Statin Users May Have a Reason to Rejoice After This Data

Whether or not you've been keeping tabs, the American Society of Clinical Oncology's annual meeting is less than two weeks away. ASCO, as it's more commonly known, is arguably the single-most important event in the biotechnology and pharmaceutical sector each year.

You might be straining for a reason why a mention of ASCO would find its way into a discussion about high-cholesterol medications, but the release this week of the hundreds of study abstracts from this upcoming conference have potentially shed positive light on a class of LDL-lowering drugs known as statins.

Statins: the gold standard in high-cholesterol treatment
Those with high cholesterol who are at high risk of cardiovascular disease really have five options when it comes to cholesterol medications: statins, bile acid resins, fibrates, niacin, and cholesterol absorption inhibitors. Despite this handful of choices, statins are the most commonly prescribed medication in the world because of their superior results in trials compared with the remaining cholesterol-lowering choices with relatively few serious adverse events.

Bile acid resins, such as WelChol, which is manufactured by Daiichi Sankyo, have been shown to lower LDL-cholesterol by an average of 15%-20% in studies, but they haven't shown any measurable effect in preventing heart disease or heart attacks in women. Fibrates, such as AbbVie's (NYSE: ABBV  ) Tricor or Teva Pharmaceutical's (NYSE: TEVA  ) Lofibra, work by activating a gene that encourages HDL-cholesterol production (the good type of cholesterol) while also breaking down triglycerides, which can cause cardiovascular problems if their levels are too high. Their effectiveness ranges from LDL-reductions of 20% to 50%, but fibrates also come with added complication risks and can actually raise LDL-cholesterol in some patients.

Then there are statins -- of which Pfizer's (NYSE: PFE  ) now-generic Lipitor and AstraZeneca's (NYSE: AZN  ) Crestor are the best known and most successful – which work by inhibiting the HMG-CoA reductase enzyme, which is essential to producing cholesterol in the liver. By reducing LDL-production, these statins lower bad cholesterol and thus the chance that complications such as heart attack or stroke will arise in a patient.

However, some researchers and physicians think statins are overprescribed, which they suspect can lead to exacerbated occurrences of those aforementioned adverse events such as myalgias, muscle cramps, or gastrointestinal complications. This is why I think it's noteworthy that an abstract study on the effect of statins on breast cancer mortality was released this week and painted statins in positive light.

A surprising result
The study, which involved all newly diagnosed breast cancer patients in Finland between 1995 and 2003 (31,236 cases), showed that only statin use (in the patients who used them) was associated with a decreased breast cancer mortality compared with bile acid resins and fibrates, which actually delivered an increase in overall mortality. Age, tumor, and treatment characteristics throughout these studies were consistent, meaning there was little chance that the data would be skewed by chance. The ultimate conclusion here is that long-term statin use could actually be beneficial to helping prevent the progression of breast cancer, and that further studies into the matter were warranted.

This is potentially great news for statin makers who are counting on the long-term use of these drugs to grow profits and fund additional research. Even though Pfizer's Lipitor has gobe off patent, we've seen quite a bit of innovation within this field over the past couple of years.

In May, the Food and Drug Administration approved Liptruzet, which is a combination of generic Lipitor and Merck's (NYSE: MRK  ) cholesterol absorption inhibitor, Zetia. In trials, this drug combo lowered LDL-cholesterol by 53% to 61% depending on the dose, as my Foolish colleague Brian Orelli noted. By comparison, Lipitor by itself delivered LDL reductions of 37% to 54%, with Zetia alone reducing LDL-cholesterol by just 20%. These results are actually pretty similar to that of Vytorin (Merck's combination drug of Zocor and Zetia), which reduced LDL-cholesterol by 45% to 60%, depending on the dosage, when it was approved by the FDA. But as Brian also pointed out, it's not an apples-to-apples comparison.

Innovation in this sector should also be spurred on by the need for AstraZeneca to find a revenue replacement for its blockbuster statin Crestor, which netted the company $6.25 billion in sales last year. With the bulk of its patents on Crestor set to expire in 2016, AstraZeneca may try its hand at combining its drug with a competitor's LDL-lowering drug in an effort to better compete against Liptruzet or Vytorin, which it's losing ground to at the moment.

Are statins in the clear?
This might seem like just one of a number of studies conducted on statins over the years, but it should certainly give statin users a reason to feel more comfortable about these potentially positive side effects associated with long-term use. Further, I think it reinforces the notion that statins play an important role in long-term LDL-cholesterol maintenance. I'm certain other studies will be conductedwith regard to their safety, but in the interim it looks like smooth sailing for statin makers.

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Editor's note: A previous version of this article incorrectly stated that Merck's drug Liptruzet was approved in March. The Fool regrets the error.


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