PMID- 23917006
OWN - NLM
STAT- MEDLINE
DCOM- 20150504
LR  - 20181023
IS  - 1016-5169 (Print)
IS  - 1016-5169 (Linking)
VI  - 41
IP  - 5
DP  - 2013 Jul
TI  - Efficacy and safety of valsartan and amlodipine single-pill combination in 
      hypertensive patients (PEAK study).
PG  - 406-17
LID - 10.5543/tkda.2013.60052 [doi]
AB  - OBJECTIVES: This study was designed to assess the safety, compliance and efficacy 
      of amlodipine (Aml) and valsartan (Val) single-pill combination (SPC) in a large 
      hypertensive patient population. STUDY DESIGN: This is a non-interventional, 
      observational, open label study conducted in 166 centers in Turkey with a 24-week 
      follow-up period. RESULTS: Of the 1184 enrolled patients, two-thirds were female 
      (62.2%). The mean age was 57.7+/-11.3 years, and 26.1% of the patients were older 
      than 65 years. The majority of patients (82.3%) were overweight or obese. During 
      the course of the study, 150 (12.7%) patients experienced a total of 174 adverse 
      events (AEs). The overall mean (SD) compliance rate was determined to be 96.9 
      (0.2)%. The most commonly reported AE was edema, with a new-onset edema incidence 
      of 6.7%. In the entire group, Aml/Val SPC significantly reduced both systolic and 
      diastolic blood pressure (BP), with a reduction of 29.6+/-0.9 / 14.7+/-0.6 mmHg (for 
      each, p<0.001). CONCLUSION: As a result of the low incidences of AEs and 
      new-onset edema, the safety profile of Aml/Val SPC proved to be optimal. Aml/Val 
      SPC reduced BP efficiently and met the needs of most patients to achieve the 
      targets. Aml/Val SPC seems to be a beneficial option for effective BP control, 
      which is a key factor influencing cardiovascular outcome.
FAU - Kizilirmak, Pinar
AU  - Kizilirmak P
AD  - Novartis Pharmaceuticals, Istanbul, Turkey. pkizilirmak@gmail.com
FAU - Berktas, Mehmet
AU  - Berktas M
FAU - Yalcin, Mehmet Ridvan
AU  - Yalcin MR
FAU - Boyaci, Bulent
AU  - Boyaci B
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Turkey
TA  - Turk Kardiyol Dern Ars
JT  - Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir
JID - 9426239
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Tetrazoles)
RN  - 1J444QC288 (Amlodipine)
RN  - 80M03YXJ7I (Valsartan)
RN  - HG18B9YRS7 (Valine)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Amlodipine/*administration & dosage/adverse effects
MH  - Antihypertensive Agents/*administration & dosage/adverse effects
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance
MH  - Tetrazoles/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Turkey
MH  - Valine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Valsartan
EDAT- 2013/08/07 06:00
MHDA- 2015/05/06 06:00
CRDT- 2013/08/07 06:00
PHST- 2013/08/07 06:00 [entrez]
PHST- 2013/08/07 06:00 [pubmed]
PHST- 2015/05/06 06:00 [medline]
AID - 10.5543/tkda.2013.60052 [doi]
PST - ppublish
SO  - Turk Kardiyol Dern Ars. 2013 Jul;41(5):406-17. doi: 10.5543/tkda.2013.60052.