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After a long and successful run as a branded statin, Lipitor (atorvastatin) became available as a generic on Wednesday.

In an interview earlier this month at the American Heart Association meeting, Donald Lloyd-Jones, MD, of Northwestern University in Chicago, told 麻豆传媒 that the availability of generic atorvastatin could have a dramatic impact on cardiovascular care in the U.S., and many others have predicted that the generic could help usher in a new era of more widespread prescribing of statins.

Benefits and Side Effects

Besides statins' ability to lower LDL cholesterol, they have been praised for other beneficial effects including, for example, conferring a protective benefit to the brain in head trauma and to the heart in those with atrial fibrillation.

Just as important, however, is what statins won't do, since they have been associated – both correctly and incorrectly – with various unwanted side effects. But a recent study seems to have put to rest the idea that statins cause cancer.

Meanwhile, there have been reports about increased muscle injury with high doses of simvastatin (generic and branded [Zocor]), particularly when taken with certain other medications. The FDA in June outlined label changes and dose limitations for the drug.

In an email to 麻豆传媒 and ABC News, William Golden, MD, director of general internal medicine at the University of Arkansas for Medical Sciences in Little Rock, said that the FDA warnings with simvastatin, "previously the most potent generic statin, make the arrival of generic Lipitor more important now than a couple of years ago."

He added that many of his patients are on "every-other-day Crestor [rosuvastatin] or Lipitor to manage musculoskeletal side effects of high-dose generic statins" and that generic Lipitor will become his choice for patients who fail pravastatin (Pravachol) management.

Expanding the Market

Earlier this month, the American Academy of Pediatrics issued new guidelines calling for cholesterol screening in all children between the ages of 9 and 11 and again at 17 to 21. Previous guidelines called for screening only those with risk factors.

The study that set the stage for statins to be widely prescribed beyond those with high cholesterol was JUPITER. This trial found that individuals with low LDL cholesterol but high-sensitivity C-reactive protein (hsCRP) benefited from statins with reductions in myocardial infarction and stroke.

JUPITER has been criticized, but overall the results appear to have withstood the test of time. The trial was referenced in a Perspective published online this month in Nature Reviews: Cardiology that outlined reasons why it would be prudent to prescribe statins to asymptomatic adults between the ages of 35 to 50.

"This notion of vitamin-like use of LDL-cholesterol-lowering therapy by young, asymptomatic individuals is a substantial departure from current practice. However, were application of this approach to the coronary heart disease epidemic to be successful, it would be a public health breakthrough of immense consequence -- a 'game changer,'" wrote Valentin Fuster, MD, from Mount Sinai School of Medicine, and his three Perspective co-authors.

Earlier this year, the FDA approved rosuvastatin for primary prevention of cardiovascular disease in people with high levels of hsCRP, a decision primarily based on the JUPITER trial results. It is the first statin to receive approval for such an indication.

With the availability of generic Lipitor, the stage seems to be set more than ever for the widespread use of statins. But strategies and guidelines have to be hammered out before physicians begin prescribing statins to many millions of asymptomatic individuals.

Physician Response Mixed

In the meantime, what is happening in clinical practice? Are clinicians gearing up for the wholesale switch from branded to generic atorvastatin? Some are, some aren't.

Marjorie A. Bowman, MD, MPA, from the department of family medicine and community health at the University of Pennsylvania in Philadelphia, indicated that her patients probably are not aware of generic Lipitor. "However, if it lowers the price, I am all for it, and my patients would be as well," she said in an email to 麻豆传媒 and ABC News.

The scenario is a bit different for Roger Blumenthal, MD, director of the Johns Hopkins Ciccarone Preventive Cardiology Center. "Several patients have emailed me that they want to be switched from brand-name Crestor to generic atorvastatin," he said in an email. "The recent publication of the SATURN trial would suggest that generic atorvastatin did nearly as well as rosuvastatin (Crestor) did in achieving modest reversal of atherosclerotic plaque."

Typically, after a drug goes off patent, one generic brand is available for a few months at about 25% of the cost of the branded version. Then a few more generic brands come on the market and the price drops even lower.

"The real change will be six months from now when more than one company can sell the generic, and it becomes as inexpensive as simvastatin, pravastatin and lovastatin [Mevacor], which all are $4 per month at Wal-Mart and other retailers," said Christopher P. Cannon, MD, from Brigham and Women's Hospital in Boston, in an email to 麻豆传媒 and ABC News.

"The issue is that it takes cost totally out of the equation in the discussion of whether to use a statin, and whether to use high-dose statins for patients who are hospitalized," he said. "The biggest change may be from primary care physicians who hesitate to use atorvastatin 80 mg. Most would use 40 mg (for general fear of using high doses of statins), but if they adopt atorvastatin more, it will help drive down LDL levels."

Brand-Name Company Holding On

A few reports have indicated that Pfizer, the maker of Lipitor, is not quietly yielding to the eventual demise of its multi-billion dollar cash cow. The company has continued aggressive marketing of the drug and has created partnerships with insurers to keep its drug in the limelight.

In addition, the company has offered customers steep discounts to continue to take Lipitor.

How all this plays out remains to be seen, but it could be that Pfizer has tapped into consumer fears of switching from a known entity to something less known.

"Patients are awaiting the generic version because the brand-name drug is expensive. They ask if the drug will be the same and are concerned about side effects," said Nieca Goldberg, MD, medical director of NYU Women's Heart Program in New York City.

Those sentiments were echoed by Randal J. Thomas, MD, MS, from the Mayo Clinic's Cardiovascular Health Clinic in Rochester, Minn. "One area of possible concern with generic medications is the possibility that the generic atorvastatin options will be different in potency compared to Lipitor brand atorvastatin," he wrote in an email to 麻豆传媒 and ABC News. "This difference is likely to be minimal, but it will be important for patients who switch from brand-name Lipitor to generic atorvastatin to follow up with blood tests and a check-up with the healthcare provider to make sure that the atorvastatin dose is the right one for them."

Philip Ades, MD, director of cardiac rehabilitation at the University of Vermont Medical School in Burlington, took issue with Pfizer's approach.

"That Pfizer is trying to squeeze every nickel out of Lipitor is not surprising, but it is at the heart of why medical care costs so much in the U.S. On the one hand, everyone bemoans the high cost of healthcare; on the other hand, the business model of 'making money off of our patients' and maximizing profit is not compatible with controlling costs and focusing on outcomes.

"You cannot have both high-profit and low-cost outcomes-driven care. If healthcare is deemed a right and not a privilege, industry profits need to be regulated," he said in an email to 麻豆传媒 and ABC News.

Ultimately, however, the answer to whether patients should switch statins is fairly simple, according to Cannon. "Whatever is lowest cost and gets the LDL down is okay."

This article was developed in collaboration with ABC News.

From the American Heart Association:

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