AstraZeneca Pharmaceuticals LP, Wilmington, DE, March 8 (DDMAC).DDMAC DDMAC Division of Drug Marketing, Advertising and Communications reviewed AstraZeneca's television advertisement, and a direct-to-consumer print advertisement for Crestor (rosuvastatin calcium) and found the ads made false and misleading claims regarding superiority.
According to FDA's approved products labeling (PI), Crestor is indicated to reduce total-C, LDL-C LDL-C low-density-lipoprotein cholesterol , ApoB, nonHDL-C and TG levels, and to increase HDL-C HDL-C high-density-lipoprotein cholesterol. in patients with hypercholesterolemia.
The Clinical Studies section of the Crestor PI describes the STELLAR clinical trial as a six-week open label, active controlled study in which Crestor was compared to Pfizer's Lipitor (atorvastatin atorvastatin /ator·va·stat·in/ (ah-tor?vah-stat´in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used as the calcium salt in the treatment of hypercholesterolemia and other forms of dyslipidemia. ), Merck's Zocor (simvastatin simvastatin /sim·va·stat·in/ (sim´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated ) and Bristol-Myers Squibb's Pravachol (pravastatin pravastatin /prav·a·stat·in/ (prav´ah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used as the sodium salt in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the ) in 2,240 patients. But the agency found the following misleading superiority claims in the advertising materials:
[check] "All cholesterol drugs simply aren't the same. When Crestor performed in a head to head test its lowering effect was clearly the best" (TV ad).
[check] "Cholesterol high? Trouble getting it low? Perhaps your answer is right here, below" (print ad).
[check] "Lowering cholesterol isn't a game. It's vital to know not all drugs are the same" (print ad).
These were misleading comparisons because they relied solely on data that was not relevant to comparisons of the drugs, such as common dose, while ignoring data that did not support the claim of superiority made in the ads, the agency explained in the letter. F-B; Doc. 13417W