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  • Lipitor / Statins Using Bad Statistics

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    Old 10-02-2004, 06:48 PM   #46
    rahod
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by phil58
    230 is now considered high, and a prime canidate for statins. Good friend is on statins at 220, without any other risks, except his father who died from an early heart attack. He also can't do any exercising without it hurting. Side affects are affecting way too many people.
    I have to say that given your #s, your Dr probably should have told you to use diet/exercise first. Your #s are not really *high* because 70 of those points are HDL! An LDL of 120 (which I calculated) is *OK*, but not optimal. You didn't indicate any RISK factors. Do you have any?

     
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    Old 10-02-2004, 07:22 PM   #47
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    Re: Lipitor / Statins Using Bad Statistics

    Good thing all these quoted medical sources are looking out for our welfare.

    Check out the problems some of these people are having

    http://www.askapatient.com/viewratings.asp?drug=20702&name=LIPITOR& sort=Timelength

     
    Old 10-02-2004, 07:51 PM   #48
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by phil58
    Good thing all these quoted medical sources are looking out for our welfare.

    Check out the problems some of these people are having

    http://www.askapatient.com/viewratings.asp?drug=20702&name=LIPITOR& sort=Timelength
    Problem is Phil.....

    According to your analysis on statistical data ..we should not be ignoring ALL THOSE WITHOUT PROBLEMS ...get the drift? There are literally tens of millons on statins with NO problems at all including yours trully . When you see discussion boards based on statin problems...well....that's all you see. Most of those without problems remain in the SILENT MAJORITY. I'm not saying there aren't problems with statins....there are. It's all a matter of putting things in PERSPECTIVE.

     
    Old 10-03-2004, 06:44 AM   #49
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by rahod
    I understand that for TRIGS UNDER 250 or so, that the calculated method is fairly accurate. Certainly good enough to get a handle on the LDL levels. I have seen tabulated results that compare calculated with ACTUAL and they're VERY CLOSE. In this case, since he said 200+, I assumed it wasn't 300.
    There are several studies that have demonstrated the importance of directly calculating LDL-C instead of estimating it. Here is a typical one.

    A Clinical Comparison of Calculated Versus Direct Measurement of Low-Density Lipoprotein Cholesterol Level
    Posted 03/01/2004
    Cameron C. Lindsey, Pharm.D.; Maqual R. Graham, Pharm.D.; Thomas P. Johnston, Ph.D.; Chelsea G. Kiroff, Pharm.D.; Anna Freshley
    Abstract and Introduction
    Abstract

    Study Objectives: To determine if, and to what extent, the low-density lipoprotein cholesterol (LDL) level is underestimated when it is calculated by the Friedewald formula compared with the LDL level measured by a direct method. A secondary objective was to determine and compare the percentages of patients meeting LDL goal using each of these two methods.
    Design: Retrospective chart review.
    Setting: Kansas City Veterans Affairs Medical Center.
    Subjects: Patients aged 18 years or older and whose laboratory results reflected a complete lipid profile for 1 year.

    Measurement and Main Results: Calculated LDL level (C-LDL) was derived using the Friedewald formula and was compared with Wako method-derived direct LDL level (D-LDL) to ascertain whether a positive correlation existed. The absolute difference between the methods for each sample was determined and compared overall and for various subgroups. The number of patient samples achieving National Cholesterol Education Program-defined LDL goal was determined and compared for both methods. A total of 20,224 lipid profiles were generated and 19,343 were included in the analysis. A strong correlation was found between D-LDL and C-LDL (r = 0.94). The absolute difference between the two methods demonstrated an underestimation of C-LDL of 19.5 11.8 mg/dl. The degree of underestimation increased as the triglyceride level increased (p<0.05). Age within the fifth and sixth decades resulted in significantly higher differences compared with age in the eighth decade or greater (p<0.05). Female sex and elevated body mass index also resulted in increased discrepancies between the two methods (p<0.05 for both). Seventy-six percent of the lipid profiles were derived from patients with coronary heart disease (CHD) or a CHD risk equivalent. Approximately one half of these patients met their LDL goal when LDL level was measured versus calculated (p<0.0001).

