Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON

Teramoto, Tamio; Kiyosue, Arihiro; Ishigaki, Yasushi; Harada‐Shiba, Mariko; Kawabata, Yumiko; Ozaki, Asuka; Baccara‐Dinet, Marie T.; Sata, Masataka

doi:10.1016/j.jjcc.2018.10.004

Cited by 17 publications

(9 citation statements)

References 33 publications

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“…However, further evaluations are needed to examine whether isolated Lp(a)-lowering therapy without the direct effects on other atherogenic parameters can improve cardiovascular outcomes. Monoclonal antibodies that inhibit PCSK9 have emerged as a new class of drugs that effectively reduce LDL cholesterol levels and the risk of cardiovascular events in patients who receive statin therapies [6,30]. Such antibodies also reduce Lp(a) levels by approximately 30% [31,32] by increasing hepatic LDL-receptor [16].…”

Section: Discussionmentioning

confidence: 99%

Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy

Matsushita

Hibi

Komura

et al. 2020

Journal of Cardiology

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Background: Lipoprotein (a) [Lp(a)] has been reported to be a residual risk factor in patients who have achieved target lipid levels. The aim of the present study was to investigate the associations of Lp(a) with plaque progression and major cardiovascular events in patients with acute coronary syndromes (ACS). Methods: The Yokohama-ACS study included 102 patients with ACS who underwent intravascular ultrasound (IVUS) at baseline and at 10-month follow-up after percutaneous coronary intervention (PCI). The patients were randomly assigned to receive either moderate-or low-intensity statin therapy. IVUS was performed to measure the plaque volume at non-culprit lesions. We enrolled 76 patients for whom Lp(a) levels at 10-month follow-up were available. Results: The patients were divided into 2 groups according whether their Lp(a) levels were 20 mg/dl [low Lp(a) group; n = 49] or >20 mg/dl [high Lp(a) group; n = 27]. Baseline characteristics and low-density lipoprotein cholesterol levels at 10-month follow-up were similar in the low Lp(a) group and high Lp(a) group (87 AE 29 mg/dl vs. 93 AE 27 mg/dl, p = 0.42). The low Lp(a) group had significant plaque regression, whereas the high Lp(a) group showed slight plaque progression (À6.8% vs. 2.5%, p = 0.02). Ninety-five percent of the prognostic data were obtained 5 years after PCI. The cumulative event-free survival rate was significantly lower in the high Lp(a) group (p = 0.02; log-rank test). Conclusions: Lp(a) levels may be an alternative predictor of further plaque regression and the likelihood of major adverse cardiovascular events in statin-treated ACS patients.

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Section: Discussionmentioning

confidence: 99%

Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy

Matsushita

Hibi

Komura

et al. 2020

Journal of Cardiology

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“…Dedicated placebo-controlled trials of patients enrolled from Japan, South Korea, and Taiwan indicated similar lipid-lowering efficacy and safety of alirocumab compared with the overall phase 3 trial populations. [18][19][20][21][22] In addition, a phase 1 study is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of alirocumab in healthy Chinese subjects (Clinicaltrials.gov identifier: NCT02979015).…”

Section: Introductionmentioning

confidence: 99%

ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand

Han

Chen

Chopra

et al. 2020

Journal of Clinical Lipidology

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BACKGROUND: The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab significantly reduces low-density lipoprotein cholesterol (LDL-C). OBJECTIVE: This study (ODYSSEY EAST) assessed the efficacy and safety of alirocumab vs ezetimibe in high cardiovascular risk patients from Asia. METHODS: Patients (n 5 615) from China, India, and Thailand with hypercholesterolemia at high cardiovascular risk on maximally tolerated statin were randomized (2:1) to alirocumab (75 mg every 2 weeks [Q2W]; with dose increase to 150 mg Q2W at week 12 if week 8 LDL-C was .1.81 mmol/L [.70 mg/dL]) or ezetimibe (10 mg daily) for 24 weeks. The primary efficacy endpoint was percentage change in calculated LDL-C from baseline to week 24. Safety was assessed throughout. Clinical Trial Registration: NCT02715726.

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“…After the screening of the titles and abstracts, 25 studies met the criteria for a full-text review. Following the screening of the titles and abstracts, 25 papers were qualified for a full text analysis and 13 of them were included in the final review [9,[12][13][14][15][16][17][18][19][20][21][22][23]. Thirteen studies included 24,815 patients, of which 13,245 were allocated to the alirocumab intervention and 11,570 were allocated to the control group.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

“…Baseline patient characteristics for the study arms included were shown in Table 1 (Ref. [9,[12][13][14][15][16][17][18][19][20][21][22][23]). The overall quality of included studies was moderate, and the risk of bias for most items was low (Fig.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Effects of alirocumab on cardiovascular events and all-cause mortality: a systematic review and meta-analysis

Wang

Feng

Bai

2021

Reviews in Cardiovascular Medicine

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Evaluation of the effects of alirocumab on cardiovascular (CV) events, CV mortality and all-cause mortality. Data search was carried out using the Cochrane Library, PubMed, Web of Science and Embase. The search time is up to November 18, 2020. All randomized clinical trials (AEs) comparing alirocumab with placebo were searched. Meta-analysis was performed by Review Manager version 5.3 (The Cochrane Collaboration, Copenhagen, Denmark), and the heterogeneity between studies was tested by Cochrane's Q test and measured with I2 statistics. A total of 13 randomized controlled trials with 24,815 participants were included. Alirocumab usage can considerably lower the incidence of CV events when compared to the control group (risk ratio(RR) 0.89, 95% confidence interval(CI) 0.83-0.95). No significant difference in CV mortality between the two groups was observed (RR 0.87, 95% CI 0.74-1.04). Treatment with alirocumab has been associated with a major decrease in all-cause mortality compared to placebo (RR 0.80, 95% CI 0.66-0.96). The incidence of serious adverse events (AEs) was similar in the two groups (RR 0.94, 95% CI 0.90-0.99). Alirocumab can reduce CV events and all-cause mortality. The AEs were mild and tolerable.

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Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON

Cited by 17 publications

References 33 publications

Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy

Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy

ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand

Effects of alirocumab on cardiovascular events and all-cause mortality: a systematic review and meta-analysis

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