arterial pressure (MAP), reecting cardiac output multiplied by vascular resistance
(MAP = ([2 x DBP] + SBP)/3) and heart rate (HR).
ORAL SESSION 4B
DIABETES
4B.01
CONTRASTING INFLUENCES OF RENAL FUNCTION ON
BLOOD PRESSURE AND HBA1C REDUCTIONS WITH EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES AND HYPERTENSION
D. Cherney 1 , M. Cooper 2 , I. Tikkanen 3 , S. Crowe 4 , O.E. Johansen 5 , S.S. Lund 4 ,
H.J. Woerle 4 , U.C. Broedl 4 , T. Hach 4 . 1 Toronto General Hospital, University of Toronto, Toronto, CANADA, 2 Baker IDI Heart and Diabetes Institute, Melbourne, AUSTRALIA, 3 Helsinki University Central Hospital and Minerva Institute for Medical Research, Helsinki, FINLAND, 4 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY, 5 Boehringer
Results: In placebo and empagliozin groups, respectively, baseline mean SBP
was 128.6 and 129.3 mmHg, DBP was 78.0 and 78.5 mmHg, PP was 50.5 and 50.8 mmHg, MAP was 94.9 and 95.4 mmHg and HR was 74.3 and 74.1 bpm. At week 24, compared with placebo, empagliozin signicantly reduced HbA1c (mean [SE] difference: -0.65% [0.03]; p < 0.001), SBP (mean [SE]: -3.6 [0.5] mmHg; p < 0.001), DBP (mean [SE]: -1.3 [0.3] mmHg; p < 0.001), PP (mean [SE]: -2.3 [0.4] mmHg; p < 0.001) and MAP (mean [SE]: -2.1 [0.3] mmHg; p < 0.001). Adjusted mean (SE) change in HR with empagliozin compared to placebo was -0.8 (0.3); p < 0.05. Conclusions: Empagliozin had favourable effects on BP, arterial stiffness and vascular resistance, which are intermediate markers of cardiovascular risk. The EMPA-REG OUTCOMETM trial (NCT01131676) will evaluate whether these benets will translate into cardiovascular risk reduction. 4B.03
Ingelheim Norway KS, Asker, NORWAY
Objective: To determine if impaired renal function attenuates antihypertensive effects of empagliozin. Design and method: In a Phase III randomised placebo-controlled trial (EMPAREG BPTM ), patients with type 2 diabetes and hypertension (dened as mean seated ofce systolic blood pressure [SBP] 130159 mmHg and diastolic BP 8099 mmHg at screening) received empagliozin 10 mg, empagliozin 25 mg or placebo for 12 weeks (mean [SD] age 60.2 [9.0] years, HbA1c 7.90 [0.74] %, 24-hour SBP 131.4 [12.3] mmHg). We assessed changes from baseline in mean ambulatory 24-hour SBP and HbA1c in subgroups by baseline eGFR (MDRD equation). Results: In patients with normal renal function, stage 2 or 3 chronic kidney disease (CKD; eGFR >=90 [n = 261], 60 to <90 [n = 516], 30 to <60 [n = 45] ml/min/1.73m2 , respectively), empagliozin signicantly reduced HbA1c and mean 24-hour SBP versus placebo. As expected, placebo-corrected HbA1c reductions with empagliozin appeared to decrease with decreasing eGFR. Differences versus placebo in changes from baseline in mean 24-hour SBP were 3.8 (6.3,1.4) and 3.4 (5.7,1.1) mmHg with empagliozin 10 mg and 25 mg, respectively, in patients with normal renal function, 2.7 (4.4, 1.1) and 4.5 (6.2,2.8) mmHg, respectively, in patients with stage 2 CKD, and 11.0 (17.4,4.6) and 6.8 (12.6,1.0) mmHg, respectively, in patients with stage 3 CKD (all p < 0.05). Conclusions: Unlike HbA1c, reductions in mean 24-hour SBP with empagliozin in patients with type 2 diabetes and hypertension appear to be greater in patients with lower eGFR, indicating that SBP modulation with empagliozin may involve pathways other than urinary glucose excretion.
