Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The IRIS-PCSK9I study

Blanco-Ruiz, Marina; Amaya-Pascasio, Laura; Chacon, R. De Torres; Soria, María Josefa Álvarez; Padillo, Antonio Arjona; Bailén, María Magdalena Carrillo; Pinilla, Rodrigo Milán; Ortega, Irene Pérez; Rodriguez, B Sanchez; Zumárraga, Luis Andrade; Moyano, Roberto Valverde; Ortiz, Manuel Payán; Fernández, Alba María; Pérez, Cristina Del Toro; Bustos, Pablo González; Morales, E.; López, Purificación Sánchez; Martín, Beatriz; Chamorro, Ricardo Roa; Pérez, Javier Fernández; Olmedo, María Victoria Mejías; Martínez‐Sánchez, P.

doi:10.1016/j.athplu.2021.08.009

Cited by 9 publications

(5 citation statements)

References 36 publications

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“…Our ndings, which demonstrate no signi cant difference between the reduction of LDL-C and hard endpoints after the mandated switch, suggest that alirocumab and evolocumab may have similar effectiveness in reducing the risk of cardiovascular events. These ndings align with previous reports that have indicated similar effects of the two treatments on LDL-C levels and cardiovascular outcomes 5,6,11 .…”

Section: Discussionsupporting

confidence: 92%

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Effectiveness and Safety of Anti-PCSK9 Treatment in Persons with Hyperlipidemia: A Register-Based Cohort Study

Andersen

Andreasen

Bang

et al. 2023

Preprint

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Addressing dyslipidaemia, a condition involving abnormal amounts of lipids in the blood, is crucial due to its strong association with cardiovascular disease. Anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) drugs like alirocumab and evolocumab offer promising therapeutic solutions. Here we show, from our register-based cohort study in the Capital Region of Denmark (2016–2022), the efficacy and safety of these drugs in 907 persons with dyslipidaemia. Upon treatment initiation, PCSK9 inhibitors showed a substantial 49% reduction in low-density lipoprotein cholesterol (LDL-C) levels. The mandated switch from alirocumab to evolocumab resulted in no significant difference in LDL-C levels or adverse clinical outcomes, such as major cardiovascular events or mortality. Thus, we conclude both alirocumab and evolocumab can be safely and effectively used interchangeably for treating dyslipidaemia.

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Section: Discussionsupporting

confidence: 92%

“…Despite this, our study found a reduction of 49%, which is lower compared to previous clinical trials but similar to other real-world studies 5,6,11,13 . Nevertheless, it is unlikely that this bias signi cantly impacted the estimate for the switch.…”

Section: Discussionsupporting

confidence: 76%

Effectiveness and Safety of Anti-PCSK9 Treatment in Persons with Hyperlipidemia: A Register-Based Cohort Study

Andersen

Andreasen

Bang

et al. 2023

Preprint

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“…However, a Spanish mulPcenter observaPonal study showed similar safety profiles and no significant differences in the frequency of MACE occurrence between evolocumab and alirocumab. 40 Our results do not necessarily mean that ezePmibe increases the risks of MACE outcomes. It is sPll plausible to postulate that ezePmibe may possess cardioprotecPve effects but may not be as potent compared to PCSK9I; however, this hypothesis requires further verificaPon through further randomised controlled trials.…”

Section: Outcomes (Evaluapon Of Cardiovascular Outcomes Aqer An Acute...mentioning

confidence: 58%

“…However, a Spanish multicenter observational study showed similar safety profiles and no significant differences in the frequency of MACE occurrence between evolocumab and alirocumab. 40…”

Section: Discussionmentioning

confidence: 99%

Comparisons of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9I) versus Ezetimibe on Major Adverse Cardiovascular Events Amongst Patients with Dyslipidaemia: A Population-Based Study

