New guidelines promoting the diagnosis and management of hypertension are likely to result in wider and earlier treatment of the condition which affects around 40% of adults in the UK.

NICE and the Newcastle Guideline Development and Research Unit have published new guidance for England and Wales setting out expanded targets and increased prescribing of drugs, including formal risk assessment of patients who have not yet developed cardiovascular disease. Key recommendations include:

• Measuring blood pressure: Patients with a single raised blood pressure reading of more than 140/90mmHg should be asked to return for a minimum of two subsequent clinics where their blood pressure can be measured using the best conditions available.
• Cardiovascular risk: A formal cardiovascular risk assessment should be conducted in patients with hypertension to help identify diabetes, evidence of hypertensive damage to the heart and kidneys, and secondary causes of hypertension such as kidney disease.
• Lifestyle interventions: Lifestyle advice (for example, smoking cessation, diet, alcohol and caffeine consumption, exercise) should be offered initially and then periodically to patients undergoing assessment or treatment for hypertension.
• Pharmacological interventions: Drug therapy should be offered to:Patients with persistent high blood pressure of 160/100mmHg or more; Patients at raised cardiovascular risk (10-year risk of chronic heart disease >15% or cardiovascular disease >20% or existing cardiovascular disease or target organ damage) with persistent blood pressure of more than 140/90mmHg.

Drug therapy should normally begin with a low dose thiazide-type diuretic. If necessary at second line a beta-blocker should be added, unless the patient is at raised risk of new onset diabetes in which case an ACE-inhibitor should be added instead. At third line, a dihydropyridine calcium-channel blocker should be added.

• Continuing treatment: Once blood pressure is managed adequately, an annual review of care should be provided to monitor blood pressure, provide support and discuss lifestyle, symptoms and medication. Patients without cardiovascular disease and with well-controlled blood pressure wishing to reduce or stop using drugs may be offered a trial reduction or withdrawal.

Professor Bryan Williams, member of the guideline development group and professor of medicine, University Hospitals NHS Trust, Leicester said: "This is an important guideline because it has the potential to influence and improve the treatment of a huge proportion of the adult population in the UK. The NHS is making impressive progress in reducing cardiovascular disease and the effective detection and treatment of high blood pressure is fundamental to that object.

The ABPI welcomed the new guidelines and said medicines had made a vital contribution to a 22% fall in the number of deaths over the last decade, a period in which the prescribing of blood pressure drugs grew five-fold.

Meanwhile, the number of hospital bed days in England for hypertension fell 27% from 125,000 in 1991 to 91,000 by the end of 2002.

Kate Lloyd, Pfizer's medical director, said: "These guidelines are a positive step forward in the management of cardiovascular risk. The British Hypertension Society guideline published in March 2004 and the anticipated Joint British Societies guideline should also be considered when managing cardiovascular disease."

The new guidelines' recommendation of treatment, beginning with thiazide-type diuretic and progressing with a beta blocker or ACE inhibitor and then calcium channel blocker, is consistent with earlier guidance, and as such promotes the use of medicines which are almost all available generically.

The top five hypertension drugs by spending, in England, in 2003, are: Amlodipine Besilate (Pfizer's Istin), £156.7 million; Ramipril (Aventis'Tritace), £113.7 million; Doxazosin Mesilate (Pfizer's Cardura) £98.65 million; Lisinopril (AZ's Zestril), £80.37 million; *Losartan (MSD's Cozaar), £64.8 million.

The NHS spent £840 million on anti-hypertension drugs in 2001, nearly 15% of the total annual drugs bill. The latest figures from the Prescription Pricing Authority (PPA) show spending on the area grew nearly 14% in the year to March 2004, driven by the CHD national service framework.

The new GMS contract launched in April 2004 is also heavily weighted towards treating hypertension, further increasing spending on the area. To help cut spending,  major government-enforced price reductions in four of the most commonly prescribed generics, including doxazosin, (Pfizer's off-patent Cardura) comes into force from 1 September 2004.

The PPA estimates a previous price cut in the medicines is now saving £8.5 million a month, and the further reductions will contribute even more.

Of the five top-selling hypertension drugs in England last year, four are now available generically, with only Merck Sharp & Dohme's Cozaar (losartan) still under patent protection.

Sales of the drug in England grew 22% last year, and are certain to be given a further boost by the new guidelines, despite it not being anything like a first line choice.

Competing drugs in the angiotensin receptor blocker class, BMS/Sanofi's Aprovel and Novartis' Diovan are some way behind MSD's drug in sales but are also growing rapidly.

External links:

NICE hypertension guidelines

pharmafocus@pharmafile.co.uk