News & Notes

The Department of Health has awarded the contract to provide the vaccine against human papilloma virus (HPV) to GlaxoSmithKline for their vaccine Cervarix.

The contract is to supply the vaccine that protects against cervical cancer and pre‐cancerous cell changes in the cervix caused by HPV viruses. The vaccine will guard against the two strains of the HPV virus that cause 70 per cent of cases of cervical cancer. The vaccine will be made available to girls aged 12–13 years old from September 2008. From September 2009, it will also be delivered to girls up to 18 years in a two‐year catch‐up programme. Cervarix was chosen over Sanofi Pasteur MSD's Gardasil, which is the standard treatment in many European Union countries.

A new analysis of the Nurses' Health Study has shown that hormone replacement therapy (HRT) increases the risk of stroke regardless of age at initiation of therapy (Arch Intern Med 2008; 168: 861‐6).

HRT increases the risk of stroke by about 40 per cent with oestrogen alone and 27 per cent with combined HRT, whether treatment began shortly before or after the menopause and in young or older women. There was a clear relationship between the dose of conjugated oestrogen and risk of stroke over the range 0.3–1.25 mg/day.

The absolute increase in risk was low for younger women (and possibly not significant for less than 5 years' use, though this was based on low numbers), but in women aged 50–54, HRT was associated with two extra strokes per 10 000 woman‐years of use.

GlaxoSmithKline's lapatinib (Tyverb) has been approved for the treatment of ErbB2 (HER2)‐positive advanced breast cancer that has become unresponsive to trastuzumab. Lapatinib is given in combination with gemcitabine after treatment with anthracyclines, taxanes and trastuzumab for metastatic disease.

The licence is conditional on GSK providing further clinical data from the pivotal study and demonstrating a reduction in brain metastases. The company says lapatinib plus gemcitabine significantly increased median time to progression compared with gemcitabine alone (27.1 vs 18.6 weeks). A month's treatment costs approximately £1600.

Pfizer has launched fesoterodine (Toviaz) for the treatment of overactive bladder symptoms.

Fesoterodine is a prodrug for tolterodine, which accounts for its activity. In 12‐week trials, it reduced the number of daily episodes of micturition or urge incontinence by approximately one, and increased the number of continent days per week by up to one, compared with placebo. The efficacy and tolerability of fesoterodine is dose‐related; a dose of 4mg/day, which is recommended for initiating treatment, is approximately as effective and as well tolerated as tolterodine 4mg/day.

Fesoterodine is a modified‐release formulation. At the recommended doses of 4 or 8mg once daily, a month's treatment costs £29.03 – the same price as Detrusitol XL.

NHS Scotland has distributed 15 000 information packs about its HPV vaccination programme to health professionals and key staff in schools and local authorities. The programme is due to start in September.

The pack includes the campaign's marketing materials, questions and answers for parents and carers and their daughters, a fact sheet and a copy of the Green Book Chapter on HPV. 90 000 girls will be immunised by June 2009.

A new meta‐analysis has confirmed the efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of severe premenstrual syndrome and premenstrual dysphoric disorder, but suggests their impact is less than previously thought (Obstet Gynecol 2008; 111: 1175–82).

The study included 29 randomised placebo‐controlled trials involving a total of 2964 women; most data were for paroxetine, sertraline and fluoxetine. Using efficacy endpoints defined in the studies, SSRIs were significantly more effective than placebo (odds ratio for symptoms 0.40, CI_95% 0.31–0.51). Continuous treatment was superior to intermittent treatment. There was no difference in efficacy between the SSRIs.

Newer studies reported smaller effect sizes than older ones. The authors suggest this is due to improvements in diagnosis and treatment and a greater emphasis on premenstrual dysphoric disorder in recent trials.

Amgen has released the full results from the one‐year pivotal trial comparing its investigational human monoclonal denosumab with alendronate in 1189 postmenopausal women with low bone mineral density (BMD) at the 35th Annual European Symposium on Calcified Tissues (ECTS) in Barcelona.

Twice‐yearly denosumab increased BMD more than weekly alendronate in the hip (3.5 vs 2.5 per cent) (the primary endpoint) and at all other sites. There was no difference in the frequency of adverse events (arthralgia, back pain, constipa‐tion, dyspepsia).

Discussions with NICE have opened the way for patients with prostate cancer to have continued access to cryotherapy. At the British Association of Urological Surgeons annual meeting, urologists expressed concern that the NICE recommendations threatened this promising therapy.

The NICE guideline on prostate cancer advocates greater reliance on active surveillance and recom‐mended that newer treatments such as cryotherapy and high intensity focused ultrasound should only be used in the context of clinical trials. Given the ethical difficulty of establishing such trials, clinicians and patients feared that PCTs would withdraw funding.

Since publication of the guide‐line, NICE has been in discussion with industry, BAUS and the Health Technology Assessment programme of the National Institute for Health Research to identify a way forward. Discussions are progressing with BAUS to establish national data collection. In the meantime, NICE has clarified that surgeons collecting local data available for national analysis will satisfy the recommenda‐tion on use of cryotherapy, enabling PCTs to continue funding.

Pregnancy and childbirth presents the best evidence for the care of preg‐nant women to doctors, mid‐wives, students and parents. The logical sequence of chapters and the index give quick access to the abstracts of over 400 Cochrane systematic reviews. The book serves both as a stand‐alone reference, and as a companion to locating full reviews on the Cochrane Library.

A Cochrane pocketbook: pregnancy and childbirth. By Hofmeyr J, Neilson J, Alfirevic Z, et al. Wiley, 2008, 446 pages, £29.95, paperback. ISBN: 978‐0‐470‐51845‐8.

This thoroughly revised edition of Prescribing in pregnancy is a practical and authoritative guide for all doctors who prescribe for pregnant women. Covering both the prescribing of drugs for common conditions in pregnant women and the effect of different drugs on pregnancy, the fourth edition now also features: strengthened evidence for the prescribing regimens; updated prescribing information throughout; and a new user‐friendly design.

Prescribing in pregnancy, 4th edition. Edited by Rubin PC and Ramsey M. BMJ Books, 2007, 256 pages, £29.99, paperback. ISBN: 978‐1‐4051‐4712‐5. Copyright © 2008 Wiley Interface Ltd