Chou,

Li,

Chung

et al. 2023

Preprint

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Background: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9I) have potential benefits against cardiovascular disease. The comparative risks of new-onset major adverse cardiovascular events (MACE) between PCSK9I and ezetimibe remain unknown. Objective: This real-world study compared the risks of MACE upon exposure to PCSK9I and ezetimibe. Methods: This was a retrospective population-based cohort study of patients with dyslipidaemia on either PCSK9I or ezetimibe between 1st January 2015 and 30th October 2022 using a territory-wide database from Hong Kong. The primary outcome was new-onset MACE. The secondary outcomes were myocardial infarction, heart failure, stroke/transient ischaemic attack, and all-cause mortality. Propensity score matching (1:3 ratio) using the nearest neighbour search was performed. Multivariable Cox regression was used to identify significant associations. Results: This cohort included 42450 dyslipidaemia patients (median age: 65.0 years old [SD: 11.1]; 64.54 % males). The PCSK9I and ezetimibe groups consisted of 1477 and 40973 patients, respectively. After matching, 67 and 235 patients suffered from MACE in the PCSK9I and ezetimibe groups, respectively, over a total of 14514.5 person-years. PCSK9I was associated with lower risks of MACE (Hazard ratio [HR]: 0.59; 95% Confidence Interval [CI]: 0.37-0.92) compared to ezetimibe use after adjusting for demographics, past comorbidities, other medications, and time-weighted means of lipid and glucose tests. Besides, while both alirocumab and evolocumab were associated with lower risks of MACE, evolocumab was associated with significantly lower risks of myocardial infarction, heart failure, and stroke/transient ischaemic attack. The results remained consistent in the competing risk and sensitivity analyses. Conclusions: PCSK9I use amongst dyslipidaemia patients was associated with lower risks of new-onset MACE and outcomes compared to ezetimibe after adjustments. Evolocumab might perform better than Alirocumab in reducing the risks of cardiovascular diseases.

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“…Whilst the efficacy of PCSK9 inhibition has been established in several randomised clinical trials, there is no comprehensive evidence from public health settings ( 9 , 10 ); therefore, additional real-world data are required to describe the effectiveness of PCSK9 inhibition in routine clinical practice. Additionally, little is known about how oral LLT usage patterns change after the initiation of PCSK9 inhibition when the two are used in combination therapy.…”

Section: Introductionmentioning

confidence: 99%

A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels

Svensson,

James,

Ravn-Fischer

et al. 2024

ujms

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Background: Treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduces low-density lipoprotein cholesterol (LDL-C) levels and decreases the incidence of major ischaemic events in clinical trials. However, less is known about the efficacy of PCSK9 inhibition in clinical practice. This study aimed to describe the change in LDL-C levels over time and LDL-C goal achievement in patients with/without atherosclerotic cardiovascular disease (ASCVD), who were prescribed evolocumab in clinical practice, and to describe adherence to and persistence with treatment. Methods: Patients in Sweden with at least one evolocumab prescription filled between July 2015 and May 2020 were included. Medical history and lipid-lowering therapy (LLT) were sourced from national registries. LDL-C levels before and after treatment initiation were assessed using medical records. Persistence with and adherence to evolocumab and oral LLT were assessed up to 12 months after treatment initiation using the refill-gap method and proportion of days covered, respectively. Results: Of the 2,360 patients with at least one prescription for evolocumab, 2,341 were included; 1,858 had ASCVD. Persistence with (76%) and adherence to (86%) evolocumab were high throughout the 12 months following initiation. Mean LDL-C levels decreased by 53% (95% confidence interval [CI]: 51–55%) in patients adherent to evolocumab (n = 567) and 59% (95% CI: 55–63%) in patients adherent to evolocumab and oral LLT (n = 186). Similar reductions in LDL-C were observed in patients with/without ASCVD. Reduced LDL-C levels remained stable during follow-up. Amongst patients adherent to evolocumab and those adherent to evolocumab and oral LLT, 23 and 55% achieved the LDL-C goal of <1.4 mmol/L, respectively. Conclusions: The evolocumab LDL-C-lowering effect observed in clinical trials was confirmed in clinical practice in Sweden, particularly in patients also treated with oral LLT. During follow-up, adherence to and persistence with evolocumab were high, with stable reduced levels of LDL-C during observation.

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Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The IRIS-PCSK9I study

Cited by 9 publications

References 36 publications

Effectiveness and Safety of Anti-PCSK9 Treatment in Persons with Hyperlipidemia: A Register-Based Cohort Study

Effectiveness and Safety of Anti-PCSK9 Treatment in Persons with Hyperlipidemia: A Register-Based Cohort Study

Comparisons of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9I) versus Ezetimibe on Major Adverse Cardiovascular Events Amongst Patients with Dyslipidaemia: A Population-Based Study

A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels

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