    Conclusion: When compared with D-LDL, an underestimation of approximately 20 mg/dl was found with C-LDL, resulting in a loss of LDL goal attainment for half of the patients with CHD or a CHD risk equivalent.

     
    Old 10-03-2004, 07:00 AM   #50
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by rahod
    Problem is Phil.....

    According to your analysis on statistical data ..we should not be ignoring ALL THOSE WITHOUT PROBLEMS ...get the drift? There are literally tens of millons on statins with NO problems at all including yours trully . When you see discussion boards based on statin problems...well....that's all you see. Most of those without problems remain in the SILENT MAJORITY. I'm not saying there aren't problems with statins....there are. It's all a matter of putting things in PERSPECTIVE.
    If you are a typical 50-70 yr old statin user and several months after starting therapy you experience muscle aches and pains, depression, memory loss and loss of mental acuity etc. are you really going to make the connection to statin use? More likely you're just going to assume you have the typical aches and pains, forgetfulness etc. of growing older.

     
    Old 10-03-2004, 07:22 AM   #51
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    Re: Lipitor / Statins Using Bad Statistics

    It is a fact that aspirin kills people every day and has a long list of nuisance and clinically proven dire side effects for a not insignificant percent of the population. Heaven forbid we take the same position about aspirin that many do about statins.

    Last edited by pcovers; 10-03-2004 at 02:26 PM.

     
    Old 10-03-2004, 11:53 AM   #52
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by ZippyDawg
    If you are a typical 50-70 yr old statin user and several months after starting therapy you experience muscle aches and pains, depression, memory loss and loss of mental acuity etc. are you really going to make the connection to statin use? More likely you're just going to assume you have the typical aches and pains, forgetfulness etc. of growing older.
    That's a good point... IN MOST CASES the aches and pains are just that and not related to statins at all. There is a temptation to associate just about ANY adverse symptom to statins. However, CONTROLLED DOUBLE BLIND CLINICAL TRIALS..have demonstrated that statins show no more adverse effects than PLACEBO! In these cases the patients DON'T KNOW if they're getting a statin or not and that's the definitive way of determining if there is a problem with statins...not ANECDOTAL accounts.

    Last edited by rahod; 10-03-2004 at 11:54 AM.

     
    Old 10-03-2004, 12:17 PM   #53
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by rahod
    That's a good point... IN MOST CASES the aches and pains are just that and not related to statins at all. There is a temptation to associate just about ANY adverse symptom to statins. However, CONTROLLED DOUBLE BLIND CLINICAL TRIALS..have demonstrated that statins show no more adverse effects than PLACEBO! In these cases the patients DON'T KNOW if they're getting a statin or not and that's the definitive way of determining if there is a problem with statins...not ANECDOTAL accounts.
    And therein lies the danger. How is the individual patient suppose to know whether the statin is destroying his/her muscle and brain function or it's the result of the "normal" aging process?

    Drugs should only be prescribed and taken when there is a clear indication of their safety and effectiveness in treating a specific condition or disease process. There is a risk/benefit ratio that must be evaluated before taking any drug and particularly before taking a powerful statin type drug that does not actually control or cure any disease or condition.

    You take a statin in the hope/belief that it will reduce your risk for developing CAD/CVD. There is no way to determine at the current time whether you as an individual will ultimately benefit or be harmed by the use of statin drugs. Thankfully I don't need to make that decision at the current time.

