PMID- 22329591
OWN - NLM
STAT- MEDLINE
DCOM- 20120711
LR  - 20181201
IS  - 1179-187X (Electronic)
IS  - 1175-3277 (Linking)
VI  - 12
IP  - 2
DP  - 2012 Apr 1
TI  - Combination of amlodipine plus angiotensin receptor blocker or diuretics in 
      high-risk hypertensive patients: a 96-week efficacy and safety study.
PG  - 137-42
LID - 10.2165/11598110-000000000-00000 [doi]
AB  - BACKGROUND AND OBJECTIVES: 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. CLINICAL TRIALS REGISTRATION: 
      ClinicalTrials.gov number NCT01011660.
FAU - Ma, Liyuan
AU  - Ma L
AD  - Department of Evidence-Based Medicine, Cardiovascular Institute, Beijing, China.
FAU - Wang, Wen
AU  - Wang W
FAU - Zhao, Yong
AU  - Zhao Y
FAU - Zhang, Yuqing
AU  - Zhang Y
FAU - Deng, Qing
AU  - Deng Q
FAU - Liu, Mingbo
AU  - Liu M
FAU - Sun, Hui
AU  - Sun H
FAU - Wang, Jianchun
AU  - Wang J
FAU - Liu, Lisheng
AU  - Liu L
LA  - eng
SI  - ClinicalTrials.gov/NCT01011660
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Am J Cardiovasc Drugs
JT  - American journal of cardiovascular drugs : drugs, devices, and other 
      interventions
JID - 100967755
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Benzoates)
RN  - 0 (Diuretics)
RN  - 0 (Drug Combinations)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 1J444QC288 (Amlodipine)
RN  - 68529-45-3 (amiloride, hydrochlorothiazide drug combination)
RN  - 7DZO8EB0Z3 (Amiloride)
RN  - U5SYW473RQ (Telmisartan)
SB  - IM
MH  - Aged
MH  - Amiloride/administration & dosage/adverse effects/*therapeutic use
MH  - Amlodipine/administration & dosage/adverse effects/therapeutic use
MH  - Angiotensin II Type 1 Receptor Blockers/administration & dosage/adverse 
      effects/therapeutic use
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Benzimidazoles/administration & dosage/adverse effects/therapeutic use
MH  - Benzoates/administration & dosage/adverse effects/therapeutic use
MH  - Blood Pressure/drug effects
MH  - Cardiovascular Diseases/etiology/prevention & control
MH  - China
MH  - Diuretics/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Hydrochlorothiazide/administration & dosage/adverse effects/*therapeutic use
MH  - Hypertension/complications/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Risk Factors
MH  - Telmisartan
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/02/15 06:00
MHDA- 2012/07/12 06:00
CRDT- 2012/02/15 06:00
PHST- 2012/02/15 06:00 [entrez]
PHST- 2012/02/15 06:00 [pubmed]
PHST- 2012/07/12 06:00 [medline]
AID - 10.2165/11598110-000000000-00000 [doi]
PST - ppublish
SO  - Am J Cardiovasc Drugs. 2012 Apr 1;12(2):137-42. doi: 
      10.2165/11598110-000000000-00000.