follow-up of glycemic control and.pptx
TRANSCRIPT
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o ow-up o ycem c ontro an
Cardiovascular Outcomes in Type 2
Diabetes Journal Reading
Dr Doni !aputr
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"ntroduction
#atients wit$ type 2 diabetes $ave a greatlyincreased ris% of cardiovascular events
&ost observational studies $ave s$own an
association between glucose control andcardiovascular disease
T$ere were Four large' randomi(ed' controlled trialsof improved glucose control in patients wit$ type 2diabetes
)*D#!
+CCORD
+D,+C.
,+DT
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"ntroduction
)nited *ingdom #rospective Diabetes !tudy /)*#D!0
T$e most evidence for a reduction in t$e rate ofcardiovascular events wit$ intensive glucose control camefrom t$e )*#D!
Outcomes in t$e )*#D! could be related to interventions ina younger' $ealt$ier group of patients wit$ newly diagnosedtype 2 diabetes or could be related to t$e fact t$at t$e)*#D! used a less intensive glucose treatment protocolt$an t$at used in t$e ot$er trials
+ction to Control Cardiovascular Ris% in Diabetes/+CCORD0
T$e +CCORD trial also recently s$owed a signi1cantreduction in t$e rate of nonfatal cardio- vascular events in a
follow-up of its study population' but t$at bene1t was osetby an increase in mortality in t$e original trial
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"ntroduction
+ction in Diabetes and ,ascular Disease3 #retera4 andDiamicron &odi1ed Release Controlled .valuation/+D,+C.0
"n contrast' no reduction in t$e rate of cardiovascu- lar eventsor in mortality was found in a follow- up of t$e +D,+C. trial
,eteran +airs Diabetes Trial /,+DT0
+ report cardiovascular outcomes after an e4tended follow-upperiod of t$e ,+DT a multisite' randomi(ed' controlled trial of
intensive versus standard glucose control in )! militaryveterans wit$ type 2 diabetes' in w$ic$ patients werefollowed for up to 56 years /median' 67 years0
t$e primary out- come of ma8or cardiovascular events wasnonsig- ni1cantly lower in t$e intensive-t$erapy group t$an in
t$e standard-t$erapy group
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&et$ods
!tudy
Design
T$e original study included 95:9 militaryveterans wit$ type 2 diabetes w$o wererandomly assigned to receive eit$er
intensive or standard glucose control
T$e participants w$o were alive andenrolled at t$e conclusion of t$e studyare being followed t$roug$ a national
data registry
T$e coordinating sites in ;ines' "llinois'and +nn +rbor' &ic$igan' collected allt$e data for t$is follow up study
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&et$ods
Data!ourc
es
T$e central ,+ medicalinformation 1les
T$e Centers for &edicare and&edicaid !ervices /C&!0&edicare claims 1les
T$e ,+ deat$ 1les
T$e ational Deat$ "nde4 /D"0
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&et$ods
#rimary
Outcomes
• T$e time to t$e 1rst ma8or cardiovascularevent• T$ere are c$anges in t$e primary outcome
ma%e direct comparisons wit$ t$e original,+DT results di
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&et$ods
Sensitivity Analysis
To assess for potential sample-selection
bias' t$ey soug$t and were granted a;ealt$ "nsurance #ortability and+ccountability +ct waiver to e4amine t$eirprimary and secondary outcomes in t$ecomplete co$ort
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&et$ods
Statistical Analysis
T$e main analysis was performed according to t$eintention-to-treat principle' and *aplan=&eier
survival curves were generated by means of t$eproduct-limit met$od
Dierences in attributes between t$e twotreatment groups were assessed wit$ t$e use oft$e c$i-s>uare test for proportions and !tudent?s t-
test or analysis of variance for continuousvariables
T$ey prespeci1ed t$ree variables to e4amine$eterogeneity of treatment eects' following t$eapproac$ proposed by *ent and colleagues
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Results
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&et$ods
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&et$ods
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Discussion
T$e leading cause of complications anddeat$ in patients wit$ type 2 diabetes is
cardiovascu- lar disease @$en our results are combined wit$
t$ose of t$e t$ree ot$er ma8or clinicaltrials of glycemic control in type 2
diabetes' a clearer picture of t$e eect ofimproved glycemic control seems to beemerging
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T$e results s$ould not be interpreted assupporting a performance measure for
evaluating t$e >uality of care provided byclinicians and $ealt$ systems t$at usest$e proportion of patients w$o reac$ aglycated $emoglobin level of less t$an5AB
.ven wit$ t$e support of a dedicatedresearc$ team' only appro4imately $alft$e participants $ad a glycated
$emoglobin level of less t$an 5AB
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Discussion
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Conclusion
T$e study found t$at among patients w$o $ad beenrandomly assigned to intensive glucose control orstandard t$erapy for a median of 67 years' t$e
intensive-t$erapy group $ad a signi1cant 95B relativereduction in ma8or cardiovascular events' as comparedwit$ t$e standard-t$erapy group' after almost 9A yearsof total follow-up t$is relative reduction represented 7ma8or cardiovascular events prevented per 9AAAperson-years
+s compared wit$ standard t$erapy' intensive glucosecontrol was not associated wit$ a signi1cant decrease inall-cause mortality after almost 92 years of follow-up