X-Message-Number: 25068
Date: Wed, 17 Nov 2004 05:38:49 -0800 (PST)
From: Doug Skrecky <>
Subject: Simvastatin now OTC in the UK

[Canada has also liberalized a bit, and now most amino acids and melatonin
are allowed OTC. Chromium picolinate is still illegal because of safety

Am J Cardiol. 2004 Nov 4;94(9A):35F-39F
Reclassification of simvastatin to over-the-counter status in the United
Kingdom: a primary prevention strategy.
  Simvastatin (10-mg tablet) has been reclassified for sale as a
pharmacy-only over-the-counter medicine in the United Kingdom. It is
designed to be a primary prevention agent targeting that segment of the
population having a moderate risk of coronary artery disease (CAD). The
anticipated effect is a reduction of risk of a first major coronary event
(nonfatal myocardial infarction or CAD death). Simvastatin is a component
of the Heart Health Programme, which also addresses other modifiable risk
factors such as diet, exercise, and smoking. Men >/=55 years of age, men
aged 45 to 54 years with >/=1 risk factor, and women aged >/=55 years with
>/=1 risk factor have a moderate (10% to 15%) 10-year risk of developing
CAD. Risk factors include having a first-degree relative with a history
of early family CAD, smoking, being overweight, and South Asian
ethnicity. Simvastatin 10 mg lowers low-density lipoprotein cholesterol
levels by approximately 30%, with a resultant 33% reduction in risk of a
major CAD event after 3 years. After the patient completes a check-box
questionnaire regarding his or her medical history and other specific risk
factors, the pharmacist performs a few simple physical measurements and
makes a decision as to CAD risk and simvastatin eligibility. After 1
month of simvastatin therapy, cholesterol testing is highly recommended
to patients, and a kit is made available that permits home blood
collection and analysis at a central laboratory.

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