Should Statins Be Approved For Overthecounter

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Should Statins Be Approved ForOver-the-counter

• Laurie Tansman, MS, RD, CDN
• Department of Clinical Nutrition
• The Mount Sinai Hospital
• and
• Department of Community Preventive Medicine
• Mount Sinai School of Medicine

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Mitka M. Are OTC Statins Ready for Prime Time?
JAMA. 2004292317-318.
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Mitka M. Are OTC statins ready for prime time?
JAMA. 2004292317-318.

• Robert Bonow, MD, past president of the
  American Heart Association and professor of
  cardiology at Northwestern University's Feinberg
  School of Medicine in Chicago, was quoted as
  follows
• "You would love to get the drug in the hands
  of people who need it," Bonow said. "But we may
  be giving the medicine to people who don't need
  it and who will be told they have to take it for
  their lifetimes. There is another problemhuman
  nature. People who ought to be dieting and
  exercising are going to feel that since they're
  taking a pill they can now continue habits that
  are unhealthy."

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Gordon NF, Salmon RD, Franklin BA et al.
Effectiveness of therapeutic lifestyle changes in
patients with hypertension, hyperlipidemia,
and/or hyperglycemia. Am J Cardiol.
2004941558-1561.

• National clinical guidelines have
  promulgated therapeutic lifestyle changes as a
  standard of care in the management of
  conventional risk factors. However, because of
  the widespread availability of powerful
  medications, the value of therapeutic lifestyle
  changes per se in contemporary medical practice
  is often discounted by clinicians, health
  insurers, and patients.

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From The Merck Manual of Diagnosis and Therapy -
Seventeenth Edition

• In general, for mild or moderate elevations of
  LDL cholesterol, an altered diet is usually
  sufficient and is the initial step in treatment.
  Dietary changes usually should be tried for at
  least 6 mo before determining that a drug is also
  needed.
• Accessed on 1/4/05 from http//www.Merck.Co.

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Therapeutic Lifestyle Changes Diet(ATP III
Guidelines)

• Saturated fat mg/day
• Consider increased viscous (soluble) fiber (10-25
  g/day) and plant stanols/sterols (2g/day) as
  therapeutic options to enhance LDL lowering
• Weight management
• Increased physical activity

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Dietary Sources of Saturated Fat
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• If we dont provide the opportunity for a
  person to realize appropriate dietary changes,
  then of course the TLC Diet may be unsuccessful
  and medication becomes the only therapeutic
  option.

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Gordon NF, Salmon RD, Franklin BA et al.
Effectiveness of therapeutic lifestyle changes in
patients with hypertension, hyperlipidemia,
and/or hyperglycemia. Am J Cardiol.
2004941558-1561.

• Moreover, therapeutic lifestyle changes can
  generally be implemented less expensively than
  most medications and, unlike single-drug therapy,
  favorably affect multiple risk factors.

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McKenney JM, Brown WV, Cohen JD, Cahill E. The
National Lipid Association Surveys of consumers,
physicians, and pharmacists regarding an
over-the-counter statin in the United States Is
this a good idea? Am J Cardiol. 200494(Suppl
1)16-21.

• Moving statin therapy from prescription-only
  to over-the-counter (OTC) status would mark a
  major turning point for this drug class and for
  OTC therapy in general. OTC therapies have been
  approved by the US Food and Drug Administration
  (FDA) for the symptomatic relief of common
  conditions, usually of short duration.

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What next???

• If statins are approved for OTC, then can OTC
  approval for oral diabetic agents and
  antihypertensives be far behind?

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Pasternak RC, McKenney JM, Brown WV, Cahill E,
Cohen JD. Understanding physician and consumer
attitudes concerning cholesterol management
Results from the National Lipid Association
Surveys. Am J Cardiol. 200494(Suppl 1)9-15.

• Most untreated moderate-risk consumers (77)
  agreed that even high cholesterol can be lowered
  without medication by eating right and
  exercising. When asked about the actions
  currently taken to help maintain heart health,
  28 reported regularly eating a low-fat diet
  (28), and 29 reported exercising regularly.
  Surprisingly, only 28 of untreated moderate-risk
  consumers agreed that it was difficult to control
  cholesterol through diet and exercise.

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Gordon NF, Salmon RD, Franklin BA et al.
Effectiveness of therapeutic lifestyle changes in
patients with hypertension, hyperlipidemia,
and/or hyperglycemia. Am J Cardiol.
2004941558-1561.

• National clinical guidelines have
  promulgated therapeutic lifestyle changes as a
  standard of care in the management of
  conventional risk factors. However, because of
  the widespread availability of powerful
  medications, the value of therapeutic lifestyle
  changes per se in contemporary medical practice
  is often discounted by clinicians, health
  insurers, and patients.

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