Current perspectives on cardiovascular outcome trials in diabetes

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Term Occurence Count Dictionary
sitagliptin 4 endocrinologydiseasesdrugs
tolbutamide 1 endocrinologydiseasesdrugs
Exenatide 3 endocrinologydiseasesdrugs
hypoglycemia 5 endocrinologydiseases
pioglitazone 1 endocrinologydiseasesdrugs
metformin 7 endocrinologydiseasesdrugs
rosiglitazone 2 endocrinologydiseasesdrugs
Insulin 3 endocrinologydiseasesdrugs
Liraglutide 3 endocrinologydiseasesdrugs
hyperglycemia 2 endocrinologydiseases

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Select Drug Character Offset Drug Term Instance
Exenatide 10398 vs. placeboCV death, MI, or stroke32991.9902.2013–01.2016NCT01720446EXSCELOngoing, not recruiting Exenatide GLP-1 inhibitorExenatide once weekly vs. placeboCV death, MI, or stroke14,00006.2010–04.2018NCT01144338CAROLINAOngoing,
Exenatide 10422 MI, or stroke32991.9902.2013–01.2016NCT01720446EXSCELOngoing, not recruitingExenatideGLP-1 inhibitor Exenatide once weekly vs. placeboCV death, MI, or stroke14,00006.2010–04.2018NCT01144338CAROLINAOngoing, not
Exenatide 10814 inhibitorDulaglutide vs. placeboCV death, MI, or stroke962207.2011–01.2016NCT01394952ITCA650Ongoing, not recruiting Exenatide in DUROSGLP-1 inhibitorITCA 650 (exenatide in DUROS) vs. placeboCV death, MI, UA, or stroke400003.2013–07.2018NCT01455896DECLARE-TIMIOngoing,
Insulin 11269 vs. placeboCV death, MI, UA, or stroke800007.2013–01.2018NCT01897532DEVOTEOngoing, not recruiting Insulin degludecBasal insulinsInsulin degludec vs. insulin glargineCV death, MI, or stroke763710.2013–09.2016NCT01959529MK-3102Ongoing,
Insulin 11299 or stroke800007.2013–01.2018NCT01897532DEVOTEOngoing, not recruitingInsulin degludecBasal insulins Insulin degludec vs. insulin glargineCV death, MI, or stroke763710.2013–09.2016NCT01959529MK-3102Ongoing,
Insulin 15239 referred to in the textConcomitant medication @baselineAntihyperglycemic medicationN (%)CV treatmentN (%) Insulin MetforminSulphonylureaAspirinStatinsAntiplatelet/anticoagulantBeta-blockerACEI/ARBOther anti-hypertensivesSAVOR-TIMI536757
Liraglutide 10104 empagliflozin 25 mg vs. placeboCV death, MI, or stroke70003.107.2010–04.2015NCT01131676LEADERCompleted Liraglutide GLP-1 inhibitorLiraglutide vs. placeboCV death, MI, or stroke93403.808.2010–12.2015NCT01179048SUSTAIN-6CompletedSemaglutideGLP-1
Liraglutide 10130 placeboCV death, MI, or stroke70003.107.2010–04.2015NCT01131676LEADERCompletedLiraglutideGLP-1 inhibitor Liraglutide vs. placeboCV death, MI, or stroke93403.808.2010–12.2015NCT01179048SUSTAIN-6CompletedSemaglutideGLP-1
Liraglutide 10569 or stroke14,00006.2010–04.2018NCT01144338CAROLINAOngoing, not recruitingLinagliptinDPP-4 inhibitor Liraglutide vs. placeboCV death, MI, UA, or stroke600010.2010–09.2018NCT01243424REWINDOngoing, not recruitingDulaglutideGLP-1
metformin 3099 randomized patients to either standard or intensive diabetes care with either insulin, sulphonylurea or metformin . After 10 years, there was a significant reduction of MI risk and all-cause mortality in the intensive
metformin 3318 therapy group with any of the three drugs. However, the reduction of CV-associated risk was greater with metformin (39 % MI, 36 % all-cause) than with insulin or sulphonylurea (15 % MI, 13 % all-cause) [[12]]. A
metformin 3476 sulphonylurea (15 % MI, 13 % all-cause) [[12]]. A later meta-analysis of randomized trials using metformin found highly diverse results in terms of mortality risk increase/reduction as well as possible CV deleterious
metformin 3609 results in terms of mortality risk increase/reduction as well as possible CV deleterious effects of a metformin /sulphonylurea combination [[13]], which were found to be greatly diminished 10 years after the end
metformin 35968 DEVOTE trial on insulin glargine versus insulin degludec. To date there is not a single CVO trial on metformin or sulphonylurea alone. Considering that metformin is a first line treatment for T2D [[77]] and that
