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Residual Cardiovascular Risk in Treated Hypertension and Hyperlipidaemia: the PRIME Study

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Residual Cardiovascular Risk in Treated Hypertension and Hyperlipidaemia: the PRIME Study Journal of Human Hypertension (2010) 24, 19–26 & 2010 Macmillan Publishers Limited All rights reserved 0950-9240/10 $32.00 www.nature.com/jhh ORIGINAL ARTICLE Residual cardiovascular risk in treated hypertension and hyperlipidaemia: the PRIME Study J Blacher1,2, A Evans3, D Arveiler4, P Amouyel5, J Ferrie`res6, A Bingham1, J Yarnell3, B Haas4, M Montaye5, J-B Ruidavets6 and P Ducimetie`re1, on behalf of the PRIME Study Group 1INSERM, Hoˆpital Paul Brousse, Villejuif, France; 2Hoˆtel-Dieu, APHP, Universite´ Paris Descartes, Paris, France; 3Belfast-MONICA, Department of Epidemiology and Public Health, Queen’s University Belfast, Belfast, UK; 4MONICA-Strasbourg, Laboratoire d’Epide´miologie et de Sante´ Publique, Faculte´ de Me´decine, Universite´ Louis Pasteur, Strasbourg, France; 5INSERM, U 744, Institut Pasteur, MONICA-Lille, Lille, France and 6MONICA-Toulouse, INSERM, Faculte´ de Me´decine Purpan, Toulouse, France Although pharmacological treatments of hypertension lowering drug use, after adjusting for classic risk factors and dyslipidaemia are both associated with a reduction (age, smoking, total cholesterol, high-density lipopro- in cardiovascular risk, little is known about the degree of tein cholesterol, systolic blood pressure and diabetes). cardiovascular risk remaining in treated individuals, by Similar results were obtained for coronary heart disease assessing the levels of their risk factors achieved, that is (RR ¼ 1.46, 95% CI: 1.18–1.80), stroke (RR ¼ 1.75, 95% their ‘residual cardiovascular risk’. We then used the CI: 1.14–2.70) and cardiovascular death (RR ¼ 1.62, 95% data from the Prospective Epidemiological Study of CI: 1.02–2.58), but neither for total death (RR ¼ 1.15, 95% Myocardial Infarction (PRIME), which involved 9649 CI: 0.89–1.48) nor for non-cardiovascular death men aged 50–59 years, from France and Northern (RR ¼ 1.00, 95% CI: 0.74–1.36). For any cardiovascular Ireland with a 10-year follow-up, to test the presence of end point, residual risks did not globally differ accord- specific residual cardiovascular risks of coronary ing to the antihypertensive drug class prescribed heart disease, stroke, total of fatal and non-fatal at baseline. In conclusion, treatment with antihyperten- cardiovascular events and cardiovascular mortality, in sive agents, but not with lipid-lowering agents, patients treated with antihypertensive agents or lipid- was associated with a sizeable residual cardiovascular lowering agents. In the whole cohort, a total of 796 risk, suggesting that more efficient risk reduction patients developed a fatal or non-fatal cardiovascular strategies in hypertension should be developed as a event. Antihypertensive drug use at baseline was priority. significantly associated (RR ¼ 1.50, 95% CI: 1.25–1.80) Journal of Human Hypertension (2010) 24, 19–26; with total cardiovascular event risk, but not lipid- doi:10.1038/jhh.2009.34; published online 28 May 2009 Keywords: epidemiology; risk prediction; antihypertensive agents; population Introduction tion, blood pressure decrease is associated with a reduction in major cardiovascular complications: Management of individual patients requires the coronary heart disease (CHD), stroke, congestive integration of the results of both observational and 3 1 heart failure and cardiovascular mortality. To interventional epidemiology. In the field of hyper- improve hypertensive treatment, we should remem- tension, observational epidemiology clearly demon- ber that although antihypertensive treatment re- strates that hypertensives have an increased risk of 2 duces cardiovascular risk, it cannot completely developing cardiovascular complications. In addi- reverse the hypertension-induced risk of morbid events. Therefore, antihypertensive treatment can- Correspondence: Professor J Blacher, Unite´ HTA, Pre´vention et not be considered effective if only part of the The´rapeutique Cardiovasculaires Centre de Diagnostic et de cardiovascular events attributable to hypertension The´rapeutique, Universite´ Paris Descartes; Assistance Publique- is prevented. Conventional therapeutic trials do not Hoˆpitaux de Paris, Hotel-Dieu, Place du Parvis Notre-Dame, furnish this information because patients are highly 75004 Paris, France. E-mail: [email protected] selected. Other sources of evidence are needed to Received 10 February 2009; revised 1 April 2009; accepted 2 determine the proportion of hypertension-induced April 2009; published online 28 May 2009 cardiovascular events prevented by antihyper- Residual cardiovascular risk in hypertension J Blacher et al 20 tensive drugs as they are prescribed and monitored the survey staff with the