The GPC believe that there is insufficient evidence of significant overall benefit to low-risk individuals to allow GPs to have confidence in the recommendation to reduce the risk-threshold for prescribing cholesterol lowering drugs, and that doing so might distort health spending priorities and disadvantage other patients.
We welcome the majority of the NICE Clinical Guideline on Lipid Modification which is a useful summary of current management, but continue to have concerns over the recommendation to lower the threshold for drug therapy for primary prevention of cardiovascular disease. It is important to note that these concerns apply to low risk people only and those at higher risk or with existing disease should continue treatment.
Until now, disease prevention has generally concentrated on lifestyle measures for the entire population combined with drug treatment for those at abnormal levels of risk. In advocating drug therapy for people who are at normal (or lower) levels of risk than those expected for their age group this guidance represents a step-change in medical practice which deserved wider public debate and more robust evidence of benefit.
Our particular concerns include:
· NICE has not had access to all trial data, having instead only made an assessment of the likelihood of unseen data affecting their conclusions.
· Many of the studies referenced show no benefit or benefits assessed by NICE themselves as being too small to be of clinical importance.
· In low risk patients, drug treatment has not been shown to significantly reduce mortality.
· In low risk patients, the number of people benefiting by reduction in risk of non-fatal myocardial infarction is balanced by those harmed by increased risk of developing diabetes.
The economic evaluation has not taken into account the impact in a cash-limited health-care system such as the NHS of the effect that providing this service might have on patients with other problems.