Can consumers self-select for appropriate use of an over-the-counter statin? The Self Evaluation of Lovastatin to Enhance Cholesterol Treatment Study.
Access to over-the-counter (OTC) statins has the potential to improve public health by reducing cardiovascular events. The Self Evaluation of Lovastatin to Enhance Cholesterol Treatment (SELECT) Study was designed to assess consumers' ability to self-select for treatment with lovastatin in an unsupervised setting. Subjects examined proposed OTC lovastatin cartons with labels that detailed an algorithm for self-selection based on age, lipid profile, and cardiovascular risk factors. Subjects viewed a carton with either a low-density lipoprotein cholesterol-based self-selection algorithm or one based on total cholesterol. Labels also contained warnings against use based on health conditions that might increase the risk of adverse events. Subjects were asked if the drug was appropriate for their use (self-assessment) and whether they would like to purchase the drug (purchase decision). A total of 1,326 consumers provided self-assessment decisions. After viewing the low-density lipoprotein cholesterol-based label, 82%, 36%, and 82% of those who self-assessed that the drug was appropriate for their use were correct with respect to the age, lipid, and risk-factor criteria, respectively. Corresponding numbers for the total cholesterol algorithm were 85%, 50% and 75%. Almost 90% of women aged <55 years who evaluated the drug indicated the drug was not right for them, and women in this age group made up only 9% of the total group of subjects who believed the drug was appropriate for their use. The label was also effective in discouraging use by women who were or may become pregnant, consumers with liver disease, and those with potential drug interactions. In conclusion, SELECT showed that consumers could use an OTC drug label in an unsupervised setting to appropriately self-select for self-management of their cholesterol with lovastatin.
Brass
Eric P
EP
Harbor-UCLA Center for Clinical Pharmacology, Torrance, California, USA. ebrass@ucla.edu
Vassil
Theodore
T
Replogle
Amy
A
Hwang
Peggy
P
Rusche
Steven
S
Shiffman
Saul
S
Levine
Jeffrey G
JG
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D003256:Community Participation / Q000379:methods*; D004348:Drug Labeling / Q000379:methods; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D008148:Lovastatin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D015995:Prevalence; D011446:Prospective Studies; D011634:Public Health / Q000379:methods*; D012307:Risk Factors; D012655:Self-Evaluation Programs / Q000379:methods*; D011795:Surveys and Questionnaires; D014481:United States / Q000453:epidemiology
D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D004366:Nonprescription Drugs; D008148:Lovastatin