studies (137,663 participants and 4,906 cases) investigated the association between 100% fruit juice and risk of incident type 2 diabetes. A higher intake of sugar-sweetened fruit juice was significantly associated with risk of type 2 diabetes (RR = 1.28, 95%CI = 1.04-1.59, p = 0.02), while intake of 100% fruit juice was not associated with risk of developing type 2 diabetes (RR = 1.03, 95% CI = 0.91-1.18, p = 0.62). CONCLUSIONS Our findings support dietary recommendations to limit sugar-sweetened beverages, such as fruit juice with added sugar, to prevent the development of type 2 diabetes.
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Nut consumption in relation to cardiovascular disease risk and type 2 diabetes: a systematic review and meta-analysis of prospective studies.
Zhou, D, Yu, H, He, F, Reilly, KH, Zhang, J, Li, S, Zhang, T, Wang, B, Ding, Y, Xi, B
The American journal of clinical nutrition. 2014;(1):270-7
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BACKGROUND Many prospective cohort studies have investigated the association between nut consumption and risk of coronary artery disease (CAD), stroke, hypertension, and type 2 diabetes (T2D). However, results have been inconsistent. OBJECTIVE We aimed to investigate the association between nut consumption and risk of CAD, stroke, hypertension, and T2D. DESIGN PubMed and EMBASE databases were searched up to October 2013. All prospective cohort studies of nut consumption and risk of CAD, stroke, hypertension, and T2D were included. Summary RRs with 95% CIs were estimated by using a fixed- or random-effects model. RESULTS A total of 23 prospective studies (9 studies for CAD, 4 studies for stroke, 4 studies for hypertension, and 6 studies for T2D) from 19 publications were included in the meta-analysis. There were 179,885 participants and 7236 CAD cases, 182,730 participants and 5669 stroke cases, 40,102 participants and 12,814 hypertension cases, and 342,213 participants and 14,400 T2D cases. The consumption of each 1 serving of nuts/d was significantly associated with incident CAD (RR: 0.81; 95% CI: 0.72, 0.91; P < 0.001) and hypertension (RR: 0.66; 95% CI: 0.44, 1.00; P = 0.049). However, there was no association between the consumption of each 1 serving of nuts/d and risk of stroke (RR: 0.90; 95% CI: 0.71, 1.14) or T2D (RR: 0.80; 95% CI: 0.57, 1.14). CONCLUSIONS A higher consumption of nuts was associated with reduced risk of CAD and hypertension but not stroke or T2D. Large randomized controlled trials are warranted to confirm the observed associations.