The Jupiter study, as the recently-released Crestor drug trial results have been dubbed, points out some potentially groundbreaking advantages of statin drugs for patients not currently in the “must take” category. While wise individuals will take every new study release with a grain of salt (as there are often contradictory studies completed in a short time-frame), researchers seem to be pretty confident of the results of this particular trial because of its definitive results.
The study, which has sparked quite a bit of discussion in the medical and non-medical communities, found that AstraZeneca’s statin drug Crestor reduced heart-attacks and other cardiac ailments by 44% in patients that previously weren’t considered candidates for cholesterol-reducing treatments because their cholesterol levels were perceived as healthy and they showed no signs of cardiac duress. The 18,000 study participants were instead chosen for their high levels of C-reactive protein (CRP), a biomarker that is believed to cause cardiovascular inflammation.
AstraZeneca CEO David Brennan has pointed out that the company can’t market the drug for C-reactive protein effects until regulatory agencies OK the drug for that application. But if the FDA feels that the cause is particularly worthy for the health of Americans, this could happen quickly and AstraZeneca could be putting new feel-good commercials on the air in record time. Despite Brennan’s downplaying the effects of the new study on Crestor’s sales figures, I imagine the company is secretly crossing its fingers while jumping with glee.
The question is, will doctors pick up the ball and advise a larger pool of patients to take statins? It’s not rocket science to deduce that if doctors become more diligent about prescribing the drugs, patients will be more likely to take them. Another big question is whether patients that have previously prided themselves on not having to take cholesterol medicines will be willing to change their daily regime for conceivably the rest of their lives.
Despite the Colbert-ish skepticism that is sure to permeate some individuals’ decisions to begin taking statins (“I’m perfectly healthy, why would I take something I don’t need?”), I imagine there will also be those who take the preventative philosophy of “What can it hurt?” As Americans are known for taking high volumes of medicines for real or perceived ailments, it is conceivable that a large number of individuals could fall into the latter category.
In addition to AstraZeneca, statin drug producers such as Pfizer (Lipitor) could benefit from the study should the trend take shape. If such drug companies choose to pursue the new application, they will likely push for the change wholeheartedly to extend their statin-generated revenues as long as possible (several generic statin cholesterol drugs are already on the market). Also set to gain are diagnostic product makers like Orion, as physicians would need to conduct a large number of CRP tests to figure out which patients fall under the new guidelines.
Remembering that cholesterol drug Vytorin (which combines Merck’s statin Zocor with Schering-Plough’s Zetia) recently came under fire for its questionable benefits against heart attacks, and keeping in mind the possibility of non-cardiovascular related side effects from statins, I’m personally hanging onto that proverbial grain of salt until more information is available to form a solid opinion. What the rest of America does is difficult to predict, but it’s inevitable that this study will spark future studies and its full effect won’t be seen for some time.
Comments
Mgood Says:
November 19th, 2008 at 9:23 pm
Safety, effectiveness and cost must be the three considerations. As far as cholesterol-related illnesses go, only one medication, thus far, has proven to qualify for proactive use. Interestingly, what could be the best, more efficacious, alternative to statin drugs is niacin. The website, http://www.cholesterolscore.com , a site that’s primarily about niacin therapy, has many articles & studies about CRP. Inflammation, lipid particle size, HDL enhancement, as well as all the other cholesterol numbers are discussed, there.
Dan Says:
November 26th, 2008 at 5:30 pm
With statins as a class of medications:
A.E.s are thought to occur more often than they are reported- with high dose statins in particular.
Statins used with macrolide antibiotics can cause muscle disease as well more than monotherapy.
Additionally, there is no reduction in mortality or increase in the lifespan of one on statin therapy. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient.
Several risk factors should determine if one is placed on statin therapy, and not just one.
Statins do decrease CV events and risks significantly. The statins do in fact increase endothelial function, stabilize coronary plaque build- up, and decrease thrombus formation. Maximum reduction in LDL is evaluated after about a month of therapy. Statins stabilize cornorary plaque, which is beneficial.
There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP), those with dementia or Parkinson’s disease, and some forms of Cancer and cataracts.
It appears those statins produced by fermentation, such as Zocor and Pravachol, have less myopathy than the other synthetic statins, possibly due to being more hydrophyllic.
Yet overall, the existing cholesterol lowering recommendation should be re-evaluated, as they may be over-exaggerated, if one chooses to compare these guidelines with others in the past.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and prevent them from being candidates for statin therapy,
Dan Abshear
jeffrey dach md Says:
December 1st, 2008 at 7:42 am
It appears that journalists have a short memory.
