A Consumer Use Study of Over-the-Counter Lovastatin (CUSTOM)

The Consumer Use Study of OTC Mevacor evaluated the ability of subjects to self-manage high levels of low-density lipoprotein (LDL) cholesterol by using a multifaceted cholesterol self-management program (the Mevacor * * Mevacor is a trademark of Merck & Co., Inc., Whitehouse Station, New Jersey...

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Bibliographic Details
Published in:The American journal of cardiology 2004-11, Vol.94 (10), p.1243-1248
Main Authors: Melin, Jeffrey M., Struble, William E., Tipping, Robert W., Reynolds, James M., Vassil, Theodore C., Levy, Stephanie J., Petrohoy, Theresa M., Midgette, Paulette, Hemwall, Edwin L., Levine, Jeffrey G., Irvin, John D.
Format: Article
Language:English
Subjects:
Anticholesteremic Agents - therapeutic use
Biological and medical sciences
Cardiology. Vascular system
Cholesterol
Cholesterol, LDL - blood
Female
Health Behavior
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hyperlipidemias - blood
Hyperlipidemias - drug therapy
Lovastatin - therapeutic use
Low density lipoprotein
Male
Medical sciences
Middle Aged
Nonprescription drugs
Nonprescription Drugs - therapeutic use
Self Administration
Self Care
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Summary:The Consumer Use Study of OTC Mevacor evaluated the ability of subjects to self-manage high levels of low-density lipoprotein (LDL) cholesterol by using a multifaceted cholesterol self-management program (the Mevacor * * Mevacor is a trademark of Merck & Co., Inc., Whitehouse Station, New Jersey. Over-the-Counter Self-Management System; MOTC-SMS). This 26-week all-comers multicenter observational study was conducted in naturalistic storefront settings that used the fully functional MOTC-SMS to guide subjects' behavior. Of 3,316 subjects who evaluated the product (evaluators), 1,061 took ≥1 20-mg tablet of Mevacor OTC (users). Eighty-four percent of evaluators made appropriate initial use decisions. Most users demonstrated acceptable ongoing use behavior regarding treatment to goal, compliance/persistence, changes in health status, dietary patterns, and exercise habits. Throughout the study, 23 users (2%) demonstrated behavior that created the potential for suboptimal safety. After 26 weeks, median levels of LDL cholesterol were reduced by 25% among users who fasted. Of the 878 users who completed the study lipid test, 548 (62%) achieved the LDL cholesterol target goal (
ISSN:0002-9149
1879-1913
DOI:10.1016/j.amjcard.2004.08.007