Category Archives: AstraZeneca Crestor $3B in 2008 to $8B per year by 2014

But Before You "Go Long, All In" on AstraZeneca, Pfizer, or the Other Statin-Makers. . . .

Consider what this NEJM editorial-source, released on the web, just this morning, had to say:

. . . .The aphorism “prevention is better than cure” makes perfect sense when applied to healthy habits such as following a sensible diet, maintaining an ideal body weight, exercising regularly, and not smoking. But increasingly, prevention of cardiovascular disease includes drug therapy, particularly statins to lower cholesterol levels. Statins were first tested in subjects at high risk for coronary events, and the limits of treatment have subsequently been expanded to include persons at progressively lower risk. The results of the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER; ClinicalTrials.gov number, NCT00239681 [ClinicalTrials.gov] ), reported by Ridker et al. in this issue of the Journal,2 might push the orbit of statin therapy outward to include even more of the general population. Before pharmacologic treatment for primary prevention is expanded further, however, the evidence should be examined critically. . . .

. . . .”Jupiter” provides yet more evidence about the effectiveness of statin therapy in reducing cardiovascular risk, even among persons who would not currently be considered for pharmacotherapy. Guidelines for primary prevention will surely be reassessed on the basis of the JUPITER results, but the appropriate size of the orbit of statin therapy depends on the balance between the benefits of treatment and its long-term safety and cost. . . .

Note — as ever — doctors are far more likely to suggest vigorous, regular exercise, and a healthy, low-fat diet, to the vast bulk of the targeted United States population — the population of US men over 50, and US women over 60 — typically the age/gender groupings where heart-attacks begin to show-up as a significantly elevated risk-factor in overall life-expectancy. . . .

Diet, and exercise. Not some “take this, daily, for the rest of your life” pill, at least not for otherwise healthy, stable-weight and BMI Baby-Boomers. So — again — diet and exercise. Sometimes (and most times, in science), the simplest answer tends to be the correct one.

UPDATED — More cautionary commentary, about over-applying these Jupiter results — from today’s panel of the AHA:

. . . .“This study demonstrated a significant reduction in heart attacks and strokes in treating this group, selected from an initially screened group of more than 89,000. However, it was not designed to answer the question of whether the impact on risk was due to a reduction in inflammation (marked by hs-CRP) or a reduction in LDL,” said Timothy Gardner, M.D., president of the American Heart Association.

“Statins lower both LDL cholesterol and hsCRP. Thus, the findings presented today cannot determine whether lowering cholesterol, reducing inflammation, or a combination of both is responsible for the effects seen in this paper.”

In a study by Wilson, et. al., published today in Circulation: Journal of the American Heart Association, researchers concluded that circulating levels of CRP do help to estimate risk for initial cardiovascular events and may be used most effectively in persons at intermediate risk for vascular events, offering moderate improvement in reclassification of risk. These results agree with the 2003 AHA/CDC scientific statement about the use of markers of inflammation such as hs-CRP. In the Wilson study, using the Framingham data, CRP did also offer some ability to reclassify individuals at lower risk.

In the 2003 statement the American Heart Association and the Centers for Disease Control and Prevention concluded that measurement of CRP is not useful for broad screening of the entire American adult population. Rather, at a physician’s discretion, it was suggested to be useful for people at intermediate risk, to determine the specific preventive measures that might be employed. For those at high risk, treatment should already be aggressive. The new studies raise the question of how much CRP measurement will help define treatment for people at low risk, and these studies will be included in the ongoing updating of guidelines for prevention. . . .

Indeed, it is certain that statin use will now expand — and expand significantly (compared to the vastly-expensive placebo of Vytorin/Zetia) — but it is not at all clear that most, or all, otherwise-healthy 50-plus-year old Americans will be taking statins, effectively for the rest of their lives.

Here endeth the sermon.

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The Swan Song for Vytorin/Zetia Begins, in Earnest. . . .

or, Crestor’s “Jupiter” Study is a three bagger!

It’s very hard to imagine why anyone would, after today, pay for a three- to ten-times more expensive placebo, when 48 percent reductions in CV event risks are being achieved on statins (albeit a rather pricey, branded statin). In my estimation, plain old generic statins are sure to benefit from this data, as well. So, stick a fork in Vytorin/Zetia — that barbeque is over:

. . . .“Compared to those who received placebo, patients receiving the drug rosuvastatin also had a 48 percent reduction in stroke, a 46 percent reduction in the need for interventions to reopen blocked blood vessels and a 20 percent drop in all-cause mortality,” said Paul M. Ridker, M.D., lead author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston, Mass. . . .