     
    Old 10-03-2004, 12:36 PM   #54
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by ZippyDawg
    And therein lies the danger. How is the individual patient suppose to know whether the statin is destroying his/her muscle and brain function or it's the result of the "normal" aging process?
    You determine that by immediately STOPPING the drug and see if symptoms abate. Bottom line>>the incidence of "destroying his/her muscle and brain function" with a statin is no greater than NOT USING A STATIN AT ALL. This has been demonstrated in the clinical trials I alluded to. There are going to be individuals who manifest symptoms with statins, but you see this just about ANY DRUG. Statins are no different in this regard. You don't *THROW OUT THE BABY WITH THE BATH WATER*

     
    Old 10-03-2004, 01:04 PM   #55
    ZippyDawg
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    Re: Lipitor / Statins Using Bad Statistics

    Unfortunately drugs are evaluated under strict guidelines using screened control groups. When these drugs are released for use by the general public numerous other factors come into play that affect both the efficacy and adverse reactions of drugs. Based on numerous responses on this and other boards many people have reported muscle aches, memory loss etc. to their Doctor only to be told that statins aren't the cause and to continue to take them. The vast majority of people do not challenge their doctor's advice.

    Australian Adverse Drug Reactions Bulletin
    Volume 23, Number 1, February 2004

    Prepared by the Adverse Drug Reactions Advisory Committee (ADRAC).

    Risk factors for myopathy and rhabdomyolysis with the statins

    Four statins (HMG CoA inhibitors) are available in Australia for the treatment of hypercholesterolaemia: simvastatin, atorvastatin, pravastatin and fluvastatin. Each of the statins may cause myalgia or rhabdomyolysis. Cerivastatin was removed from the market worldwide because of an unacceptably high rate of rhabdomyolysis, including fatal cases, particularly when used with gemfibrozil.1

    The rates of muscle disorders observed in clinical trials of statins have not been significantly different from those with placebo,2 but wider clinical use involves individuals having multiple disease states or taking potentially interacting medication. Recent reviews indicate that factors which increase the plasma concentrations of statins are associated with an increase in the risk of myalgia, myopathy and, particularly, rhabdomy-olysis.3,4 For simvastatin and atorvastatin which are metabolised by the liver enzyme CYP3A4 these factors are presented in Table 1.

    For the rest of the article:

    [url]http://www.tga.gov.au/adr/aadrb/aadr0402.htm[/url]

    Last edited by ZippyDawg; 10-03-2004 at 01:08 PM.

     
    Old 10-03-2004, 01:07 PM   #56
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    Re: Lipitor / Statins Using Bad Statistics

    Released by FDA: 8/12/02. Posted by FDA: 9/4/02

    Christopher A. Graham
    Director, Worldwide Regulatory Strategy
    Pfizer Inc.
    235 Fast 42ndd Street
    New York, NY 10017

    RE: NDA 20-702
    Lipitor (atorvastatin calcium) Tablets
    MACMIS ID#: 10939

    Dear Mr. Graham:

    This letter notifies Pfizer Inc. (Pfizer) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct-to-consumer (DTC) print advertisement (#LP 106204-B) for Lipitor (atorvastatin calcium) Tablets that is in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable regulations. The ad misleadingly suggests that Lipitor is safer than other statins. The Lipitor DTC print ad has appeared in magazines with national distribution such as, Time, Reader's Digest, Good Housekeeping, Woman's Day, Cooking Light, and Health. The Lipitor "Brief Summary" part of the DTC print ad is misleading because it indicates that Lipitor may lack the side effects of other members of the statin class of lipid-lowering medications.

    For the rest of the warning letter:

    http://www.pharmcast.com/WarningLetters/Yr2002/August2002/Pfizer0802.htm

     
    Old 10-03-2004, 02:36 PM   #57
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    Re: Lipitor / Statins Using Bad Statistics

    "The rates of muscle disorders observed in clinical trials of statins have not been significantly different from those with placebo,2 but wider clinical use involves individuals having multiple disease states or taking potentially interacting medication"

    I guess that says it all. Those few "having multiple disease states or taking potentially interacting medication", should probably not be taking a statin. Pretty obvious you would think.

