Approximately one-third of the patients experienced levels of LDL-C that were less than 100 mg/dl - close to the recommended therapeutic goals- at some point during the study, and concomitant lipid-lowering therapy was modified in a subset of these patients during the safety phase.
Table 1 summarizes data for age, sex, body mass index, current smoking, and use of lipid-lowering therapy for these individuals (with and without diabetes) according to the time since the last meal.
Thirteen of the 23 patients were able to have their background lipid-lowering therapy reduced during the Safety Phase of the study (between Week 26 and Week 56).
After adjusting for age, hypertension, smoking, alcohol consumption, atrial fibrillation, lipid-lowering therapy, and--in women--hormone replacement therapy and menopausal status, the researchers found that women with triglycerides above 445 milligrams per deciliter (mg/dL) had a four-fold increased risk for stroke compared with women whose non-fasting triglycerides were below 90 mg/dL.
Furthermore, placebo recipients who cross over to lipid-lowering therapy in the open-label phases of the studies demonstrate survival benefits as well, but never attain the protection achieved by being randomized to active treatment earlier on, according to Dr.
This double-blind, placebo-controlled Phase III study was designed to test the efficacy and safety of adding mipomersen to stable lipid-lowering therapy.