Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial

Pandey, A. Shekhar; Bissonnette, Stéphane; Boukas, Stella; Rampakakis, Emmanouil; Sampalis, John S.

doi:10.5114/aoms.2011.25550

Cited by 9 publications

(7 citation statements)

References 33 publications

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“…Insights from randomized controlled trials in patients with heart failure, atrial fibrillation and CKD suggest that there are still some questions regarding the role of statins in these conditions [ 67 ]. Statins activate LDL receptor (LDLR) gene expression, but also activate the expression of proprotein convertase subtilisin/kexin type 9 (PCSK9), a secreted inhibitor of LDLR, thereby limiting their beneficial effects [ 68 ].…”

Section: Lipid Update 2013mentioning

confidence: 99%

Lipid, blood pressure and kidney update 2013

et al. 2014

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The year 2013 proved to be very exciting as far as landmark trials and new guidelines in the field of lipid disorders, blood pressure and kidney diseases. Among these are the International Atherosclerosis Society Global Recommendations for the Management of Dyslipidemia, European Society of Cardiology (ESC)/European Society of Hypertension Guidelines for the Management of Arterial Hypertension, American Diabetes Association Clinical Practice Recommendations, the Kidney Disease: Improving Global Outcomes Clinical Practice Guidelines for Managing Dyslipidemias in Chronic Kidney Disease (CKD) Patients, the American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, the Joint National Committee Expert Panel (JNC 8) Evidence-Based Guideline for the Management of High Blood Pressure in Adults, the American Society of Hypertension/International Society of Hypertension Clinical Practice Guidelines for the Management of Hypertension in the Community, the American College of Physicians Clinical Practice Guideline on Screening, Monitoring, and Treatment of Stage 1–3 CKD and many important trials presented among others during the ESC Annual Congress in Amsterdam and the American Society of Nephrology Annual Meeting—Kidney Week in Atlanta, GA. The paper is an attempt to summarize the most important events and reports in the mentioned areas in the passing year.

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Section: Lipid Update 2013mentioning

confidence: 99%

Lipid, blood pressure and kidney update 2013

et al. 2014

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“…Ezetimibe is characterized by good tolerance and low incidence of adverse effects [ 13 ]. The drug has become an increasingly popular therapeutic option for statin-resistant patients, as well as for statin-intolerant patients [ 14 , 15 ]. The choice of ezetimibe for our experiment was also based on data from experimental [ 16 , 17 ] and clinical studies [ 18 , 19 ] suggesting antioxidant properties of this agent.…”

Section: Introductionmentioning

confidence: 99%

Experimental research Influence of ezetimibe on selected parameters of oxidative stress in rat liver subjected to ischemia/reperfusion

Trocha¹,

Merwid-Ląd²,

Chlebda³

et al. 2014

aoms

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IntroductionIschemia/reperfusion (I/R) is considered to be one of the main causes of liver damage after transplantation. The authors evaluated the effect of ezetimibe on selected oxidative stress parameters in ischemic/reperfused (I/R) rat liver.Material and methodsRats were administered ezetimibe (5 mg/kg) (groups E and E-I/R) or saline solution (groups C and C-I/R) intragastrically for 21 days. Livers of animals in groups C-I/R and E-I/R were subjected to 60 min of partial ischemia (left lateral and median lobes) followed by 4 h of reperfusion. Alanine and asparagine aminotransferase (ALT, AST) activity was determined in blood before I/R and during reperfusion (at 15 and 240 min). After the reperfusion period, malondialdehyde (MDA), superoxide dismutase (SOD), glutathione (GSH) and glutathione peroxidase (GPx) were determined in liver homogenates using colorimetric methods.ResultsEzetimibe caused a significant increase in GSH level in groups subjected to I/R (E-I/R (99.91 ±9.01) vs. C-I/R (90.51 ±8.87), p < 0.05). Additionally, under I/R the decrease of GPx activity in the drug-treated group was lower compared to the non-treated group (E-I/R (3.88 ±1.11) vs. E (5.31 ±1.83), p = 0.076). Neither ezetimibe nor I/R affected SOD or MDA levels. I/R produced a significant increase in aminotransferase levels (ALT240-0: C-I/R (42.23 ±43.56) vs. C (9.75 ±11.09), and E-I/R (39.85 ±26.53) vs. E (4.38 ±1.36), p < 0.05 in both cases; AST 240-0: E-I/R (53.87 ±17.23) vs. E (24.10 ±9.66), p < 0.05) but no effect of ezetimibe on those enzymes was found.ConclusionsEzetimibe demonstrates antioxidant properties in rat livers subjected to I/R. However, neither a hepatoprotective nor a hepatotoxic effect of ezetimibe was demonstrated, regardless of I/R.

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“…In the EZE (STAT) 2 trial [13], 40% of the patients treated with current statin co-administered with ezetimibe achieved LDL-C < 2.0 mmol/L at 6 weeks compared with 18% of those treated with doubling of the current statin dose. In order to detect a similar magnitude of difference for this outcome, with 5% significance and 90% power, a total of 111 patients per group were required.…”

Section: Methodsmentioning

confidence: 99%

A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study

Madan

Vira

Rampakakis

et al. 2012

Advances in Preventive Medicine

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Background. There is a paucity of data regarding the effectiveness and safety of lipid-lowering treatments among South-Asian patients. Methods. Sixty-four South-Asian Canadians with coronary artery disease or diabetes and persistent hypercholesterolemia on statin therapy, were randomized to ezetimibe 10 mg/day co-administered with statin therapy (EZE + Statin) or doubling their current statin dose (STAT2). Primary outcome was the proportion of patients achieving target LDL-C (<2.0 mmol/L) after 6 weeks. Secondary outcomes included the change in lipid profile and the incidence of treatment-emergent adverse events through 12 weeks. Exploratory markers for vascular inflammation were assessed at baseline and 12 weeks. Results. At 6 weeks, the primary outcome was significantly higher among the EZE + Statin patients (68% versus 36%; P = 0.031) with an OR (95% CI) of 3.97 (1.19, 13.18) upon accounting for baseline LDL-C and adjusting for age. At 12 weeks, 76% of EZE + Statin patients achieved target LDL-C compared to 48% (P = 0.047) of the STAT2 patients (adjusted OR (95% CI) = 3.31 (1.01,10.89)). No significant between-group differences in exploratory markers were observed with the exception of CRP. Conclusions. Patients receiving ezetimibe and statin were more likely to achieve target LDL-C after 6 and 12 weeks compared to patients doubling their statin dose. Ezetimibe/statin combination therapy was well tolerated among this cohort of South-Asian Canadians, without safety concerns.

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Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial

Cited by 9 publications

References 33 publications

Lipid, blood pressure and kidney update 2013

Lipid, blood pressure and kidney update 2013

Experimental research Influence of ezetimibe on selected parameters of oxidative stress in rat liver subjected to ischemia/reperfusion

A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study

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