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BENEDICT CORE RESOURCE KIT

BENEDICT



Please remember to include prescribing information when adapting these materials for local use



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



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



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



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



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%



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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