Are OTC Statins the Right Option for

America?James M. McKenney, Pharm.D.President and CEONational Clinical ResearchProfessor EmeritusVirginia Commonwealth University

NLA SecretaryNLA Board of DirectorsChairman, NLA Consumer Affairs Committee

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 J&J Merck or Bristol Myers Squibb.

MissionTo enhance the practice of lipid management in clinical medicine.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

NATIONAL LIPI D ASSOCIATION

Acidophilus

Artichoke leaf

Bilberry leaf

L-carnitine

ChondrotinCopper

Calcium

Fiber

Flaxseed oil

Genistein

Lecithin He shou wu

Maitake

-3 fatty acids

Red yeast rice

Silicon dioxide

SpirulinaAshwagandha

-carotene

Chromium

Indole-3-carbinol

Garlic

Gugulipid

Gums

Fenugreek

Fungal polysaccharides

Pantethine

Niacin

Saponin-sitosterol

Tocotrienols

Soy Protein

Basil

Creatine

Lycopene

Aortic glycosaminoglycans

Ginger

PectinLicorice Root

Plant Stanols

Ginger

Walnuts

Selenium

Carnitine

Arginine

CoQ10

Amla

Hawthorn

Danshen

Aconite

Beeswax

Dietary Supplements for Cholesterol Lowering

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?

Should Consumers Be Given an OTC-Statin Option to Help Reduce Their CHD Risk?

Exploring the EvidenceThe Current State of Cardiovascular W. Virgil Brown, MDDisease Risk Reduction in the US

Considerations for Approval of Eric P. Brass, MD, PhDPrescription Drugs To OTC Sale

A Survey of the Attitudes, Beliefs, and James M. McKenney, PharmDPerceptions 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

THE NLA MONOGRAPH

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%)

Consumer Interest in an OTC Statin

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

Consumer’s Interaction with Physicians

Characteristics of OTC Users

PREDICT

(n=720)

OPTIONS

(n=404)

CUSTOM

(n=1059)

Consulted MD 82% 49% 57%

Followed Diet/Exercise

85% NA ~ 95%

Appropriately self selected

93% 89% 65-90%

Potential Safety Concerns

CUSTOM DATAUsers with Specified Potential

Safety Concern (n=1059)

Potential drug interactions 11

Current liver disease 3

Pregnant/breast feeding 0

Drug allergy to lovastatin 0

Use of prescription lipid modifying medication

9

TOTAL 23 (2%)