Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
retrospective, Japan, PCSK9i, adherence
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
The patients are included if they meet all the following criteria: 1. At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period. 2. At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period. 3. At least 18 years on the index date. 4. 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. 1. Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date. 2. 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). 3. At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period. 4. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with good adherence | 12 months | Proportion of patients with good adherence at 12 months follow-up period, defined as PDC ≥ 80%. |
| Number of patients by demographic category | Baseline | — |
| Time to discontinuation | 12 months | The date of discontinuation of first treatment drug will be considered as the date of outcome occurrence. |
| Proportion of patients receiving LLTs | 12 months | Proportion of patients receiving LLTs (statin only/ezetimibe only/statin and ezetimibe) during the baseline period and 12 months follow-up period |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed