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NCT Number: NCT07468500

Real World Adherence of PCSK9 Targeted Therapy

Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.

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Key information

Conditions

Dyslipidemia, Hypercholesterolemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patients are included if they meet all the following criteria:

  • At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
  • At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
  • At least 18 years on the index date.
  • At least one claim record within the 210 days prior to the index date (excluding the index date).

Exclusion criteria

Those with any of the following criteria will be excluded.

  • Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
  • At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
  • At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
  • Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).

Treatment and study plan

Primary outcomes

  1. Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent

    Time frame: 12 months

    Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days.

Secondary outcomes

  1. Proportion of patients with good adherence

    Time frame: 12 months

    Proportion of patients with good adherence at 12 months follow-up period, defined as PDC ≥ 80%.

  2. Number of patients by demographic category

    Time frame: Baseline

  3. Time to discontinuation

    Time frame: 12 months

    The date of discontinuation of first treatment drug will be considered as the date of outcome occurrence.

  4. Proportion of patients receiving LLTs

    Time frame: 12 months

    Proportion of patients receiving LLTs (statin only/ezetimibe only/statin and ezetimibe) during the baseline period and 12 months follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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