December 1, 2007Journal of Hypertension85 citations

Prevalence and incidence of the metabolic syndrome in the European Lacidipine Study on Atherosclerosis (ELSA) and its relation with carotid intima–media thickness

AZAlberto Zanchetti MHMicheal Hennig HBHansjörg Baurecht

Structured PICO

Does lacidipine compared to atenolol reduce the incidence of metabolic syndrome and progression of carotid IMT in hypertensive patients?

Population

2,334 hypertensive patients from the European Lacidipine Study on Atherosclerosis (ELSA) trial (2,034 with baseline measurements for metabolic syndrome, 1,444 with 4-year follow-up).

Intervention

Lacidipine (lipophilic calcium antagonist) for 4 years, with about 35% receiving additional hydrochlorothiazide (12.5-25 mg/day).

Comparator

Atenolol (beta-blocker) for 4 years, with about 35% receiving additional hydrochlorothiazide (12.5-25 mg/day).

Outcome

Prevalence and incidence of metabolic syndrome (MS), changes in carotid intima-media thickness (IMT), incidence of cardiovascular events, and new-onset diabetes.surrogate

In hypertensive patients, treatment with lacidipine resulted in a significantly lower incidence of new-onset metabolic syndrome compared to atenolol.

Limitations

Post-hoc analysis

Abstract

BACKGROUND: The European Lacidipine Study on Atherosclerosis (ELSA) randomized 2334 hypertensive patients to either the lipophilic calcium antagonist lacidipine or the beta-blocker atenolol for 4 years. About 35% of subjects in both groups received additional hydrochlorothiazide (12.5-25 mg/day). The patients were followed up for carotid intima-media thickness (IMT) changes for 3.7 years. OBJECTIVES: The present post-hoc analyses were aimed at: describing the prevalence of the metabolic syndrome (MS) at baseline; investigating the effect of long-term antihypertensive therapy (and separately of atenolol and lacidipine) on MS prevalence; exploring whether MS at baseline influenced changes in carotid IMT and incidence of cardiovascular events during treatment; and describing the relations between MS and new cases of diabetes developing during treatment. METHODS: At baseline 2034 patients had, in addition to blood pressure (BP), measurements of blood glucose, serum high-density lipoprotein (HDL)-cholesterol, triglycerides and body mass index (BMI > 28.8 for men and > 26.2 for women were taken to correspond to waist circumference > 102 and > 88 cm, respectively). These measurements were repeated after 4 years of treatment in 1444 patients. MS was defined according to Adults Treatment Panel III (ATP III). RESULTS: A high proportion of ELSA patients (33.3%) had MS at baseline, with no difference between atenolol and lacidipine. Baseline IMT was slightly greater in MS patients, but only the difference in mean maximum IMT at common carotids and bifurcations (CBMmax) achieved significance (P = 0.0325). Progression of CBMmax was also slightly greater in MS patients (P = 0.0241), but significance was lost when adjusted for covariates. No significant difference was found in the incidence of new cardiovascular events between patients with and without MS. The incidence of new MS was 21.4%, and significantly greater in patients under atenolol (25.2%) than lacidipine (17.7%; P = 0.0045). New-onset diabetes occurred in 5.54% of ELSA patients, and was three times higher among patients with than those without MS (10.28 versus 3.43%, P > 0.0001). CONCLUSIONS: Our analyses show a high prevalence of MS in ELSA hypertensives, a substantial incidence of new cases of MS and diabetes, the latter mostly among patients with MS. These analyses also show that in ELSA lacidipine was superior to atenolol, not only in showing a lower progression of carotid atherosclerosis, but also in causing a significantly lower incidence of new MS.

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