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

ASHP Statement on the Over-the-Counter Availability of Statins

“…CUSTOM, or the Consumer Use Study of OTC Mevacor, was an open-label study designed to observe consumers' initial and continued use of a statin to lower LDL cholesterol. 8 Although the results may indicate that some consumers in the study sample could use an OTC statin as directed, the study was not, by the investigators' own admission, designed to evaluate clinical outcomes and therefore unable to demonstrate efficacy. The study certainly did not prove that the existing OTC dispensing model would provide the level of counseling required to reduce cardiovascular risk factors other than LDL cholesterol levels.…”

Should cholesterol-lowering medications be available in Canada without a prescription?

“…This is because OTC or BTC statins would remove some of the barriers to treatment and thus lead to broader, improved access to lipid-lowering therapy. Indeed, the Consumer Use Study of OTC Mevacor (CUSTOM) trial (17), which evaluated OTC lovastatin use in subjects with moderate or intermediate risk of developing CAD (calculated 10-year risk of CAD of 10% to 20%), found that after 26 weeks, median levels of LDL-C were reduced by 25%. It has been estimated that a mere 10% decline in population-wide LDL-C levels would decrease the incidence of CAD by 30% (American, European and Israeli data [18,19]), thereby markedly decreasing the rates of morbidity and mortality, as well as the associated heavy financial costs of CAD.…”

“…This, combined with a decrease in the delays in treatment caused by limited physician access, may lead to greater motivation and compliance in statin use. In support of this argument, a study in Sweden assessing 16 drugs that had been switched from prescription to OTC status found that this resulted in a 36% increase in drug sales (17,23). This, of course, does not necessarily indicate the percentage of drug purchases that were appropriate for the intended indication, but it does indicate a trend toward greater drug usage (16).…”

Over-The-Counter Statins Are Worth Considering in Primary Prevention of Cardiovascular Disease

“…2,5 An early evaluation of a proposed self-management system, the Consumer Use Study of Over-the-the Counter Lovastatin (CUS-TOM) was an open-label, uncontrolled, multicenter study that examined the behavior of potential OTC purchasers in 14 storefront sites intended to simulate a "real-world" pharmacy setting. 20 The materials developed for the self-management system focused on describing primary prevention of CHD in the intermediate-risk population and encouraged participants to discuss their concerns about cholesterol, including OTC statin treatment, with their physicians. Nurse-practitioners, in the role of the "pharmacists," were not permitted to volunteer any information that might influence the participant's ability to self-select, but they could answer questions and perform an eligibility assessment interview at the participant's request.…”

“…Although most nonpurchasers correctly followed the label (ie, they did not qualify for the OTC statin and therefore did not buy it), only 10% of the users met all label criteria for use. 20 Most users met many, but not all, of the criteria mainly because they either were slightly outside the age range or lipid values or had no risk factors for CHD, as specified in the label. The FDA panel thought that because the preponderance of users did not match the label criteria, the general public would not be able to follow the label exactly.…”