Abstract:
INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin 25 mg (n = 5057), or placebo (n = 4904). The dataset comprised 15 randomized phase I-III trials, an extension trial and dose escalation studies. Adverse events (AEs) were assessed descriptively in participants who took ≥ 1 dose of study drug. AE incidence rates per 100 patient-years were calculated to adjust for differences in drug exposure between trials. RESULTS:Total exposure was 16,480 and 7857 patient-years in the pooled empagliflozin 10/25 mg and placebo groups, respectively. The incidence of any AEs, AEs leading to treatment discontinuation, severe AEs, and serious AEs was similar across groups. The frequency of serious AEs requiring hospitalization was 18.6% for the empagliflozin 10/25 mg group and 21.3% for the placebo group. The empagliflozin 10/25 mg group was not associated with a higher rate of confirmed hypoglycemia versus placebo, except in patients co-administered insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The incidence of events consistent with urinary tract infections (UTI) was also similar for the empagliflozin 10/25 mg group versus placebo (9.27 vs. 9.70/100 patient-years, respectively). History of UTI was identified as a risk factor for UTI during treatment. Events consistent with genital infections occurred more frequently with empagliflozin 10/25 mg than placebo (3.54 vs. 0.95/100 patient-years, respectively). The frequency of AEs consistent with volume depletion was similar across groups, but higher with empagliflozin 10/25 mg than placebo in patients aged 75 to < 85 years and those on loop diuretics at baseline. CONCLUSION:This comprehensive analysis confirms that both empagliflozin 10 mg and 25 mg are well tolerated in patients with T2DM, reinforcing the established clinical safety profile of empagliflozin. :Empagliflozin is approved to treat adults with type 2 diabetes mellitus (T2DM) insufficiently controlled by diet and exercise. It lowers blood glucose levels by inhibiting sodium-glucose co-transporter-2 (SGLT2), a protein involved in glucose reabsorption by the kidneys. By blocking SGLT2, glucose is removed in urine instead of being reabsorbed into the bloodstream. Numerous clinical studies have shown the effectiveness and safety of empagliflozin, but recent reports of two types of serious side effects [fractures and lower limb amputations (LLAs)] associated with another drug in the class, canagliflozin, has triggered a review of the risk associated with taking SGLT2 inhibitors. To examine the safety and tolerability of empagliflozin we pooled data from 20 clinical trials involving over 15,000 patients with T2DM who received either empagliflozin or placebo (control). We found that the risk of side effects was similar whether patients received empagliflozin or placebo. This included side effects that led to treatment being stopped as well as severe and serious side effects, including fractures and LLAs. Empagliflozin was not associated with a higher rate of hypoglycemia (low blood sugar) versus placebo, except in patients also treated with insulin and/or a sulfonylurea (31.5% vs. 30.2%, respectively). The risk of urinary tract infections was also similar for empagliflozin versus placebo (9.27 vs. 9.70/100 patient-years, respectively). However, genital infections, as anticipated, occurred more frequently in patients treated with empagliflozin than placebo (3.54 vs. 0.95/100 patient-years, respectively). Overall, this analysis confirms the results of previous studies showing that empagliflozin is well tolerated in patients with T2DM.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Kinduryte Schorling O,Clark D,Zwiener I,Kaspers S,Lee J,Iliev Hdoi
10.1007/s12325-020-01329-7subject
Has Abstractpub_date
2020-08-01 00:00:00pages
3463-3484issue
8eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-020-01329-7journal_volume
37pub_type
杂志文章abstract:INTRODUCTION:Synthesis of evidence on the long-term use of first-line biologic therapy in patients with early rheumatoid arthritis (RA) is required. We compared the efficacy of up to 5 years' treatment with first-line tumor necrosis factor inhibitors (TNFis) versus other treatment strategies in this population. METHOD...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-018-0869-8
更新日期:2019-03-01 00:00:00
abstract::Hyperthyroidism is associated with increased bone turnover. Besides the hormones of calcium metabolism, locally produced factors are important in maintaining normal bone metabolism. Interleukin-6 (IL-6), in particular, has a major influence on bone turnover. In this study, serum IL-6 and tumor necrosis factor-alpha (T...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850169
更新日期:2006-05-01 00:00:00
