HMG-CoA (Statins) Therapeutic Category Example
This table illustrates how SmartAlts™ are built with an HMG-CoA (Statins) therapeutic category. in this an example, SmartAlts™ are built using the most current research based on the Low-Density Lipoprotein (LDL) lowering therapeutically similar drugs.
This SmartAlts™ set reflect clinical research and activity on certain drugs:
Roszet has unsubstantiated claims of LDL lowering in the Roszet promotional materials by grouping Roszet doses per the FDA package labeling. FDA reported issues (FDALetter) to Althera Pharmaceuticals due to statements relating to Roszet (www.natlawreview.com); Concern about Roszet (fda.gov); and Label information (fda.gov).
* Atorvastatin 10mg was added to the 25-32% range due to prescriber feedback stating it is often their initial dose preferred statin to be included as an option.
** Simvastatin 80mg subset was created to provide alternatives for this strength, while considering the FDA warnings regarding its use including “Simvastatin 80 mg should not be started in new patients that are already taking lower doses of the drug.”