Only four year ago, Dr. David Graham, associate director in the FDA’s Office of Drug Safety gave senate testimony that Crestor was one of five drugs with safety concerns. The drug causes muscle breakdown and renal failure.
Surprisingly, the Jupiter study declared there were no adverse side effects from Crestor. Or at least the adverse effects in the drug group was the same as the placebo group. This is hard to believe since the FDA has issued two advisory warnings about the adverse side effects of Crestor, and a public interest group represented by Sidney Wolfe (Public Citizen) petitioned the FDA to have Crestor banned because of side effects. In addition, Crestor is one of the strongest statins and has the worst adverse effect profile.
To read more…
http://jeffreydach.com/2008/11/14/crestor-jupitor-crp-and-heart-attack–by-jefffrey-dach-md.aspx
Dan Says:
December 13th, 2008 at 10:29 pm
Facts Believed to be Associated With Statin Medications:
Adverse events associated with the statin class of pharmaceuticals are thought to occur more often than they are reported- with high doses of statins prescribed to patients in particular. Since this class of drugs has existed for use for over 20 years, statins are considered safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients..
Additionally, there is no reduction in cardiovascular morbidity or mortality, as well as an increase in a person’s lifespan, if one is on any particular statin medication for their lipid management. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient if they are absent of dyslipidemia to a significant degree, or are under the belief that one statin medication provides a greater cardiovascular benefit over another. In other words, the health care provider should be assured that any statin therapy for their patients is considered reasonable and necessary if the LDL in their patients need to be reduced..
Abstract etiologies for those who prescribe statin drugs on occacsion , such as reducing CRP levels, or for Alzheimer’s treatment, or anything else not involved with LDL reduction is not appropriate prophylaxis at this point for any patient. All other benefits that appear to have favorable effects in such areas are speculative at this point, and require further research for disease states aside from dyslipidemia.
Several risk factors should determine if one is placed on statin therapy, and not just one particular reason. High LDL cholesterol is the apex of rationale for statin therapy, yet other risk factors of the patient should be examined and evaluated as well by their health care provider, perhaps- depending on the patient’s cardiovascular history to determine the appropriate dosage and strength of statin therapy for such patients as it relates to their present LDL level and the reduction that is needed.
Statins do decrease the risk of cardiovascular events significantly, it has been proven. This may be due to the fact that statins improve endothelial function as well as statins having the ability to stabilize coronary artery plaques, which prevents myocardial infarctions. Statins also decrease thrombus formation as well as modulate inflammatory responses. For those patients with dyslipidemia who are placed on a statin, the effects of that statin on reducing a patient’s LDL level can be measured after about five weeks of therapy on a particular statin drug. Liver Function blood tests are recommended for those patients on continued statin therapy, and most are chronically taking statins for the rest of their lives to manage their lipid profile in regards to maintaining the suitable LDL level for a particular patient.
In regards to other uses of statins besides just LDL reduction, there is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP) with patients on statin therapy, those patients with dementia or Parkinson’s disease may benefit from statin medication, as well as those patients who may have certain types of cancer or even cataracts. Yet again, these other roles for statin therapy have only been minimally explored. Because of the limited evidence regarding additional benefits of statins, the drug should again be prescribed for those with dyslipidemia only at this time involving elevated LDL levels as detected in the patient’s bloodstream.
It appears those statins that are produced specifically by fermentation, such as Zocor and Pravachol, have less incidences of myopathy than the other synthetic statins that exist presently. This may possibly due to the fact that fermented statins are believed to be much more hydrophyllic, which may optimize safety for a patient on a statin medication. Regardless, the lower the dose, the better, with any pharmaceutical prescribed to a patient. All pharmaceuticals have side effects, or they would not be pharmaceuticals. Statin drugs are not an exception.
Yet overall, the existing cholesterol lowering recommendations or guidelines should be re-evaluated, as they may be over-exaggerated upon tacit suggestions from the makers of statins to those who create these current lipid lowering guidelines. This is notable if one chooses to compare these cholesterol guidelines with others in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable, unnecessary, and possibly detrimental to a patient’s health, according to others. Yet statins are beneficial medications for those many people that exist with elevated LDL levels that can cause cardiovascular events to occur because of this abnormality.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and this may prevent them from being candidates for statin therapy now and in the future. Dietary management should be the first consideration in regards to correcting lipid dysfunctions,
Dan Abshear
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