The Risk Concept in health care Definition of a risk factor  a disease precursor associated with a higher than average morbidity or mortality rate. John Sahl Andersen

The Risk Concept in health care Disease precursors (for CVD)  certain individual behaviors (life style)  certain physiologic changes (lipid status, BP)  demographic variables (gender, age)  familial and individual histories (heredity, CVD, diabetes)

The Risk Concept in health care  Risk data is derived from groups  The information may not be relevant to the individual, unique patient  To most healthy persons risk is an abstraction  The perception of risk may be influenced by several factors such as dread, personal experiences, control, the nature of the risk, awareness, and trust  Decisions on risk identification and intervention should be balanced with the individuals’ interests

The Risk concept in health care The new American guidelines state that The new American guidelines state that “it is reasonable to offer treatment with a moderate intensity statin” to adults without cardiovascular disease and diabetes who have a 10-year risk of cardiovascular disease of 5 to 7.5%” The Danish guidelines 2007 “Treatment with drugs is relevant for adults without cardiovascular disease and diabetes who have a 10- year risk of cardiovascular death of 5%” Rejsen gennem sundhedsvæsenet

The Risk Concept in health care  The new American guidelines would increase the number of U.S. adults receiving or eligible for statin therapy from 43.2 million to 56.0 million  Most of this increase in numbers (10.4 million of 12.8 million) would occur among adults without cardiovascular disease.  In adults between the ages of 60 and 75 years without cardiovascular disease, the percentage who would be eligible for such therapy would increase from 30.4% to 87.4% among men and from 21.2% to 53.6% among women Rejsen gennem sundhedsvæsenet

The Risk Concept in health care  Commercial interests take advantage of risk information to increase sales and finite resources in society  GPs would have to spend 7.4 hours per working day to provide all the preventive services recommended by the US Preventive Services Task Force  The sale in UK has risen to more than £500 million (DKK 4.5 billion) in 2006 (NICE 2006).  Are resources better spent elsewhere? Rejsen gennem sundhedsvæsenet

Cochrane 2013 Inclusion Randomised controlled trials of statins versus placebo or usual care control with minimum treatment duration of one year and follow-up of six months, in adults with no restrictions on total, low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD. Rejsen gennem sundhedsvæsenet

Cochrane 2011 and 2013 Cochrane 2011   Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk. Cochrane 2013  Reductions in all-cause mortality, major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins.

JAMA 2013 “When used for primary prevention, statins are associated with lower rates of all-cause mortality, major vascular events, and revascularizations compared with placebo. Statin therapy is not associated with increased rates of life-threatening adverse effects such as cancer.” Rejsen gennem sundhedsvæsenet

BMJ 2013 “Statin therapy in low risk people does not reduce all cause mortality or serious illness and has about an 18% risk of causing side effects that range from minor and reversible to serious and irreversible.” What low risk patients need to know Lifestyle factors—including lack of exercise, tobacco use, and unhealthy diet—account for 80% of cardiovascular disease Lifestyle factors—including lack of exercise, tobacco use, and unhealthy diet—account for 80% of cardiovascular disease For people at low risk of cardiovascular disease (<10% risk over next five years), statins do not reduce the overall risk of death or For people at low risk of cardiovascular disease (<10% risk over next five years), statins do not reduce the overall risk of death or serious illness In order to prevent one heart attack or stroke, 140 low risk people (< 10% five year risk) must receive statins for five years In order to prevent one heart attack or stroke, 140 low risk people (< 10% five year risk) must receive statins for five years The side effects of statins—including muscle symptoms, increased risk of diabetes (especially in women), liver inflammation, cataracts, The side effects of statins—including muscle symptoms, increased risk of diabetes (especially in women), liver inflammation, cataracts, decreased energy, sexual dysfunction, and exertional fatigue—occur in about 20% of people treated with statins Rejsen gennem sundhedsvæsenet

BMJ 2013 What low risk patients need to know Lifestyle factors—including lack of exercise, tobacco use, and unhealthy diet—account for 80% of cardiovascular disease Lifestyle factors—including lack of exercise, tobacco use, and unhealthy diet—account for 80% of cardiovascular disease For people at low risk of cardiovascular disease (<10% risk over next five years), statins do not reduce the overall risk of death or For people at low risk of cardiovascular disease (<10% risk over next five years), statins do not reduce the overall risk of death or serious illness In order to prevent one heart attack or stroke, 140 low risk people (< 10% five year risk) must receive statins for five years In order to prevent one heart attack or stroke, 140 low risk people (< 10% five year risk) must receive statins for five years The side effects of statins—including muscle symptoms, increased risk of diabetes (especially in women), liver inflammation, cataracts, decreased energy, sexual dysfunction, and exertional fatigue—occur in about 20% of people treated with statins The side effects of statins—including muscle symptoms, increased risk of diabetes (especially in women), liver inflammation, cataracts, decreased energy, sexual dysfunction, and exertional fatigue—occur in about 20% of people treated with statins

Cochrane 2013 Risk reduction in fatal CHD events 251/23,019 (1.1%) statin group 306/23,075 (1.3%) placebo group RR 0.82 ( ) Absolute Risk reduced 0.2% Risk reduction in non-fatal CHD 398/20,668 (1.9%) statin group 583/20,309 (2.8%) placebo group RR 0.67 (95% CI 0.59 to 0.76) Absolute Risk reduced 0,9% Rejsen gennem sundhedsvæsenet

Stephen – a risicant  52-year-old  Jogger: 3 miles a day  BMI = 25  Smoker  Total cholesterol 4.7  HDL cholesterol 0.9  LDL cholesterol 3.0  Blood pressure 130/85  Farther type 2 diabetes  Both parents have hypertension Rejsen gennem sundhedsvæsenet

Stephen – a risicant  The calculator estimates his 10-year risk of an event such as a heart attack or stroke at 10.9%.  The new American guidelines recommend statin treatment Rejsen gennem sundhedsvæsenet

Judge 1 No statin  Whether a statin would reduce his risk of cardiovascular disease is unknown  “Kicking the habit” Stop smoking! Risk halves!  LDL cholesterol levels were below (elderly) evidence for statin treatment Rejsen gennem sundhedsvæsenet

Judge 2  Three risk factors for CVD (gender, BP, dyslipidemi?)  The metabolic syndrome doubles the 5-to-10-year risk  HDL too low and risky  Change lifestyle  If not successful, join the JUPITER statin program  Be aware of statin-induced diabetes and other adverse reactions  A reduction in LDL cholesterol levels may be useful as a marker of adherence….  Monitor LDL  Therapy should be tailored to the individual patient.

Judge 3  Shared decision-making  Quit smoking. The risk would be lower than the treatment recommendation threshold. He still may decide that the magnitude of benefit is a sufficiently large motivation to choose statin therapy ????  The number needed to treat to avoid a cardiovascular event in 10 years is 50. May Stephen be one of them!  No need for monitoring LDL level. Just treat.