Efficacy and Safety of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide Combinations

Abstract

Background: In stage II hypertensive patients, a combination antihypertensive therapy is required as in most of the cases the blood pressure (BP) -lowering goal is not achieved by monotherapy. Aliskiren [a first-in-class, orally active direct inhibitor of rennin] is effectively reduces the BP, both as monotherapy as well as in combination with other antihypertensive drugs. Although the safety of aliskiren in combination with amlodipine and hydrochlorothiazide is well established, a regional variation in response and safety of the combination may arise due to the genetic makeup of the study population and lifestyle choices. Objective: To evaluated the safety and efficacy of a combination of aliskiren and amlodipine with or without hydrochlorothiazide in stage II Hypertension in Thai patients population. Method: A 18-week, open-label non randomized study. Following a 2-week run-in period, 230 patients with stage II hypertension were enrolled treated to reach a target blood pressure (BP) < 130/80 mm Hg with treatment intensification sequence of aliskiren/amlodipine 150/5 mg, aliskiren/amlodipine 300/10 mg, aliskiren/amlodipine/hydrochlorothiazide 300/10/12.5 mg,andaliskiren/amlodipine/hydrochlorothiazide 300/10/25 mg for every 4 weeks. At each visit, patients achieving the BP goal (<130/80 mmHg) were excluded from further visits. The efficacy and safety were evaluated. Result: 88.2%(n = 195) patients achieved BP target with aliskiren/amlodipine 150/5 mg, whereas 10.4% (n = 23) required a treatment up-titration to aliskiren/amlodipine 300/10 mg, and only 1.3% (n = 3) patients required an addition of hydrochlorothiazide to the aliskiren/amlodipine combination. Subgroup analysis by age and diabetes status revealed similar treatment outcomes in this study. The combination was well tolerated, with only headache and vertigo as the most commonly occurring adverse events in 1.7% (n = 4) and 1.3% (n = 3) of the patients, respectively. Conclusion: Combinations of aliskiren and amlodipine or an addition of hydrochlorothiazide to the combination is effective and safe in the treatment of patients with stage II hypertension in Thailand.