Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Rimonabant restricted by NICE

The National Institute for Health and Clinical Excellence (NICE) has issued guidance (PDF) for using rimonabant (Acomplia®) for the treatment of obesity.

The guidance allows the use of rimonabant but only in patients for whom orlistat and sibutramine has proved inadequate, been poorly tolerated or is contraindicated. The guidance further qualifies that steatorrhoea associated with orlistat when not adhering to dietary advice is not considered as intolerance.

Action: NICE has clearly placed rimonabant as the third line treatment for obesity after orlistat and sibutramine. Clinicians should ensure that treatment of obesity reflects this advice.

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HPV vaccine announced

The Department of Health has announced that the national contract for human papillomavirus vaccine (HPV) has gone to Cervarix®. This announcement has also been reported in the general media (BBC, The Times).

As previously noted, Gardasil® has a wider range of licensed indications based on the current Summaries of Product Characteristics (Cervarix and Gardasil). In addition to the wider range of indications, Gardasil is also licensed in a wider age group and for both genders.

The official announcement notes that the decision was based on a wide range of criteria such as their scientific qualities and cost effectiveness but that the price remains commercially confidential. At a time when the NHS has a significant cash surplus it must be hoped that, for reasons of transparency, the rationale for choosing what appears to be an inferior vaccine are made public.

Action: Clinicians need to be aware of the national HPV vaccination programme and the chosen vaccine.

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New treatment for OAB

Fesoterodine (Toviaz®) has been launched as a new treatment for over-active bladder (OAB). Fesoterodine is a pro-drug of tolterodine.

The summary of product characteristics recommends a starting dose of 4mg daily with the option to increase to 8mg based on individual response. Dose restriction is recommended in renal and hepatic impairment and caution in use should be exercised in patients taking enzyme inhibitors.

A comparative study has assessed the efficacy of fesoterodine 4mg and 8mg in comparison to placebo and tolterodine 4mg modified release. The study found that fesoterodine was superior to placebo and equivalent to tolterodine. Drop out rates were similar in the 3 active treatment groups although dry mouth, constipation and dry eyes were more common in patients treated with fesoterodine.

Both strengths of fesoterodine will be available at £29.03 for 28 days supply; this is the same price as tolterodine 4mg modified release.

Action: Clinicians should be aware of this new drug. Given the similar efficacy to tolterodine, higher rate of side effects and black triangle status, use should be reserved to patients who have failed all other treatment options.

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June CKS Update

Clinical Knowledge Summaries (CKS) has been updated in June for the following clinical areas:

In addition, there is also a pointer to the National Knowledge Week topic of age related macular degeneration. This section has recently been updated with new evidence that has emerged in the last year.

Action: Clinicians who see patients with any of these conditions may find the updated information useful when reviewing current clinical practice.

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Carbocisteine may prevent COPD exacerbations

The Lancet has published the results of a study that aimed to assess the efficacy of carbocisteine in reducing the yearly exacerbation rate in patients with chronic obstructive pulmonary disease (COPD).

The study was conducted in 709 Chinese patients aged 40 to 80 years with a diagnosis of COPD. Participants were randomly assigned to treatment with 1500 mg carbocisteine or placebo per day for a year. The primary endpoint was COPD exacerbation.

The annual per-patient rate of exacerbation was 1.01 in the treated group compared to 1.35 in the placebo group. There was a statistically significant difference in the risk ratio (RR=0·75; 95% CI 0·62–0·92, p=0·004).

The authors conclude that, “mucolytics, such as carbocisteine, should be recognised as a worthwhile treatment for prevention of exacerbations” although this statement is qualified to Chinese patients. Further research is necessary to confirm whether this finding applies to other ethnic groups.

Action: Clinicians may wish to consider using mucolytics to reduce exacerbation rates in patients who are poorly controlled despite optimal therapy with other treatments.

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