Obese patients committed to weight loss can be given orlistat, says the NICE
Obese patients can be prescribed orlistat (Xenical) as part of their weight loss plan, says the National Institute for Clinical Excellence (NICE) in guidance published last week. But it does not recommend its use in patients who cannot show their commitment to losing weight.
The NICE has advised the National Health Service that orlistat should be made available to patients between the ages of 18 and 75 years who are either:
The guidance states that when treatment with orlistat is offered, arrangements should be made to offer advice, support and counselling on diet, physical activity and behavioural strategies.
Under the NICE recommendations, patients will only be eligible for treatment with orlistat if they have attempted long-term control of body weight using diet and exercise without success. In addition, they must have lost 2.5kg in weight in the month before treatment starts. The NICE says that therapy should only continue for more than three months if the patient has lost at least 5 per cent of their body weight from the start of drug treatment and for more than six months if weight loss has been at least 10 per cent of body weight. It adds that treatment should not usually continue beyond 12 months, and never beyond 24 months.
Dr Ian Campbell (chairman, National Obesity Forum) said in a press release issued on behalf of Roche (manufacturer of Xenical): “By treating obesity and overweight, we can reduce the burden of disease linked to obesity, such as coronary heart disease and diabetes. The guidance from NICE will reassure health care professionals that they should continue to treat obese and overweight patients with prescription medicines if appropriate, benefiting their health in the longer term.”
Mrs Irene Gummerson (a pharmacist on three national diabetes committees) told The Journal on March 12: “Losing weight can help decrease insulin resistance and improve blood glucose control in overweight people with type 2 diabetes. Orlistat reduces the amount of fat absorbed from the intestine, and may also help people adhere to a low fat diet. Once a capsule has been taken, a person may be discouraged from eating fatty food by the thought of a more frequent bowel action and passing fatty stools.” She added that it was important for pharmacists to be aware that the concomitant use of orlistat with metformin, acarbose and fibrates was not recommended by orlistat’s manufacturer. This was possibly because of the potential for additional abdominal problems, she said.
The guidance was welcomed by Diabetes UK. A spokesman told The Journal: “Anything that can help people with diabetes manage their weight is a good thing.” Asked about the difficulties that patients with type 2 diabetes might have in meeting the strict criteria laid down by the NICE, he said: “In an ideal world we would have liked to see orlistat recommended for use in weight management rather than weight loss, but this is not a huge issue.”
At the launch of the guidance on March 9, Ms Anne-Toni Rodgers (executive director, NICE) said: “Some people who would benefit from this medicine are not getting it.” Prescribers can now be clear on the cost-benefit analysis which should stop variations in prescribing practice, she said. The NICE guidance states that over the past year there was a 16-fold variation in the number of prescriptions written for orlistat between different health authorities in England and Wales.
Also speaking at the launch of the NICE guidance, Professor Peter Littlejohns (clinical director, NICE) said: “Orlistat has been shown to be cost-effective, given the groups we have targeted, in terms of health of the individual and NHS resources.” He added that the NICE was recommending the treatment only as a part of a managed weight loss plan. The guidance would stop the prescribing of this drug to people who “just wanted to lose a few pounds”.
Commenting on the criteria set by the NICE for patients to be eligible for treatment with orlistat, Ms Rodgers said: “We want people to help themselves and if patients are not losing weight whilst taking the drug then the money can be better spent helping a patient who may be more committed.” She added that not all obese patients would need to take the drug as many would just need the support of a health care professional.
Before publication of the NICE guidance on orlistat, the treatment options for obesity available on the National Health Service included dietary advice, behavioural modification and exercise. The direct costs to the NHS for the treatment of obesity have been estimated to be £50m per year, and the indirect costs of treating associated conditions, such as diabetes and cardiovascular disease, have been estimated as a further £1,700m to £1,900m.
The guidance applies only to England and Wales and will be reviewed in February, 2004. The full guidance is available at the NICE website (www.nice.org.uk).
Orlistat — how it works
Orlistat works by preventing the absorption of fat molecules in the intestinal tract. About 30 per cent of fat that would otherwise have been absorbed passes straight through the bowel and is excreted in the faeces.
Elderly patients find zanamavir Diskhaler easy to use, says GSK
A number of studies have shown that elderly patients find the zanamivir (Relenza) Diskhaler easy to use, according to GlaxoSmithKline, manufacturer of the product. The company has released a statement in response to a study published in the British Medical Journal last week on the use of zanamivir in elderly patients (see PJ, March 10, 2001, p306).
