The information on this page is aimed at general practitioners, pharmacists, chemists and other medical professionals that may be asked by the public about the polypill concept.
The Polypill Concept describes a treatment employing several pharmacological components designed to lower several cardiovascular risk factors simultaneously. For people who have had a cardiovascular disease event or related disorders such as angina pectoris, combination treatment has been practised for many years, although apart from the use of aspirin there has been a tendency to treat each risk factor rather than the overall risk of the disease.
For example, until recently statins have been prescribed only if serum cholesterol is raised. Blood pressure lowering drugs are given only if a diagnosis of hypertension has been made. This is inappropriate and leads to many people not receiving preventive treatment who could benefit from receiving such treatment.
The treatment we use excludes folic acid and aspirin. Folic acid is excluded because of lack of evidence of cardiovascular risk reduction from clinical trials, although recent work indicates a preventive effect on brain atrophy with increasing age. Aspirin is excluded because the risk of bleeding in people without existing cardiovascular disease might be unacceptable in relation to the expected benefit, although recent work indicating a protective effect against cancer may alter this assessment.
The basis for preventing clinical cardiovascular disease with a combination of agents that reduce causal risk factors is that, within the range of values of these risk factors in the population, there is no threshold below which a reduction in risk factor ceases to confer a reduction in risk. Indeed, cohort (prospective observational) studies show that blood pressure and cholesterol exhibit a linear relation between the level of the risk factor and the risk of the disease when the risk of the disease is plotted on a proportional (that is, logarithmic) scale. This relation has great clinical significance, because it shows that for given changes in the risk factor there is a constant proportional change in the risk of disease.
We conducted a randomized double-blind placebo-controlled crossover trial of a treatment provided as part of a Polypill Prevention Programme among individuals aged 50+ without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs. Participants took the preventive treatment (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg and simvastatin 40 mg) each evening for 12 weeks and a placebo each evening for 12 weeks in random sequence. The mean within-person differences in blood pressure and low density lipoprotein (LDL) cholesterol at the end of each 12 week period were determined.
84 out of 86 participants completed both treatment periods. The mean systolic blood pressure was reduced by 17.9 mmHg (95% CI, 15.7–20.1) on the active treatment, diastolic blood pressure by 9.8 mmHg (8.1–11.5), and LDL cholesterol by 1.4 mmol/L (1.2–1.6), reductions of 12%, 11%, and 39% respectively. The results were almost identical to those predicted; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively.
The Polypill Concept features in the press. Professor Sir Nicholas Wald, the principal founder of Polypill Limited, is a regular speaker and guest on BBC News and other UK channels. You can find more references to the polypill approach in the press by reading our press section