Statins for prevention: not been shown to provide overall health benefit

Discussion in 'Health and medical' started by Zee, Apr 2, 2004.

  1. Zee

    Zee Guest

    http://www.ti.ubc.ca/pages/letter48.htm

    The Therapeutics Initiative presents critically appraised
    summary evidence primarily from controlled drug trials. Such
    evidence applies to patients similar to those involved in
    the trails, and may not be generalizable to every patient.
    We are committed to evaluate the effectiveness of our
    educational activities using the Pharmacare/PharmaNet
    databases without identifying individual physicians,
    pharmacies or patients. The Therapeutics Initiative is
    funded by the BC Ministry of Health through a 5-year grant
    to the University of BC. The Therapeutics Initiative
    provides evidence based advice about drug therapy, and is
    not responsible for formulating or adjudicating provincial
    drug policies

    ___________________________________________________________-
    _____________________

    Do Statins have a Role in Primary Prevention?

    Conclusion: "...Therefore, statins have NOT BEEN SHOWN
    to provide an overall health benefit in primary
    prevention trials."

    ------------------------------------------------------------
    --------------------

    Click here to go to a comment regarding Therapeutics Letter
    #48, posted on October 16, 2003 about the evidence of
    benefit for primary prevention in women.

    ------------------------------------------------------------
    --------------------

    Two important questions regarding statin therapy are:

    What is the overall health impact when statins are
    prescribed for primary prevention? Should the dose of statin
    be titrated to achieve target lipid levels? Three new
    randomized controlled trials1-3, which help answer the first
    question and one trial providing insight into the second
    question have been published since our last Letter on lipid
    lowering therapy (#42). This Letter addresses the first
    question and the next Letter (#49) will address the second.
    Estimating the overall health impact of statins in primary
    prevention requires balancing possible benefits and possible
    harms. In this Letter benefit is estimated by combining two
    cardiovascular serious adverse events known to be reduced by
    statins in secondary prevention trials: total myocardial
    infarction (fatal and non-fatal)5 and total stroke (fatal
    and non-fatal).6 The balance between benefit and harm
    (overall health impact) is estimated by total mortality and
    total serious adverse events. Serious adverse events include
    any untoward medical occurrence that results in death, is
    life threatening, requires hospitalization or prolongation
    of hospitalization, or results in persistent or significant
    disability.

    Prospective Study of Pravastatin in the Elderly at Risk
    (PROSPER)1 PROSPER studied the effect of pravastatin
    compared to placebo in two older populations of patients:
    56% primary prevention (no past or symptomatic
    cardiovascular disease) and 44% secondary prevention (past
    or symptomatic cardiovascular disease) (Table 1).
    Pravastatin did not reduce total myocardial infarction or
    total stroke in the primary prevention population, RR 0.94
    [0.78 – 1.14], but did so in the secondary prevention
    population, RR 0.80 [0.68 – 0.94], ARR 4.3%, NNT 23 for 3.2
    years. Measures of overall health impact in the combined
    populations, total mortality and total serious adverse
    events, were unchanged by pravastatin as compared to
    placebo, RR 0.98 [0.84 – 1.14] and 1.01 [0.96 – 1.06],
    respectively.

    Antihypertensive and Lipid-Lowering Treatment to Prevent
    Heart Attack Trial (ALLHAT-LLT)2 ALLHAT-LLT was designed
    to determine whether pravastatin compared with usual care
    reduces all-cause mortality in older, moderately
    hypercholesterolemic, hypertensive patients with at least
    1 additional coronary heart disease risk factor. The
    published data is for the whole population, 86% of which
    was primary prevention. Pravastatin did not reduce total
    myocardial infarction and total stroke, RR 0.91 [0.82 –
    1.01]. Pravastatin also did not reduce total mortality,
    RR 0.99 [.89 – 1.09]. Total serious adverse events were
    not reported.

    Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm
    (ASCOT-LLA)3 ASCOT-LLA was designed to assess the benefits
    of atorvastatin versus placebo in hypertensive patients with
    average or lower-than-average cholesterol concentrations and
    at least 3 other cardiovascular risk factors. The published
    data is for the whole population, 82% of which was primary
    prevention. The trial was originally planned for 5 years,
    but was stopped after a median follow-up of 3.3 years
    because of a significant reduction in cardiac events.
    Atorvastatin reduced total myocardial infarction and total
    stroke, RR 0.82 [0.70 – 0.96], ARR
    1.2%, NNT 83. Total mortality was not significantly reduced,
    RR 0.87 [.71 – 1.05]. The trial report stated that total
    serious adverse events "did not differ between patients
    assigned atorvastatin or placebo", but the actual numbers
    of serious adverse events were not given.

    What is the overall health impact when statins are
    prescribed for primary prevention? To attempt to answer this
    question we combined the data from the 5 mostly primary
    prevention trials, the 3 above plus 2 published earlier7,8
    (Table 1 & Table 2). Note that these calculations reflect a
    population that is 84% primary prevention and 16% secondary
    prevention. In the pooled data the statins reduced the
    cardiovascular measures, total myocardial infarction and
    total stroke, by 1.4% as compared to control. This value
    indicates that 71 mostly primary prevention patients would
    have to be treated for 3 to 5 years to prevent one such
    event. This can be compared with the same pooled outcome in
    4 large secondary prevention statin trials, ARR 4.8%, NNT 21
    for 5 years. (Letter #42, HPS4) In the 2 trials where
    serious adverse events are reported, the 1.8% absolute
    reduction in myocardial infarction and stroke should be
    reflected by a similar absolute reduction in total serious
    adverse events; myocardial infarction and stroke are, by
    definition, serious adverse events. However, this is not the
    case; serious adverse events are similar in the statin
    group, 44.2%, and the control group, 43.9% (Table 2). This
    is consistent with the possibility that unrecognized serious
    adverse events are increased by statin therapy and that the
    magnitude of the increase is similar to the magnitude of the
    reduction in cardiovascular serious adverse events in these
    populations. This hypothesis needs to be tested by analysis
    of total serious adverse event data in both past and future
    statin trials. Serious adverse event data is available to
    trial authors, drug companies and drug regulators. The other
    measure of overall impact, total mortality, is available in
    all 5 trials and is not reduced by statin therapy (Table
    2).

    Conclusions: If cardiovascular serious adverse events are
    viewed in isolation, 71 primary prevention patients with
    cardiovascular risk factors have to be treated with a
    statin for 3 to 5 years to prevent one myocardial
    infarction or stroke.

    This cardiovascular benefit is not reflected in 2 measures
    of overall health impact, total mortality and total
    serious adverse events. Therefore, statins have not been
    shown to provide an overall health benefit in primary
    prevention trials.

    ------------------------------------------------------------
    --------------------

    RR = Relative Risk. CI = Confidence Interval. ARR =
    Absolute Risk Reduction. NNT = Number Needed to Treat to
    prevent one event.

    MORE AT URL including charts and graphs.

    B'adant
     
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  2. listener

    listener Guest

  3. Sonos

    Sonos Guest

    On 2-Apr-2004, zwalanga@yahoo.com (Zee) wrote:

    > Do Statins have a Role in Primary Prevention?

    Before the debate starts, perhaps this question should be
    better understood.

    First 'primary prevention' must be better understood in
    its proper context, and second, the question posed is
    rather vague.

    In other words, 'primary prevention' against what disease?

    --
    Winning against heart attack and stroke
    http://www.sonoscore.com
     
  4. Sonos

    Sonos Guest

    On 2-Apr-2004, "Sonos" <Sonos@despammed.com> wrote:

    > > Do Statins have a Role in Primary Prevention?
    >
    > Before the debate starts, perhaps this question should be
    > better understood.
    >
    > First 'primary prevention' must be better understood in
    > its proper context, and second, the question posed is
    > rather vague.
    >
    > In other words, 'primary prevention' against what disease?

    let me clarify further...

    Primary prevention against atherosclerosis, or primary
    prevention of the complications from atheroclerosis?

    --
    Winning against heart attack and stroke
    http://www.sonoscore.com
     
  5. George

    George Guest

    On 2 Apr 2004 11:00:44 -0800, zwalanga@yahoo.com (Zee) wrote:

    >http://www.ti.ubc.ca/pages/letter48.htm
    >
    Actually this link that Zee has posted is the first thing he
    has posted about statins that has value (at least to me).

