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cebo-treated pa tients at 7.2%. An other sig nif i cant find ing was that as long as the drug was given at least
three days af ter a stroke, pa tients’ car dio vas cu lar mor bid ity and mor tal ity were im proved. No car dio vas -
cu lar or cerebrovascular events oc curred as a re sult of low blood pres sure after treatment with
candesartan cilexetil.
Re sults of the SCOPE study in volv ing 4,964 el derly pa tients with high sys tolic blood pres sure were re -
ported at the Amer i can Heart As so ci a tion meet ing in No vem ber 2003. Candesartan dra mat i cally re duced
the risk of fa tal and non-fa tal strokes ver sus pla cebo, de spite both groups of pa tients main tain ing sim i lar
val ues for systolic blood pressure.
AstraZeneca an nounced in July 2004 that it had sub mit ted a sup ple men tal NDA to the US FDA for ap -
proval of Atacand for the treat ment of chronic heart fail ure (CHF). The study re search ers con cluded that
candesartan should be con sid ered in all chronic heart fail ure pa tients. How ever, other ex perts at the
meet ing were not as cer tain that the find ings could be ap plied so broadly, point ing to less con vinc ing data
for pa tients with pre served left ven tric u lar func tion. Ear lier in April 2004, Takeda Eu rope R&D Cen ter in
Lon don filed a Eu ro pean ap proval ap pli ca tion for Blopress for CHF (the UK will act as ref er ence mem ber
state). The mu tual rec og ni tion vari a tion pro ce dure for the prod uct cov ers Aus tria, Ger many, It aly, Ire -
land, Por tu gal, Spain, and the UK, where the Jap a nese firm has mar ket ing rights. Sep a rate sub mis sions
will be made soon in France and Swit zer land. The filings were based on the results of the CHARM
program.
In Au gust 2004, data pre sented at the Eu ro pean So ci ety of Car di ol ogy (ESC) Con gress re in forced the
ben e fits of candesartan cilexetil in pa tients with CHF and re duced left ven tric u lar ejec tion frac tion (LVEF).
The data dem on strated a sig nif i cant re duc tion in deaths and CHF hos pi tal ad mis sions in fa vor of the com -
pound, add ing fur ther sup port to the July 2004 an nounce ment. A pre-spec i fied anal y sis in the group of
CHARM pa tients with heart fail ure and re duced LVEF, the higher risk pop u la tion most fre quently stud ied
in pre vi ous heart fail ure clin i cal tri als, dem on strated a 12% rel a tive risk re duc tion in all cause deaths and
a 16% rel a tive risk re duc tion in car dio vas cu lar deaths when candesartan was added to stan dard treat -
ment. The ef fect of treat ment with candesartan was sim i lar ir re spec tive of background treatment with
ACE-inhibitors, beta-blockers, or spironolactone.
Lifecycle Man age ment: In Au gust 2008, Takeda re vealed that it is de vel op ing a fixed-dose com bi na -
tion of candesartan with the cal cium an tag o nist amlodipine in Ja pan, un der go ing phase III development.
A com bi na tion prod uct with a di uretic (Blopress Comp/Blopress R) has been launched in a num ber of
mar kets (see sep a rate drug re cord), and Takeda is now de vel op ing the drug for sev eral new indications.
In 2000, Takeda and AstraZeneca launched the DI RECT (DI a betic REtinopathy Candesartan Trial) pro -
gram, which com prises three clin i cal tri als within one pro gram is ex am in ing whether candesartan can
pre vent the on set and pro gres sion of di a betic retinopathy, a com pli ca tion of di a be tes that can lead to
blind ness. There is cur rently no spe cific treat ment for di a betic retinopathy, though glycemic and blood
pres sure con trol can help. The trial has com pleted the ran dom iza tion of 5238 pa tients with type I and II
di a be tes in 30 coun tries, to re ceive ei ther 32 mg candesartan cilexetil or pla cebo and AstraZeneca re -
ported base line data for 5231 di a betic pa tients en rolled in this trial in May 2005. Full re sults of the three
dou ble-blind stud ies in volv ing 5,213 pa tients, ran dom ized to re ceive 32mg of candesartan or pla cebo for
at least four years were re ported in Sep tem ber 2008 and pub lished in The Lan cet. Candesartan re duced
the in ci dence of di a betic retinopathy by 18% com pared with pla cebo. In the type I di a bet ics with
retinopathy there was no dif fer ence in pro gres sion be tween the two groups while candesartan re duced
the pro gres sion of retinopathy in type 2 di a bet ics by 13% com pared with pla cebo. As a con se quence of
the re sults, Takeda de cided not to pursue this indication in prevention of the onset and progression of
diabetic retinopathy.
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