metformin 36019 degludec. To date there is not a single CVO trial on metformin or sulphonylurea alone. Considering that metformin is a first line treatment for T2D [[77]] and that sulphonylurea and insulin are also very common therapeutic
metformin 37084 CV safety of GLP-1 receptor agonists to DPP-4 inhibitors, sulfonylureas, or insulin in addition to metformin , in a similar fashion to real-world conditions [[80]].Despite including analysis of adverse outcomes
pioglitazone 5154 treatment [[21], [24]]. The PROactive trial [[25]] on the CV safety of the addition to usual care of pioglitazone versus placebo found a slight trend toward a combined primary CV end-point—CVD and interventions in
rosiglitazone 4734 suggested to increase CV risk in diabetes. For instance, several inter-related meta-analyses infer that rosiglitazone might raise MI and heart failure (HF) risk [[20], [21]]. Despite the RECORD trial [[22], [23]] only
rosiglitazone 5001 results on MI, a meta-analysis including RECORD data still concludes that the high risk/benefit ratio of rosiglitazone does not support its use for diabetes treatment [[21], [24]]. The PROactive trial [[25]] on the CV safety
sitagliptin 17095 for UA in the primary MACE. Corresponding data in Table 4 shows that for saxagliptin (SAVOR-TIMI), sitagliptin (TECOS), lixisenatide (ELIXA) and alogliptin (EXAMINE) treatment, occurrence of the primary composite
sitagliptin 25798 slightly more often in the treatment groups than with placebo when employing saxagliptin (SAVOR-TIMI), sitagliptin (TECOS), alogliptin (EXAMINE) or lixisenatide (ELIXA), and even when no significant differences between
sitagliptin 28922 2008 showed that new glucose lowering agents like the DPP-4 inhibitors saxagliptin, alogliptin, and sitagliptin and the GLP-1 receptor agonist lixisenatide are safe with respect to CV outcomes in high CV risk patient
sitagliptin 30924 found no difference in hospitalization rates for HF between treatment with saxagliptin compared with sitagliptin or with DPP-4 inhibitors compared with other classes of anti-diabetes agents [[63], [64]].The analyses
tolbutamide 2781 Program) of T2D glucose-lowering treatments assessing CV outcomes was interrupted, as all oral drugs ( tolbutamide , phenformin) seemed to increase CV risk in comparison to placebo or insulin [[9]–[11]]. However, this
Select Disease Character Offset Disease Term Instance
hyperglycemia 4264 underpowered, and a post hoc analysis seems to suggest a positive effect of controlling postprandial hyperglycemia in some subgroups of subjects, like older patients [[17], [18]]. The more recent ORIGIN trial, [[19]]
hyperglycemia 24676 lowering drugs was investigated. Even though rates were similar to placebo in all CVOTs, and major hyperglycemia events did not differ between saxagliptin (SAVOR-TIMI) treatment and placebo, hypoglycemia occurrence
hypoglycemia 7697 under glucose-lowering therapies could not ascertain a clear relationship between HbA1c target levels, hypoglycemia incidence and CV risk, despite a tendency for intense glucose control being beneficial in the long-term
hypoglycemia 16607 death and HF. Finally, we will review a few other relevant safety end-points, namely: pancreatitis, hypoglycemia occurrence, and renal events/microvascular effectsPrimary MACE composite end-point Diverse individual
hypoglycemia 21685 events0.5 %0.330.7 %0.861.9 %0.330.6 %1.3 %3.3 %0.0222.4 %caSuperiority testbAverage across all age rangescSevere hypoglycemia as defined by ADACardiovascular death In all terminated trials, treatment with the new agent did not
hypoglycemia 24768 and major hyperglycemia events did not differ between saxagliptin (SAVOR-TIMI) treatment and placebo, hypoglycemia occurrence generally increased with saxagliptin in combination with sulphonylureas or insulin. This
hypoglycemia 25202 which might be due to a reduced need for insulin co-therapy [[51]]. In SUSTAIN-6, the rates of severe hypoglycemia did not significantly differ between the two semaglutide-dose treatment groups and placebo [semaglutide

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