MD Conference Express - ENDO 2015 - (Page 6)
FEATUrED ArTIClES
Table 2. Ongoing Cardiovascular Trials for Diabetes Drugs (Noninsulin)
Study
Class
SAVOR
EXAMINE
TECOS
CAROLINA
CARMELINA
DPP4i
Saxagliptin
Alogliptin
Sitagliptin
Linagliptin
Linagliptin
Placebo
Placebo
Placebo
Sulfonylurea
Placebo
Comparator
No.
Results
16 500
5400
14 000
6000
8300
2013
2013
2015
2017
2017
LEADER
Comparator
No.
Results
SGLT2i
Comparator
SUSTAIN6
EXSCEL
REWIND
Liraglutide
Lixisenatide
Semaglutide
Exenatide LR
Dulaglutide
Placebo
Placebo
Placebo
Placebo
Placebo
16 500
14 000
6000
5400
8300
2016
2015
2016
2018
2019
EMPA-REG
GLP1-RA
ELIXA
CANVAS
DECLARE
NCT01986881
Empaglifozin
Canagliflozin
Dapagliflozin
Ertugliflozin
Placebo
Placebo
Placebo
Placebo
No.
7300
4300
22 200
3900
Results
2015
2017
2019
2020
DPP4i, dipeptidyl peptidase-4 inhibitor; GLP-1 RA, glucagon-like peptide 1 receptor agonist; SGLT2i, sodium-glucose cotransporter-2 inhibitor.
Reproduced with permission from SE Inzucchi, MD.
A number of other trials are ongoing, with results due
over the next few years (Table 2). Dr Inzucchi emphasized
that although these preliminary studies may report effects
on CV markers and surrogates, these effects do not necessarily predict what will happen to patients in terms of
actual clinical events in the CVOTs. In addition, while the
drugs may present no CV safety signals during these trials,
it may be overly optimistic to think that they will show any
differences in effectiveness on CV end points over a period
of just 2 to 4 years. And because the FDA has demanded
the recruitment of high-risk patients into these CVOTs,
there is some concern that the presence of advanced CV
disease and an underlying predilection for further overt
macrovascular complications will outweigh any possible
CV benefits of a glucose-lowering drug.
Dr Inzucchi then reviewed the updated 2015
American Diabetes Association/European Association
6
May 2015
for the Study of Diabetes treatment algorithm for managing hypertension in T2DM (Figure 1). He noted that
if any of the compounds included in 1 of the ongoing
CVOTs were to show a CV benefit, the current treatment algorithm would likely be updated to reflect that
benefit.
In closing, Dr Inzucchi emphasized that although
diabetes confers additional CV disease risk, glycemic
control itself appears to only modestly reduce nonfatal
MI. Any benefit from glycemic control will likely have to
accrue over many years and may be negated by progressive atherosclerosis. The ideal glucose-lowering agent
will reduce CV events as well as maintain glycemic control. For now, however, glycemic control should be used
mainly to prevent microvascular complications, while
control of lipids and BP is the best means for preventing
macrovascular complications.
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MD Conference Express - ENDO 2015
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