AstraZeneca looks to be in pole position to benefit from new guidelines issued in the USA which recommend more intensive statin therapy to prevent heart disease.
The American Heart Association and the American College of Cardiology have jointly released four cardiovascular disease prevention guidelines based on studies published between 1990 and 2012, developed for adults who would benefit from lowering their blood cholesterol and blood pressure. The AHA and ACC note that about one-third of US adults have elevated levels of LDL or 'bad' cholesterol, while one-third have high blood pressure; another 30% are at high risk of developing the latter.
The guidelines address cholesterol, lifestyle management, risk assessment and overweight/obesity. Regarding the former, it recommends "moderate- or high-intensity statin therapy" for four major groups at risk of a heart attack, stroke or major cardiovascular event. These are people with cardiovascular disease; patients with a 'bad' cholesterol level of 190 mg/dL or higher, type 2 diabetics aged between 40-75 years and patients with an estimated 10-year risk of cardiovascular disease of 7.5% or higher aged 40-75.
While claiming that "the cornerstone of all guidelines dealing with cholesterol is a healthy lifestyle", Neil Stone of the Northwestern University Feinberg School of Medicine and chair of the expert panel that wrote the new guidelines, said "the likely impact of the recommendations is that more people who would benefit from statins are going to be on them, while fewer people who wouldn't benefit from statins are going to be on them".
An end to 'lowest is best' approach
"No other cholesterol-lowering drug is as effective as statins," said Dr Stone, adding that if someone already has atherosclerosis, "lifestyle changes alone are not likely to be enough to prevent heart attack, stroke, and death, and statin therapy will be necessary". Rather than use a 'lowest is best' approach that combines a low dose of a statin along with several other cholesterol-lowering drugs, the panel found that "it can be preferable to focus instead on a healthy lifestyle along with a higher dose of statins, eliminating the need for additional medications".
Under this new criteria, the number of adults eligible for statins will rise from about 15% to over 30%. Most statins are off-patent, such as Pfizer's Lipitor (atorvastatin) and Merck & Co's Zocor (simvastatin) but AstraZeneca's Crestor (rosuvastatin) is not.
Philip de Vane, head of US medical affairs at AstraZeneca, noted that the company has "long advocated for and educated about the importance of cardiovascular risk assessment, lifestyle change, and aggressive cholesterol lowering in patients at increased risk". He added that "we are pleased that the new guideline provides physicians with clear definitions of these statin-eligible patients", saying that it "reinforces the importance of Crestor as an appropriate treatment option".
Savvas Neophytou at Panmure Gordon is not so sure whether it is particularly good news. In an investor note, he says that "initially, we looked at the inclusion of diabetes and stroke as significant fillips to the statin market as it could have doubled overall volumes. However, at closer inspection the true impact [on Crestor] begins to emerge.
Mr Neophytou argues that with target LDL levels "no longer a metric to push towards, Crestor's main differentiation will be blunted in our view". As such, "we shave off some $300 million from our full-year 2014 and 2015 forecasts", and the broker has downgraded the stock to sell from hold.
The guidelines mean bad news for non-statins such as Merck & Co's Zetia (ezetimibe) and AbbVie's Tricor (fenofibrate) as Dr Stone argued that they do not provide enough risk prevention. He added on a conference call that there has been over-treatment with drugs that are not proven to add incremental benefit.