Liraglutide (known by the brand name Victoza®) is a medicine used to treat diabetes. Another formulation (known as Saxenda®) is now being used to help weight management in obese patients and overweight patients with additional weight-related illnesses, even if they don’t have diabetes. The European Medicines Agency have requested a study of liraglutide to understand how this medicine is being used in the UK.
This study will describe the patients who receive a prescription for liraglutide from their GP practice (either branded as Victoza® or Saxenda®, or where the brand was not recorded). Patient characteristics will be described (age, sex, whether they were obese or overweight, what illnesses they had and what other medicines they were being prescribed), as well as the characteristics of the area of their UKGP practice e.g. how deprived or wealthy the area was. The study will also describe how many prescriptions patients received, for which dosages, how often, and for how long. Patient’s weight, and whether they were obese or overweight, will also be described over time.
We will use GP responses to a questionnaire on a sample of 400 patients to understand whether these patients were prescribed liraglutide for diabetes or for weight management, what dose they were meant to take, or whether the GP meant for them to receive Victoza® or Saxenda®. The findings from this study will help medicines regulators to understand whether additional guidance about treatment with Saxenda® may be needed to ensure that this medicine is prescribed safely.
Technical Summary (Max. 300 words)
Rationale and background
Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m² (obese), or
• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity.
Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. As part of the risk management plan for Saxenda®, the aim of this study is to investigate liraglutide usage for weight management in clinical practice using CPRD primary care databases.
Primary objective
To describe the use of Saxenda® assessing the proportion of patients initiating and discontinuing treatment in line with the approved indication.
Secondary objectives
Descriptive analyses of
1. Potential use of Victoza® for weight management.
2. Use of Saxenda® according to approved posology.
3. Use of liraglutide where intended brand is not recorded in primary care
Study design
Descriptive drug utilisation study to investigate the use of liraglutide for weight management in patients with newly initiated treatment. The study population will include adult patients with a first ever prescription record of liraglutide in CPRD Aurum or CPRD GOLD after the UK launch of Saxenda®. Descriptive statistics (n, %, mean, s.d.) will be reported throughout.
Primary care data are supplemented with questionnaires to GPs of approximately 200 Victoza® and 200 Saxenda® patients to request further information on indication, dosage and intended brand to supplement data poorly recorded or missing in coded primary care data. All analyses are repeated amongst the patients whose GPs respond to the questionnaire. Practice Level of Multiple Deprivation is added to understand prescribing patterns by practice deprivation category.
Number (%) of patients with BMI>=30 kg/m2; number (%) of patients with 27 kg/m2<=BMI<30 kg/m2 and >=1 relevant comorbidity; number (%) of patients with 27 kg/m2<=BMI<30 kg/m2 and no relevant comorbidities; number (%) of patients with BMI<27 kg/m2; number (%) of patients with BMI not measured within 6 months before index date (i.e. the first recorded prescription of liraglutide).
Number (%) of patients with at least 5% weight loss (measured 16-24 weeks after index date) and continuing treatment; number (%) of patients with less than 5% weight loss (measured 16-24 weeks after index date) and continuing treatment; mean weight loss (measured 16-24 weeks after start date of treatment) in patients not treated according to stopping rule.
Number (%) of patients with Victoza® prescriptions at a prescription interval corresponding to a daily dose of 3.0 mg, or with dose information of 3.0 mg per day, or with indication weight management and no indication of type 2 diabetes.
Number (%) of patients who have reached 3.0 mg by 12 weeks after index date.
Number (%) of Saxenda® initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda®; number (%) of Saxenda® initiators with other products for weight management prescribed during continued treatment with Saxenda®.
Duration (mean, s.d.) of treatment with Saxenda®; number (%) of patients with a treatment duration of 0-6, 7-12, 13-18, 19-24, 25-36, 37-48, 49-60 months, or ongoing (current users).
Anne Helene Olsen - Chief Investigator - Novo Nordisk A/S
Anne Helene Olsen - Corresponding Applicant - Novo Nordisk A/S
Atheline Major-Pedersen - Collaborator - Novo Nordisk A/S
Nina Harder-Lauridsen - Collaborator - Novo Nordisk A/S
Rachael Williams - Collaborator - CPRD
Sonia Coton - Collaborator - CPRD
Tarita Murray-Thomas - Collaborator - CPRD
Practice Level Index of Multiple Deprivation