Effectiveness and tolerability of fixed dose combination of amlodipine/valsartan in treatment of hypertension in the real-life setting among Egyptian patients

IntroductionMany hypertension international guidelines recommend the use of fixed-dose combination of antihypertensive therapies as a first- line in high-risk hypertensive patients, in whom more rapid and pronounced blood pressure (BP) control is desired. The aim of this study was to evaluate the effectiveness, safety and tolerability of the single-pill combination of amlodipine/valsartan among Egyptian patients with arterial hypertension in a real-life setting.MethodThis prospective, open-label, multi-center, non-comparative post-marketing surveillance study enrolled adults with arterial hypertension (systolic BP >>140 mmHg and/or diastolic BP >>90 mmHg) treated with single-pill combination (SPC) of amlodipine/valsartan; 5/160 mg or 10/160 mg once daily dose. Patients were observed over a 3-months period with approximately monthly intervals between clinic visits. Primary objectives were comparison of systolic and diastolic blood pressure and heart rate at study start and after 12 weeks of therapy. Secondary objectives were evaluation of the blood pressure lowering effect in terms of response rates, evaluation of safety and tolerability of study medication.ResultsA total of 2489 patients were enrolled and 2357 completed the study. Mean age was 54 years and 85% of patients had received prior antihypertensive therapy. At study end, a significant mean BP reduction of −39.4/−21.7 mmHg (baseline: 171.5/103.4 mmHg; p << 0.001) was seen in the overall population. The corresponding mean BP reduction for patients on amlodipine/valsartan 5/160 mg was −34.6/−19.2 mmHg (baseline: 166/101 mmHg; p << 0.001) and for patients on amlodipine/valsartan 10/160 mg was −47.1/−24.3 mmHg (baseline: 178.6/106.4 mmHg; p << 0.001). In a post-hoc analysis for subgroups with important co-morbid conditions, the corresponding mean BP reductions were: patients with diabetes; −41.1/−21.6 mmHg (baseline 173.2/103.5 mmHg; p = 0.00001), patients with history of heart failure; −45.2/−22.8 mmHg (baseline 175.9/104.6 mmHg; p = 0.00001), patients with history of coronary heart diseases; −43/22.7 mmHg (baseline: 175.8/105 mmHg; p = 0.00001). A small change in the heart rate was noticed (82 bpm at baseline and 78.4 bpm at the end of study; p << 0.001). 70.3% of patients had their blood pressure controlled (BP <<140/90 mmHg). Subjective investigators assessment as “excellent to very good” for amlodipine/valsartan SPC was 97.3% for effectiveness and 96.8% for tolerability. The corresponding investigators and patients assessment for compliance was 96.6% and 93.3% respectively. Adverse events were reported in 4.4% of patients mainly due to edema in 3.6%. Amlodipine/valsartan SPC was generally well tolerated.ConclusionThe Results of this study showed that Single-pill combination of amlodipine/valsartan effectively reduced BP among Egyptian hypertensive patients with high tolerability profile and provided evidence that most of hypertensive patients may benefit from this combination.