ADHT

Background

More than 1/4th diabetic hypertensives not responding to ACE inhibitor/ARB monotherapy attain BP goals with addition of amlodipine.

Aim

To determine the efficacy & safety of amlodipine in diabetic hypertensives who do not respond to ACE inhibitor or ARB monotherapy.

Study Patients

Patients with hypertension & diabetes who did not reach target BP goals with ACE inhibitor/ARB monotherapy (N=411).

Study Groups

ACE inhibitor (quinapril 20-40 mg/day) + Amlodipine (5-10 mg/day) [n=96]
ACE inhibitor (quinapril 20-40 mg/day) + Placebo [n=103]
ARB (losartan 50-100 mg/day) + Amlodipine (5-10 mg/day) [n=115]
ARB (losartan 50-100 mg/day) + Placebo [n=97]

Study Period

12 weeks

Primary Efficacy Outcome

Percentage of patients with BP <130/80 mmHg

Results

Addition of amlodipine to ACE inhibitor/ARB monotherapy more than doubled the percentage of patients attaining BP goals vs placebo (Figure 1)

Figure 1: Percentage of patients achieving BP goal (<130/80 mmHg) with add-on amlodipine therapy vs placebo

Addition of amlodipine also yielded significantly greater reductions in systolic & diastolic BP vs placebo (Figure 2)

Figure 2: Reduction in BP with add-on amlodipine therapy vs placebo

Serum creatinine levels & glomerular filtration rate (GFR) improved with addition of amlodipine unlike placebo (Table 1)

Table 1: Effect on serum creatinine & GFR

Safety

There was no significant difference in adverse events across the study groups.

Conclusion

Addition of amlodipine in diabetic hypertensives not responding to ACE inhibitor/ARB monotherapy may be a good option for intensive BP lowering to achieve target BP goals.

Ann Pharmacother. 2008 Nov;42(11):1552-62