Obesity Pharmacological treatments

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Obesity Pharmacological treatments

• Jill Titterton
• Pharmacist
• Derbyshire County PCT

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Management of obesity

• Dietary management
• A low energy,low fat diet is the most effective
  lifestyle intervention for weight loss
• Exercise
• Encourage adults to take part in moderate
  physical activity
• Behavioural modification
• Drugs
• Considered as an addition to the above approaches
  to help tackle obesity
• Orlistat (Xenical)
• Sibutramine (Reductil)
• Rimonabant (Acomplia)

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Orlistat-Clinical Evidence, Issue 4 Dec 2000

• Orlistat works by preventing the absorption of
  fat from the intestinal tract- producing an
  approx100 kcal per day deficit
• Produces a weight loss over placebo of about
  2-5kg on average
• Proportion who lost 10 or more of their initial
  weight at 12 months (full support and advice
  provided in trials)
• Orlistat - 20.2
• placebo - 8.3, (P lt 0.001).
• Adverse effects
• Oily spotting
• Flatulence
• Fatty oily stools
• Faecal urgency
• People taking Orlistat may require vitamin
  supplementation

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Orlistat - NICE Clinical guidelines 43

• Prescribe only as part of an overall plan for
  managing obesity in adults who have
• a BMI of 28.0 kg/m2 or more with associated
  risk factors, or
• a BMI of 30.0 kg/m2 or more.
• Continue treatment for longer than 3 months only
  if the person has lost at least 5 of their
  initial body weight since starting drug treatment
  (less strict goals may be appropriate for people
  with type 2 diabetes).
• Continue for longer than 12 months (usually for
  weight maintenance) only after discussing
  potential benefits and limitations with the
  patient.
• Co-prescribing with other drugs for weight
  reduction is not recommended.

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Sibutramine Clinical Evidence, Issue 4 Dec 2000

• Sibutramine is a centrally acting agent shown to
  affect weight loss by enhancing satiety.
• In two 12 months studies, mean weight loss was
• Sibutramine - 4.4-5.2 kg
• placebo - 1.6 kg.
• In both trials, weight loss stabilised after 6
  months of Sibutramine.
• Adverse effects
• Increase in blood pressure
• Constipation ,Nausea Dry mouth
• Recommended Only as part of a long-term
  integrated therapeutic approach for weight
  reduction under the care of a physician
  experienced in the treatment of obesity

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Sibutramine - NICE guidelines

• Prescribe only as part of an overall plan for
  managing obesity in adults who have a BMI of
  27.0 kg/m2 or more and other obesity-related risk
  factors such as type 2 diabetes or dyslipidaemia,
  or
• a BMI of 30.0 kg/m2 or more.
• Prescribe only if there are adequate arrangements
  for monitoring both weight loss and adverse
  effects (specifically pulse and blood pressure).
• Continue treatment for longer than 3 months only
  if the person has lost at least 5 of their
  initial body weight since starting drug treatment
  (less strict goals may be appropriate for people
  with type 2 diabetes)
• Treatment is not recommended beyond the licensed
  duration of 12 months.
• Co-prescribing with other drugs aimed at weight
  reduction is not recommended.

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Rimonabant- NICE review in progress

• Rimonabant is a cannabinoid receptor antagonist
  licensed as an adjunct to diet and exercise for
  obese or overweight patients with associated risk
  factors.
• Mean weight reduction of 4.7kg (95Cl 4.1 to 5.3
  plt0.0001)
• 1 in every 15 patients treated dropped out due to
  side effects (number needed to harm NNH 15).
  Depression and anxiety
• Patients with psychiatric illnesses were excluded
  from trials
• Still ? requiring close monitoring of side
  effects
• Not currently approved for prescribing in the PCT

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Meta-Analysislong term pharmacotherapy for obese
and overweight patientsBMJ online15thNov

• Orlistat reduced weight by 2.9kg (95
  CL,2.5kg-3.2kg)
• Sibutramine by 4.2kg (3.6kg to 4.7 kg)
• Rimonabant 4.7 kg (4.1 kg to 5.3kg)

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Side effects seen in trials
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Management drug treatment for adults- NICE CG 43

• Drug treatment should be considered for adults
• only after dietary and exercise advice have
• been started and evaluated
• for patients who have not reached their
• target weight or have reached a plateau
• These recommendations update the NICE
• technology appraisals on orlistat and sibutramine

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NICE guidelines on drug treatments

• Before deciding to start treatment, and choosing
  the drug, discuss with the patient the potential
  benefits and limitations, including the mode of
  action, adverse effects and monitoring
  requirements ,and their potential impact on the
  patients motivation.
• When prescribing, make arrangements for
  appropriate healthcare professionals to offer
  information, support and counselling on
  additional diet, physical activity and
  behavioural strategies.
• Give information on patient support programmes.
• Follow the drugs summary of product
  characteristics.

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Continued prescribing and withdrawalNICE
Clinical Guidelines 43

• Review regularly, to monitor the effect of drug
  treatment, and to reinforce lifestyle advice and
  need for adherence.
• Drug treatment may be used to help people to
  maintain weight loss, as well as to continue to
  lose weight.
• Consider withdrawing drug treatment if the person
  does not lose enough weight
• Consider less strict goals for people with type 2
  diabetes, because they may lose weight more
  slowly.
• Agree goals with the person and review regularly.
• If concerned about micronutrient intake, consider
  giving a supplement providing the reference
  nutrient intake for all vitamins and trace
  elements, particularly for vulnerable groups such
  as older people, who may be at risk of
  malnutrition.
• If withdrawing a persons drug treatment, offer
  support to help maintain weight loss because
  their self-confidence and belief in their ability
  to make changes may be low.

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Cost of these products

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Spend on Obesity Treatments in Derbyshire County
PCT

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Results of Local Audits

• Audits have been undertaken in our local GP
  practices against the NICE standards
• Results showed 73 of orlistat prescribing and
  40 of sibutramine prescribing was outside of
  NICE guidance
• That is treatment continued beyond three months
  when patients had not achieved a least 5 weight
  loss

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Conclusions

• Drugs do help some people achieve better weight
  loss, each drug resulted in lt5kg weight reduction
  compared with placebo.
• But most trials on non elderly and white so
  extrapolation to other populations should be made
  with caution
• They should be integrated with other approaches
  that address the patients motivation and prevent
  the idea that obesity can be fixed by a medicines
  and undermine healthy livingmessages
• Drugs to be used in line with NICE guidance