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Abstract e 53

ORAL SESSION

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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