Saxenda (Liraglutide)

SCALE Study: (2011-13)

Liraglutide 3mg given as once daily subcutaneous injection as adjunct to lifestyle intervention, signficantly reduce body weight compared to a placebo. 

Patients were given the drug at increasing doses until a maximum dose of 3mg was reached. 

Randomised, double-blind, placebo-controlled study (27 countries across all continents)

Study lasted 56 weeks and 3731 patients were recruited

Patients did not have Diabetes and had BMI over 30 or BMI >27 with untreated dyslipidaemia or hypertension. 

NB. Was funded by Novo Nordisk 

– Total body weight loss 8% vs 2.6%

– more than 5% weight loss in 63.2% vs 27.1%

– more than 10% weight loss in 33.1% vs 10.6%

NICE Recommendations:

Liraglutide may be considered in the management of Obesity in the following situations:

  • After dietary, exercise and behavioural approaches have been started and evaluated. 
  • When patients have not been able to reach a target weight loss or have plateaud with the above interventions
  • After disscussion of the implications of drug treatment: mode of action, side effects and monitoring requirements, and possible implications on motivation. 
  • After additional support from health professionals on diet, physical activity and behavioural approaches have been commenced and patients signposted to support programmes (???)
In October 2020, NICE appraised the use of Liraglutide in obesity management in non-diabetic hyperglycaemia (pre-diabetes) in specialist weight management services. (TA 644)
 

 Saxenda can only be prescribed in secondary care whilst supported by an MDT based WMS

  • As an adjunct to comprehensive lifestyle interventions to adults with pre-diabetes (HbA1C 42-47 mmols/L or plasma glucose 5.5 – 6.9) AND is either BMI >34 or at high risk of cardiovascular disease like hypertension or high cholesterol 
  • If Orlistat and bariatric surgery in not an option or if patient is waiting for weight loss surgery
There should be trained group of clinicians and advanced health practitioners who will be approved to provide prescription

Initiation

At the first assessment clinic, baseline blood tests, and other investigations (eg sleep apnoea studies) are requested.

They are referred to the Saxenda working group to initiate the prescription for the drug and for needles

MDT follow up is carried out at 3, 9, 15, 21 and 24 months in the MDT for ongoing assessment / end of treatment / weight loss surgery performed

Further regular follow-up by dieticians or other members of the working group is every 4-6 weeks (to titrate the dose and provide dietary support). 

Discontinuation of Saxenda 

If patients show any of the following, they will be considered circumstances for discontinuation:

  • Adverse reaction
  • Not reached 5% weight loss on 3mg of Saxenda in 12 weeks (16 weeks post initiation)
  • Weight gain whilst using Saxenda
  • Failed to attend WAMS leading to discharge
  • After 2 years of using Saxenda
  • Planned date for surgery confirmed – Saxenda will be stopped by the pre-op assessment clinic 
  • Intolerance to the drug

 

Standard dose titration

At 1 weekly intervals:

  • 0.6 mg
  • 1.2 mg
  • 1.8 mg
  • 2.4 mg 

And then maintenance dose of 

  • 3.0 mg 
If a dose is delayed, then if there is more than 12 hours remaining to the next dose, it should be taken. If there is less than 12 hours to the next dose, then it should be missed (and no changes made to the ongoing regimen
 

Patients with Type 2 DM

  • Saxenda should not be used alongside other GLP-1 agonist diabetic medications
  • Saxenda should not replace existing diabetes management 
  • When initiating Saxenda, reduction in the dose of insulin or insulin secretagogues (such as sulfonylureas) to reduce risk of hypoglycaemia.