Selection of Patients

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Pharmacological treatments of obesity have had a controversial history and are still regarded with skepticism and suspicion by some medical practitioners. This results from experiences with older agents that turned out to have serious side effects and were withdrawn as a result. Current agents approved for use have been shown to be safe and effective both in weight reduction and in the improvement of comor-bidities of obesity. Nevertheless, it is important that doctors who prescribe such drugs are fully familiar with the mode of action and potential risks.

Several sets of guidelines have been developed for the use of drugs in the treatment of obesity. In the UK, The Royal College of Physicians' guidance on the use of anti-obesity drugs suggests that it may be appropriate to consider use of drugs after at least 3 months of supervised diet, exercise, and behavioral management. Exceptionally, this period may be shortened when the clinician judges that drug treatment is justified at an earlier stage due to over-riding medical circumstances. Table 4 lists the criteria that should be applied to judge the suitability of a patient for drug treatment.

Table 4 Criteria for selecting obese patients suitable for obesity drug treatment

• Drug treatment may be appropriate where diet and exercise have not achieved acceptable weight loss relative to medical risk

• In such patients drug treatment may be appropriate for:

- those whose BMI is more than 30

- those with established comorbidities whose BMI is more than 27, if the drug license permits

• Weight-lowering drugs should be targeted at those at high risk from obesity, not obesity alone

The following groups will have priority for drug treatment

• Patients with established comorbidities such as type 2 diabetes, hypertension, and dyslipidemia

• Patients who are physically restricted by their weight either because of breathlessness or arthritis

• Patients considered to be at high risk - for example, those with a family history of overweight or obese parents who died prematurely from CHD or developed type 2 diabetes with complications

The criteria applied to the use of an anti-obesity drug are similar to those applied to the treatment of other relapsing disorders. It is important to avoid offering anti-obesity drug therapy to patients who are seeking a 'quick fix' for their weight problem. The initiation of drug treatment will depend on the clinician's judgement about the risks to an individual from continuing obesity. It may be appropriate after at least 3 months of supervised diet, exercise, and behavioral management, or at a subsequent review, if a patient's BMI is equal to or greater than 30kgm~2 and weight loss is less than 10% of the presenting weight. In certain clinical circumstances it may also be appropriate to consider anti-obesity drug treatment for those patients with established comorbidities whose BMI is 27kgm~2 or greater if this is permitted by the drug's licence (see Figure 1). An anti-obesity drug should not be prescribed for a patient whose BMI is less than that specified in the product licence for the drug - the licence indication does not presently take account of the morbidity from obesity seen in certain populations at a lower BMI.

The experience from the use of anti-obesity drugs during 12-24 month randomized controlled trials indicate that approximately 50% of the actively treated patients respond as judged by 5-10% reduction in body weight maintained over 12 months. The weight loss occurs in the 'responder' group within 12 weeks. This indicates a suitable time period when a response to drug treatment can be identified and a decision taken to continue the medication. Continuing assessment of drug therapy for efficacy and safety is essential. If the drug is efficacious in helping a patient to lose and/or maintain weight loss, and there are no serious side effects, it may be continued.

Management pathways and therapeutic responsiveness

Management pathways and therapeutic responsiveness

Figure 1 A management pathway for the appropriate prescription of an anti-obesity drug. (Adapted with permission from RCP Guidelines 2003.)

If not, it should be discontinued. Once a weight loss target has been achieved, there should be an opportunity for re-negotiation of a new target, if indicated, and/or long term monitoring with reinforcement.

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