Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

Home, Philip; Pocock, Stuart J.; Beck‐Nielsen, Henning; Curtis, Paula; Gomis, Ramón; Hanefeld, Markolf; Jones, Nigel C.; Komajda, Michel; McMurray, John J.V.

doi:10.1016/s0140-6736(09)60953-3

Cited by 1,263 publications

(919 citation statements)

References 22 publications

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“…These diseases are not regulated by a single molecular target but caused by multi-factorial, and there are often multiple ways or alternate processes that may be switched on in response to the inhibition of a specific target (Home et al, 2009;Rather et al, 2013), for which a new technical term polypharmacology has been proposed (Efferth and Koch, 2011;Xie et al, 2012). Depression is one of these multi-target diseases, and various hypothesis or protein factors participate in its pathogenesis, such as monoaminergic hypothesis, HPA axis hypothesis, BDNF, CREB and ERK signaling pathways.…”

Section: Discussionmentioning

confidence: 99%

Piper sarmentosum Roxb. produces antidepressant-like effects in rodents, associated with activation of the CREB-BDNF-ERK signaling pathway and reversal of HPA axis hyperactivity

Gao

et al. 2017

Journal of Ethnopharmacology

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Ethnopharmacological relevance: There are many plants of genus Piper which have been reported to induce antidepressant-like effects, Piper sarmentosum (PS) is one of them. PS is a Chinese herbal medicine and a traditional edible vegetable. Materials and Methods:In the present study, the antidepressant-like effects of PS extracts and the ethyl acetate fraction of PS extracts (PSY) were assessed using the open field test (OFT), forced swimming test (FST), and tail suspension test (TST) in mice. Furthermore, we applied a 4 consecutive weeks of chronic unpredictable mild stress (CUMS) as a model of depression in rats, followed by a sucrose preference test. Then we examined the possible mechanisms of this action.The activity of the hypothalamic-pituitary-adrenal (HPA) axis was evaluated by detecting the serum corticosterone (CORT) concentrations, and the protein expression levels of brain-derived neurotrophic factor (BDNF), the phosphorylated form CREB and ERK1/2 were detected by qRT-PCR or Western blot. Results:The results showed that PS extracts (100, 200 mg/kg) and PSY (12.5, 25, 50 mg/kg) treatment produced antidepressant-like effects in mice similar to fluoxetine (20 mg/kg), indicated by the reduced immobility time in the FST and TST, while both had no influence on the locomotor activity in the OFT. PSY treatment significantly increased sucrose preference and reduced serum CORT levels in CUMS rats. Moreover, PSY up-regulated BDNF protein levels, and increased CREB and ERK phosphorylation levels in the hippocampus on CUMS rats. Conclusions:These findings suggest that the antidepressant-like effects of PS extracts and PSY are mediated, at least in part, by modulating HPA axis, BDNF, CREB and ERK phosphorylation and expression in the hippocampus.

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Section: Discussionmentioning

confidence: 99%

Piper sarmentosum Roxb. produces antidepressant-like effects in rodents, associated with activation of the CREB-BDNF-ERK signaling pathway and reversal of HPA axis hyperactivity

Gao

et al. 2017

Journal of Ethnopharmacology

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“…Nissen and Wolski [40] performed a meta-analysis to study the effect of rosiglitazone on cardiovascular morbidity and mortality and concluded that rosiglitazone therapy was associated with an increased risk of myocardial infarction. The recently published RECORD trial evaluated the effect of addition of rosiglitazone to glucose-lowering therapy and found an increased risk of heart failure in patients treated with rosiglitazone compared to controls, whereas the overall cardiovascular morbidity and mortality was similar [41]. The results of the current study, suggesting a hypertrophic effect of rosiglitazone, and the previously recognized relation between LV hypertrophy and cardiac events such as ischemia and heart failure [12], might add to the paradigm of sodium and water retention to explain the increased risk of these events in patients using rosiglitazone.…”

Section: Discussionmentioning

confidence: 99%

Effect of lifestyle intervention plus rosiglitazone or placebo therapy on left ventricular mass assessed with cardiovascular magnetic resonance in the metabolic syndrome

Roes

Dehnavi

Westenberg

et al. 2011

Journal of Cardiovascular Magnetic Resonance

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BackgroundTo evaluate the effect of lifestyle intervention in conjunction with rosiglitazone or placebo therapy on left ventricular (LV) mass, using cardiovascular magnetic resonance (CMR) in the metabolic syndrome.MethodsThe present study was a pre-specified substudy of a double-blind randomized controlled trial evaluating the effect of lifestyle intervention in conjunction with rosiglitazone or placebo therapy on carotid artery atherosclerosis in the metabolic syndrome. From this original study population, 10 subjects from the placebo group and 10 from the rosiglitazone group were randomly selected. At baseline and follow-up (52 weeks), clinical and laboratory measurements were assessed and a CMR-examination was performed to evaluate LV mass indexed for body surface area (LV mass-I). Subsequently, the effect of therapy (rosiglitazone vs. placebo) and clinical and laboratory variables on LV mass-I was evaluated.ResultsIn both groups, body mass index, waist circumference, systolic and diastolic blood pressure significantly decreased during follow-up. Interestingly, LV mass-I significantly decreased in the placebo group (48.9 ± 5.3 g/m2 vs. 44.3 ± 5.6 g/m2, p < 0.001) indicating reverse remodeling, whereas LV mass-I remained unchanged in the rosiglitazone group (54.7 ± 9.9 g/m2 vs. 53.7 ± 9.2 g/m2, p = 0.3). After correction for systolic and diastolic blood pressure and triglyceride, the kind of therapy (rosiglitazone vs. placebo) remained the only significant predictor of LV mass-I reduction.ConclusionsLifestyle intervention resulted in a reduction of LV mass-I in the metabolic syndrome, indicating reverse remodeling. However, rosiglitazone therapy may have inhibited this positive reverse remodeling.Trial registrationCurrent Controlled Trials ISRCTN54951661.

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“…22 A meta-analysis of clinical trials of rosiglitazone (Avandia), a thiazolidinedione, pointed to an increased risk of MI, 23 although the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study did show an increased risk of major adverse cardiovascular events (MACE). 24 The initial concern with rosiglitazone led the FDA to issue an updated Guidance for Industry in 2008 requiring preapproval and post approval studies for all new antidiabetic drugs to rule out excess cardiovascular risk. In a postmarketing trial, the two-sided 95% CI for the estimated increased risk (risk ratio) should be less than 1.3.…”

Section: Glycemic Control and Cardiovascular Outcomesmentioning

confidence: 99%

“…Aronson 20,112 Reduced restenosis after coronary stenting 113,114 Heart failure 115,116 Excess ischemic cardiovascular risk with rosiglitazone (?) 23,24 Alpha-glucosidase inhibitors Reduced inflammatory markers 112 Possible …”

mentioning

confidence: 99%

Coronary Artery Disease and Diabetes Mellitus

Aronson

Edelman

2016

Heart Failure Clinics

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Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

Cited by 1,263 publications

References 22 publications

Piper sarmentosum Roxb. produces antidepressant-like effects in rodents, associated with activation of the CREB-BDNF-ERK signaling pathway and reversal of HPA axis hyperactivity

Piper sarmentosum Roxb. produces antidepressant-like effects in rodents, associated with activation of the CREB-BDNF-ERK signaling pathway and reversal of HPA axis hyperactivity

Effect of lifestyle intervention plus rosiglitazone or placebo therapy on left ventricular mass assessed with cardiovascular magnetic resonance in the metabolic syndrome

Coronary Artery Disease and Diabetes Mellitus

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