The cholesterol-lowering drug Crestor has “the poorest safety profile” of four major drugs in the category, a study showed, in a huge setback for pharmaceutical group AstraZeneca.
The study appearing in Circulation: Journal of the
American Heart Association, linked Crestor to possible kidney and muscle ailments that required hospitalization.
The drug, which generated some 908 million dollars in 2004 sales, is one of the major “statins” used to lower cholesterol and reduce the risk of heart attacks. Others include Pfizer’s Lipitor, Merck’s Zocor and Bristol-Myers Squibb’s Pravachol.
The study concluded that Crestor had the largest number of adverse effects compared with the other medications.
“After reviewing a national database for adverse event reports, the study found rosuvastatin (Crestor) to have the poorest safety profile,” said a summary of the study released by Tufts-New England Medical Center.
“The most serious reactions resulted in damage to the kidney (proteinuria/nephropathy), and muscle (rhabdomyolysis), which frequently resulted in patients requiring hospitalization.”
“It is very important to note that as a family, statins are very safe drugs that have clearly been shown to reduce the risk of heart disease,” said Richard Karas, Tufts University researcher and lead author of the report.
“Although rosuvastatin (Crestor) was found to be less safe than others, it does not mean patients should immediately stop taking this medication. In fact, the overall risks of rosuvastatin remain low, and people taking this drug should talk to their doctor before deciding whether to continue on it or stop it.”
Earlier this year, the US Food and Drug Administration (FDA) backed the Anglo-Swedish pharmaceuticals giant’s anti-cholesterol drug, saying there was no higher chance of developing muscle destruction with Crestor than for any other similar medicine.
But the latest study renewed concerns about the safety of the blockbuster drug, said the researchers.
“This study raises concern about the safety of this drug at the range of doses currently used in common clinical practice in the general population,” said Karas.
“I would advise healthcare providers to consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination (cholesterol) lowering therapy, and to closely monitor patients for adverse events if rosuvastatin (Crestor) is used.”
There was no immediate comment from the company.