Abstract:
BACKGROUND:Vulvovaginitis, balanitis, and related genital infections are common in patients with type 2 diabetes. Glucosuria, which is an outcome of treatment with sodium glucose cotransporter 2 (SGLT2) inhibitors, is among the possible causes. Dapagliflozin, an SGLT2 inhibitor with demonstrated glycemic benefits in patients with diabetes, has been studied across a broad spectrum of patients. Analysis of multi-trial safety data may better define the relationship between glucosuria and genital infection. METHODS:Safety data were pooled from 12 randomized, placebo-controlled Phase 2b/3 trials to analyze the association of glucosuria with genital infection in patients with suboptimally controlled diabetes (HbA1c >6.5%-12%). Patients were randomized to receive dapagliflozin (2.5mg, 5mg, or 10mg) or placebo once daily, either as monotherapy or add-on to metformin, insulin, sulfonylurea, or thiazolidinedione for 12-24weeks. The incidence of clinical diagnoses and of events suggestive of genital infection was evaluated. RESULTS:The pooled safety data included 4545 patients: 3152 who received once-daily dapagliflozin (2.5mg [n=814], 5mg [n=1145], or 10mg [n=1193]) as monotherapy or add-on treatment, and 1393 placebo-treated patients. For dapagliflozin 2.5mg, 5mg, 10mg, and placebo, diagnosed infections were reported in 4.1%, 5.7%, 4.8%, and 0.9%, respectively. Most infections were mild or moderate and responded to standard antimicrobial treatment. Discontinuation due to these events was rare. No clear dose-response relationship between dapagliflozin and genital infection was demonstrated. CONCLUSIONS:Treatment with dapagliflozin 2.5mg, 5mg, or 10mg once daily is accompanied by an increased risk of vulvovaginitis or balanitis, related to the induction of glucosuria. Events were generally mild to moderate, clinically manageable, and rarely led to discontinuation of treatment.
journal_name
J Diabetes Complicationsjournal_title
Journal of diabetes and its complicationsauthors
Johnsson KM,Ptaszynska A,Schmitz B,Sugg J,Parikh SJ,List JFdoi
10.1016/j.jdiacomp.2013.04.012subject
Has Abstractpub_date
2013-09-01 00:00:00pages
479-84issue
5eissn
1056-8727issn
1873-460Xpii
S1056-8727(13)00107-4journal_volume
27pub_type
杂志文章,meta分析abstract:AIM OF THE STUDY:The aim of this study was to evaluate reverse volumetric left ventricular (LV) remodeling after cardiac resynchronization therapy (CRT) in patients with heart failure (HF) with vs. without diabetes mellitus (DM). METHODS:The study comprised 130 consecutive patients with HF (mean age, 61+/-12 years) wh...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2008.04.003
更新日期:2009-09-01 00:00:00
abstract::As the average life expectancy of patients with cystic fibrosis (CF) improves, the long term co-morbidities assume increasing importance. CF related diabetes (CFRD) has adverse effects on both nutrition and pulmonary function, and is associated with increased mortality. Abnormalities of glucose metabolism in CF repres...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/j.jdiacomp.2014.06.012
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND AND AIMS:Attenuated retinal vasoreactivity in patients with type 2 diabetes preceding diabetic retinopathy development has been proposed to reflect local endothelial dysfunction. Whether retinal vessel reactivity is associated with peripheral endothelial dysfunction and large artery stiffness in patients wit...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2019.05.024
更新日期:2019-09-01 00:00:00
abstract:AIMS:Type 2 diabetes (T2DM) is associated with cognitive impairment. We examined whether undiagnosed cognitive impairment in T2DM-patients is associated with a reduced health status and depressive symptoms. METHODS:In an observational study, 225 T2DM-patients aged ≥70years were examined at their homes and (some of the...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2015.07.010
更新日期:2015-11-01 00:00:00
abstract::Although the etiology of diabetic neuropathic pain remains enigmatic, two types of neuropathic pain are now recognized: nerve trunk pain following a discrete often vascular lesion as seen in ocular mononeuropathy and hyperalgesic pain as seen in diffuse involvement of peripheral sensory fibers. Our understanding of th...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/1056-8727(92)90050-u
更新日期:1992-01-01 00:00:00
abstract:AIMS:Recent studies suggest that circadian rhythms regulate glucose metabolism, weight loss, and even drug efficacy. Moreover, molecules targeted at the circadian clock show promise in treating metabolic disease. Therefore, this study set out to better characterize interactions among diurnal rhythms in prediabetes. ME...