abstract::The efficacy and safety of the butterbur leaf extract Ze 339 (carbon dioxide extract from the leaves of Petasites hybridus L., 8 mg petasines per tablet) were tested in patients with seasonal allergic rhinitis. In an open postmarketing surveillance study, 580 patients were treated with an average of 2 tablets of Ze 33...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850143
更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of ep...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0029-0
更新日期:2013-05-01 00:00:00
abstract:INTRODUCTION:The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS. METHODS:Safety data of Japanese subjects en...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-018-0788-8
更新日期:2018-10-01 00:00:00
abstract:INTRODUCTION:To evaluate, from the patient's perspective, the burden of pain associated with hip/knee osteoarthritis (OA) in the USA and selected European Union (EU) countries. METHODS:Data were drawn from the 2017 global Adelphi OA Disease Specific Programme™ (DSP). Patients with hip/knee OA were stratified based on ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01445-4
更新日期:2020-09-01 00:00:00
abstract::The prognosis for patients with rheumatoid arthritis or spondyloarthritides has improved dramatically due to earlier diagnosis, recognition of the need to treat early with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), alone or in combinations, the establishment of treatment targets, and the ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0142-8
更新日期:2014-08-01 00:00:00
abstract::Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis exhibit a progressive clinical phenotype. These chronic progressive fibrosing ILDs have a variety of underlying diseases, and their prevalence is currently unknown. Here we carry out the first systematic review of literature ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01578-6
更新日期:2020-12-14 00:00:00
abstract::Hypertension is recognized as a major risk factor for cardiovascular and renal diseases and represents the leading cause of mortality worldwide. In spite of proven benefits of hypertension treatment, blood pressure control rates are poor, even in high-income countries with virtually full-access to therapies. Nearly 75...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-013-0020-9
更新日期:2013-04-01 00:00:00
abstract:INTRODUCTION:The purpose of this study was to evaluate the clinical outcomes of patients with anterior segment neovascularization treated with or without intravitreal bevacizumab. METHODS:This was a retrospective, comparative case series of 60 patients with anterior segment neovascularization: 30 consecutive patients ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0001-1
更新日期:2009-02-01 00:00:00
abstract::Unfortunately, the fourteenth author's name was incorrectly published in the Original Article. The correct author name is Cen Hong. ...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-019-01009-1
更新日期:2019-08-01 00:00:00
abstract:INTRODUCTION:Recent research has suggested that serum tumor markers can give valuable prognostic information in gastric cancer. In this study, we examined the relationship between preoperative serum carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 19-9, CA 72-4, and alfa fetoprotein (AFP) levels on clinicopath...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0100-4
更新日期:2008-10-01 00:00:00
abstract:OBJECTIVE:Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP). METHODS:MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were in...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0056-z
更新日期:2009-08-01 00:00:00
abstract:INTRODUCTION:It is unclear whether patients and their loved ones appreciate that cardiovascular disease (CVD) is the major cause of morbidity and mortality in type 2 diabetes mellitus (T2DM). The purpose of this survey was to evaluate the degree of awareness regarding the link between T2DM and CVD. METHODS:An online s...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0871-9
更新日期:2019-03-01 00:00:00
abstract:INTRODUCTION:Evidence suggests that elevated plasma levels of B-type natriuretic peptide (BNP) are found in patients with chronic obstructive pulmonary disease (COPD) and right ventricular dysfunction. We examined the effects of exercise on plasma BNP levels in patients with COPD who have normal right ventricular funct...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:10.1007/s12325-008-0067-1
更新日期:2008-07-01 00:00:00
abstract:INTRODUCTION:Ample evidence suggested a role of sigma-1 receptor in affective disorders since the interaction of numerous antidepressants with sigma receptors was discovered. A recent study on Japanese subjects found a genetic variant within the encoding gene SIGMAR1 (rs1800866A>C) associated with major depressive diso...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0482-2
更新日期:2017-03-01 00:00:00
