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BENEDICT CORE RESOURCE KIT
BENEDICT
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Please remember to include prescribing information when adapting these materials for local use
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Tarka
Progression of nephropathy in type 2 diabetes
● Previous clinical trials (IRMA-2,2 MICRO-HOPE,3 IDNT,4 and
RENAAL5) have studied patients in whom albuminuria was
already present
BENEDICT: the first and only large-scale trial to show thatmicroalbuminuria can be prevented
in hypertensive type 2 diabeticpatients with normoalbuminuria1
*Primary endpoint was time to progression to microalbuminuria
†Primary endpoint was time to progression to macroalbuminuria
‡Endpoint was time to progression to macroalbuminuria
§Primary endpoint was time to progression to end-stage renal disease
BENEDICT 1*
Urinary Albumin Excretion (mg/l) <20
MNormoalbuminuria
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Mortality rates rise as urinary albumin excretion increases6
● Urinary albuminexcretion is a strong
predictor of overall
mortality in the general
population
● Urinary albumin
excretion is strongly
related to overall
mortality, even in
normoalbuminuric
individuals
●
A particularly strongassociation is seen
between urinary
albumin excretion and
cardiovascular death
A cohort study of over 40,000 members of the general population,
published in Circulation in 2002,6 found that:
30
20
10
0
4.53.5
10-200-10
C r u d e I n c i d e n c
e R a t e f o r O v e r a l l M o r t a l i t y / 1 0 0 0
P e r s o n - Y e a r s 6
Normoalbuminur
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Tarka: preventing microalbuminuriain diabetic hypertensive patients1
Background1
● Past studies have shown proteinuria reduction with
renin-angiotensin inhibitors and non-dihydropyridine
calcium channel blockers (non-DHP CCBs) in
hypertensive type 2 diabetic patients with
microalbuminuria
● BENEDICT compared Tarka with placebo in the
prevention of microalbuminuria in hypertensive type 2
diabetic patients with normal albumin excretion rates
Key inclusion criteria1,7
● Hypertensive patients aged ≥40 years (mean baseline
BP 151/88 mm Hg)
● Known history of type 2 diabetes (≤25 years)
● Normoalbuminuria (urinary albumin excretion rate
<20 µg/min)
The first and only large-scale trial to indicate that
microalbuminuria can be prevented in hypertensive patients
with type 2 diabetes
BENEDICT the BErgamo NEphrologicDIabetes Complications Trial1,7
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Tarka: preventing microalbuminuriain diabetic hypertensive patients1
BENEDICT evaluated the ability of Tarka to prevent micro-albuminuria in hypertensive type
2 diabetic patients withnormoalbuminuria1
Primary endpoint 1
● Time to progression to microalbuminuria
with Tarka vs placebo
Secondary endpoints 1
● Time to progression to microalbuminuria
with:
Trandolapril vs placebo
Verapamil SR vs placebo
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Tarka is the first and only fixed-dose combination to show prevention of microalbuminuria
in hypertensive type 2 diabeticpatients1
Management goals for normoalbuminuric
diabetic patients
● Microalbuminuria is one early marker of
diabetic nephropathy and a risk factor for
cardiovascular events1,9
● 30% of middle-aged
diabetic patients(type 1 and 2)
have developed
microalbuminuria9
● About one-third of type 2 diabetic patients
will develop diabetic nephropathy1
● Preventing or delaying the onset of
microalbuminuria is therefore a key goal for
both renal and cardioprotection in
hypertensive diabetic patients1,7
30%
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Current international guidelines(ESH/ESC and JNC 7) recommendcombination therapy in diabetic
hypertensive patients
10,11
● Target BP in these high-risk patients is <130/80 mm
Hg10,11
● In INVEST, over 80% of patients were taking two or
more antihypertensive drugs12
● Diabetic patients in INVEST required a mean of 2.9
antihypertensive drugs13
No. of antihypertensive drugs used in INVEST
1 2 ≥3
15
31
52
60
50
40
30
20
10
0
% o
f p a t i e n t s
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