Observational studyCardiovascular drugs and therapy2026

Real-World Efficacy of Inclisiran in Veneto Region (Italy): The INCLIVEN Multicenter Registry.

Francesco Briani, Elena Sani, Gabriele Venturi, Francesco Bacchion, Sara Balzano, Marialberta Battocchio, Katia D'Elia, Giulia Maria Frigo, Luca Licchelli, Antonio Lupo and 7 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cardiovascular drugs and therapy, 2026. The graph read 2 numbers from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 4 papers, 1 of them a synthesis that pooled it.

2numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

Read, but not usablea number the graph found but could not read as for or against

LDL-C concentrationinclisiran vs baselinedescribes a change within one group, not a comparison · ascvd, dyslipidemiafeeds one cell of the map
Δ -50.0<0.001
RESULTS: Mean LDL-C levels at baseline (n = 240) were 118.7 ± 48.7 mg/dl, then they significantly fell to 56.7 ± 40.4 mg/dl (-52.3 ± 24.3%; p < 0.001) at 3 months (n = 238) and to 60.5 ± 40.1 mg/dl (-50.0 ± 22.7%; p < 0.001) at 9 months (n = 138).
LDL-C concentrationinclisiran vs baselinedescribes a change within one group, not a comparison · ascvd, dyslipidemiafeeds one cell of the map
Δ -52.3<0.001
RESULTS: Mean LDL-C levels at baseline (n = 240) were 118.7 ± 48.7 mg/dl, then they significantly fell to 56.7 ± 40.4 mg/dl (-52.3 ± 24.3%; p < 0.001) at 3 months (n = 238) and to 60.5 ± 40.1 mg/dl (-50.0 ± 22.7%; p < 0.001) at 9 months (n = 138).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

PCSK9 inhibitors×lipids

No readable resultOpen on the map →What to test next →

34 readable studies in this cell: 29 favour the treatment, 2 find no difference, 3 favour the comparator.

Belief with this paper
0.93established · 26 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017638662,067 enrolled · 2013
Δ -71.4-77.5 to -65.3
NCT034008001,617 enrolled · 2017
Δ -53.5-56.7 to -50.4
NCT02662569986 enrolled · 2016
Δ -70.3-75.4 to -65.2
NCT04807400892 enrolled · 2021
Least Squares Mean -31.8-37.9 to -25.8
NCT01380730631 enrolled · 2011
Δ -66.1-71.5 to -60.7
NCT01763827615 enrolled · 2013
Δ -57.1-61.1 to -53.1
NCT01984424511 enrolled · 2013
Δ -37.8-42.3 to -33.3
NCT02833844467 enrolled · 2017
Δ -56.9-61.5 to -52.3
NCT04929249450 enrolled · 2021
Δ -53.0-60.0 to -46.0
NCT02739984424 enrolled · 2016
Δ -64.1-68.2 to -60.1
NCT02642159413 enrolled · 2016
Δ -32.5-38.1 to -27.0
NCT01375777411 enrolled · 2011
Δ -47.2-54.5 to -39.9

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

17 authors.

Francesco BrianiDivision of Cardiology, Mater Salutis Hospital Legnago, Verona, Italy.
Elena SaniDivision of Endocrinology, Diabetes and Metabolism, University of Verona, Verona, Italy.
Gabriele VenturiDivision of Cardiology, Mater Salutis Hospital Legnago, Verona, Italy.
Francesco BacchionDivision of Cardiology, Mater Salutis Hospital Legnago, Verona, Italy.
Sara BalzanoDivision of Endocrinology, San Bassiano Hospital, Bassano del Grappa, Italy.
Marialberta BattocchioDepartment of Medicine, Cittadella Hospital, Padua, Italy.
Katia D'EliaDivision of Cardiology, Rovigo Hospital, Rovigo, Italy.
Giulia Maria FrigoDivision of Cardiology, San Bonifacio Hospital, Verona, Italy.
Luca LicchelliDepartment of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padua, Padua, Italy.
Antonio LupoDivision of Cardiology, Mirano Hospital, Venice, Italy.
Alberto MarangoniDepartment of Medicine, Feltre Hospital, Belluno, Italy.
Luigi RivettiDivision of Cardiology, Conegliano Hospital, Treviso, Italy.
Mauro ScanferlatoDepartment of Medicine, Portogruaro Hospital, Venice, Italy.
Sabina ZambonDepartment of Medicine, University of Padua, Padua, Italy.
Maria Grazia ZentiDepartment of Diabetology and Metabolic Diseases, Peschiera del Garda Hospital, Verona, Italy.
Elisabetta RinaldiDivision of Endocrinology, Diabetes and Metabolism, University of Verona, Verona, Italy.
Antonio MugnoloDivision of Cardiology, Mater Salutis Hospital Legnago, Verona, Italy. antonio.mugnolo@aulss9.veneto.it.

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

purposeInclisiran is a long-acting small interfering RNA (siRNA) which prevents the synthesis of PCSK9 in hepatocytes, reducing LDL-C concentration. Only limited data are available in the literature regarding its use in real-world settings.

methodsIn this observational multicenter registry, we included high cardiovascular risk patients from 12 lipid clinics in the Veneto region of Italy who started inclisiran therapy between October 2022 and February 2024. Primary endpoint was changes in LDL-C concentrations at 3 months of follow-up after inclisiran administration. Secondary endpoints were changes in LDL-C concentrations at 9 months of follow-up, safety, percentage of patients reaching LDL-C targets and efficacy of inclisiran according to background therapy and clinical characteristics of the population.

resultsMean LDL-C levels at baseline (n = 240) were 118.7 ± 48.7 mg/dl, then they significantly fell to 56.7 ± 40.4 mg/dl (-52.3 ± 24.3%; p < 0.001) at 3 months (n = 238) and to 60.5 ± 40.1 mg/dl (-50.0 ± 22.7%; p < 0.001) at 9 months (n = 138). Three (1.3%) patients reported mild injection-site side effects. LDL-C target achievement according to ESC/EAS 2019 guidelines was 64.7% at 3 months and 62.3% at 9 months. Patients on statin therapy had a greater LDL-C reduction compared to patients with statin intolerance. At 3 months across we observed greater LDL-C reduction in patients with diabetes (59.9 ± 23.2% vs 49.7 ± 24.1%; p = 0.004). In the multivariable analysis diabetes mellitus (p = 0.006) and background statin therapy (p = 0.034) were independent predictors for greater LDL-C reduction.

conclusionThis real-world multicenter registry supports inclisiran as an effective, well-tolerated option for managing hypercholesterolemia in high cardiovascular risk patients.

Indexed as

Cardiovascular DiseasesCholesterol, LDLPCSK9 InhibitorsRNAi TherapeuticsRNA, Small InterferingAgedBiomarkersFemaleHumansItalyMaleMiddle AgedProprotein Convertase 9RegistriesTime FactorsTreatment OutcomeALN-PCSBiomarkersCholesterol, LDLPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9RNA, Small InterferingAtherosclerotic cardiovascular disease (ASCVD)InclisiranLipid-lowering therapyLow-density lipoprotein cholesterolSmall interfering RNA (siRNA)

Identifiers

PMID40663298
PMCPMC12992455

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.