subjects at the clinic. Data in the population. Little is known about the on educational level, occupational activity, personal cardiovascular risk of patients receiving antihyper- and family history, tobacco and alcohol consump- tensive treatment, taking into account the levels of tion, drug intake and physical activity were col- risk factors achieved, that is their ‘residual cardio- lected by the staff. During the examination, a vascular risk’. Some data support a residual cardi- questionnaire on personal medical history was ovascular risk in treated hypertensives, even in completed along with the London School of Hygiene patients with controlled blood pressure levels.4–10 Cardiovascular (Rose) Questionnaire for Chest Pain Residual cardiovascular risk is important at the on Effort and Possible Infarction,13 and a standard public health level to implement new guidelines, 12-lead electrocardiogram was recorded. Question- and at the epidemiological level to built more naires were designed in French and rigorously realistic prediction models, taking into account both translated into English. Anthropometric measure- the current level of the risk factor and type of drug ments included height and weight without shoes. treatment. The confirmation of an important resi- Subjects were considered free of coronary disease dual cardiovascular risk in hypertension or in at entry if they had no history of myocardial hypercholesterolaemia would bear important clin- infarction and/or angina pectoris diagnosed by a ical implications, opening discussions on earlier physician; no electrocardiographic evidence of treatment, more intensive treatment and the need for myocardial infarction, defined as major or moderate developing new drugs. Q-wave coding using the Minnesota system11 and no In an earlier PRIME (Prospective Epidemiological positive answer to the Rose questionnaire.13 Sub- Study of Myocardial Infarction) Study paper, we jects were considered free of cerebrovascular disease demonstrated a sizeable residual coronary risk in at entry if they had no history of stroke or transient treated hypertensives after a 5-year follow-up. The ischaemic attack. 10-year follow-up might give enough power to test All subjects receiving antihypertensive, lipid- the presence of specific residual cardiovascular lowering or antidiabetic therapy were included in risks, not only of CHD, but also of stroke, total of the present analysis. Antihypertensive agents were fatal and non-fatal cardiovascular events and cardi- divided into b-blockers, diuretics, angiotensin-con- ovascular mortality. Furthermore, because hyperch- verting enzyme (ACE) inhibitors, calcium channel olesterolaemia might behave similarly, we also antagonists (CCAs), a-blockers and centrally acting tested the presence of a residual cardiovascular risk agents, the latter two were grouped together in the associated with lipid-lowering drugs. analysis because of small numbers. Subjects taking drug combinations were included in the analysis as if they were taking the drugs separately. Lipid- Methods lowering agents were divided into fibrates and Cohort recruitment, examination methods and the statins. protocol for the analysis of fatal and non-fatal Blood pressure was measured once with an coronary and cerebrovascular events have been automatic device (Spengler SP9) at the end of the described previously,7,11,12 and only the main details examination after a 5 min rest in the sitting position are given below. and before blood was drawn. A standard cuff size was used, but a large cuff was available when necessary. To minimize systematic between-centre Population sampling differences, we circulated and recalibrated devices The PRIME Study was established in 1991 in the every 3 months at the coordinating centre in Paris. populations of four WHO MONICA Collaborating Blood samples were processed within 4 h of 11 Centres in Belfast (UK), and Lille, Strasbourg and venesection. Plasma for lipid analysis was sent Toulouse (France) (see Appendix). The target was to each week at 4 1C to the Central Laboratory in Lille, recruit 2500 men, aged 50–59 years, in each centre France. and to follow them over 10 years. The sample was recruited to broadly match the social class structure of the background population. The recruitment frame Follow-up was based on industry, various employment groups, Subjects were contacted annually by letter and health screening centres and general practice. Ap- asked to complete a clinical event questionnaire to proval from the appropriate local ethics committees be returned to the centre in a prepaid envelope. If was obtained and subjects who accepted to partici- the subject did not comply, phone contact was pate gave their written consent at examination. established with him or with his general practi- tioner. For all subjects reporting a possible event, clinical information was sought
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