A spokeswoman for GlaxoSmithKline told The Journal on March 12 that there were no plans to change the inhaler used to deliver zanamivir. “The Diskhaler is already widely used to deliver drugs for the treatment of asthma and has proved to be fine,” she said. In its statement the company highlighted a number of Diskhaler handling studies, carried out in patients who have had Relenza prescribed, which show that elderly patients find the device easy to use. “These studies showed that 94 per cent of patients found the Diskhaler instructions easy to understand and 89 per cent found the device easy to use.”
In the BMJ study, Dr Paul Diggory and colleagues (Mayday hospital, Croydon) comment that, in elderly patients, treatment with zanamivir is unlikely to be effective unless the delivery system used is improved. Seventy-three patients aged over 65 years were given either a placebo Diskhaler or placebo Turbohaler to use. The researchers found that 50 per cent of those allocated the Diskhaler were unable to load and prime the device after 15 minutes of inhaler technique tuition and that 66 per cent were unable to do so 24 hours later.
The Canterbury & Coastal Primary Care Group has implemented a patient group direction for pharmacist supply of Relenza. As part of the implementation, pharmacists involved with the scheme were trained in the use of the Diskhaler. Mr Jonathan Mason (prescribing adviser, Canterbury & Coastal PCG) told The Journal on March 13 that he was confident that pharmacists would be able to demonstrate use of the inhaler to patients prescribed Relenza. He added that he did not foresee any additional problems over and above those associated with other Diskhalers, such as manual dexterity problems.
Pharmacists can access detailed information (abbreviated in panel below) on how to use the Relenza Diskhaler at www.relenza.com. A Royal Pharmaceutical Society registration number is required to access the website.
Further information concerning Relenza can be obtained by contacting GlaxoSmithKline’s medical information department (tel 0800 371891).
Instructions for using the diskhaler
A. To load a medicine disk into the Diskhaler device
B. To puncture the medicine disk blister
C. To inhale the medicine
D. To take another inhalation
Second oral fluoropyrimidine launched for metastatic colorectal cancer
A second oral fluoropyrimidine has been marketed for treating metastatic colorectal cancer. Bristol-Myers Squibb has introduced Uftoral capsules, just one month after the launch of Roche’s Xeloda (capecitabine) (PJ, February 17, p232). Both drugs are 5-fluorouracil (5-FU) prodrugs and are licensed for first-line use in metastatic colorectal cancer [see p370].
NICE endorses pioglitazone use
Patients with type 2 diabetes should be offered pioglitazone combination therapy as an alternative to insulin, according to guidance issued on March 9 by the National Institute for Clinical Excellence (NICE).
HIV treatment based on viral load could miss vulnerable women
Guidelines for HIV treatment based on viral load may lead to differences in eligibility between the sexes. Researchers have found that the median initial viral load of women who progressed to AIDS was almost five times lower than that in men but that there was no difference in rate of progression to AIDS.
Slower infusion of amphotericin safer than rapid infusion
Continuous, rather than rapid infusion of amphotericin B decreases nephrotoxicity and side effects, Swiss researchers say.
Serious liver reactions with leflunomide
A statement regarding serious liver injury associated with leflunomide (Arava) has been issued this week by the European Agency for the Evaluation of Medicinal Products (EMEA).
Mixed results for Parkinson’s disease foetal cell transplants
Treating Parkinson’s disease by transplantation of foetal cells into the brain has been successful in patients aged 60 or under but has serious side effects, a study has found.
Risk of cardiovascular events with sildenafil is not increased
There is no evidence of a higher incidence of fatal myocardial infarction or ischaemic heart disease among men taking sildenafil (Viagra), prescription event monitoring has shown.
A researcher has suggested that information is inadequate in sildenafil’s package insert. Complete and well-defined product information is fundamental for appropriate usage of medicines, says Dr Jay Cohen (University of California, San Diego). He reviewed data for sildenafil, including package inserts, descriptions from the Physicians? Desk Reference, unpublished data from Pfizer (manufacturer of sildenafil) and relevant articles. For example, more data on sildenafil’s effect on blood pressure are needed, he says (Annals of Pharmacotherapy 2001;35:337)
MMR and other matters
The latest edition of Current Problems in Pharmacovigilance covers MMR vaccine, blockage of CFC-free inhalers, a safety reminder about amfebutamone (bupropion, Zyban) and the availability of emergency hormonal contraception.
Citation: The Pharmaceutical Journal URI: 20004130
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