Potential impact on cardiovascular public health of over-the-counter statin availability.

Over-the-counter (OTC) statin availability has been hypothesized to represent a strategy for treating consumers at moderate risk of coronary heart disease (CHD) who are currently not receiving drug therapy. The viability of this strategy has been questioned, particularly with respect to the public health benefit that can be obtained in an unsupervised treatment environment. The previously reported Consumer Use Study of Over-the-Counter Lovastatin (CUSTOM) examined consumer behavior in a simulated OTC setting in which 20 mg lovastatin could be purchased. Framingham CHD risk scores were calculated for 981 self-selected consumers who used OTC lovastatin in CUSTOM. Overall, this group had a median 10-year CHD risk of 10%, but with significant numbers of consumers with estimated risks of <5% and >20%. According to the risk profile of CUSTOM consumers, the use of 20 mg lovastatin for 10 years would be expected to prevent approximately 33,100 CHD events per 1 million users. This represents a 10-year number needed to treat of 30 consumers. This optimal benefit may be reduced because some higher risk consumers in CUSTOM used lovastatin rather than appropriate, more aggressive supervised care. On the basis of the frequencies of diversion from optimal care observed in CUSTOM, the number of events prevented might be reduced to 23,000 (number needed to treat 43 consumers). Sensitivity analyses have demonstrated that these estimates are robust and that the predicted public health benefit likely falls in the range of 23,000 to 33,000 CHD events prevented per 1 million treated for 10 years. In conclusion, on a population basis, OTC statin availability is likely to result in clinically meaningful reductions in CHD morbidity and mortality. The analyses also identified opportunities for optimizing the use of OTC statins in the marketplace.

Frequency of myopathy in patients receiving lovastatin.

Lovastatin (Mevacor) 20 mg is being considered for nonprescription availability. Because the most severe untoward consequence of therapy with any statin is rhabdomyolysis, the clinical data for lovastatin pertaining to this adverse event were reviewed. Evidence to date, based on almost 2 decades of experience, points to an extremely low risk for myopathy and rhabdomyolysis associated with lovastatin.

Estimating cholesterol treatment rates among individuals with multiple risk factors and without coronary heart disease.

This retrospective study examined lipid-lowering therapy treatment rates from 2000 to 2001 using the Ingenix LabRx Database. Patients with multiple risk factors without coronary heart disease were identified based on the presence of >/=2 of the following: men >/=45 years, women >/=55 years, hypertension, high-density lipoprotein cholesterol <40 mg/dl, total cholesterol >/=200 mg/dl, or obesity. Lipid treatment rates were estimated among those needing therapy (defined as low-density lipoprotein cholesterol >/=130 mg/dl or currently receiving lipid-lowering therapy). The overall lipid-lowering therapy treatment rate was 38% and the estimated lipid treatment gap (percent needing treatment who were not receiving it) was 62%.

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 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 >or=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 (<130 mg/dl). Physician interactions were common. Mevacor OTC was well tolerated, with no observable adverse experiences from drug interactions or reports of myopathy. This actual use study demonstrates that the MOTC-SMS can effectively guide consumers to interact with health care professionals and to make appropriate initial and ongoing use decisions to manage their elevated levels of LDL cholesterol, with minimal potential or actual safety risk.

Hidden cost of rheumatoid arthritis (RA): estimating cost of comorbid cardiovascular disease and depression among patients with RA.

OBJECTIVE: To examine resource utilization and direct healthcare cost associated with comorbid cardiovascular disease (CVD) and depression among patients with prevalent rheumatoid arthritis (RA) based on analyses of retrospective healthcare claims data. METHODS: The index date was set as the first observed claim with an RA diagnosis. Patients were required to be >or=18 years of age, to have received RA-related treatment during the pre-index period, and to have 12-month pre- and post-index data. Based on pre-index utilization, patients were classified into 4 diagnosis groups: RA alone, RA+CVD, RA+depression, and RA+CVD+depression. Analyses focused on annual differences in costs between patients with RA alone and those with CVD and/or depression. A generalized linear model was applied to control for demographic and clinical characteristics and to estimate cohort-specific adjusted mean annual healthcare cost. RESULTS: Of 10,298 patients, 8,916 had RA alone (86.6%), 608 had RA+CVD (5.9%), 716 had RA+depression (7.0%), and 58 had RA+CVD+depression (0.5%). All patients with CVD and/or depression incurred significantly higher followup costs compared with patients with RA alone. Adjusted annual mean healthcare costs were highest for RA+CVD (US$14,145), followed by RA+CVD+depression ($13,513), RA+depression ($12,225), and RA alone ($11,404). Although patients with CVD and/or depression had a greater rate of RA-related hospitalization, adjusted RA-related healthcare costs did not reflect any statistically significant differences as compared to the RA-alone cohort. CONCLUSION: A significant proportion (13.4%) of patients with prevalent RA have comorbid CVD and/or depression. The presence of these conditions significantly affects annual healthcare costs as well as specific RA-related utilization patterns.