Post Marketing Surveillance Study on Amlopres-NB (Amlodipine/Nebivolol combination)

18 Mar, 14

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Study Title

SUPREME: Post Marketing Surveillance to Evaluate the Safety and Efficacy in Hypertension of the Combination of Amlodipine & Nebivolol (Amlopres-NB).

Aim

To evaluate the safety and efficacy of the fixed-dose combination of amlodipine and nebivolol (Amlopres-NB) in hypertensives.

Patients

Hypertension (N=673)

Exclusion Criteria

Hypersensitivity to either component
Severe bradycardia
Heart block greater than first degree
Cardiogenic shock
Decompensated cardiac failure
Sick sinus syndrome (unless a permanent pacemaker is in place)
Severe hepatic impairment (Child-Pugh >B)

Study Design

Patients were prescribed one tablet of Amlopres-NB once daily
Follow-up visits at week 2 and week 4
SBP, DBP and effect on angina assessed at baseline, week 2 and week 4
Pulse rate & clinical examination done at all occasions

Results

Significant reduction in SBP

P <0.0001 for visit 1 vs. baseline, visit 2 vs. visit 1 and visit 2 vs. baseline

N = 673 hypertensives from 136 clinics across India

Duration = 4 weeks

Significant reduction in DBP

Duration = 4 weeks

Change in BP

P<0.0001 for visit 1 vs. baseline, visit 2 vs. visit 1 and visit 2 vs. baseline

Effect on angina

No. of patients with angina

Frequency of anginal episodes

Effect on pulse rate

P<0.0001 for visit 1 vs. baseline, visit 2 vs. visit 1 and visit 2 vs. baseline

Adverse events (27 pts)

Mild nature (26) and moderate severity (6)

Association
- Possible-7
- Probable-6
- Certain-4
- Conditional-1
- Unlikely-1
2 patients withdrawn due to pedal edema

Conclusion

Thus, Amlopres-NB is effective and well tolerated in Indian hypertensives.

Indian Pract. 2009; 62(9):565-70

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