The Heart Protection Study was a

randomized controlled trial A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical te ...

run by the

Clinical Trial Service Unit The Clinical Trial Service Unit (CTSU) is a medical research institute within the Nuffield Department of Population Health at Oxford University. It primarily conducts large scale clinical trials (phase III – Final Testing) and epidemiological ...

, and funded by the Medical Research Council (MRC) and the

British Heart Foundation The British Heart Foundation (BHF) is a cardiovascular research charity in the United Kingdom. It funds medical research related to heart and circulatory diseases and their risk factors, and runs influencing work aimed at shaping public policy ...

(BHF) in the

United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...

. It studied the use of the cholesterol lowering drug,

simvastatin Simvastatin, sold under the brand name Zocor among others, is a statin, a type of lipid-lowering medication. It is used along with exercise, diet, and weight loss to decrease elevated lipid levels. It is also used to decrease the risk of heart ...

40 mg and

vitamin A vitamin is an organic molecule (or a set of molecules closely related chemically, i.e. vitamers) that is an Nutrient#Essential nutrients, essential micronutrient that an organism needs in small quantities for the proper functioning of its ...

supplementation (

vitamin E Vitamin E is a group of eight fat soluble compounds that include four tocopherols and four tocotrienols. Vitamin E deficiency, which is rare and usually due to an underlying problem with digesting dietary fat rather than from a diet low in vitami ...

vitamin C Vitamin C (also known as ascorbic acid and ascorbate) is a water-soluble vitamin found in citrus and other fruits and vegetables, also sold as a dietary supplement and as a topical 'serum' ingredient to treat melasma (dark pigment spots) an ...

and

beta carotene Beta (, ; uppercase , lowercase , or cursive Greek, cursive ; grc, βῆτα, bē̂ta or ell, βήτα, víta) is the second letter of the Greek alphabet. In the system of Greek numerals, it has a value of 2. In Modern Greek, it represents th ...

) in people who were at risk of

cardiovascular disease Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. CVD includes coronary artery diseases (CAD) such as angina and myocardial infarction (commonly known as a heart attack). Other CVDs include stroke, h ...

. It was led by

Jane Armitage Jane Margaret Armitage is a professor of clinical trials and epidemiology in the Clinical Trial Service Unit at the University of Oxford. She works on the epidemiology of cardiovascular disease and has led large-scale randomized controlled trials ...

, an epidemiologist at the

Results

An outline of the study protocol was published in 1999. Initial results were published in 2002, which indicated that vitamins made little difference in modifying cardiovascular risk, but that simvastatin could significantly reduce the risk of cardiovascular events. Further publications, from 2003 and 2004, were concerned with the efficacy of simvastatin in diabetes patients and preventing stroke. A 2005 paper analyses the cost-effectiveness of a prescribing strategy similar to the one employed in the study.

Interpretation

The HPS is to date the largest study to investigate the use of

statin Statins, also known as HMG-CoA reductase inhibitors, are a class of lipid-lowering medications that reduce illness and mortality in those who are at high risk of cardiovascular disease. They are the most common cholesterol-lowering drugs. Low- ...

s in the prevention of

. While there have been concerns about side-effects associated with statins (

myopathy In medicine, myopathy is a disease of the muscle in which the muscle fibers do not function properly. This results in muscular weakness. ''Myopathy'' means muscle disease (Greek : myo- ''muscle'' + patheia '' -pathy'' : ''suffering''). This meani ...

and

rhabdomyolysis Rhabdomyolysis (also called rhabdo) is a condition in which damaged skeletal muscle breaks down rapidly. Symptoms may include muscle pains, weakness, vomiting, and confusion. There may be tea-colored urine or an irregular heartbeat. Some of th ...

), these were rare in this study. The

number needed to treat The number needed to treat (NNT) or number needed to treat for an additional beneficial outcome (NNTB) is an epidemiological measure used in communicating the effectiveness of a health-care intervention, typically a treatment with medication. The ...

in the study was 57 to postpone one death and 19 to prevent one cardiovascular "event" (in those taking the drug simvastatin for 5 years). There was no mortality benefit in women with a statistical "p-value" that did not reach significance (0.08) while the Kaplan-Meier mortality curves, for men and women separately, have not been published as of 2016.

Cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

risk was not significantly lower in the treatment group; in fact, there was no difference except for non-melanoma skin cancers, wherein the placebo group had a barely-significant lower risk of diagnosis. No worsening of

lung disease The lungs are the primary organs of the respiratory system in humans and most other animals, including some snails and a small number of fish. In mammals and most other vertebrates, two lungs are located near the backbone on either side of t ...

was found, an initial concern with statin drugs, and simvastatin did not decrease

osteoporosis Osteoporosis is a systemic skeletal disorder characterized by low bone mass, micro-architectural deterioration of bone tissue leading to bone fragility, and consequent increase in fracture risk. It is the most common reason for a broken bone ...

Pharmaceutical funding

£5.5M plus drug supply was received from Merck and £5.5M plus drug supply from Roche.

References

{{reflist

Results

Interpretation

Pharmaceutical funding

See also

References

Further reading