journal_title:Journal of diabetes and its complications
pub_type: 临床试验,杂志文章
doi:10.1016/j.jdiacomp.2014.04.001
更新日期:2014-11-01 00:00:00
abstract::Non-insulin-dependent diabetes mellitus (NIDDM) is associated with approximately two fold increase in coronary heart disease (CHD) in men and fourfold increase in CHD in women. In most studies, the duration of diabetes and severity of glycemia are only weakly related to CHD in NIDDM, suggesting that the prediabetic pe...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/s1056-8727(96)00099-2
更新日期:1997-03-01 00:00:00
abstract:AIMS:To assess the association between dipstick hematuria and estimated glomerular filtration rate (eGFR) decline in Japanese patients with type 2 diabetes. METHODS:Longitudinal data were obtained from 3068 Japanese patients with type 2 diabetes. To assess the independent association between dipstick hematuria and eGF...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2017.04.016
更新日期:2017-07-01 00:00:00
abstract::Plasma semicarbazide-sensitive amine oxidase (SSAO) and angiotensin-converting enzyme (ACE) were studied for their correlation with diabetes (DM) complication. The effect of interaction between SSAO and ACE in DM complication is of interest. Studying the functional change due to interaction between SSAO and ACE is dif...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2007.02.007
更新日期:2008-11-01 00:00:00
abstract:AIM:To evaluate the use of the FINDRISC score in an overweight and obese population to predict glucose status. METHODS:In 651 overweight/obese subjects (M/F: 193/458, age 43±13 y, BMI 38.2±6.1kg/m(2)) glucose status was tested using OGTT and HbA1c. Furthermore, the FINDRISC questionnaire and CT visceral fat (VAT) and ...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2016.05.004
更新日期:2016-08-01 00:00:00
abstract:AIMS:The aim of this study is to investigate the effects of a low-carbohydrate staple food (i.e., low-carbohydrate bread) on glucose and lipid metabolism and pancreatic and enteroendocrine hormone secretion in comparison with meals containing normal-carbohydrate bread, without consideration of the carbohydrate content ...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2019.107415
更新日期:2019-11-01 00:00:00
abstract:OBJECTIVES:Hyperglycemia-induced inflammation is central to the vascular complications in diabetes. Toll-like receptors (TLRs) are key players in regulating inflammatory responses. There are sparse data on the role of TLR2 and TLR4 in regulating human macrovascular aortic endothelial cells (HMAECs) inflammation and gly...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2016.01.014
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Although lifestyle modifications are known to be effective in type 2 diabetes (T2D) as well as in prediabetes, adherence to a healthy diet is difficult for some, and interventions of lifestyle modifications need to be revised occasionally. Meal sequence has been gaining attention as a part of a healthy diet ...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2019.107450
更新日期:2019-12-01 00:00:00
abstract:BACKGROUND:In diabetes, foot ulceration may result from increased skin fragility. Retinoids can reverse some diabetes-induced deficits of skin structure and function, but their clinical utility is limited by skin irritation. The effects of diabetes and MDI 301, a nonirritating synthetic retinoid, and retinoic acid have...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2011.10.002
更新日期:2011-11-01 00:00:00
abstract:OBJECTIVE:Two insulin regimens were used to explore acute and chronic postprandial changes in glycemia, lipemia, and metabolic markers associated with increased risk of cardiovascular disease. METHODS:An open-label, randomized, two-period crossover study (12 weeks/period) compared a prandial regimen [premeal insulin l...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jdiacomp.2005.11.005
更新日期:2007-01-01 00:00:00
abstract::Paecilomyces is a saprophytic soil fungus that is an uncommon human pathogen. We report a diabetic patient who developed an upper lobe pulmonary infection due to Paecilomyces varioti. This pneumonia responded poorly to oral imidazole therapy with ketoconazole. Eventual treatment of the chronic infiltrating process req...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/1056-8727(92)90027-i
更新日期:1992-04-01 00:00:00
abstract::Diabetes mellitus (DM) can lead to the development of macro- and microvascular complications. Homocysteine (Hcy) may play a role in the development of cardiovascular (CV) diseases (CVDs). The role of Hcy in the development of the vascular complications associated with DM is not clearly defined. Despite a strong initia...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/j.jdiacomp.2020.107834
更新日期:2020-12-31 00:00:00
abstract::The aim of our study was to compare ambulatory blood pressure monitoring (ABPM) measures (mean systolic/diastolic blood pressure, diurnal rhythm, and pressure burden) in matched normo- and microalbuminuric (IDDM) adolescents and healthy controls. Twenty-four hour monitoring was undertaken in 39 normotensive (normal cl...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/s1056-8727(97)00050-0
