The Pharmaceutical Journal
Vol 269 No 7224 p707-708
16 November 2002

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Costs and compliance affect statin use

As recent research suggests new roles for statins (p704), Harriet Adcock (on the staff of The Journal) examines some of the issues with which clinicians are grappling over their use in the treatment and prevention of coronary heart disease

Related websites
American Heart Journal: Alternate day dosing (more)

THE evidence base behind statin therapy is growing. Its place in reducing the burden of coronary heart disease (CHD) is well established and the Government has set targets for the use of statins within national service frameworks in England and Wales as well as through guidelines issued by the Scottish Intercollegiate Guidelines Network.

The message from the guidelines is clear. Statins are a cost-effective therapy for reducing CHD in high-risk patients with high levels of low-density lipoprotein cholesterol (LDL-C). This message has had a huge impact on practice, not just in helping to prevent coronary events but also in increasing spend.

Compared with 2000, an extra 1.2 million prescriptions were written for simvastatin (Zocor) in 2001 with a cost to the National Health Service of £40m. Prescriptions for other statins have also increased with an additional 1.5 million prescriptions being written for atorvastatin (Lipitor) in 2001. The Wanless report, on financing the NHS, published earlier this year, also estimated that the cost of prescribing statins will rise to £2.1bn by 2010.

Next week, at the American Heart Association meeting in Chicago, investigators involved in the Heart Protection Study, who suggested that patients at risk of coronary events should be treated with statins whether or not they have high cholesterol levels (PJ, 6 July, p4), are expected to announce the results of a cost analysis from the study.

If the HPS investigators can show that statins are a cost-effective therapy for all those groups who have been found to benefit from them then the stakes may be raised again.

Patients at risk from CHD who are prescribed statins are likely to require treatment for many years. However, it is not just a question of how much it will cost the NHS. Poor compliance reduces the beneficial effects of statins and patients with hyperlipidaemia, an asymptomatic condition, may not be motivated to continue taking these drugs.

Dr Gillian Cruikshank, a practice pharmacist, delivers medicines management services to several CHD clinics at the Princes Street surgery in Dundee where she is based. Her clinics have succeeded in increasing the number of myocardial infarction (MI) patients receiving cholesterol-lowering medicines, and services are now being extended to target angina patients, peripheral vascular disease and stroke patients as well as for the primary prevention of CHD.

Audits have shown that compliance rates run at 85 per cent for MI patients attending clinics. "We would like to think that similar levels of compliance can be achieved for primary prevention, but compliance is a huge issue," Dr Cruikshank says. She also believes that compliance may improve further when community pharmacists get more involved in chronic disease management. "Repeat dispensing schemes may have an impact because community pharmacists will be able to identify patients who are not coming back for prescriptions."

Dr Jon Dowell, senior lecturer in general practice at the University of Dundee, says that some people may find accepting long-term medication difficult. "This issue should not be underestimated," he says.

With treatments for asymptomatic conditions there is the added problem that patients cannot make a judgement as to whether the drug is working. "The rationale for statins will either be trust in the clinician or an understanding and belief of the evidence," he says. Dr Dowell supports the creation of roles for practice-based pharmacists in helping patients get the most from their medicines. But he believes that a concordant approach is necessary.

With pharmacists helping to raise compliance rates among patients taking statins, and with new and more expensive statins on the horizon, the prescribing costs for this class of drugs are set to increase further.

However, a generic version of simvastatin is expected next year and the savings that are likely to be made will ease the current pressure on prescribing budgets. In addition, a recent study has suggested that comparable benefits can be obtained using alternate day dosing strategies for atorvastatin (see Panel).

But what of the next generation of statins? AstraZeneca's rosuvastatin (Crestor) has now gained approval in the Netherlands and should reach the UK market some time next year. Will the clinical benefits associated with its use be judged to be great enough to warrant prescribing Crestor at the levels seen for other statins?

Statin safety

The withdrawal of cerivastatin (Lipobay) in August 2001 following reports of muscle toxicity in patients treated with the drug led to concerns over the safety of statins as a class. However, a European review initiated by the Committee for Proprietary Medicinal Products found that the risk of developing muscle disease in association with statin use is low. In the latest issue of Current Problems in Pharmacovigilance, the Medicines Control Agency and Committee on Safety of Medicines conclude that the risk of myopathy must be considered in the context of the "overwhelming beneficial effect" of statins in the prevention of coronary heart disease. "These benefits clearly outweigh the potential risks," they say.

The side effects most commonly associated with statin treatment are relatively non-serious and transient. However, side effects can be hugely troubling for patients, as reported in the letters pages of The Journal this week (p711). If patients do not perceive any benefit from their statin therapy, the occurrence of side effects might cause them to stop taking their medicine.

Dr Cruikshank does not think that side effects from statins will have an important effect on compliance rates. "Side effects are generally transient. We monitor for raised creatine kinase, a sign of potential myopathy, at six weeks and at three months. We also take baseline bloods, so if a patient has abnormal liver function tests, we do not initiate statins."

The trend of increasing statin precribing looks set to continue. With this in mind, the NHS must face the issues of cost and compliance if it is to reap the benefits from these valuable drugs.

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