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How long had lipitor been used before the dose shift?

See the DrugPatentWatch profile for lipitor

How long had Lipitor been on the market before the 80 mg dose became available?

Lipitor (atorvastatin) reached the U.S. market in 1997. The 80 mg tablet was approved later, in 1999.

Why did the 80 mg dose appear so baldly in clinical practice?

The 80 mg table was driven by the need to push LDL cholesterol reductions beyond 50 percent in very high-risk patients. Clinical trials such as the 1999 PROVE-IT study showed that intensive lowering with 80 mg gave better cardiovascular-outcome results than moderate lowering.

What happened to the 80 mg dose after it reached patients?

After 2001, routine clinical use of 80 mg atorvastatin increased, but liver-enzyme elevations rose noticeably. Regulators later issued a 2011 FDA warning that 80 mg Lipitor should be avoided unless a patient had already tolerated it for 12 months.



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