PMID- 27703364
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 12
DP  - 2016
TI  - In vitro and in vivo postmarketing surveillance of valsartan, alone or in 
      combination with amlodipine or hydrochlorothiazide, among Palestinian 
      hypertensive patients.
PG  - 1425-1432
AB  - OBJECTIVES: The objectives of this study were to evaluate the general quality of 
      the most prescribed products of valsartan (VL; alone or in combination) and to 
      evaluate their efficacy and safety among Palestinian population through in vivo 
      postmarketing surveillance. PATIENTS AND METHODS: The first part was 
      pharmacopeial quality control assay, including dissolution, disintegration, 
      friability, and weight uniformity for VL. The second part was a 3-month 
      cardiology clinics, observational, postmarketing surveillance pilot study that 
      included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as 
      monotherapy or combination therapy. The end points were reduction in blood 
      pressure (BP) and the rate of incidence of adverse effects (AEs) at weeks 4 and 
      8. RESULTS: According to our quality control tests, all VL products showed 
      high-quality standards according to the international guidelines. A reduction in 
      BP was observed at weeks 4 and 8, and no significant difference was observed 
      between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after 
      the use of combination therapy. Moreover, VL was well tolerated; most of the AEs 
      were of mild-to-moderate intensity. In general, the most frequently reported AEs 
      included headache (17.5%), dizziness (11.75%), and weakness (11.7%). No serious 
      AEs or death cases were reported during the study period. CONCLUSION: High 
      quality of VL tablet products was used; hence, the observed efficacy and safety 
      results should be related to patient's factors and not due to any product defects 
      or substandard quality. Moreover, VL is an effective treatment for essential 
      hypertension.
FAU - Zaid, Abdel Naser
AU  - Zaid AN
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Ghanem, Masshour
AU  - Ghanem M
AD  - Pharmacare Ltd, Ramallah, Palestine.
FAU - Shweiki, Dua'a
AU  - Shweiki D
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Shtewi, Hala
AU  - Shtewi H
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Shaheen, Raja'
AU  - Shaheen R
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Al Helaly, Sondos
AU  - Al Helaly S
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Khayyat, Zeina
AU  - Khayyat Z
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Al Ramahi, Rowa'a
AU  - Al Ramahi R
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
FAU - Zyoud, Sa'ed H
AU  - Zyoud SH
AD  - Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National 
      University, Nablus.
LA  - eng
PT  - Journal Article
DEP - 20160919
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC5036554
OTO - NOTNLM
OT  - Palestine
OT  - postmarketing
OT  - quality control
OT  - surveillance
OT  - valsartan
EDAT- 2016/10/06 06:00
MHDA- 2016/10/06 06:01
PMCR- 2016/09/19
CRDT- 2016/10/06 06:00
PHST- 2016/10/06 06:00 [entrez]
PHST- 2016/10/06 06:00 [pubmed]
PHST- 2016/10/06 06:01 [medline]
PHST- 2016/09/19 00:00 [pmc-release]
AID - tcrm-12-1425 [pii]
AID - 10.2147/TCRM.S110727 [doi]
PST - epublish
SO  - Ther Clin Risk Manag. 2016 Sep 19;12:1425-1432. doi: 10.2147/TCRM.S110727. 
      eCollection 2016.