Inclisiran: Efficacy in Real World—Systematic Review and Meta-Analysis Article Swipe
Álvaro Rodrigo Alaíz
,
Luís Corral-Gudino
,
Leopoldo Pérez de Isla
,
Héctor García Pardo
,
David González Calle
,
José Pablo Miramontes‐González
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/jcm14124163
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/jcm14124163
Background: Inclisiran is a novel lipid-lowering agent targeting PCSK9 via small interfering RNA (siRNA) technology. While clinical trials such as the ORION studies have demonstrated significant reductions in low-density lipoprotein cholesterol (c-LDL), real-world data (RWD) often differ due to variations in patient populations and clinical practices. Methods: This systematic review and meta-analysis adhered to PRISMA guidelines. A comprehensive search was conducted in MEDLINE for real-world studies evaluating inclisiran’s efficacy in reducing c-LDL. Articles meeting predefined inclusion criteria were assessed for quality and bias using RTI Item Bank. Data transformations were applied to harmonize median and IQR values to means and standard deviations for meta-analytic synthesis using RevMan 5.4. Results: A total of 3774 articles were identified, of which 7 studies comprising 1454 patients met the inclusion criteria. The meta-analysis revealed an average c-LDL reduction of 42.77% (95% CI: 37.42–48.12%). The subgroup analysis indicated greater reductions in patients receiving inclisiran alongside statins (45.67%; 95% CI: 36.64–54.71%) compared to monotherapy (37.53%; 95% CI: 29.91–45.15%). Discrepancies with clinical trials (e.g., 52% reduction in ORION studies) were attributed to baseline c-LDL differences and real-world adherence. Conclusions: Inclisiran demonstrates robust efficacy in real-world settings, achieving significant c-LDL reductions with a convenient dosing schedule. However, the observed discrepancies with clinical trials highlight the need for further RWD studies to bridge gaps in effectiveness and optimize therapeutic outcomes.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.3390/jcm14124163
- https://www.mdpi.com/2077-0383/14/12/4163/pdf?version=1749700182
- OA Status
- gold
- Cited By
- 1
- References
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- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4411248471
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4411248471Canonical identifier for this work in OpenAlex
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https://doi.org/10.3390/jcm14124163Digital Object Identifier
- Title
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Inclisiran: Efficacy in Real World—Systematic Review and Meta-AnalysisWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-06-12Full publication date if available
- Authors
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Álvaro Rodrigo Alaíz, Luís Corral-Gudino, Leopoldo Pérez de Isla, Héctor García Pardo, David González Calle, José Pablo Miramontes‐GonzálezList of authors in order
- Landing page
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https://doi.org/10.3390/jcm14124163Publisher landing page
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https://www.mdpi.com/2077-0383/14/12/4163/pdf?version=1749700182Direct link to full text PDF
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goldOpen access status per OpenAlex
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https://www.mdpi.com/2077-0383/14/12/4163/pdf?version=1749700182Direct OA link when available
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Medicine, Meta-analysis, Internal medicineTop concepts (fields/topics) attached by OpenAlex
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1Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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| referenced_works | https://openalex.org/W4211134725, https://openalex.org/W6756602680, https://openalex.org/W2889378692, https://openalex.org/W4378952150, https://openalex.org/W2596179513, https://openalex.org/W2899997727, https://openalex.org/W4313554841, https://openalex.org/W4308184058, https://openalex.org/W3012265841, https://openalex.org/W4308178887, https://openalex.org/W2015712245, https://openalex.org/W4321004374, https://openalex.org/W2766784925, https://openalex.org/W4386046419, https://openalex.org/W3118615836, https://openalex.org/W4380630135, https://openalex.org/W4311501066, https://openalex.org/W4311309800, https://openalex.org/W6854016466, https://openalex.org/W4386836462, https://openalex.org/W4390889283, https://openalex.org/W4398785255, https://openalex.org/W4401047454, https://openalex.org/W4405289766, https://openalex.org/W3134963806, https://openalex.org/W2740060821, https://openalex.org/W2943413777, https://openalex.org/W2100097418, https://openalex.org/W3208942900, https://openalex.org/W2319983832, https://openalex.org/W4223992912, https://openalex.org/W3183857127, https://openalex.org/W4383652804, https://openalex.org/W2900034165 |