     
    Old 10-03-2004, 04:13 PM   #58
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    Re: Lipitor / Statins Using Bad Statistics

    But that is exactly the point. These drugs aren't tested in the populations and under the conditions that they will ultimately be prescribed for in real life. If the tests were conducted using these subjects they would never receive FDA approval. Pfizer is recommending that every diabetic should be taking Lipitor. If you look at table 1 diabetes is a risk factor for muscle disorders when taking Lipitor.

    Australia has a very small population taking statins. You need to extrapolate the number of known adverse effects to the much larger statin using population in the U.S. You also need to keep in mind that many adverse effects are either never reported to doctors or doctors don't bother to report them to the FDA.

    Table 1: Factors increasing the risk of muscle disorders with simvastatin and atorvastatin

    Substances inhibiting metabolism by CYP3A4: cyclosporin, diltiazem, verapamil, macrolide antibiotics, azole antifungals, protease inhibitors, grapefruit juice

    Medicine inhibiting metabolism by other means: gemfibrozil

    Disease states: diabetes, hypothyroidism, renal and hepatic disease

    Advanced age: ≥ 70 years

    High statin dose: ≥ 40 mg/day

    ADRAC has received 91 reports of rhabdomyolysis with simvastatin and 26 with atorvastatin, as well as many reports of myalgia, myopathy or creatine kinase (CK) increase. Table 2 (top section) shows the percentage of cases with identified risk factors, as defined in Table 1. For simvastatin the factors listed most commonly in reports describing rhabdomyolysis were age ≥ 70 years (40 reports) dose ≥ 40 mg (33), cyclosporin (19), gemfibrozil (21), diltiazem (20) and diabetes (15). Over half of the simvastatin cases with rhabdomyolysis had more than one identified risk factor. Individuals with several risk factors may be at risk of developing rhabdomyolysis, rather than a less serious muscle disorder.

    A feature of the cases of rhabdomyolysis is that long term statin therapy was well tolerated until after a change in medication (e.g. increase in the dose of statin, or addition of clarithromycin or diltiazem).

     
    Old 10-03-2004, 05:09 PM   #59
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    Re: Lipitor / Statins Using Bad Statistics

    "These drugs aren't tested in the populations and under the conditions that they will ultimately be prescribed for in real life. If the tests were conducted using these subjects they would never receive FDA approval."

    Statins have now been around for over 15 years and have been taken by tens of millions world wide....WITHOUT ANY SIGNIFICANT ADVERSE EFFECTS. That's a simple fact that has stood the test of time. That's what I call a REAL LIFE TEST

    Last edited by rahod; 10-03-2004 at 05:11 PM.

     
    Old 10-03-2004, 05:18 PM   #60
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    Re: Lipitor / Statins Using Bad Statistics

    Quote:
    Originally Posted by rahod
    Statins have now been around for over 15 years and have been taken by tens of millions world wide....WITHOUT ANY SIGNIFICANT ADVERSE EFFECTS. That's a simple fact that has stood the test of time. That's what I call a REAL LIFE TEST
    No significant adverse effects of statins?


    Baycol Pulled From Market as Numerous Deaths Linked to It

    By David Brown

    The maker of Baycol (cerivastatin), a popular cholesterol-lowering drug used by about 700,000 Americans, voluntarily pulled the medicine off the market August 8 because of numerous deaths associated with its use.

    Officials at the Food and Drug Administration said 31 people have died of complications of severe muscle breakdown, a rare but well-recognized side effect of many cholesterol-lowering drugs. In about one-third of the cases, the person was on a second cholesterol drug, gemfibrozil, known to especially increase the risk of problems.

    Baycol is one of six "statins," a popular family of drugs prescribed to about 12 million Americans to treat, and possibly prevent, coronary heart disease. Reports of severe side effects, including death, are at least 10 times more common for Baycol than for other drugs in the class.

    The FDA is currently not considering any regulatory action with regard to the other approved statins which are lovastatin (Me****r), pravastatin (Pravachol), Zocor (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor).

     
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