abstract:INTRODUCTION:To date, no study has reported the prevalence of cannabis use in chronic pain patients. The aim of this study is to investigate the trends in cannabis use among chronic pain in-patients from 2011 to 2015 in the USA. METHODS:Patients were identified from the National Inpatient Sample (NIS) database using t...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01416-9
更新日期:2020-08-01 00:00:00
abstract::The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in ai...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0074-x
更新日期:2009-10-01 00:00:00
abstract::Duodenal self-expandable metal stents (SEMS) are designed for palliation and prompt relief of malignant gastric outlet obstruction (GOO). This mini-invasive endoscopic treatment is preferable to surgery due to its lower morbidity and mortality, shorter hospitalization, and earlier symptoms relief; furthermore endoscop...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0061-2
更新日期:2010-10-01 00:00:00
abstract:INTRODUCTION:In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse eve...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01477-w
更新日期:2020-11-01 00:00:00
abstract:INTRODUCTION:A combination of magnetic resonance imaging (MRI) with real-time high-resolution ultrasound (US) known as fusion imaging may improve visualization of musculoskeletal (MSK) sports medicine injuries. The aim of this study was to evaluate the applicability of MRI-US fusion technology in MSK sports medicine. ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0217-1
更新日期:2015-06-01 00:00:00
abstract::The origin of chronic periodontal disease is strongly related to the nature and physiology of the subgingival bacterial biofilm, of which Porphyromonas gingivalis is a main protagonist. This study was conducted in vitro, to test the susceptibility of the W83 strain of P gingivalis to several oral antiseptics, bearing ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02877764
更新日期:2007-11-01 00:00:00
abstract::This study was conducted to determine the reasons for the choice of self-prescribed laxatives and to acquire information on how they were used and tolerated. From November 1999 to February 2000, 70 pharmacies, uniformly located throughout the Campania region of southern Italy, distributed a questionnaire to purchasers...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850360
更新日期:2002-09-01 00:00:00
abstract::Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections in adolescents. Such infection is associated with substantial health risks and is unpredictable in its resolution. Genital warts are the most common clinical manifestations of genital HPV infections. Most genital warts are c...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/BF02849928
更新日期:2005-05-01 00:00:00
abstract::Salivary gland carcinomas of the larynx are uncommon. Adenoid cystic carcinoma is the most prevalent type of salivary gland carcinoma in this region, although other histologies such as mucoepidermoid carcinoma and adenocarcinomas have been reported. These tumors may present with advanced-stage due to nonspecific sympt...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-017-0494-y
更新日期:2017-04-01 00:00:00
abstract:INTRODUCTION:Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) approved to date are administered by injection; therefore, patient perceptions of an oral GLP-1 RA are unknown. This discrete choice experiment explored preferences for (unbranded) oral and injectable GLP-1 RA profiles among Japanese patients with typ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01561-1
更新日期:2020-11-27 00:00:00
abstract:INTRODUCTION:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome meas...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00920-x
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Adrenocortical carcinoma (ACC) is a rare malignancy with poor prognosis. It is vitally important to predict prognosis and restrict unnecessary adjuvant treatments for patients with ACC. This study aims to confirm the prognostic value of Ki-67 and provide a prognostic evaluation on ACC after primary surgery...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01050-0
更新日期:2019-10-01 00:00:00
abstract::In a randomized, controlled, double-blind trial, 70 patients (mean age, 49.7 years) suffering from mild to moderate depression received one tablet of either St. John's Wort (Hypericum perforatum) extract (Calmigen) or fluoxetine hydrochloride (Prozac) twice a day for 6 weeks. Efficacy was determined according to the 1...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2002-01-01 00:00:00
abstract::Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent and relevant healthcare issues. Direct oral anticoagulants (DOACs) are now the first-choice for anticoagulant treatment of these conditions displaying a better efficacy/safety profile than vitamin-K antagonists, mainly due to significantly ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01307-z
更新日期:2020-05-01 00:00:00