更新日期:1998-01-01 00:00:00
abstract:AIM:To assess the contribution of β-cell dysfunction and insulin resistance to type 2 diabetes (T2D) in obese and non-obese Chinese people. METHODS:In this cross-sectional study, we recruited 1384 newly diagnosed T2D patients and 1712 healthy controls. Insulin resistance was estimated by homeostasis model assessment o...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2016.03.001
更新日期:2016-07-01 00:00:00
abstract::In patients with insulin-dependent diabetes mellitus (IDDM), albuminuria reflects widespread vascular dysfunction. Albuminuria has been associated to defects of heparan sulfate proteoglycan (HSPG) within the extracellular matrix. Our hypothesis is that loss of HSPG in vascular walls reduces the HSPG-bound lipoprotein-...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/s1056-8727(96)00048-7
更新日期:1997-07-01 00:00:00
abstract:AIM:To examine the relationship between immigration and dietary patterns among South Asian adults at risk for diabetes and living in Canada. METHODS:We recruited 428 South Asian adults affiliated with Sikh and Hindu temples in Metro Vancouver. Of the total sample, 422 completed self-report surveys including demographi...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2016.08.003
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To determine the prevalence of a negative insulinogenic index (change in plasma insulin/change in plasma glucose from 0 to 30 min) from an oral glucose tolerance test according to glucose tolerance category. MATERIALS AND METHODS:Data from the San Antonio Heart Study (n=2494), Japanese American Community Dia...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2012.09.011
更新日期:2013-03-01 00:00:00
abstract::With the rise in childhood obesity, type 2 diabetes mellitus (T2DM) has been recognized to occur in adolescents with increasing frequency. Although much is known about T2DM in adults, few studies have examined the treatment and complications of T2DM in youth. The Treatment Options for type 2 Diabetes in Adolescents an...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/j.jdiacomp.2014.10.009
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:Metabolic Syndrome (MetS) is a cardio-metabolic cluster that confers an increased risk of developing both diabetes and atherosclerotic cardiovascular disease (ASCVD). The mechanisms governing the increased ASCVD risk remains to be elucidated. Moreover, lipidomics poses as an exciting new tool that has potent...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2018.05.014
更新日期:2018-08-01 00:00:00
abstract:AIMS:Previous studies have reported beneficial effects of chronic resistance exercise in the prevention and treatment of type 2 diabetes. To clarify potential modulators of acute responses to resistance exercise, we reviewed the literature to determine the effects of a single bout of resistance exercise on cardiometabo...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2020.107610
更新日期:2020-08-01 00:00:00
abstract:OBJECTIVE:Type 1 diabetes (T1DM) is a pro-inflammatory state characterized by high C-reactive protein (CRP) levels. However, there is a paucity of data examining the role of CRP in promoting the pro-inflammatory state of diabetes. Thus, we examined the pro-inflammatory effects of human CRP using spontaneously diabetic ...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2012.03.020
更新日期:2013-01-01 00:00:00
abstract::There has been a substantial evolution of concepts related to disordered gastric emptying in diabetes. While the traditional focus has hitherto related to the pathophysiology and management of upper gastrointestinal symptoms associated with gastroparesis, it is now apparent that the rate of gastric emptying is central...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章,评审
doi:10.1016/j.jdiacomp.2014.06.005
更新日期:2014-11-01 00:00:00
abstract:AIM:Analyze clustering of unhealthy lifestyle behavior and its relationship with nonadherence to clinical preventive care services among Spanish diabetic adults. METHODS:Cross-sectional study including 2156 diabetic adults from the 2006 Spanish National Health Survey. Subjects were asked about their uptake of BP measu...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2010.04.002
更新日期:2011-03-01 00:00:00
abstract:AIMS:Albuminuria and reduced glomerular filtration rate (GFR) are manifestations of diabetic kidney disease and are both shown to be associated with cardiovascular outcomes. However, the differential association of albuminuria and reduced GFR with endothelial dysfunction, an early feature of atherosclerotic vascular da...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/j.jdiacomp.2020.107702
更新日期:2020-12-01 00:00:00
abstract::The importance of routine screening for microalbuminuria in patients with diabetes has gained widespread acceptance. Since shortened collection times and random urine sampling facilitate outpatient testing for patients, it is necessary to establish whether a recent fluid intake might alter test results. Specifically, ...
journal_title:Journal of diabetes and its complications
pub_type: 杂志文章
doi:10.1016/s1056-8727(01)00216-1
更新日期:2002-07-01 00:00:00