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com pared with 0.002 for the pioglitazone-treated pa tients. At the end of the study, pa tients treated with
pioglitazone had a re duc tion of 0.33% in A1C lev els, com pared with pa tients treated with glimepiride,
who had a re duc tion of 0.01%. Treat ment with pioglitazone de creased triglyceride lev els by 13.5% ver -
sus an in crease of 2.1% in pa tients treated with glimepiride. Pioglitazone-treated pa tients showed an in -
crease in HDL-C lev els of 12.8% com pared with a de crease of 1.1% in pa tients treated with glimepiride.
Both treat ment groups showed in creased LDL-C lev els, pioglitazone by 5.8% and glimepiride by 1%.
Data pre sented in No vem ber 2006 and pub lished in the Jour nal of the Amer i can Med i cal As so ci a tion
(JAMA) dem on strated that Actos halted the pro gres sion of ath ero scle ro sis as in di cated by ca rotid in -
tima-me dia thick ness (CIMT), with the anal y sis dem on strat ing a sig nif i cant rel a tive re duc tion in the pro -
gres sion of CIMT with Actos in pa tients with type 2 diabetes. The 18-month study involved 462 patients
and found that the drug raised HDL (which seems to protect against heart attacks) levels by about 13%.
In Sep tem ber 2006, Takeda re ported fur ther anal y ses of data from a Eu ro pean phase III trial of
pioglitazone, des ig nated PROactive (PRO spec tive pioglitazone Clin i cal Trial In macroVascular Events).
The ran dom ized, dou ble-blind, pla cebo-con trolled study eval u ated the ef fects of pioglitazone in ad di tion
to stan dard care treat ment on mor tal ity and macrovascular mor bid ity in 5,238 pa tients with Type 2 di a -
be tes and macrovascular dis ease. The re sults showed that pioglitazone re duced the in ci dence of strokes
in pa tients who had al ready ex pe ri enced a stroke from 10.2% to 5.6%. The agent re duced the com bined
risk of death, myo car dial in farc tion or stroke by 28%, but had no ef fect on sub se quent strokes in pa tients
who had never ex pe ri enced a stroke. As re ported in Sep tem ber 2005, the trial’s com bi na tion pri mary
end point of risk of seven macrovascular dif fer ent events was re duced by 10% but had not reached sta tis -
ti cal sig nif i cance by the end of the trial. The main sec ond ary end point of com bined risk of death, heart at -
tack and stroke was reduced by 16% in high-risk patients with Type 2 diabetes.
At the Amer i can Di a betic As so ci a tion 65th An nual Meet ing in June 2005, a num ber of stud ies were pre -
sented, in clud ing one where Actos showed anti-in flam ma tory ef fects by re duc ing CRP lev els, thought to
be a marker of in flam ma tion and risk fac tor for car dio vas cu lar dis ease al though anal y sis in 2008 showed
that this risk was no higher in in di vid u als with ge net i cally de ter mined high CRP lev els. An other study
showed that Avandia may re duce blood pres sure in com bi na tion with a sulfonylurea or with metformin
(where it was also shown to re duce microalbuminuria); re sults re leased the pre vi ous month (pub lished in
‘Cir cu la tion’) re vealed that Actos re duced ca rotid ar tery intimamedia thick ness (IMT), CRP lev els and
blood pres sure as well as in su lin re sis tance, all of which con trib ute to the over all risk for car dio vas cu lar
dis ease. Data pre sented at the Amer i can Col lege of Car di ol ogy meet ing in March 2005 showed that Actos
sig nif i cantly re duced neointima for ma tion af ter stent im plan ta tion with out af fect ing met a bolic pa ram e -
ters in 50 non-di a betic pa tients. While pre vi ous stud ies into the role of thiazolidinedione antidiabetics
(TZDs), in clud ing Avandia, in di a betic pa tients have led to un cer tainty, this study showed that Actos may
ex hibit pro tec tive ef fects on the vessel wall. More studies are required however to see how this can be
translated into clinical benefits.
Re sults of an other (24-week) study, in volv ing 802 di a betic pa tients, were pub lished in Di a be tes Care in
June 2005, dem on strat ing that Actos im proved com po nents of di a betic dyslipidemia to a sig nif i cantly
greater ex tent than Avandia. Switch ing pa tients tak ing a statin from Avandia to Actos was also re ported
(from the Com ple ment study) to pro duce ben e fits be yond those re sult ing from tra di tional cho les terol
low er ing statin therapy in key lipid parameters.
The first di rect com par i son of Actos and GlaxoSmithKline’s (GSK, UK) Avandia in type 2 di a bet ics showed
that Actos is su pe rior at con trol ling lipid lev els. The re sults, pre sented at the Amer i can Heart As so ci a tion
meet ing in New Or leans in No vem ber 2004, con firmed pre vi ous sug ges tions that there may be dif fer -
ences be tween the two prod ucts in terms of their lipid pro files. This could have im pli ca tions for the risk of
car dio vas cu lar dis ease in long-term us age and would thus in flu ence doc tor’s pre scrib ing choices. Con fir -
ma tion of a ben e fit in terms of car dio vas cu lar out comes would be a big as set for Actos. Actos was also
shown to re duce the thick ness of the ca rotid ar tery in type 2 diabetics compared to glimepride, an older
drug.
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