PMID- 27747834
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 3
IP  - 3
DP  - 2016 Sep
TI  - Real-life Effectiveness and Safety of Amlodipine/Valsartan Single-pill 
      Combination in Patients with Hypertension in Egypt: Results from the EXCITE 
      Study.
PG  - 307-315
AB  - BACKGROUND: EXCITE (clinical experience of amlodipine and valsartan in 
      hypertension) evaluated the real-world effectiveness and safety of single-pill 
      combinations (SPCs) of amlodipine/valsartan (Aml/Val) and 
      amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with 
      hypertension from the Middle East and Asia. OBJECTIVE: The objective of this 
      study was to report the results of EXCITE study from Egypt, where all patients 
      were prescribed Aml/Val. METHODS: This was a 26-week, observational, multicenter, 
      prospective, non-interventional, open-label study. Effectiveness was assessed as 
      change in the mean sitting systolic/diastolic blood pressure (msSBP/msDBP) from 
      baseline and the proportion of patients achieving the therapeutic blood pressure 
      (BP) goal (<140/90; <130/80 mmHg in patients with diabetes mellitus) and BP 
      response (SBP <140 mmHg or reduction of >/=20 mmHg; DBP <90 mmHg or reduction of 
      >/=10 mmHg). Safety was monitored by recording the incidence of adverse events 
      (AEs) and serious AEs (SAEs). RESULTS: A total of 2566 patients (mean age, 52.6 
      years; mean duration of hypertension, 7.9 years) were prescribed Aml/Val, of whom 
      2439 (95.1 %) completed the study. At week 26, Aml/Val SPC significantly (p < 
      0.0001) reduced msSBP/msDBP by -34.5/-19.4 mmHg from baseline (BP: 164.3/100.5 
      mmHg). Therapeutic goal, SBP response, and DBP response was achieved by 49.3, 
      91.1, and 91.4 % of patients, respectively. AEs were reported in 12.5 % of 
      patients, with the most common including peripheral edema (1.8 %), bronchitis 
      (1.1 %), and gastritis (0.8 %), and SAEs in 0.5 % of patients. Two deaths were 
      reported during the study, none of which were considered to be study drug related 
      by the investigators. CONCLUSION: Aml/Val SPC provided clinically significant BP 
      reductions and was generally well tolerated in patients with hypertension from 
      Egypt.
FAU - Assaad-Khalil, Samir H
AU  - Assaad-Khalil SH
AD  - Department of Internal Medicine, Alexandria Faculty of Medicine, 27 Talaat Harb 
      Str./Ramleh Station/Attarin, Alexandria, Egypt. assaadkhalil@hotmail.com.
FAU - Nashaat, Nashwa
AU  - Nashaat N
AD  - Novartis Pharma S.A.E, Cairo, Egypt.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC5042938
COIS- Compliance with Ethical Standards Ethical approval The study protocol was 
      reviewed and approved by an institutional review board/independent ethics 
      committee/research ethics board before the start of the study. All procedures 
      performed in studies involving human participants were in accordance with the 
      ethical standards of the institutional and/or national research committee and 
      with the 1964 Helsinki Declaration and its later amendments or comparable ethical 
      standards. Informed consent Informed consent was obtained from all individual 
      participants included in the study. Conflict of interest Samir H. Assaad-Khalil 
      has received investigator fees related to the conduct of the EXCITE study from 
      Novartis and its affiliates. Nashwa Nashaat was an employee of Novartis Pharma 
      S.A.E at the time of study completion and manuscript preparation. Funding The 
      EXCITE study was funded by Novartis Pharma AG, Basel, Switzerland. This work was 
      supported by Novartis Pharma, Cairo, Egypt. Medical writing and editorial 
      assistance for manuscript preparation was funded by Novartis Pharma, Cairo, 
      Egypt.
EDAT- 2016/10/18 06:00
MHDA- 2016/10/18 06:01
PMCR- 2016/08/08
CRDT- 2016/10/18 06:00
PHST- 2016/10/18 06:00 [entrez]
PHST- 2016/10/18 06:00 [pubmed]
PHST- 2016/10/18 06:01 [medline]
PHST- 2016/08/08 00:00 [pmc-release]
AID - 10.1007/s40801-016-0082-5 [pii]
AID - 82 [pii]
AID - 10.1007/s40801-016-0082-5 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2016 Sep;3(3):307-315. doi: 10.1007/s40801-016-0082-5.