Normal LDL? Here.. have some Crestor

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From: dcdocbrian@...To: Subject: RE: FW: [Chirolist-CA] Normal LDL? Here.. have some CrestorDate: Fri, 12 Feb 2010 16:41:48 -0800

If you haven't already, get a copy of "good calories, bad calories" by Taubes. 400 pages that will get you further PO'd with regards to the great cholesterol con! Seitz, DC Tuality Physicians 730-D SE Oak St Hillsboro, OR 97123 (503)640-3724celticfire01@...; jtunick@...; anngoldeen@...; drbob@...; gregghelms@...; kjholzdc@...; allenknecht@...; abowoman@...; bradrethwilldc@...; drmatsuno@...; drscott@...; manleyb1@...; goughdc@...; tcclinic@...; alansmithdc@...; drchrisallen@...; drbobdc83@...; drjohansen@...; drbobdc@...; corll@...; feinberg@...; docgumby30@...; drjoe@...; adesiena@...; metta@...; ; drdeanclark@...; chirodoc@...; donferrante@...; chirokrsna@...; deadmed@...; robalbert@...; creswellchiro@...; twogems@...; mekabou@...; drrick@...; jocelynkdc@...; res0btan@...; mbtdc@...; l.g.rutherford@...; drchaka@...; drmfreeman@...From: skrndc1@...Date: Fri, 12 Feb 2010 14:38:22 -0800Subject: FW: [Chirolist-CA] Normal LDL? Here.. have some Crestor

Here we go again, gang......... the FDA (in all of their splendid wisdom) has just decreed that another 4% of the (healthy) population can be deemed 'appropriate' for treatment with a statin ............ Big Pharma wins again!

Sunny

Sunny Kierstyn, RN DC Fibromyalgia Care Center of Oregon 2677 Willakenzie Road, 7CEugene, Oregon, 97401541- 654-0850; Fx; 541- 654-0834www.drsunnykierstyn.com