    The conclusions sum up the current thinking of physicians.
    This could all change though when more studies come out with
    different parameters.

    Then you get theTime Magazine articles and CNN cover stories
    and people (like some posters on this forum) who have been
    given medical advice according to the latest established
    guidelines want to do "more" because of the publicity. The
    media has a role in the way we view ourselves and let's face
    it, the media is in business to sell advertising by
    increasing readership/viewership through sensationalistic
    reporting.
     
  6. listener

    listener Guest

    On Fri, 02 Apr 2004 21:32:30 GMT, George <someone@nowhere.com> wrote:

    >On 2 Apr 2004 11:00:44 -0800, zwalanga@yahoo.com
    >(Zee) wrote:
    >
    >>http://www.ti.ubc.ca/pages/letter48.htm
    >>
    >Actually this link that Zee has posted is the first
    >thing he has posted about statins that has value (at
    >least to me).

    She's posted this many times in the past. It's usually one
    of the first links the CAUSers post. This one:

    http://www.ti.ubc.ca/pages/letter49.htm

    is also good, too.

    >The conclusions sum up the current thinking of physicians.
    >This could all change though when more studies come out
    >with different parameters.

    "Some" physicians, I would say. Yes, lets have more studies.

    >Then you get theTime Magazine articles and CNN cover
    >stories and people (like some posters on this forum) who
    >have been given medical advice according to the latest
    >established guidelines want to do "more" because of the
    >publicity. The media has a role in the way we view
    >ourselves and let's face it, the media is in business to
    >sell advertising by increasing readership/viewership
    >through sensationalistic reporting.

    Partially because Science is not *really* a precise science.

    L.
     
  7. > http://www.ti.ubc.ca/pages/letter49.htm
    >
    > is also good, too.
    >
    >
    > >The conclusions sum up the current thinking of
    > >physicians. This could all change though when more
    > >studies come out with different parameters.
    >
    > "Some" physicians, I would say. Yes, lets have more
    > studies.
    >
    > >Then you get theTime Magazine articles and CNN cover
    > >stories and people (like some posters on this forum) who
    > >have been given medical advice according to the latest
    > >established guidelines want to do "more" because of the
    > >publicity. The media has a role in the way we view
    > >ourselves and let's face it, the media is in business to
    > >sell advertising by increasing readership/viewership
    > >through sensationalistic reporting.
    >
    > Partially because Science is not *really* a precise
    > science.
    >
    > L.
    We should try to remember that Medicine is not a Science but
    is an Art..

    48 is true so is 49 at this time.

    Trying to help folks and cause no harm. Tall order.

    So what can be done?

    Bill

    --
    Zone 5 In South Jersey USA Shade Consider Hearing all sorts
    of music at http://xpn.org/
     
  8. Al. Lohse

    Al. Lohse Guest

    listener@nospam.net wrote:
    >
    > On Fri, 02 Apr 2004 21:32:30 GMT, George
    > <someone@nowhere.com> wrote:
    >
    > >On 2 Apr 2004 11:00:44 -0800, zwalanga@yahoo.com
    > >(Zee) wrote:
    > >
    > >>http://www.ti.ubc.ca/pages/letter48.htm
    > >>
    > >Actually this link that Zee has posted is the first
    > >thing he has posted about statins that has value (at
    > >least to me).
    >
    > She's posted this many times in the past. It's usually one
    > of the first links the CAUSers post. This one:
    >
    > http://www.ti.ubc.ca/pages/letter49.htm
    >
    > is also good, too.
    >
    > >The conclusions sum up the current thinking of
    > >physicians. This could all change though when more
    > >studies come out with different parameters.
    >
    > "Some" physicians, I would say. Yes, lets have more
    > studies.
    >
    > >Then you get theTime Magazine articles and CNN cover
    > >stories and people (like some posters on this forum) who
    > >have been given medical advice according to the latest
    > >established guidelines want to do "more" because of the
    > >publicity. The media has a role in the way we view
    > >ourselves and let's face it, the media is in business to
    > >sell advertising by increasing readership/viewership
    > >through sensationalistic reporting.
    >
    > Partially because Science is not *really* a precise
    > science.

    Is this another example of statintalk, statinthink?

    A.L.

    >
    > L.
     

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