Consistent LDL‐C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies

Stroes, Erik S.G.; Robinson, Jennifer G.; Raal, Frederick J.; Dufour, Robert; Sullivan, David; Ma, Yuhui; Wasserman, Scott M.; Koren, Michael

doi:10.1002/clc.23049

Cited by 25 publications

(20 citation statements)

References 32 publications

(30 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

supporting

confidence: 65%

“…However, there were no noteworthy differences between the global population 41 and the Chinese population in terms of type or severity of the most frequently reported AEs and no noteworthy differences between the evolocumab and placebo treatment groups in either population, and the overall safety profile of evolocumab in Chinese patients was similar to that reported in previous global studies of evolocumab. 23,25,37,42 As in the global population, although AEs of diabetes occurred more often in the evolocumab treatment group than in the placebo group (5.6% vs 2.0%) no notable changes in glycaemic control (HbA1c and FPG) in patients at Chinese centres were noted between treatment groups, and most events were mild (grades 1 or 2) in severity. Although this study was limited to a 12-week follow-up period, the efficacy and safety results are consistent with those of prior prespecified and post hoc analyses of evolocumab in patients with T2DM that have a larger sample size and/or a longer duration.…”

Section: Safetymentioning

confidence: 90%

“…Least-squares mean Lp(a) reduction with evolocumab, a co-secondary efficacy endpoint, was also greater in Chinese patients compared with the global population. 24,37 Prior analyses showed that the LDL-C treatment effect with evolocumab is maintained over time in patients with and without diabetes. Observations in the Chinese population are consistent with results reported in Japanese patients treated with evolocumab over 12 weeks, with least-squares mean LDL-C reductions ranging from 67% to 76%, compared with placebo, when combined with atorvastatin 20 mg daily, and LDL-C less than 1.8 mmol/L was achieved by 96% to 98% of patients.…”

Section: Safetymentioning

confidence: 99%

“…34 The substantial reductions in LDL-C with evolocumab vs placebo among Chinese patients in the BERSON study are consistent with those observed in prior evolocumab global studies in patients with hypercholesterolaemia or mixed dyslipidaemia, 35 in patients with T2DM, 36 and in a meta-analysis and pooled analysis of data from 12-week phase 3 studies. 24,37 Prior analyses showed that the LDL-C treatment effect with evolocumab is maintained over time in patients with and without diabetes. 21,23 Our results are also consistent with those from a systematic review including 20 randomized controlled studies with PCSK9 inhibitors (alirocumab, bococizumab and evolocumab).…”

Section: Safetymentioning

confidence: 99%

See 3 more Smart Citations

Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre‐specified analysis of the Chinese population from the BERSON clinical trial

Chen

Yuan

et al. 2019

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

Aim The aim of this study was to evaluate the efficacy and safety of evolocumab with background atorvastatin in Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia. Materials and methods This is a pre‐specified analysis of patients in the BERSON study (http://clinicaltrials.gov, NCT02662569) in China. Patients initiated background atorvastatin 20 mg/d, after which they were randomized 2:2:1:1 to evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) or to placebo Q2W or QM. Co‐primary endpoints were percentage change in LDL cholesterol (LDL‐C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures and adverse events (AEs). Results Among 453 patients randomized in China, 451 received at least one dose of study drug (evolocumab or placebo). Evolocumab significantly reduced LDL‐C compared with placebo at week 12 (Q2W, −85.0%; QM, −74.8%) and at the mean of weeks 10 and 12 (Q2W, −80.4%; QM, −81.0%) (adjusted P < 0.0001 for all) when administered with background atorvastatin. Non‐HDL‐C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL‐C and VLDL‐C significantly improved with evolocumab vs placebo. No new safety findings were observed with evolocumab. The incidence of diabetes AEs was higher with evolocumab compared with placebo. There were no differences over time between evolocumab and placebo in measures of glycaemic control. Conclusions In patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving background atorvastatin, evolocumab significantly reduced LDL‐C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures.

show abstract

supporting

confidence: 65%

Section: Safetymentioning

confidence: 90%

Section: Safetymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

See 2 more Smart Citations

Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre‐specified analysis of the Chinese population from the BERSON clinical trial

Chen

Yuan

et al. 2019

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

show abstract

“…Lipid‐lowering therapy status had to be unchanged for ≥4 weeks before LDL‐C screening. Patients on statin therapy at screening with an LDL‐C of ≥2.6 mmol/L and those not on statin therapy at screening with an LDL‐C of ≥3.4 mmol/L entered in a lipid stabilization period and started daily oral atorvastatin 20 mg, after which eligible patients were randomized to subcutaneous evolocumab 140 mg every 2 weeks (Q2W), evolocumab 420 mg monthly (QM), placebo Q2W or placebo QM (2:2:1:1) added to daily oral atorvastatin 20 mg. Dosing groups were pooled in the present analysis of vitamin E and steroidal and gonadal hormones because the doses were clinically equivalent in prior analyses . The co‐primary end‐points of the BERSON study were per cent change in LDL‐C from baseline to week 12 and to the mean of weeks 10 and 12.…”

