[Gnumed-devel] data point re medication widget: FWD: Can the polypill replace poly-policy for heart health?]

[Karsten Hilbert]

This, from our friends at e-drug, about solves the question
of what combinations of acting agents to expect in a
"typical" drug ;-)

Karsten

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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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