Real-World Insights Into Evolocumab Use in Patients With Hyperlipidemia: Canadian Analysis From the ZERBINI Study

Gupta, Milan; Mancini, G.B. John; Wani, Rajvi J.; Ahooja, Vineeta; Bergeron, Jean; Manjoo, Priya; Pandey, Amritanshu; Reiner, Maureen; Beltran, Johnny; Oliveira, Thiago; Mackinnon, Erin S.

doi:10.1016/j.cjco.2022.03.003

Cited by 23 publications

(21 citation statements)

References 29 publications

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“…Treatment persistence was high and comparable with the rate reported for another country participating in the ZERBINI study (i.e. Canada [20]). Evolocumab was also found to have a favorable safety profile in this study population, with no treatment-emergent adverse drug reactions recorded, even in patients achieving very low LDL-C levels (<1.3 mmol/L).…”

Section: Plos Onesupporting

confidence: 84%

“…The effectiveness of evolocumab in both patient populations is consistent with the available evidence from other reports. For example, the ZERBINI study results from Canada showed a 59% reduction in LDL-C levels over the 12-month study period [20]. LDL-C reduction rates with evolocumab in clinical trials (FOURIER study [22] and the RUTHERFORD-2 FH patient cohort [23]), as well as real-world evidence (HEYMANS European study [24]), are also comparable.…”

Section: Plos Onementioning

confidence: 89%

“…Persistence reflects the proportion of patients who received evolocumab for the entire follow-up period after initiation, and who had no dose gaps exceeding the allowable based on the evolocumab dosing instructions (56 consecutive days). Based on this, patients were categorized as either persistent or nonpersistent [19,20]. Patients were excluded from persistence calculations if they did not complete the study for reasons that were not evolocumab related (N = 32): patient request (n = 9), lost to follow-up (n = 8), discontinuation unrelated to evolocumab (n = 15).…”

Section: Discussionmentioning

confidence: 99%

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Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

et al. 2023

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Objectives Dyslipidemia is a prevalent condition with significant morbidity and mortality across the world, including in the Arabian Gulf. The present study aimed to describe the characteristics of patients receiving evolocumab in clinical practice. Methods ZERBINI was a multi-country, observational, retrospective/prospective study of subjects receiving evolocumab as part of routine clinical management of their hyperlipidemia. This regional publication reports on adult participants from Saudi Arabia and Kuwait who have had ≥1 dose of evolocumab before enrollment and ≤6 months’ prior exposure to evolocumab. Patient characteristics and treatment persistence data were collected in addition to baseline and follow-up data up to 12 months post-evolocumab initiation. Results Overall, 225 patients were included from two sites, Saudi Arabia (N = 155) and Kuwait (N = 70). Mean age was comparable across sites and most patients had baseline coronary artery disease and/or hypertension. Baseline LDL-C levels (mean ± SD 3.6 ± 1.4 mmol/L in Saudi Arabia, 3.1 ± 1.4 mmol/L in Kuwait) were reduced by approximately 57%–62% in the first 6 months after evolocumab initiation (1.5 ± 1.2 mmol/L in Saudi Arabia [n = 63], 1.2 ± 0.8 mmol/L in Kuwait [n = 28]). This decrease was maintained over the 12-month follow-up period. Most patients achieved ACC 2018 LDL-C goals (<1.8 mmol/L; 74.6% in Saudi Arabia, 93.1% in Kuwait) and ESC 2019 LDL-C goals (<1.4 mmol/L; 66.7% in Saudi Arabia, 75.9% in Kuwait) in the first 6 months after evolocumab initiation. Medication persistence with evolocumab was high (up to 90.7%). Evolocumab had a favorable safety profile and no treatment-emergent adverse events were observed at either site. Conclusion Evolocumab is an effective lipid-lowering treatment in local populations. LDL-C goal achievement is increased when evolocumab is added to background lipid-lowering therapy with high tolerability and persistence. Long-term follow-up and large-scale data are needed to further support these observations.

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Section: Plos Onesupporting

confidence: 84%

Section: Plos Onementioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

et al. 2023

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“…The PCSK9i monoclonal antibodies evolocumab and alirocumab were approved in Canada in 2015, and are currently indicated as adjuncts to diet and standard-of-care therapy to reduce the risk of CV events in adult patients with ASCVD by further lowering LDL-C levels. Recent realworld studies have demonstrated that PCSK9i can safely and effectively lower LDL-C levels in Canadians with atherosclerotic disease, consistent with larger clinical trials [8][9][10]. To our knowledge, a real-world study exclusively in post-AMI patients known to have greater risk of subsequent ASCVD events has not been conducted.…”

