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[Gnumed-devel] data point re medication widget: FWD: Can the polypill re
From: |
Karsten Hilbert |
Subject: |
[Gnumed-devel] data point re medication widget: FWD: Can the polypill replace poly-policy for heart health?] |
Date: |
Mon, 18 May 2009 10:59:53 +0200 |
User-agent: |
Mutt/1.5.18 (2008-05-17) |
This, from our friends at e-drug, about solves the question
of what combinations of acting agents to expect in a
"typical" drug ;-)
Karsten
----- Forwarded message from E-Drug <address@hidden> -----
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> Subject: [e-drug] Can the polypill replace poly-policy for heart health?
>
> E-DRUG: Can the polypill replace poly-policy for heart health?
> --------------------------------------------------------------
> [Interesting articles from India about the "polypill". Cadilla India has
> apparently obtained a registration to market this polypill.
> Copied as fair use. WB]
>
> http://www.hindu.com/2009/05/06/stories/2009050655071000.htm
>
> Can the polypill replace poly-policy for heart health?
>
> K. Srinath Reddy
>
> Rational combinations of proven life-saving drugs have a role in the
> secondary prevention of cardiovascular disease. But there is no acceptable
> substitute for creating social conditions that stimulate, support, and
> sustain healthy living habits across the lifespan.
>
> Considerable media interest has recently been evinced in the use of a
> ?polypill,? as a means of protection against heart attacks and strokes. The
> published results of an Indian ?polycap? trial provided the immediate source
> of excitement, even though the idea of a ?combination pill? or ?polypill? for
> protection against cardiovascular diseases (CVD) has been around for some
> years.
>
> The rationale for a polypill evolved over the last two decades of the 20th
> century, when a series of large clinical trials demonstrated that four
> classes of drugs were highly effective in reducing the risk of recurrent
> heart attacks and death in persons who survived a first heart attack. These
> drugs (beta-blocker, aspirin, ACE-inhibitor and statin) were not only
> effective when given individually but also had incremental benefit when added
> to one another. It has therefore become the standard practice to prescribe
> all of these drugs to a post-heart attack patient for ?secondary prevention?
> of further adverse events.
>
> The other dreaded cardiovascular event is a ?stroke,? or paralysing ?brain
> attack.? Although the clinical manifestation is neurological, the underlying
> cause lies in blocked blood vessels and impeded blood flow. One of the main
> causes of a stroke is high blood pressure that is unrecognised, untreated, or
> poorly controlled. Blood pressure-lowering drugs have been shown to reduce
> the risk of a stroke, heart attack, and death. Such drugs include diuretics,
> ACE inhibitors, and betablockers. Cholesterol-lowering statins have also been
> shown to reduce the risk of one major form of stroke (?ischemic? stroke
> produced by blood clotting). Aspirin is highly effective in reducing the risk
> of an ischemic stroke but increases the risk of a ?haemorrhagic? stroke,
> resulting from bleeding into the brain. Aspirin and statin are not helpful in
> preventing a haemorrhagic stroke, which is mainly linked to high blood
> pressure.
>
> Even a first heart attack can be prevented by lowering blood cholesterol and
> pressure as well as by reducing the clotting ability of blood. However, it is
> not clear whether four or five drugs are collectively beneficial and needed,
> as clinical trials of ?primary prevention? have not employed such four or
> five drug combinations to assess impact on CVD or death. Indeed, while some
> primary prevention trials of aspirin suggested benefit in terms of reducing
> the risk of heart attack or death, others indicated that net harm may result
> from an increased risk of bleeding related strokes.
>
> In 2001, a scientific meeting organised by the World Health Organisation and
> the Wellcome Trust called for the development of a ?combination pill? for
> secondary prevention of CVD. The rationale lay in the potential for improved
> patient adherence (?one pill is easier to swallow than four?) and lower cost
> (anticipated but not estimated). The frequently observed under prescription
> of these life-saving drugs by doctors was also expected to be overcome by
> making the prescription simpler. Spurred on by this report, an Indian drug
> manufacturer set about developing a ?red heart pill? in 2002.
>
> In 2003, Wald and Law published a landmark article in the British Medical
> Journal, in which they modeled the potential benefit of combining six drugs
> for ?primary prevention.? Folic acid was recommended for addition to aspirin,
> betablocker, ACE-inhibitor, statin, and a diuretic. It was argued that since
> these drugs could prevent the first heart attack or stroke in persons with
> predisposing risk factors, all persons above the age of 55 years should be
> administered this ?preventive polypill.? This, they said, would reduce the
> risk of CVD by 75 per cent.
>
> This claim generated huge waves of interest as well as controversy. While
> folic acid was not shown to be protective against CVD in later trials,
> several efforts commenced to combine three or more of these six drugs. One of
> these involved a clever packaging of six drugs in a single capsule, avoiding
> the need to prepare blended tablets. This ?polycap,? prepared by an Indian
> firm, was tested for its efficacy in persons who did not have a prior heart
> attack or stroke but had at least one of several risk factors (ranging from
> hypertension to smoking). This ?proof of concept? trial did not test impact
> on major CVD events but observed reductions in blood pressure and blood fats
> (though to a lesser extent than predicated by Wald and Law). In the
> meanwhile, others from India, New Zealand, the U.K., Iran, and Spain have set
> out to develop blended pills, using different combinations, and are ready to
> launch major trials of ?primary? or ?secondary? prevention.