4B.02
THE SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR
EMPAGLIFLOZIN REDUCES BLOOD PRESSURE AND MARKERS OF ARTERIAL STIFFNESS AND VASCULAR RESISTANCE IN TYPE 2 DIABETES
R. Chilton 1 , I. Tikkanen 2 , C.P. Cannon 3 , S. Crowe 4 , T. Hach 4 , H.J. Woerle 4 ,
U.C. Broedl 4 , O.E. Johansen 5 . 1 University of Texas Health Science Center, San Antonio, TX, USA, 2 Helsinki University Central Hospital and Minerva Institute for Medical Research, Helsinki, FINLAND, 3 Harvard Clinical Research Institute, Boston, MA, USA, 4 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY, 5 Boehringer Ingelheim Norway
KS, Asker, NORWAY
EMPAGLIFLOZIN REDUCES SYSTOLIC BLOOD PRESSURE
IN DIPPER AND NON-DIPPER PATIENTS WITH TYPE 2 DIABETES AND HYPERTENSION
R. Chilton 1 , I. Tikkanen 2 , S. Crowe 3 , O.E. Johansen 4 , U.C. Broedl 3 ,
H.J. Woerle 3 , T. Hach 3 . 1 University of Texas Health Science Center, San Antonio, TX, USA, 2 Helsinki University Central Hospital and Minerva Institute for Medical Research, Helsinki, FINLAND, 3 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY, 4 Boehringer Ingelheim
Norway KS, Asker, NORWAY
Objective: To assess changes in systolic blood pressure (SBP) with empagliozin in patients with type 2 diabetes and hypertension (dened as mean seated ofce SBP 130159 mmHg and diastolic BP 8099 mmHg) categorised as dippers or non-dippers. Design and method: In a subgroup analysis of patients who received empagliozin 10 mg, empagliozin 25 mg or placebo in a Phase III randomised trial (EMPAREG BPTM ), we assessed changes from baseline in SBP (mean 24-h, awake-time, sleep-time) via ambulatory BP monitoring at week 12 in patients categorised as dippers (sleep-time mean SBP <=90% of awake-time mean; n = 417) or non-dippers (sleep-time mean SBP > 90% of awake-time mean; n = 350). Results: Baseline mean (SD) 24-h SBP (mmHg) was 129.9 (11.6) in dippers and 133.1 (12.4) in non-dippers. Adjusted mean (SE) changes from baseline in mean 24-h SBP (mmHg) in dippers were -0.2 (0.7) with placebo versus -3.8 (0.6) and -3.9 (0.7) with empagliozin 10 and 25 mg, respectively (both p < 0.001), and in non-dippers were 1.0 (0.7) with placebo versus -1.6 (0.7) with empagliozin 10 mg (p = 0.013) and -3.8 (0.7) with empagliozin 25 mg (p < 0.001). Hourly mean SBP patterns over 24 h for dippers and non-dippers were maintained with empagliozin 10 mg and 25 mg. Compared with placebo, changes from baseline in awake-time and sleep-time SBP were signicantly greater with empagliozin 10 mg or 25 mg, except for sleep-time SBP with empagliozin 10 mg. Conclusions: In patients with type 2 diabetes and hypertension, empagliozin 10 mg and 25 mg signicantly reduced SBP versus placebo in dippers and nondippers. 4B.04
COST-UTILITY OF ANGIOTENSIN-CONVERTING ENZYME
INHIBITOR COMPARED TO THIAZIDE DIURETIC BASED TREATMENT FOR HYPERTENSION IN ELDERLY AUSTRALIANS CONSIDERING DIABETES AS COMORBIDITY
E. Chowdhury 1 , Z. Ademi 1,2 , J. Moss 3 , L. Wing 4 , C. Reid 1 . 1 Department of
Objective: To assess the vascular effects of empagliozin, beyond reducing systolic
blood pressure (SBP) and diastolic BP (DBP) in patients with type 2 diabetes. Design and method: Using pooled data from patients with type 2 diabetes (n = 2477) who participated in four 24-week phase III randomised trials of empagliozin 10 mg or 25 mg (n = 1652) versus placebo (n = 825) as monotherapy or add-on therapy (mean [SD] age 55.6 [10.2] years, HbA1c 8.0 [0.9]%, BMI 28.7 [5.5] kg/m2 ), we assessed changes in HbA1c, SBP, DBP, pulse pressure (PP; SBP -DBP), a validated surrogate marker of the stiffening of the conduit vessels, mean
Epidemiology and Preventive Medicine, Monash University, Melbourne,
AUSTRALIA, 2 European Centre of Pharmaceutical Medicine (ECPM), University of Basel, Basel, SWITZERLAND, 3 School of Population Health, the University of Adelaide, Adelaide, AUSTRALIA, 4 Department of Clinical Pharmacology, School of Medicine, Flinders University, Adelaide, AUSTRALIA Objective: To examine the cost-effectiveness of angiotensin-converting enzyme inhibitor-based (ACEI) treatment compared to thiazide diuretic-based treatment
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Copyright 2015 Wolters Kluwer Health, Inc. All rights reserved.