Are OTC Statins the Right Option for America

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Are OTC Statins the Right Option for America?
James M. McKenney, Pharm.D. President and
CEO National Clinical Research Professor
Emeritus Virginia Commonwealth University NLA
Secretary NLA Board of Directors Chairman, NLA
Consumer Affairs Committee
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• Disclosure of Affiliations and Significant
  Relationships for James M. McKenney
•  
• Speaker honorarium AstraZeneca LP, Kos
  Pharmaceuticals, Merck Co. and Pfizer, Inc.
• Research Grants AstraZeneca LP,
  GlaxoSmithKline, Kos Pharmaceuticals,
  LipoScience, Merck Co., Pfizer, Inc.,
  Schering-Plough, and Takeda.
• Consultant Services AstraZeneca LP, Kos
  Pharmaceuticals, Merck Co., Pfizer, Inc., and
  Sankyo Pharma, Inc.
• No speaker honorarium, research grants, or
  consultant fees from JJ Merck or Bristol Myers
  Squibb.

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Mission
NATIONAL LIPI D ASSOCIATION

• To enhance the practice of lipid management in
  clinical medicine.
•  
• Multidisciplinary membership based professional
  association
• Education programs that focus on continuous
  growth and development 
• Social responsibility with respect to review and
  analysis of pending consumer issues and national
  medical policy
• Cooperation with key organizations to achieve
  common goals
• Public service focus to advance practice
  standards that emphasize positive patient
  outcomes

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Dietary Supplements for Cholesterol Lowering
Creatine
Walnuts
Plant Stanols
Tocotrienols
Pectin
Licorice Root
Bilberry leaf
Lycopene
Lecithin
He shou wu
Soy Protein
L-carnitine
Carnitine
Fiber
Maitake
Gugulipid
Danshen
Beeswax
Genistein
Arginine
Copper
Chondrotin
?-3 fatty acids
Artichoke leaf
Flaxseed oil
Silicon dioxide
Aortic glycosaminoglycans
?-carotene
Hawthorn
Red yeast rice
Ginger
Aconite
Ashwagandha
Spirulina
Niacin
Chromium
Amla
Gums
Pantethine
Indole-3-carbinol
Fenugreek
Selenium
Garlic
Saponin
CoQ10
?-sitosterol
Fungal polysaccharides
Acidophilus
Ginger
Basil
Calcium
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A LINE OF REASONING

• How can consumers possibly do what health
  professionals do in managing lipids to reduce CHD
  risk?
• We are not getting the job done.
• We can try to overcome this by doing more.
• We can also consider encouraging consumers to
  take more responsibility for their own health
  care.
• For this to work, the treatments available to
  consumers must be effective and very safe and
  consumers must be able to implement the treatment
  effectively and safely.
• Key questions
• Is the statin sufficiently safe and effective?
• Can the consumer safely and effectively implement
  treatment?

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Should Consumers Be Given an OTC-Statin Option
to Help Reduce Their CHD Risk?Exploring the
Evidence
THE NLA MONOGRAPH

• The Current State of Cardiovascular W. Virgil
  Brown, MD
• Disease Risk Reduction in the US
• Considerations for Approval of Eric P. Brass,
  MD, PhD
• Prescription Drugs To OTC Sale
• A Survey of the Attitudes, Beliefs, and James
  M. McKenney, PharmD
• Perceptions of Consumers Regarding
• CHD And High Blood Cholesterol
• Overview of Consumer-Use Research Jerome D.
  Cohen, MD
•  
• Value-Added Services Provided by Janet P. Engle,
  Pharm.D.
• Pharmacists in an Environment of OTC
• Statins

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Consumer Interest in an OTC Statin

• 74 of respondents said they were likely to
  learn more about an OTC statin if one became
  available
• 57 said they were likely to purchase and use
  an OTC statin, if approved
• Consumers with a high interest in the OTC statin
  option are demographically similar to those with
  less interest in terms of age, income, and
  ethnicity.
• But they are more concerned and more interested
  in learning more about cholesterol and more open
  to OTC medications.
• Many of those with interest in an OTC statin are
  also either regularly or occasionally already
  doing things to lower their cholesterol level
• 58 are taking supplements
• 64 are avoiding smoking
• 72 are exercising
• 80 are eating a low fat diet (80)
• 82 are trying to lose weight (82)

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Consumers Interaction with Physicians

• 85 of consumers say that they would be very
  likely to consult with their physician or other
  healthcare professional before (80) or just
  after purchasing an OTC statin (5)
• 82 of consumers say that they would continue to
  consult with their physician after buying an OTC
  statin

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Characteristics of OTC Users
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Potential Safety Concerns
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