To assess the effectiveness, safety and tolerability of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCT) single pill combination (SPC) in Egyptian patients with hypertension who were not controlled on any dual therapy.Design and method:
Prospective, open label, multicenter, observational, cohort study conducted in patients with hypertension from Egypt, who were uncontrolled on any dual antihypertensive therapy and to whom Aml/Val/HCT SPC was indicated. Patients were treated with Aml/Val/HCT (5/160/12.5 mg or 10/160/25 mg; the only two available forms in Egypt) for 12 weeks. The primary endpoint was mean change in systolic and diastolic blood pressure (SBP and DBP) at week 12. Secondary endpoints included mean change in SBP and DBP at week 2, BP goal (<140/90 mmHg), safety and tolerability, change in heart rate, and compliance with SPC at week 12.Results:
A total of 1080 patients completed the study. The mean baseline BP was 165.5/100.8 mmHg. Significant reduction in SBP/DBP -35.9/-20.3 mmHg (P < 0.0001) from baseline was observed at week 12. Similarly, the reduction in SBP/ DBP −28.0/−15.7 mmHg (P < 0.0001) was significant after 2 weeks of treatment. Majority of patients (76.85%) reached the BP goal of <140/90 mmHg. The most common adverse events were ankle edema (10.92%), lower limb edema (5.88%), and palpitation (5.88%). Physician's evaluation showed that 61.76% (667/1080) of the patients had excellent tolerability to study medication. The sitting pulse significantly reduced from 80.3 bpm at baseline to 77.2 bpm (P < 0.0001). Compliance was better for patients taking Aml/Val/HCT 5/160/12.5 mg as compared to 10/160/25 mg (60.56% vs 39.35%).Conclusions:
In this observational study conducted in Egypt, Aml/Val/HCT (5/160/12.5 mg or 10/160/25 mg) SPC significantly reduced BP in patients not controlled on any previous dual therapy. It also showed significant improvement in BP control and good safety profile.