Abstract 292: Baseline characteristics of patients starting on Niacin extended-release

Abstract

Background: The lack of CV benefit in the recent AIM-HIGH clinical trial, where niacin was given on a background of statin treatment in patients with baseline lipids that were already well-controlled, led us to ask the question as to what are the baseline characteristics of real-world patients that physicians were starting on prescription Niacin extended-release (NER). Objectives: To evaluate, using a real-world database, the baseline characteristics of real-world patients started on niacin monotherapy or combination therapy. Methods: This was a retrospective analysis using electronic medical records. Individuals receiving the first prescription for NER monotherapy or single pill statin-niacin combination (SPC) between July 2000-September 2011 were identified. The date of the first prescription was set as the index date. Patients were 18 years or older on index date, and during the six months prior to index date they had a lipid panel but had no prescription for NER or statin-niacin SPC. Patients were classified based on therapy: NER monotherapy, statin-niacin (includes SPC), and all other combinations of NER. NCEP guidelines were used to evaluate/classify risk-adjusted optimal lipid levels. Results: A total of 45,518 patients fulfilled all inclusion criteria. Overall, 58% of the patients had hypertension, 28% had diabetes, and 48% had CHD or CHD risk equivalent. Irrespective of LDL-C levels, 66% had low HDL-C. Among the remaining 34% of the patients with HDL-C at goal, 75.8% had LDL-C>100mg/dL and/or TG >200mg/dL. A total 17,042 patients (37%) were started on niacin extended release monotherapy, 18,782 (41%) were treated with statin-niacin (including SPC), and 9,696 (21%) were treated with all other combinations of niacin extended release. Among the high-risk patients treated with statin-niacin (excluding SPC) 64% had LDL-C<100mg/dL and 54% had non-HDL also at goal; 25% had LDL-C<70mg/dL and 16% had non-HDL also at goal. The baseline average LDL-C and HDL-C and median TG for statin-niacin patients were 93.1 mg/dL(33.5), 39.5mg/dL(11.3) and 165.0mg/dL, respectively. Conclusion: Half the patients starting on NER have hypertension and/or CHD/CHD risk equivalents and the majority have low HDL-C. While the majority of high risk patients for whom niacin was added to baseline statin, or who were starting statin-niacin combinations had LDL-C<100mg/dL, fewer patients had LDL-C <70mg/dL goal, and even fewer had non-HDL <100mg/dL. In comparison to AIM-HIGH the average LDL-C and non-HDL levels were higher in the real-world, raising the question whether patients enrolled in AIM-HIGH were only the well-controlled patients, and that the sample size had to have been considerably higher for us to see any additional benefit of adding niacin to statin therapy.