The Indian Polycap Study (TIPS)
2009; Elsevier BV; Volume: 374; Issue: 9692 Linguagem: Inglês
10.1016/s0140-6736(09)61584-1
ISSN1474-547X
Autores Tópico(s)Pharmaceutical Economics and Policy
ResumoThe TIPS results (April 18, p 1341)1The Indian Polycap Study (TIPS)Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial.Lancet. 2009; 373: 1341-1351Summary Full Text Full Text PDF PubMed Scopus (413) Google Scholar are welcome in showing that a polypill can be produced and used in healthy people in a practical manner. Surprisingly, the TIPS investigators imply priority for proposing a polypill from a 2002 publication. This is incorrect: we detailed the polypill 2 years earlier2Wald NJ Law MR Formulation for the prevention of cardiovascular disease. UK patent application no 0008791.6.http://www.ipo.gov.uk/p-find-number/patents?csbpub=GB2361185&csbtype=FGoogle Scholar and cited the source in 2003.3Wald NJ Law MR A strategy to reduce cardiovascular disease by more than 80%.BMJ. 2003; 326: 1419-1423Crossref PubMed Google Scholar Also, we did not claim that “reductions in risk factors were independent of initial levels”.1The Indian Polycap Study (TIPS)Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial.Lancet. 2009; 373: 1341-1351Summary Full Text Full Text PDF PubMed Scopus (413) Google Scholar We showed that absolute and proportional blood pressure changes and absolute cholesterol changes vary with pretreatment level but that proportional cholesterol changes do not.4Law MR Wald NJ Rudnicka AR Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.BMJ. 2003; 326: 1423-1427Crossref PubMed Google Scholar, 5Law MR Wald NJ Morris JK Jordan RE Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials.BMJ. 2003; 326: 1427-1431Crossref PubMed Google Scholar Cholesterol and blood pressure reductions in TIPS were smaller than our 2003 estimates.3Wald NJ Law MR A strategy to reduce cardiovascular disease by more than 80%.BMJ. 2003; 326: 1419-1423Crossref PubMed Google Scholar, 4Law MR Wald NJ Rudnicka AR Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.BMJ. 2003; 326: 1423-1427Crossref PubMed Google Scholar, 5Law MR Wald NJ Morris JK Jordan RE Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials.BMJ. 2003; 326: 1427-1431Crossref PubMed Google Scholar We believe our estimates are correct. They were based on average pretreatment LDL cholesterol (4·8 mmol/L) and blood pressure (150/90 mm Hg) in people who develop cardiovascular disease,4Law MR Wald NJ Rudnicka AR Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.BMJ. 2003; 326: 1423-1427Crossref PubMed Google Scholar, 5Law MR Wald NJ Morris JK Jordan RE Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials.BMJ. 2003; 326: 1427-1431Crossref PubMed Google Scholar the group relevant to quantifying disease prevention;3Wald NJ Law MR A strategy to reduce cardiovascular disease by more than 80%.BMJ. 2003; 326: 1419-1423Crossref PubMed Google Scholar, 4Law MR Wald NJ Rudnicka AR Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.BMJ. 2003; 326: 1423-1427Crossref PubMed Google Scholar, 5Law MR Wald NJ Morris JK Jordan RE Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials.BMJ. 2003; 326: 1427-1431Crossref PubMed Google Scholar corresponding values in TIPS were lower (3·0 mmol/L, 135/86 mm Hg). Lower pretreatment cholesterol, lower simvastatin dose (20 mg not 40 mg), and non-adherence to prescribed therapy can explain the smaller LDL cholesterol reduction in TIPS (0·70 mmol/L). Blood pressure reductions on the polycap in TIPS (7·4/5·6 mm Hg) were 42% (diastolic) and 53% (systolic), smaller than expected after allowing for pretreatment blood pressure and non-adherence. This seems an anomalous TIPS result rather than an overestimated expectation, since the blood pressure reductions in groups allocated one, two, or three blood-pressure-lowering drugs confirm additive effects of each drug and were only about 2·5/1·5 mm Hg per drug—less than that seen in meta-analysis of randomised trials.5Law MR Wald NJ Morris JK Jordan RE Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials.BMJ. 2003; 326: 1427-1431Crossref PubMed Google Scholar The small reductions in cholesterol (explained) and blood pressure (unexplained) in TIPS both underestimate the health benefits of a polypill. NW and ML hold a European patent for the “ Polypill ” (number EP1272220 , priority date April 10, 2000) and have patent pending in the USA and Canada. The Indian Polycap Study (TIPS) – Authors' replyNicholas Wald and Malcolm Law are concerned about priority of the polypill concept. This is not addressed by our article. Moreover, the issue of priority is not important from scientific or medical perspectives. The key is to assess whether the concept is valid, and test it in randomised trials so that reliable data which benefit people will emerge. Full-Text PDF
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