title: Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.
abstract: BACKGROUND
  The clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy.
  
  
  METHODS
  Patients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed.
  
  
  RESULTS
  Of a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated.
  
  
  CONCLUSIONS
  This large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.
authors: Department of Diabetology, Lipidology and Metabolism, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
authors: Samir Helmy
authors: SH
authors: Assaad-Khalil
authors: Lebanese University Hospital, Beirut, Lebanon.
authors: Robert
authors: R
authors: Najem
authors: Medical Center Manila, Manila, Philippines.
authors: Jorge
authors: J
authors: Sison
authors: Pakistan Institute of Medical Sciences, Islamabad, Pakistan.
authors: Asad Riaz
authors: AR
authors: Kitchlew
authors: Seoul National University College of Medicine, Seoul, South Korea.
authors: Belong
authors: B
authors: Cho
authors: Chung Shan Medical University Hospital, Taichung City, Taiwan.
authors: Kwo-Chang
authors: KC
authors: Ueng
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Shelley
authors: S
authors: DiTommaso
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Abhijit
authors: A
authors: Shete
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; 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*; D001208:Asia / Q000453:epidemiology; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D008877:Middle East / Q000453:epidemiology; D011446:Prospective Studies; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D013607:Tablets; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine
keywords: amlodipine; hydrochlorothiazide; real world; single-pill combinations; valsartan
references: Lancet. 2005 Jan 15-21;365(9455):217-23
references: 15652604
references: Adv Ther. 2014 Jul;31(7):762-75
references: 24985411
references: J Clin Hypertens (Greenwich). 2004 Sep;6(9):501-8
references: 15365277
references: Hypertension. 2003 Dec;42(6):1206-52
references: 14656957
references: Am J Cardiovasc Drugs. 2013 Jun;13(3):163-75
references: 23579967
references: J Clin Hypertens (Greenwich). 2008 Mar;10(3):185-94
references: 18326958
references: JAMA. 2013 Sep 4;310(9):959-68
references: 24002282
references: Am J Hypertens. 2004 Oct;17(10):904-10
references: 15485752
references: J Am Soc Hypertens. 2008 Jul-Aug;2(4):294-302
references: 20409909
references: J Clin Hypertens (Greenwich). 2008 Jul;10(7):567-74
references: 18607142
references: Integr Blood Press Control. 2013 Jun 17;6:69-78
references: 23837009
references: J Cardiometab Syndr. 2007 Spring;2(2):114-8
references: 17684464
references: J Clin Hypertens (Greenwich). 2007 May;9(5):355-64
references: 17485971
references: Curr Med Res Opin. 2014 Oct;30(10):1937-45
references: 25007309
references: Clin Interv Aging. 2009;4:379-89
references: 19851513
references: J Formos Med Assoc. 2010 Oct;109(10):740-73
references: 20970072
references: J Hum Hypertens. 2009 Jul;23(7):479-89
references: 19190658
references: Blood Press. 2013 Sep;22 Suppl 1:11-21
references: 23713686
references: Int J Clin Pract. 2008 Sep;62(9):1306-12
references: 18643931
references: J Hypertens. 2013 Jul;31(7):1281-357
references: 23817082
references: Hypertension. 2000 May;35(5):1021-4
references: 10818056
references: Curr Med Res Opin. 2013 Aug;29(8):901-10
references: 23721363
references: Clin Ther. 2007 Feb;29(2):279-89
references: 17472820
references: J Clin Hypertens (Greenwich). 2014 Jan;16(1):14-26
references: 24341872
references: Obesity (Silver Spring). 2013 Jan;21(1):8-24
references: 23401272
references: Adv Ther. 2009 Nov;26(11):1012-23
references: 20024680
references: BMJ. 1998 Sep 12;317(7160):703-13
references: 9732337
references: Expert Rev Cardiovasc Ther. 2012 Nov;10(11):1367-73
references: 23244357
references: JAMA. 2003 May 21;289(19):2560-72
references: 12748199
references: Turk Kardiyol Dern Ars. 2013 Jul;41(5):406-17
references: 23917006
references: Vasc Health Risk Manag. 2010;6:321-5
references: 20531950
references: Diabetes Care. 2011 May;34 Suppl 2:S128-31
references: 21525443