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Efficacy of Ompatrilat in Patients with Hypertension and Atherosclerotic Disease - OCTAVE Substudy
Description:
Substudy of the OCTAVE trial comparing the vasopeptidase inhibitor, ompatrilat, to enalapril in control of hypertension.
Hypothesis:
Ompatrilat would be more efficacious than enalapril in control of blood pressure in high risk patients with atherosclerotic disease.
Study Design
Study Design:
Patients Enrolled: 15,167 (2,370 in this subgroup)
Mean Follow Up: 6 months
Patient Populations:
1) Blood pressure >140/90 mm Hg on or off one or more anti-hypertensive medications 2) History of myocardial infarction, stroke, angina or transient ischemic attack
Secondary Endpoints:
1) Blood pressure control at 8 weeks 2) Cardiovascular mortality 3) Incidence of angioedema 4) Blood pressure control stratified by number of medications used
Drug/Procedures Used:
Randomization of ompatrilat or enalapril in three groups of patients : Group 1) Untreated hypertension, Group 2) JNC VI Stage I hypertension on medication and Group 3) JNC VI Stage II hypertension on medication. Untreated patients and Group 2 patients (after withdrawal of medications) received the study medication over 8 weeks titrated upward for elevated SBP. If SBP remained >140 mm Hg, other medications were added to control blood pressure. In Group 3 patients, ompatrilat or enalapril were added to the existing medical regimen and titrated upward to achieve SBP <140 mm Hg.
Principal Findings:
In groups 1 and 2, blood pressure decrease was significantly greater at 8 weeks with ompatrilat (Group 1 –4.7 mm Hg; p=0.002 and Group 2 –3.5 mm Hg; p<0.0001). The difference in group 3 was not significantly different at 8 weeks. At 6 months, across all groups, blood pressure control was greater in patients treated with ompatrilat. The incidence of cardiovascular death at 6 months was not significantly different between ompatrilat an enalapril (HR 0.89; p=NS). The incidence of angioedema was 1.18% in the ompatrilat group at 6 months compared to 0.60% in the enalapril group. This incidence of angioedema was lower in this group than in the overall cohort and no occurrences were life threatening or required hospitalization.
Interpretation:
In patients with atherosclerotic disease, ompatrilat compared to enalapril reduced blood pressure more effectively and achieved better blood pressure control across untreated hypertensives as well as patients who remain mildly to moderately hypertensive on medications. However, the use of this medication is limited by the incidence of angioedema. The incidence of angioedema is double that of enalapril in this subgroup. In certain subgroups of patients such as those of African American descent, the incidence may be higher.
References:
Presented by M. Weber at the Annual Meeting of the European Society of Cardiology, September 4, 2002.
Keywords: Myocardial Infarction, Stroke, Enalapril, Ischemic Attack, Transient, Hypertension
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