Effects of direct-to-consumer advertising of hydroxymethylglutaryl coenzyme a reductase inhibitors on attainment of LDL-C goals

Abstract

Background: Although highly controversial, directto-consumer (DTC) television advertising for prescription drugs is an established practice in the US health care industry. While the US Food and Drug Administration is currently reexamining its regulatory stance, little evidence exists regarding the impact of DTC advertising on patient health outcomes. Objective: The objective of this research was to study the relationship between heavy television promotion of 3 major hydroxymethylglutaryl coenzyme A reductase inhibitors (“statins”) and the frequency with which patients are able to attain low-density lipoprotein cholesterol (LDL-C) blood-level goals after treatment with any statin. Methods: We used logistic regression to determine achievement of LDL-C goals at 6 months after statin treatment, using electronic medical record extract data from patients from geographically dispersed primary care practices in the United States. We identified LDL-C blood levels as being at or less than goal, as defined by risk-adjusted guidelines published by the National Heart, Lung, and Blood Institute from the Adult Treatment Panel III (ATP III) data. A total of 50,741 patients, identified from 88 practices, were diagnosed with hyperlipidemia and had begun therapy with any statin medication during the 1998–2004 time period. In addition, total dollars spent each month on television advertising at the national and local levels for atorvastatin, pravastatin, and simvastatin were obtained. DTC advertising data were merged by local media market where the physician practice was located and by the month in which the patient was first prescribed a statin. The models were run for all patients who initiated therapy, and also on a subsample of patients who continued to receive prescriptions for the drugs for at least 6 months. Logistic regressions were used to predict the likelihood that each patient attained the ATP III LDL-C blood-level goals as a function of DTC advertising and other factors. Results: High levels of national DTC advertising when therapy was initiated were found to increase the likelihood that patients attained LDL-C goals at 6 months by 6% ( P < 0.001)—although the effect was concentrated among patients with the least-restrictive ATP III LDL-C goals (≤160 mg/dL). This result was found in both the entire set of patients as well as the restricted sample of patients who maintained therapy for at least 6 months. Conclusions: The results of this study suggest that higher levels of DTC television advertising of statin treatment were significantly associated with improvements in the likelihood of attaining cholesterol-management goals for at least some patients. While this paper does not address the impact of DTC advertising on the costs of care or on unnecessary switching between statin treatments, the results do suggest that DTC advertising can have beneficial effects, which should be a factor when additional restrictions on DTC advertising are considered. This result—that DTC ad vertising might have beneficial effects-should be weighed against existing studies that have found that patients' suggestions (conceptually which could be induced by DTC advertising) may be associated with overprescribing (eg, in the case of the use of antidepressants for adjustment disorder).