Intended for healthcare professionals

Analysis And Comment Controversy

Should we lower cholesterol as much as possible?

BMJ 2006; 332 doi: (Published 01 June 2006) Cite this as: BMJ 2006;332:1330

Are eligibility criteria for over the counter (OTC) statins appropriate?

Dear Editor,

Ravskov et al discuss optimal cholesterol levels and more widespread use of statins.1 Over the counter (OTC) statins should also be considered in this debate.

In primary prevention of coronary heart disease (CHD), current guidelines recommend that high-risk patients (equivalent to CHD risk ≥ 15% using Framingham equations) should be prescribed a statin by their general practitioner (typically simvastatin 20-40mg).2 Royal Pharmaceutical Society of Great Britain (RPSGB) criteria for OTC simvastatin 10mg aim to target patients at moderate risk of CHD (10-year CHD risk 10-15%) using an assessment of age, sex and a count of CHD risk factors.3 Higher risk patients are also identified using RPSGB criteria, ideally including blood pressure (BP) and cholesterol checks (when available), and are advised to see a doctor.

We have investigated how accurately RPSGB criteria for OTC statins identify patients at moderate risk of CHD using data from the nationally representative Scottish Health Survey 1998 (SHS). The analysis included data from 2,760 people aged 40 to 74 years without cardiovascular disease (CVD) or diabetes, identifying those with 10-year CHD risk 10-15% using two methods – Framingham equations, and RPSGB criteria. Agreement between the two approaches was assessed using the kappa statistic (SPSS 11.5, Chicago). The analysis for RPSGB criteria was then repeated without taking BP and cholesterol readings into account.

Using Framingham equations, 1587 (58%) SHS participants aged 40 to 74 years were at low risk of CHD (10-year CHD risk <_10 _528="_528" _19="_19" were="were" at="at" moderate="moderate" risk="risk" of="of" chd="chd" _10-year="_10-year" _10-15="_10-15" and="and" _645="_645" _23="_23" high="high" _880515.="_880515." the="the" numbers="numbers" people="people" in="in" each="each" category="category" those="those" eligible="eligible" for="for" otc="otc" statins="statins" are="are" shown="shown" figure.="figure." using="using" rpsgb="rpsgb" criteria="criteria" including="including" bp="bp" cholesterol="cholesterol" _312="_312" _11="_11" shs="shs" participants="participants" agreement="agreement" about="about" which="which" was="was" less="less" than="than" that="that" expected="expected" by="by" chance="chance" when="when" compared="compared" with="with" framingham="framingham" equations="equations" kappa="kappa" _-0.1="_-0.1" p0.001="p0.001" _35="_35" _5="_5" high-risk="high-risk" would="would" have="have" been="been" identified="identified" as="as" being="being" statins.="statins." but="but" omitting="omitting" _766="_766" _28="_28" there="there" poor="poor" _0.2="_0.2" _250="_250" _39="_39"""/>

In conclusion, large numbers of middle aged and elderly people would potentially be eligible for OTC statins. However, RPSGB criteria for OTC statins show little agreement with more commonly used Framingham equations. These findings introduce further complexity to the statin debate as up to 40% of high-risk patients could be under-treated with low dose statins, while people at low-risk could be exposed to the potential side-effects of statins unnecessarily. It would be preferable if the assessment for OTC statins included a full assessment of CVD risk using Framingham equations (or an alternative such as the SCORE system4) and BP and cholesterol measurement – but this would require additional training for some pharmacists.5

D Graham Mackenzie, Specialist Registrar in Public Health, Public Health Department, NHS Fife, Cameron House, Leven, KY8 5RG

Sarah H Wild, Senior Lecturer in Public Health and Epidemiology, Public Health Sciences, University of Edinburgh, Teviot Place, EH8 9AG

Philip Rutledge, Consultant in Medicines Management, Lothian NHS Board, 148 Pleasance, Edinburgh, EH8 9RS

Figure. CHD risk of SHS participants (n=2760). Those eligible for OTC statins using full RPSGB criteria are shown in black, and the additional participants identified after removing BP and cholesterol from the criteria are shown in white. Participants at moderate risk not identified using RPSGB criteria are shown in blue.

(a higher resolution version of this image can be viewed at


  1. Ravnskov U, Rosch PJ, Sutter MC, Houston MC. Should we lower cholesterol as much as possible? BMJ 2006;332:1330 –2
  2. Wood DA et al. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice Heart 2005;91:v1-v52
  3. OTC simvastatin practice guidance, concise version. accessed 1/7/2006
  4. Conroy RM, Pyörälä K, Fitzgerald AP et al on behalf of the SCORE project group. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. European Heart Journal 2003: 24; 987-1003
  5. Practice guidance on: sale of over-the-counter simvastatin. accessed 1/7/2006

Competing interests:
None declared

Competing interests: No competing interests

15 August 2006
D Graham Mackenzie
Specialist Registrar in Public Health
Sarah H Wild, Philip Rutledge
Public Health Department, NHS Fife, Cameron House, KY8 5RG