In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

Study Overview
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Brief Summary
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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.

Official Title
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In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br>Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months) | Drug: Liraglutide<br>* No treatment given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only) | Number | Less than 6 months before the date of the first prescription | 
| 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) | With at least 1 relevant comorbidity: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities) | Less than 6 months before the date of the first prescription | 
| 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) | None of the relevant comorbidities: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities) | Less than 6 months before the first prescription | 
| Number of patients with BMI below 27 kg/m^2 (Saxenda® only) | Number | Less than 6 months before the first prescription | 
| Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only) | Number | Week 0 (first prescription) to week 16; week 24 | 
| 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) | Number | Less than 6 months before the first prescription | 
| Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only) | Number | Week 16 - week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Number of patients with Victoza® prescriptions | Within 4-12 weeks from the date of the first prescription | 
| Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only) | Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date | From date of first prescription until 24 months | 
| Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only) | Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date | From date of first prescription until 24 months | 
| Number of patients who have reached 3.0 mg (Saxenda® only) | Number | 12 weeks from time of first prescription | 
| Number of patients with a treatment duration of 0-6 months (Saxenda® only) | Number | Month 6 | 
| Number of patients with a treatment duration of 7-12 months (Saxenda® only) | Number | Month 12 | 
| Number of patients with a treatment duration of 13-18 months (Saxenda® only) | Number | Month 18 | 
| Number of patients with a treatment duration of 19-24 months (Saxenda® only) | Number | Month 24 | 
| Number of patients with a treatment duration of 25-36 months (Saxenda® only) | Number | Month 36 | 
| Number of patients with a treatment duration of 37-48 months (Saxenda® only) | Number | Month 48 | 
| Number of patients with a treatment duration of 49-60 months (Saxenda® only) | Number | Month 60 | 
| Number of patients with ongoing treatment (current users) (Saxenda® only) | Number | Month 60 |