Obesity, Overweight
Conditions
Brief summary
This study is conducted in Europe. The aim of this study is to investigate the usage of liraglutide for weight management in clinical practice using the CPRD (Clinical Practice Research Datalink) primary care database.
Interventions
DRUGLiraglutide
No treatment given
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-New initiators of liraglutide (unbranded, or branded prescription, i.e. Saxenda® or Victoza®), who have no liraglutide prescriptions in the twelve months prior to index date (time of first prescription). Patients must be research standard (registered as acceptable in the database) with at least one year of up-to-standard registration prior to their index date
Exclusion criteria
-Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only) | Less than 6 months before the date of the first prescription | Number |
| Number of patients with a BMI above or equal to 27 kg/m^2 and below 30 kg/m^2 and 1 or more comorbidities (Saxenda® only) | Less than 6 months before the date of the first prescription | With at least 1 relevant comorbidity: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities) |
| Number of patients with a BMI above or equal to 27 kg/m^2 and less than 30 kg/m^2 and no comorbidities (Saxenda® only) | Less than 6 months before the first prescription | None of the relevant comorbidities: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities) |
| Number of patients with BMI below 27 kg/m^2 (Saxenda® only) | Less than 6 months before the first prescription | Number |
| Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only) | Week 0 (first prescription) to week 16; week 24 | Number |
| Mean weight loss in patients not treated according to stopping rule (Saxenda® only) | Week 0 (first prescription) to week 16; week 24 | — |
| Number of patients with a BMI not measured (Saxenda® only) | Less than 6 months before the first prescription | Number |
| Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only) | Week 16 - week 24 | Number |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a treatment duration of 25-36 months (Saxenda® only) | Month 36 | Number |
| Number of patients with a treatment duration of 37-48 months (Saxenda® only) | Month 48 | Number |
| Number of patients fulfilling at least one of the following: 1) a prescription interval corresponding to a daily dose of 3.0 mg, 2) dose information of 3.0 mg per day, or 3) indication of weight management (Victoza® only) | Within 4-12 weeks from the date of the first prescription | Number of patients with Victoza® prescriptions |
| Number of patients with ongoing treatment (current users) (Saxenda® only) | Month 60 | Number |
| Number of patients with a treatment duration of 49-60 months (Saxenda® only) | Month 60 | Number |
| Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only) | From date of first prescription until 24 months | Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date |
| Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only) | From date of first prescription until 24 months | Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date |
| Number of patients who have reached 3.0 mg (Saxenda® only) | 12 weeks from time of first prescription | Number |
| Number of patients with a treatment duration of 0-6 months (Saxenda® only) | Month 6 | Number |
| Number of patients with a treatment duration of 7-12 months (Saxenda® only) | Month 12 | Number |
| Number of patients with a treatment duration of 13-18 months (Saxenda® only) | Month 18 | Number |
| Number of patients with a treatment duration of 19-24 months (Saxenda® only) | Month 24 | Number |
Countries
Denmark
Outcome results
None listed