> chirolist-cachirolists> From: bacdocearthlink (DOT) net> Date: Fri, 12 Feb 2010 12:45:46 -0800> Subject: [Chirolist-CA] Normal LDL? Here.. have some Crestor> > All communication within this forum is private and is for the benefit of the members of this forum> and may NOT be forwarded without express permission from the list administrators.> ******************************************************************> FDA Expands Rosuvastatin Use to People With Normal LDL> > O'Riordan and Wood> > Updated February 9, 2010 (Silver Spring, land) — The FDA has > agreed to broader labeling for rosuvastatin (Crestor, AstraZeneca), > the company announced late Monday [1]. Following recommendations that > the agency's advisory panel made last December, the FDA has now > approved the statin for reducing the risk of stroke, myocardial > infarction, and revascularization procedures in individuals who have > normal low-density lipoprotein (LDL) levels and no clinically evident > coronary heart disease but who do have an increased risk based on > age, C-reactive protein (CRP) levels, and the presence of at least > one additional cardiovascular disease risk factor.> > As previously reported by heartwire, the FDA's Endocrinologic and > Metabolic Drugs Advisory Committee voted 12 to 4 on December 15, 2009 > to recommend an expansion of rosuvastatin labeling.> > Specifically, the advisory panel felt there was sufficient evidence > of benefit to justify the risks of prescribing rosuvastatin in men > >50 years old and women >60 years old who had fasting LDL- > cholesterol levels <130 mg/dL, hs-CRP >2.0 mg/dL, triglycerides <500 > mg/dL, and no prior history of cardiovascular or cerebrovascular > disease or of coronary heart disease risk equivalents.> > The FDA's decision is based on results from the Justification for the > Use of Statins in Primary Prevention: an Intervention Trial > Evaluating Rosuvastatin (JUPITER) study, reported in detail by > heartwire.> > "Appropriately Conservative"> > Although the sponsor had sought an expanded indication that mirrored > the inclusion criteria of the JUPITER trial, the new label includes > one additional cardiovascular risk factor, something that was not > required for patients to be enrolled in the trial. During the > December 2009 advisory hearing, panel members remained uncertain > about the possibility of allowing an indication based on age and > elevated CRP levels alone. In JUPITER, age was the lone > cardiovascular risk factor, in addition to elevated CRP, in 25% of > patients, while nearly 50% of patients had at least one other risk > factor.> > In a post hoc subgroup analysis, the benefit of treatment was > observed only in those who met the age and elevated-CRP criteria with > at least one additional risk factor. Among patients who strictly > qualified for treatment based on age and CRP only, the reduction in > the primary end point was not statistically significant.> > Dr Ridker (Brigham and Women's Hospital, Boston, MA), the lead > investigator of JUPITER, told heartwire that the new label is > "appropriately conservative," adding that hs-CRP works best for risk > stratification among individuals with a 10-year Framingham risk of 5% > to 20% and who might not otherwise be treated with a statin.> > Similarly, Dr Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, > CA) told heartwire that the label is faithful to the evidence because > patients in JUPITER with less than two risk factors, such as those > enrolled based on age and elevated hs-CRP alone, "failed to derive > significant treatment benefit."> > Kaul, a member of the advisory panel who voted a "cautious yes" for > approval, commented that he was gratified to see the agency consider > the deliberations of the advisory panel rather than rely simply on > the vote count.> > "The results of the JUPITER trial should not be viewed as an > endorsement of CRP as a risk factor, and the FDA agreed with that," > he told heartwire .> > What Happens Now?> > Commenting on the approval for heartwire , Dr Stein (University > of Wisconsin Medical School, Madison) noted, however, that hs-CRP is > not widely used in clinical practice. He believes there may be > concerns about variability between individuals or on repeat testing, > which would give a false sense of risk when these values cross > defined thresholds of risk. Earlier recommendations suggested testing > hs-CRP twice and then taking the average to guide decisions, but any > test that requires testing twice complicates clinical practice, he > added.> > "Also, the constant debate about the value of a high-sensitivity CRP > [level] has discouraged primary-care docs from using the test," Stein > told heartwire . "Having said that, there really is no new or > emerging biomarker with a stronger evidence base for its value as a > predictive marker than hs-CRP. And there is no other new or emerging > biomarker that has a prospective, randomized, controlled trial > showing that you can use it to identify a patient population that > otherwise would not be treated [and] who, if treated with a statin, > will have a reduction in cardiovascular events and an improvement in > mortality."> > From his point of view, the new label is "more liberal" than the > criteria employed in the JUPITER study. Although JUPITER enrolled > patients based on CRP and age and did not require patients to have an > additional cardiovascular risk factor, as the expanded label now > requests, the study excluded individuals on cholesterol therapy and > postmenopausal hormone-replacement therapy, those with elevated liver > or muscle enzyme levels, those with kidney disease, diabetes, severe > hypertriglyceridemia, uncontrolled hypertension, or thyroid disease, > as well as those with cancer within the past five years or drug or > alcohol abuse.> > "So it looks like many, many more patients than just those who could > have been in JUPITER will be eligible for treatment based on the new > indication," Stein told heartwire . "It is not necessarily bad. It > just is not exactly the JUPITER trial entry criteria."> > In a separate analysis, Stein and Dr Jon Keevil (University of > Wisconsin, Madison) applied the JUPITER enrollment criteria to the > 1999–2002 National Health and Nutrition Examination Surveys and > reported that of 174 million US adults who were 20 to 85 years old, > approximately seven million (4%) met the JUPITER inclusion criteria. > Based on the label, which would include many more patients with > diabetes, elevated cholesterol levels, and high blood pressure, a > back-of-the-envelope calculation estimates another 16 or 17 million > people eligible for treatment based on the FDA indication, he pointed > out.> > > Dr. > Chiropractor> Teacher-Sports Therapy - TCHS> > ********************************************************************************> "Building Chiropractic Community through enhanced communication."> > To change your preferences or unsubscribe:> http://ww3.chirolists.com/mailman/listinfo/chirolist-ca> email: Chirolist-CA-requestchirolists?subject=unsubscribe> List options tutorial:> http://www.chirolists.com/index.cfm?nid=6> Email filters tutorial:> http://www.chirolists.com/index.cfm?nid=7> ********************************************************************************* Hotmail: Trusted email with powerful SPAM protection. 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