Calcium antagonists and cardiovascular risk in patients with hypertension and Type 2 diabetes mellitus: evidence from the PIUMA Study. Progetto Ipertensione Umbria Monitoraggio Ambulatoriale.
We conducted a retrospective analysis of all subjects with essential hypertension and Type 2 diabetes mellitus enrolled in the PIUMA (Progetto Ipertensione Umbria Monitoraggio Ambulatoriale) registry, in order to evaluate whether the use of calcium antagonists is associated with an increase in cardiovascular risk in these subjects. One hundred and sixty-four consecutive subjects with no previous cardiovascular morbid events and coexistence of essential hypertension and Type 2 diabetes mellitus were studied before therapy and followed for up to 12 years (mean 5). There were periodical contacts with family doctors and patients in order to ascertain the occurrence of major cardiovascular events. The use of calcium antagonists that preceded the event was considered for classification. None of the patients was lost to follow-up. At entry, the patients who were subsequently given calcium antagonists (n=50) had a higher clinical (174/98 vs 161/92 mmHg, both p<0.01) and 24-hr ambulatory blood pressure (150/90 vs 141/84 mmHg, both p<0.01) than those who were not. During follow-up there were 53 major cardiovascular morbid events (6.46 per 100 person-years). The rate of total cardiovascular events [5.6 vs 6.8 events per 100 person-years, relative risk 0.88 (95% CI: 0.47-1.61)] and that of cardiac events [4.0 vs 3.3 events per 100 person-years, relative risk 1.33 (95% CI: 0.62-2.89)] did not differ between users of calcium antagonists and non-users. The use of angiotensin converting enzyme inhibitors (n=66) was unrelated to the risk of cardiovascular events (relative risk 1.24, 95% CI: 0.71-2.16). In a Cox multivariate analysis, only age (p=0.002) and 24-hr pulse pressure (p=0.04) were independent predictors of cardiovascular events. In conclusion, this cohort study does not support the hypothesis that use of calcium antagonists is associated with an excess risk of adverse cardiovascular events in uncomplicated subjects with essential hypertension and Type 2 diabetes mellitus.