Section: Introductionmentioning

confidence: 65%

Guideline LDL-C Threshold Achievement in Acute Myocardial Infarction Patients: A Real-World Evidence Study Demonstrating the Impact of Treatment Intensification with PCSK9i

et al. 2023

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Introduction: A high proportion of Canadian patients with acute myocardial infarction (AMI) do not achieve the threshold low-density lipoprotein cholesterol (LDL-C) levels recommended by the Canadian Cardiovascular Society in 2021. This increases the risk of subsequent atherosclerotic cardiovascular disease (ASCVD) events. Here, we assess LDL-C levels and threshold achievement among patients by lipid-lowering therapies (LLT) received post-AMI. Methods: A retrospective cohort study of patients identified with AMI between 2015 and 2019 was conducted using administrative health databases in Alberta, Canada. Patients were grouped by their highest-intensity LLT post-AMI (proprotein convertase subtilisin/ kexin type 9 inhibitors (PCSK9i) ? another LLT; PCSK9i alone; ezetimibe ? statin; statins (high, moderate, low intensity); or ezetimibe alone), and available LDL-C levels were examined in the year before and after LLT dispense date. Results: The cohort included 15,283 patients. In patients on PCSK9i ? LLT, the median [95% confidence interval (CI)] LDL-C levels decreased from 2.7 (2.3-3.4) before to 0.9 (0.5-1.2) mmol/ l after treatment, the largest decrease among treatment groups. In the ezetimibe ? statin and high-intensity statin groups, median (95% CI) values after treatment were 1.5 (1.5-1.6) and 1.4 (1.4-1.4) mmol/l, respectively. The proportion of patients below the 1.8 mmol/l threshold increased by 77.7% in the PSCK9i ? LLT group after treatment, compared to 45.4 and 32.4% in the ezetimibe ? statin and high-intensity statin groups, respectively. Conclusions: Intensification with PCSK9i in AMI patients results in a greater proportion of patients achieving below the recommended LDL-C threshold versus statins and or ezetimibe alone. Increased focus on achieving below the LDL-C thresholds with additional LLT as required may benefit patient cardiovascular outcomes.

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“…PCSK9 binds to LDL receptors on the hepatocytes surface and induces degradation of them after internalization, resulting in reduced uptake of LDL-C by the liver and increased levels of circulating LDL-C. PCSK9 inhibitors exert lipid-lowering effects by decreasing plasma PCSK9, ultimately leading to a reduction in the major cardiovascular events [ 39 ]. These agents could not only effectively decrease levels of LDL-C, but also reduce apolipoprotein B (apoB), lipoprotein (a) [Lp(a)], and non-HDL-C levels.…”

Section: Discussionmentioning

confidence: 99%

PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a bayesian network meta-analysis

Wang

Wen

Chen

et al. 2022

Cardiovasc Diabetol

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Background The Food and Drug Administration has approved Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors for the treatment of dyslipidemia. However, evidence of the optimal PCSK9 agents targeting PCSK9 for secondary prevention in patients with high-risk of cardiovascular events is lacking. Therefore, this study was conducted to evaluate the benefit and safety of different types of PCSK9 inhibitors. Methods Several databases including Cochrane Central, Ovid Medline, and Ovid Embase were searched from inception until March 30, 2022 without language restriction. Randomized controlled trials (RCTs) comparing administration of PCSK9 inhibitors with placebo or ezetimibe for secondary prevention of cardiovascular events in patients with statin-background therapy were identified. The primary efficacy outcome was all-cause mortality. The primary safety outcome was serious adverse events. Results Overall, nine trials totaling 54,311 patients were identified. Three types of PCSK9 inhibitors were evaluated. The use of alirocumab was associated with reductions in all-cause mortality compared with control (RR 0.83, 95% CrI 0.72–0.95). Moreover, evolocumab was associated with increased all-cause mortality compared with alirocumab (RR 1.26, 95% CrI 1.04–1.52). We also found alirocumab was associated with decreased risk of serious adverse events (RR 0.94, 95% CrI 0.90–0.99). Conclusions In consideration of the fact that both PCSK9 monoclonal antibody and inclisiran enable patients to achieve recommended LDL-C target, the findings in this meta-analysis suggest that alirocumab might provide the optimal benefits regarding all-cause mortality with relatively lower SAE risks, and evolocumab might provide the optimal benefits regarding myocardial infarction for secondary prevention in patients with high-risk of cardiovascular events. Further head-to-head trials with longer follow-up and high methodologic quality are warranted to help inform subsequent guidelines for the management of these patients.

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Real-World Insights Into Evolocumab Use in Patients With Hyperlipidemia: Canadian Analysis From the ZERBINI Study

Cited by 23 publications

References 29 publications

Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

Guideline LDL-C Threshold Achievement in Acute Myocardial Infarction Patients: A Real-World Evidence Study Demonstrating the Impact of Treatment Intensification with PCSK9i

PCSK9 inhibitors for secondary prevention in patients with cardiovascular diseases: a bayesian network meta-analysis

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