Latest news and product developments

Poor asthma control with off‐licence prescribing

Children who are prescribed off‐licence medications are more likely to have poor asthma control, according to an analysis from Dundee (Br J Gen Practice 2007;57:220‐2).

The review of 17 163 consultations identified 1050 (6.1 per cent) who received a prescription for an unlicensed use (defined as not licensed for children or the particular age group, or dose not licensed). High doses (4.5 per cent) were more frequent than unlicensed indications (1.9 per cent).

Children who received off‐label prescriptions reported statistically significantly more symptoms in the day or night, symptoms during activity, and increased use of daily short‐acting beta2‐agonists. The authors note that off‐label prescribing appears to be increasing.

Atkins diet most effective over one year?

The ultra low‐carbohydrate, high‐protein Atkins diet achieved greater weight loss than other popular diets in overweight women over one year, say US investigators (J Am Med Assoc 2007;297:969‐77).

The study compared the Atkins diet with three diets designed as low‐ or very high‐carbohydrate, or based on USA nutritional guidance, in 311 women with body mass index 27‐40.

After one year, mean weight loss was 4.7kg with the Atkins diet – significantly greater than with the low‐ carbohydrate diet (1.6kg) but not compared with very high‐carbohydrate (2.2kg) or the nutrition‐based diet (2.6kg). Metabolic endpoints were comparable or more favourable in women using the Atkins diet.

Androgen therapy linked to gum disease

The majority of men treated with androgen deprivation therapy for prostate cancer are more likely to have periodontal disease (J Urol 2007;177:921‐4).

After controlling for risk factors, the prevalence of periodontal disease was 80.5 per cent among treated men compared with 3.7 per cent in matched controls not receiving treatment. There was no difference in bone mineral density between the groups but plaque scores were significantly higher among treated men.

Food Commission rebuts MHRA on additives

An independent watchdog has not accepted the MHRA's justification for including certain additives in medicines for children.

The Food Commission ( www.foodcomm.org.uk) found that most medicines for children contained additives, some of which – including azo dyes and benzoates – are not permitted in food. The Commission called on the pharmaceutical industry to stop using ‘questionable additives’.

The MHRA stated that the licensing process takes into account the likely exposure to excipients that are considered essential to make medicines palatable to children. Colouring helps children to identify the correct medicine, and preservatives ensure a reasonable shelf‐life. A list of additives is included in the product's summary of product characteristics and patient information leaflet.

In response, the Commission states: ‘ … it is quite possible to flavour medicines with natural oils or extracts, and natural colourings such as beetroot and beta‐carotene can be used instead of azo dyes. If parents were advised to give these medicinal products at mealtimes the manufacturers could also add a little sugar to sweeten their products, rather than relying on artificial sweeteners.’

All triptans the same?

There is no economic case for choosing one triptan over another and no evidence for preferring a particular triptan for adults, a systematic review has concluded.

The Canadian Agency for Drugs and Technologies in Health ( www.cadth.ca) found that published trials had compared most triptans with sumatriptan but not with one another, and most economic evaluations were flawed.

New drug for HIV

Janssen‐Cilag has introduced darunavir (Prezista), a new protease inhibitor for the treatment of HIV infection.

Licensed for highly pre‐ treated patients in whom more than one other pro‐ tease inhibitor regimen has failed, darunavir must be co‐administered with ritonavir (Norvir).

A month's treatment at the recommended dose of 600mg twice daily costs £446.70.

Variation in liquid captopril for children

The NHS uses a wide range of liquid formulations of captopril to treat children with heart failure – with no assurance of their bioequivalence (Arch Dis Child 2007; published online 15 March. doi: 10.1136/adc.2006.109389).

Specialists in Leicester surveyed 13 tertiary paediatric cardiac centres and 13 hospitals that referred patients to them. Only three tertiary centres supplied the same liquid for‐mulation of captopril as their referring hospitals. Four hospitals supplied tablets for crushing and dissolving in water; the other hospitals and centres used a total of nine different formulations.

The authors say the formulations had widely varying shelf‐lives, determined empirically in all but one case, and were used interchangeably despite a lack of quality control data to establish their bioequivalence.

QOF CVD targets not good enough for GPs

Two‐thirds of GPs want Quality Outcome Framework (QOF) targets for cardiovascular disease brought into line with those of the Joint British Societies latest guidance (JBS2), according to a survey by doctor.net.uk.

The survey of 1000 GPs showed that 88 per cent were aware of the JBS2 guidelines and most were already implementing the targets for lipids, blood pressure and blood glucose in some form; however, only 55 per cent were implementing the JBS2 obesity target and 14 per cent were implementing screening for the over‐40s.

The JBS2 target for lipids in at‐risk patients is <4mmol per litre total cholesterol and <2 mmol per litre LDL‐cholesterol, compared with <5 and <3mmol per litre respectively in QOF and the NSF. The survey was commissioned by Merck Sharp & Dohme and Schering‐ Plough.

Fracture warning

Following warnings in the US that rosiglitazone (Avandia) is associated with an increased risk of fractures in women, Takeda has advised prescribers that pioglitazone (Actos) carries a similar risk.

An analysis of the company's clinical trials database has revealed an excess risk of fractures of bones below the elbow and knee. The incidence was similar to the excess risk associated with rosiglitazone and also confined to women.

Scottish approvals

The Scottish Medicines Consortium ( www.scottish medicines.org.uk) has approved for use within NHS Scotland the sublingual tablet formulation buprenorphine/naloxone (Suboxone) for the treatment of opioid dependence. It has also approved the combined formulation of valsartan and amlodipine (Exforge) and the restricted use of the I_f inhibitor ivabradine (Procoralan).