Section: Methodsmentioning

confidence: 99%

Effects of evolocumab therapy and low LDL‐C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes

Blom

Chen

Yuan

et al. 2020

Endocrino Diabet & Metabol

View full text Add to dashboard Cite

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AbstractAims: We assessed the change from baseline in vitamin E, steroid hormones, adrenocorticotropic hormone (ACTH), and gonadotropins, overall and by lowest achieved low-density lipoprotein-cholesterol (LDL-C) level, in patients with type 2 diabetes and dyslipidaemia after 12 weeks of treatment with evolocumab. Materials and Methods:This was a prespecified analysis of vitamin E, cortisol, ACTH, gonadal hormones and gonadotropins in the 12-week, placebo-controlled BERSON trial of evolocumab in patients with type 2 diabetes and dyslipidaemia. In BERSON, 981 (451 in China) patients on daily atorvastatin 20 mg were randomized to placebo or one of two doses of evolocumab. We measured analyte levels at baseline and week 12 (vitamin E in all patients; steroid/gonadal hormones only in Chinese patients). Results:In both the global and Chinese populations, absolute vitamin E levels decreased from baseline to week 12 by approximately 6 μmol/L (P < .0001) among evolocumab-treated patients; however, when normalized for LDL-C, apoB or non-HDL-C, we observed no decrease in vitamin E levels. In Chinese patients, levels of cortisol and ACTH as well as the cortisol:ACTH ratio did not change significantly from baseline to week 12. No patient had a cortisol:ACTH ratio <3.0 (nmol/pmol), suggestive of adrenocortical deficiency. We did not observe clinically relevant changes for gonadal hormones and gonadotropins (oestradiol and testosterone in female and male patients, respectively, luteinizing and follicle-stimulating hormones for both). Conclusions:In the BERSON study, evolocumab did not adversely affect vitamin E, steroid hormone or gonadotropin levels in the Chinese or global type 2 diabetic populations.ClinicalTrials.gov NCT02662569. K E Y W O R D Sdiabetes, dyslipidaemia, hypercholesterolaemia, PCSK9 inhibitor

show abstract

Gender Disparities in Health Resource Utilization in Patients with Atherosclerotic Cardiovascular Disease: A Retrospective Cross-Sectional Study

2019

View full text Add to dashboard Cite

IntroductionGender disparities in access to healthcare have been documented, including disparities in access to care for cardiovascular diseases (CVDs). Disparities in access to cardiologists could disadvantage some patients to the newer lipid-lowering proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) antibodies, as utilization management criteria for PCSK9is often require step therapy with statins and/or ezetimibe and prescription by a cardiologist. To assess whether these utilization management criteria disproportionally limit access to patients with certain characteristics, we assessed the use of cardiologist care and receipt of statin and/or ezetimibe prescriptions from a cardiologist by gender and other patient demographic and clinical characteristics.MethodsThis cross-sectional study used administrative claims data from Inovalon’s Medical Outcomes Research for Effectiveness and Economics Registry (MORE2 Registry®) for patients enrolled in commercial and Medicare Advantage healthcare plans from January 1, 2014, through December 31, 2014. Provider data from the registry were linked to individual demographic and administrative claims data. Logistic regression models were used to assess characteristics associated with outpatient visits to a cardiologist and receipt of a prescription for statin and/or ezetimibe from a cardiologist.ResultsData from 39,322 patients in commercial plans and 261,898 patients with Medicare Advantage were analyzed. Female gender (vs male) was associated with a significantly lower likelihood of visiting a cardiologist for patients in commercial plans (odds ratio [OR] 0.85; 95% confidence limit [CL] 0.81–0.88) and in Medicare Advantage plans (OR 0.82; 95% CL 0.81–0.83). Female gender was also associated with a lower likelihood of receiving a statin and/or ezetimibe prescription from a cardiologist for patients in commercial plans (OR 0.69; 95% CL 0.65–0.74) and in Medicare Advantage plans (OR 0.78; 95% CL 0.76–0.79).ConclusionsCompared with men, women were less likely to visit a cardiologist and less likely to receive a prescription for a statin and/or ezetimibe from a cardiologist.FundingAmgen Inc.

show abstract

Consistent LDL‐C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies

Abstract: Consistent reductions in LDL-C were observed in the evolocumab group regardless of demographic and disease characteristics.

Cited by 25 publications

References 32 publications

Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre‐specified analysis of the Chinese population from the BERSON clinical trial

Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre‐specified analysis of the Chinese population from the BERSON clinical trial

Effects of evolocumab therapy and low LDL‐C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes

Gender Disparities in Health Resource Utilization in Patients with Atherosclerotic Cardiovascular Disease: A Retrospective Cross-Sectional Study

Contact Info

Product

Resources

About