New cholesterol guidelines will cost healthcare system millions in unnecessary drug prescriptions

New Canadian guidelines to treat patients with high cholesterol would lead to hundreds of thousands more people at relatively low risk of heart disease being prescribed statins – resulting in only very small potential benefits for patients, but very significant costs to the healthcare system.

The 2003 Canadian guidelines for the management and treatment of dyslipidemia recommend screening for everyone with at least one (as opposed to two) risk factor for coronary heart disease (CHD), and lower target cholesterol levels.

In an article appearing in the April 12, 2005 issue of the Canadian Medical Association Journal (CMAJ), ICES researchers estimate how these new guideline revisions would affect the Canadian population in terms of people screened and recommended for statin therapy, and the potential benefits from these drugs for those at low, moderate and high risk of CHD.

Results:

• Using Canadians 18-74 years old between 1988 and 1992 as the reference population, the 2003 guidelines increase the number of people recommended statin therapy by 27%, from 2 million to 2.53 million.
• If this 27% increase were added to the $1.1 billion spent on statins in 2000, it would result in an extra $250 million in drug costs per year.
• Almost all of the recommended increases in statin therapy occur in people at low or moderate risk of CHD.
• The guidelines fail to recommend statin treatment for 13% of the highest risk Canadians.
• Under the 2003 guidelines, the number of people at low risk of CHD who would be newly recommended statin therapy increase nine-fold from 61,000 to 595,000. However, the potential benefit from statins for people at low risk of CHD is incredibly small.

“If the 2003 guidelines were modified to recommended statins for all high-risk people and no low-risk people, we could potentially avoid 1,000 more CHD deaths over five years while treating 400,000 fewer patients and saving hundreds of millions of dollars each year,” said lead author and ICES scientist Dr. Doug Manuel. “At a minimum, the guidelines should discuss the costs, benefits and potential harms of statins so that doctors, patients and policy makers can make informed decisions about them.”

“Low-risk patients who are recommended statin therapy need to be made aware of the very small absolute benefits and the risks of statins, such as liver and muscle problems. Clinicians should also ensure that they are offering statin therapy to high-risk patients, since they are the patients with the most to gain,” said Dr. Manuel.

Author affiliations: ICES (Drs. Manuel, Anderson, Alter and Laupacis, and Mr. Tanuseputro, and Ms. Schultz), Department of Public Health Sciences, the University of Toronto (Dr. Manuel and Mr. Mustard); Institute for Work & Health (Mr. Mustard); Department of Health Policy, Management and Evaluation (Drs. Anderson and Laupacis); Central East Health Information Partnership (Mr. Ardal); Divisions of Cardiology, Schulich Heart Centre (Dr. Alter), and General Internal Medicine, Sunnybrook and Women’s College Health Sciences Centre and the University of Toronto (Dr. Laupacis); Clinical Epidemiology and Healthcare Research Program, Sunnybrook and Women’s College Health Sciences Centre site (Dr. Laupacis).

ICES is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of healthcare issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting healthcare needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy.

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