Effectiveness and Safety of Amlodipine in Newly Diagnosed Hypertensive Patients and in Previously Diagnosed Hypertensive Patients not Controlled with their Usual Treatment (NOTA Study).

OBJECTIVE

To evaluate the effectiveness and safety of amlodipine in two cohorts of hypertensive patients, one newly diagnosed and the other previously diagnosed but not controlled with drug therapy, and to assess the risk factors for the entire sample at the outset of the study.

PATIENTS AND DESIGN

We designed a postmarketing, multicentre, open-label, prospective, observational surveillance study with a 6-month follow-up, which included hypertensive patients (systolic blood pressure [SBP] >/=140mm Hg and/or diastolic blood pressure [DBP] >/=90mm Hg) who attended specialised units and had either newly diagnosed or previously diagnosed pharmacologically uncontrolled arterial hypertension.

RESULTS

Of the total of 1797 patients eligible for evaluation, 760 (42.3%) were newly and 1037 (57.7%) were previously diagnosed. Of these, 22.9% were classified as being in the high-risk and 43.2% in the very high-risk groups at the outset of the study (WHO-ISH [International Society of Hypertension]). On conclusion of the 6-month follow-up, 54.3% of newly diagnosed and 44.4% of previously treated patients had attained the BP therapy targets defined as SBP <140mm Hg and DBP <90mm Hg, representing a statistically significant difference (p < 0.0001). A total of 8% of patients experienced some adverse event during the course of the study, with this percentage being somewhat higher in the previously treated than in the newly diagnosed group (10.8% vs 5.1%, p < 0.0001). Only 0.3% experienced some severe adverse event, although in no case was this linked to the drug under evaluation.

CONCLUSIONS

We conclude that amlodipine has shown itself to be an effective and safe drug for the control of hypertension, whether isolated or associated with other cardiovascular risk factors, both in patients without a previous diagnosis of arterial hypertension and in those previously diagnosed although not controlled under a prior treatment regimen.