Latest news and product developments

Varenicline (Champix) is a novel agent for smoking cessation that appears to be more effective than bupropion (Zyban).

It acts as a partial agonist at neuronal nicotinic acetylcholine receptors, alleviating withdrawal symptoms such as craving but potentially blocking the rewarding effect of nicotine. In clinical trials, the cessation rate after a standard 12‐week course was 44 per cent, and smokers using varenicline were twice as likely to quit as those using bupropion. A further course of 12 weeks is a licensed option and may increase the odds of quitting by 34 per cent. One‐year cessation rates were 22 per cent compared with 15 per cent with bupropion.

The commonest adverse effect associated with varenicline is nausea during early treatment (29 per cent); in trials, discontinuation rates were 11.4 per cent with varenicline and 9.7 per cent with placebo.

A 12‐week course of treatment with varenicline costs approximately £164 plus £27.30 for a treatment initiation pack; bupropion costs approximately £80 for nine weeks' treatment.

Rosiglitazone (Avandia) is superior to glibenclamide in controlling blood glucose levels in the long term in men with newly diagnosed type 2 diabetes, according to ADOPT (A Diabetes Outcome Progression Trial, N Engl J Med 2006;355:2427‐43). However, its benefits compared with metformin are less clear.

ADOPT randomised 4360 obese middle‐aged men to treatment with rosiglitazone (up to 8mg per day), metformin (up to 2g per day) or glibenclamide (up to 15mg per day). The primary end‐point was the time to needing additional drug therapy, defined as a fasting plasma glucose (FPG) of >10mmol per litre. FPG is no longer the standard by which glycaemic control is measured but HbA_1C was a secondary end‐point. Approximately 40 per cent of patients withdrew from the study prematurely.

After five years, additional treatment was needed by 15 per cent of patients taking rosiglitazone, 21 per cent with metformin and 34 per cent with glibenclamide. The proportions of patients attaining an HbA_1C <7 per cent after four years were 40, 36 and 26 per cent respectively.

The overall incidence of adverse events was similar in the three groups. Rosiglitazone was associated with a mean weight gain of 4.8kg compared with a weight loss of 2.9kg with metformin and weight gain at one year of 1.6kg with glibenclamide, which then stabilised. Compared with rosiglita‐zone, metformin was associated with more gastrointestinal events and fewer cases of oedema; glibenclamide was associated with fewer cardiovascular events and oedema but a higher incidence of hypoglycaemia.

Use of oral steroids is associated with a small increase in the risk of a cardiovascular (CV) event in patients with rheumatoid arthritis (RA), say US investigators (Arthr Rheum 2006;54:3790‐8).

Their case control study involved 3501 patients with RA, of whom 946 were admitted with myocardial infarction or stroke. Treatment with methotrexate and biological immunosuppressive agents, either alone or in combination, did not increase CV risk, but monotherapy with a steroid did and there was a non‐significant trend to greater risk from steroids combined with other agents. Azathioprine, ciclosporin (Neoral) and leflunomide (Arava) were also associated with an increased CV risk.

Inactivated flu vaccine protects about 70 per cent of patients immunised, even when circulating virus is antigenically dissimilar to the vaccine (N Engl J Med 2006;355:2513‐22).

In the 2004/05 season, the vaccine prevented infection in 67‐77 per cent of patients (depending on how efficacy was determined). At the time, antigenic drift meant that circulating flu viruses were distinct from the strains used to prepare the vaccine.

• In the UK, vaccination of home care staff has been shown to reduce morbidity and mortality, hospitalisation and GP consultation rates among residents (BMJ 2006;333:1241‐6). The benefits occurred even though only 43 per cent of staff received the vaccine.

This research follows closely the publication of a review criticising the lack of evidence for the efficacy of flu vaccine (BMJ 2006;333: 912‐5).

Standardised advice from a doctor, a bi‐weekly visit and a tapering schedule for discontinuation of long‐term benzodiazepine use achieves permanent withdrawal in one in three patients, Spanish research has shown (Br J Gen Pract 2006;56:958‐63).

A total of 139 patients who had been taking a benzodiazepine for more than a year were randomised to the intervention or routine care. After 12 months, successful discontinuation rates were 45 and 9 per cent respectively. In addition, 22 per cent of those receiving the intervention and 17 per cent of controls had reduced their dose by more than 50 per cent.

Too little is known about the risk of medication errors in mental health‐care in the community or in hospitals, specialists from London and the South‐East have concluded (Qual Safety Health Care 2006;15:409‐13).

They found no published studies examining causes or clinical outcomes associated with medication errors, though studies of medication management processes suggested the error rate was comparable with that in general hospitals. However, given the high risk of adverse reactions associated with psychotropic drugs, further research focussing on outcomes is needed, particularly in community settings.

Treatment with botulinum toxin type A appears to offer long‐term improvement in urine flow rates and quality of life in most men with benign prostatic hypertrophy (BJU Int 2006;98:1033‐7).

Forty‐one men with treatment‐resistant BPH received 100 or 200 units of the toxin into the prostate. Symptoms and quality‐of‐life scores improved by more than 30 per cent in 76 per cent of men, even in those with no change in prostate volume. Of five men with retention, four were able to void spontaneously one month later. Benefits were sustained after 12 months.

The charity Developing Patient Partnerships ( www.dpp.org.uk) has produced a new booklet and poster to help patients and their families cope with depression. Dealing with Depression describes the symptoms and causes, offers advice for self‐help, and describes treatment with the aim of empowering patients to make informed decisions. Further information is available from rdorban@bma.org.uk.

Scheduled interruption of antiretroviral treatment does not improve safety and increases mortality, the SMART trial has shown (N Engl J Med 2006;355:2283‐96).

The trial compared continuous treatment with episodic use of drugs aiming to keep the CD4 count above 250 cells per mm³ and interrupting treatment when the count reached 350 cells per mm³. Episodic use was associated with a greater than two‐fold increased risk of opportunistic disease or death.