Empagliflozin improves blood pressure in patients with type 2 diabetes (T2DM) and hypertension

Tikkanen, I.; Narko, Kirsi; Zeller, Cordula; Green, A; Salsali, Afshin; Broedl, UC; Woerle, HJ

doi:10.1055/s-0034-1374901

Cited by 4 publications

(8 citation statements)

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“…These findings were similar for the 10-mg dose ( Table 2). Of note, 24-h ambulatory blood pressure monitoring utilized in one of the included studies reported similar estimates [30]. The observed blood pressure lowering benefit for empagliflozin was also evident in active-controlled trials ( Table 2).…”

Section: Blood Pressurementioning

confidence: 61%

“…In total, we included 11 records describing 10 studies with 6203 participants in our systematic review and meta-analysis [20][21][22][23][24][25][26][27][28][29][30]. Of these, seven records were published in full text [20][21][22][23][26][27][28], whereas the remaining four records were identified through hand-search of major scientific meetings and were available 12 studies on healthy or nondiabetic subjects 10 in vitro or animal studies 1 trial on patients with type 1 diabetes 3 trials with less than 12weeks duration 1 trial protocol 3 pooled-analyses 2 systematic reviews 11 records describing 10 studies included in systematic review and meta-analysis only in abstract and/or e-poster forms [24,25,29,30]. Of note, our search of ClinicalTrials.gov identified four additional eligible studies (NCT01306214, NCT01368081, NCT01422876 and NCT01649297) that have been completed only recently and have not yet been publicized.…”

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

“…In all included trials empagliflozin was compared with placebo, whereas in one trial [21,22] and another two trials [22,27,28] empagliflozin was also compared with metformin and sitagliptin respectively. Participants in four studies received no background antidiabetic therapy [21,22,25,27,30]. In the remaining studies, participants were on background treatment with metformin [22,24,28], metformin plus sulfonylurea [23], metformin plus pioglitazone [26], any oral antidiabetic drug [20] or basal insulin [29].…”

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

“…In the remaining studies, participants were on background treatment with metformin [22,24,28], metformin plus sulfonylurea [23], metformin plus pioglitazone [26], any oral antidiabetic drug [20] or basal insulin [29]. Finally, one trial [20] enrolled patients exclusively with renal impairment (eGFR between 15 and 90 ml/min/1.73 m 2 ), while one study [30] recruited participants with hypertension.…”

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

“…Risk-of-bias assessment is shown in Table S1. Eight studies [21][22][23][24][25][26][28][29][30] were rated at high risk of bias owing to the use of inappropriate imputation method [i.e. last observation carried forward (LOCF)] to handle missing data for HbA1c.…”

Section: Risk-of-bias Assessmentmentioning

confidence: 99%

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Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta‐analysis

Liakos

Karagiannis

Athanasiadou

et al. 2014

Diabetes Obesity Metabolism

188

144

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Section: Blood Pressurementioning

confidence: 61%

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

Section: Results Of Search and Study Characteristicsmentioning

confidence: 99%

Section: Risk-of-bias Assessmentmentioning

confidence: 99%

See 3 more Smart Citations

Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta‐analysis

Liakos

Karagiannis

Athanasiadou

et al. 2014

Diabetes Obesity Metabolism

188

144

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Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

Zinman

Inzucchi

Lachin

et al. 2014

Cardiovasc Diabetol

227

164

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BackgroundEvidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes.MethodsPatients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of <1.3 with a one-sided α of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved.ResultsBetween Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, and eGFR 74 ± 21 ml/min/1.73 m2. The study is expected to report in 2015.DiscussionEMPA-REG OUTCOME™ will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.Trial registrationClinicaltrials.gov NCT01131676

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Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study

Nishimura

Tanaka

Koiwai

et al. 2015

Cardiovasc Diabetol

100

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BackgroundThis study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM).MethodsPatients (N = 60; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m2) were randomized to receive empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19) or placebo (n = 21) once daily as monotherapy for 28 days. A meal tolerance test and continuous glucose monitoring (CGM) for 24 hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast (AUC1–4h for PPG) at day 28.ResultsAdjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were −97.1 (−126.5, −67.8) mg · h/dl with empagliflozin 10 mg and −91.6 (−120.4, −62.8) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were −85.5 (−126.0, −45.0) mg · h/dl with empagliflozin 10 mg and −104.9 (−144.8, −65.0) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were −20.8 (−27.0, −14.7) mg/dl with empagliflozin 10 mg and −23.9 (−30.0, −17.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were −24.5 (−35.4, −13.6) mg/dl with empagliflozin 10 mg and −31.7 (−42.5,-20.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ≥70 to <180 mg/dl increased from 52.0% at baseline to 77.0% at day 28 with empagliflozin 10 mg and from 55.0% to 81.1% with empagliflozin 25 mg, without increasing time spent with hypoglycemia.ConclusionEmpagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM.Trial registrationClinicaltrials.gov NCT01947855Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-014-0169-9) contains supplementary material, which is available to authorized users.

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Empagliflozin improves blood pressure in patients with type 2 diabetes (T2DM) and hypertension

Cited by 4 publications

References 0 publications

Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta‐analysis

Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta‐analysis

Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study

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