| referenced_works_count | 34 |
| abstract_inverted_index.7 | 118 |
| abstract_inverted_index.A | 56, 109 |
| abstract_inverted_index.a | 3, 194 |
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| abstract_inverted_index.52% | 167 |
| abstract_inverted_index.95% | 152, 159 |
| abstract_inverted_index.CI: | 137, 153, 160 |
| abstract_inverted_index.IQR | 95 |
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| abstract_inverted_index.RTI | 84 |
| abstract_inverted_index.RWD | 210 |
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| abstract_inverted_index.ORION | 21, 170 |
| abstract_inverted_index.PCSK9 | 8 |
| abstract_inverted_index.While | 15 |
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| abstract_inverted_index.c-LDL | 132, 176, 191 |
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| abstract_inverted_index.which | 117 |
| abstract_inverted_index.(e.g., | 166 |
| abstract_inverted_index.42.77% | 135 |
| abstract_inverted_index.PRISMA | 54 |
| abstract_inverted_index.RevMan | 106 |
| abstract_inverted_index.bridge | 213 |
| abstract_inverted_index.c-LDL. | 71 |
| abstract_inverted_index.differ | 36 |
| abstract_inverted_index.dosing | 196 |
| abstract_inverted_index.median | 93 |
| abstract_inverted_index.review | 49 |
| abstract_inverted_index.robust | 184 |
| abstract_inverted_index.search | 58 |
| abstract_inverted_index.trials | 17, 165, 204 |
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| abstract_inverted_index.(siRNA) | 13 |
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| abstract_inverted_index.statins | 150 |
| abstract_inverted_index.studies | 22, 65, 119, 211 |
| abstract_inverted_index.(37.53%; | 158 |
| abstract_inverted_index.(45.67%; | 151 |
| abstract_inverted_index.(c-LDL), | 31 |
| abstract_inverted_index.Articles | 72 |
| abstract_inverted_index.However, | 198 |
| abstract_inverted_index.Methods: | 46 |
| abstract_inverted_index.Results: | 108 |
| abstract_inverted_index.analysis | 141 |
| abstract_inverted_index.articles | 113 |
| abstract_inverted_index.assessed | 78 |
| abstract_inverted_index.baseline | 175 |
| abstract_inverted_index.clinical | 16, 44, 164, 203 |
| abstract_inverted_index.compared | 155 |
| abstract_inverted_index.criteria | 76 |
| abstract_inverted_index.efficacy | 68, 185 |
| abstract_inverted_index.observed | 200 |
| abstract_inverted_index.optimize | 218 |
| abstract_inverted_index.patients | 122, 146 |
| abstract_inverted_index.reducing | 70 |
| abstract_inverted_index.revealed | 129 |
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| abstract_inverted_index.harmonize | 92 |
| abstract_inverted_index.highlight | 205 |
| abstract_inverted_index.inclusion | 75, 125 |
| abstract_inverted_index.indicated | 142 |
| abstract_inverted_index.outcomes. | 220 |
| abstract_inverted_index.receiving | 147 |
| abstract_inverted_index.reduction | 133, 168 |
| abstract_inverted_index.schedule. | 197 |
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| abstract_inverted_index.targeting | 7 |
| abstract_inverted_index.Inclisiran | 1, 182 |
| abstract_inverted_index.adherence. | 180 |
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| abstract_inverted_index.inclisiran | 148 |
| abstract_inverted_index.practices. | 45 |
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| abstract_inverted_index.real-world | 32, 64, 179, 187 |
| abstract_inverted_index.reductions | 26, 144, 192 |
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| abstract_inverted_index.populations | 42 |
| abstract_inverted_index.significant | 25, 190 |
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| abstract_inverted_index.therapeutic | 219 |
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| abstract_inverted_index.discrepancies | 201 |
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| abstract_inverted_index.36.64–54.71%) | 154 |
| abstract_inverted_index.transformations | 88 |
| abstract_inverted_index.29.91–45.15%). | 161 |
| abstract_inverted_index.37.42–48.12%). | 138 |
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