# Presentation: 241515

## Should Statins Be Approved ForOver-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

## Mitka M.  Are OTC Statins Ready for Prime Time?  JAMA.  2004;292:317-318.

## Mitka M.  Are OTC statins ready for prime time?  JAMA.  2004;292:317-318.

-       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 problem—human 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."**** **

## Gordon NF, Salmon RD, Franklin BA et al.  Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia.  Am J Cardiol.  2004;94:1558-1561. 

-     “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.”**

## 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.*

## Therapeutic Lifestyle Changes Diet(ATP III Guidelines)

** **
- Saturated fat <7% of calories, cholesterol <200 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

## Dietary Sources of Saturated Fat

-     If we don’t 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.

## Gordon NF, Salmon RD, Franklin BA et al.  Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia.  Am J Cardiol.  2004;94:1558-1561.

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

## 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.  2004;94(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.

## What next???

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

## 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.  2004;94(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.

## Gordon NF, Salmon RD, Franklin BA et al.  Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia.  Am J Cardiol.  2004;94:1558-1561. 

-     “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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