>
> Several scientific questions currently remain, especially with respect to
> primary prevention. Are three or four or five drugs required and will the
> increasing number provide incremental benefits that exceed the risks and are
> worth the cost? How will this drug combination compare with behaviour change
> involving healthy diets, regular exercise, and smoking cessation? Will only
> one or two drugs, along with behavioural interventions, equal a four or five
> drug combination in primary prevention, even if some drug therapy is
> required?
>
> Should poly-drug therapy be reserved for persons at a high ?absolute? risk of
> a future CVD event, usually because of multiple co-existing risk factors?
> Practising physicians have been uncomfortable with the idea of a fixed dose
> combination. They wish to retain the freedom of ?titrating? each drug
> according to an individual?s clinical response. Trialists regard this as
> unwarranted caution and argue that trials have validated the effective dose
> of each drug, which then goes into a combo pill. It is conceivable, however,
> that several combo pills may emerge with different dose levels to permit a
> range of prescribing options.
>
> The major criticism directed at the claim that the polypill will be the
> panacea for preventing CVD comes from the public health community who view it
> as a purely biomedical approach to a problem wherein deranged biology has
> many social determinants and behavioural causes. If those antecedent causes
> are not addressed, increasing numbers of individuals from each successive
> generation would have to be put on a pill at some stage of their lives. These
> critics also worry that the promised protection of a polypill may work
> against people giving up unhealthy habits like smoking or bad diets.
>
> It is clear that the decline of CVD in developed countries over the past four
> decades has been the result of policies promoting healthier behaviours as
> well as improved clinical care. At least 50 per cent of the observed decline
> in CVD-related death in these countries has been ascribed to shifts in
> population risk profiles of diet and smoking. In the United Kingdom, 48.1 per
> cent of the total mortality decline observed during 1981-2000 has been
> attributed to a decline in smoking.
>
> Finland was at the top of the global league table for coronary heart disease
> related deaths at the beginning of the 1970s. Major population-based
> programmes, involving community health education, tobacco control as well as
> marketing of food products with lowered salt and saturated fat, have sharply
> reduced coronary mortality and made Finland the poster child of CVD
> prevention in Europe.
>
> The recent recommendations from the World Health Organisation, the World
> Bank, and several other international expert bodies estimate that tobacco
> control and reduction of salt in diet will save millions of lives over the
> next 10 years. If trans-fats are removed or reduced and saturated fat as well
> as sugar are reduced in processed foods, the gains will be even greater.
> Fruit and vegetables have been shown to be protective both against CVD and
> cancer.
>
> Policies that influence their production, processing, and pricing will affect
> the population risk of CVD. Similarly, urban design and transport policies
> can greatly enable physical activity by providing protected cycle lanes, safe
> pedestrian pathways, parks, and community sporting facilities.
>
> Some countries have used fiscal policies, taxation, and regulation to advance
> these goals. When Mauritius substituted soya oil for palm oil as the
> subsidised ration oil in the public distribution system, the mean population
> level of blood cholesterol declined. Withdrawal of subsidies for animal foods
> and increased import of vegetable oils and fruit led to a sharp decline in
> CVD mortality in Poland in mid 1990s. The U.K.?s food and health agencies
> have prevailed upon the food industry to progressively lower salt in
> processed foods. Denmark has removed trans-fats from manufactured food
> products while New York has banned their use in restaurants, bakeries, and
> hotels. Following the U.S. precedent, soft drink manufacturers are responding
> to pressure from public health advocates by promising to remove sugar-rich
> beverages from schools around the world. The U.K. and the European Union are
> placing restrictions on advertising of junk foods to children. Tobacco
> taxes are being increased in many countries, to raise prices and reduce
> consumption.
>
> It is worth noting that these regulatory measures are being taken even in
> free market countries, to make it easier for people to make and maintain
> healthy living choices. The libertarian outcry against a ?nanny state? trying
> to influence individual behaviour seems particularly misplaced at a time when
> the global economic crisis has reinstated the state?s role of a responsible
> regulator. It is imperative that governments facilitate the creation of
> social conditions that stimulate, support, and sustain healthy living habits
> across the lifespan. By preventing the augmentation or acquisition of risk in
> the first place, such policies will benefit future generations too.
>
> The bottom-line? As a cardiologist, I welcome the availability of rational
> combinations of proven life-saving drugs in easily administered and
> cost-saving formulations, especially for the secondary prevention of CVD. As
> an epidemiologist and public health advocate, however, I would like to
> caution against proclaiming the polypill as the principal pathway to primary
> prevention of CVD. A poly-policy approach involving health education and
> multi-sectoral strategies for promoting healthy behaviour is the more
> rational, cost-effective, and sustainable approach for primary prevention.
> Poly-policy and pill are of course not mutually exclusive.
>
> (Dr. K. Srinath Reddy, Professor of Cardiology at the All India Institute of
> Medical Sciences, New Delhi, is president of the Public Health Foundation of
> India.)
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Karsten Hilbert <=