title: Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients: a 96-week efficacy and safety study.
abstract: OBJECTIVE
  Antihypertensive therapy is effective in reducing the risk of major adverse cardiovascular events. However, blood pressure (BP) control rate remains poor and the optimal combination therapy against hypertension is not established in China. The objective of this study was to evaluate the long-term efficacy and safety of two antihypertensive regimens, amlodipine plus telmisartan and amlodipine plus amiloride/hydrochlorothiazide, in patients with essential hypertension and at least one cardiovascular risk factor.
  
  
  METHODS
  In a multicenter open-label clinical trial, eligible patients were randomized to receive treatment with amlodipine 2.5-5 mg plus amiloride/hydrochlorothiazide 1.25-2.5 mg/12.5-25 mg (Group A) or amlodipine 2.5-5 mg plus telmisartan 40-80 mg (Group T). If a target BP was not reached, other antihypertensive agents would be added. The target BP was <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease and <140/90 mmHg for others. Efficacy variables were changes from baseline in systolic BP and diastolic BP at the endpoint of 96 weeks. Safety evaluations included monitoring of any adverse events (AEs).
  
  
  RESULTS
  Of 13,542 patients randomized, 13,080 (96.6%) completed the study: 6529 in Group A and 6551 in Group T. At endpoint, the BP levels were reduced by 27.4/14.3 mmHg in Group A and 27.1/14.5 mmHg in Group T. The BP control rates were similar for the two therapeutic regimens (87.5% vs 86.1%). Less than 4% of patients in each group discontinued their drugs during follow-up. Peripheral edema was one of the most common AEs, and occurred in only 24 patients in Group A and 19 in Group T.
  
  
  CONCLUSIONS
  Long-term combination therapy with amlodipine plus telmisartan or amlodipine plus amiloride/hydrochlorothiazide was not only well tolerated but also efficacious in reducing BP levels with acceptable control rates in the majority of hypertensive patients.
  
  
  BACKGROUND
  ClinicalTrials.gov number NCT01011660.
authors.affiliation: Department of Evidence-Based Medicine, Cardiovascular Institute, Beijing, China.
authors.forename: Liyuan
authors.initials: L
authors.lastname: Ma
authors.forename: Wen
authors.initials: W
authors.lastname: Wang
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhao
authors.forename: Yuqing
authors.initials: Y
authors.lastname: Zhang
authors.forename: Qing
authors.initials: Q
authors.lastname: Deng
authors.forename: Mingbo
authors.initials: M
authors.lastname: Liu
authors.forename: Hui
authors.initials: H
authors.lastname: Sun
authors.forename: Jianchun
authors.initials: J
authors.lastname: Wang
authors.forename: Lisheng
authors.initials: L
authors.lastname: Liu
mesh_terms: D000368:Aged; D000584:Amiloride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001565:Benzoates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D002681:China; D004232:Diuretics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D000077333:Telmisartan; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D004232:Diuretics; D004338:Drug Combinations; D006852:Hydrochlorothiazide; D017311:Amlodipine; C010247:amiloride, hydrochlorothiazide drug combination; D000584:Amiloride; D000077333:Telmisartan