Sanofi and Regenoron’s ODYSSEY Program is a collection of clinical trials. The ODYSSEY Phase 3 program, which is comprised of 14 global clinical trials and includes more than 25, 500 patients, represents the largest collection of clinical trials ever conducted for an investigational LDL cholesterol lowering drug.
Based on the trials designed to evaluate the efficacy and safety of biweekly Alirocumab in patients with primary or secondary hypercholsteremia, Alirocumab treatment demonstrated not only consistent lowering LDL-C effects, but also tolerability and safety comparable to oral statins. Namely, in their 78 week randomized control trial (RCT) that involved 2341 patients with LDL levels of 70 mg per deciliter or higher, Robinson et al., (2015) claim that Alirocumab is highly effective at lowering LDL cholesterol levels when combined with a statin. Not only did Alirocumab yield significant bad cholesterol …show more content…
Unlike Allirocumab, Ezetimibe has a mechanism of action that differs from those of other classes of cholesterol-reducing drugs. Ezetimibe belongs to a class of lipid-lowering medications that selectively inhibits the absorption of cholesterol and related phytosterols by the small intestine, which ultimately leads to a decrease in the delivery of intestinal cholesterol to the liver (Patel, Sheehan, & Gurk-Turner, 2003). Back in 2002, FDA approved Ezetimibe monotherapy for the treatment of primary hypercholesterolemia and homozygous sitosterolemia. However, to obtain a greater effect, combination therapies with statins are also indicated for the treatment of primary hypercholesterolemia, homozygous sitosterolemia, and homozygous familial hypercholesterolemia (with Atrovastatin). Reviews of the clinical studies that have been done on Ezetimibe indicate that Ezetimibe is also effective for statin-intolearant patients (Patel et al.,