PMID- 32557349
OWN - NLM
STAT- MEDLINE
DCOM- 20210208
LR  - 20221207
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 8
DP  - 2020 Aug
TI  - Real-World Effectiveness and Safety of a Single-Pill Combination of 
      Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Essential 
      Hypertension (RESOLVE): A Large, Observational, Retrospective, Cohort Study.
PG  - 3500-3514
LID - 10.1007/s12325-020-01404-z [doi]
AB  - BACKGROUND: The efficacy and safety of a single-pill combination (SPC) of 
      olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) have been established 
      previously through multiple studies. However, the real-world data in Korean 
      patients are still limited. This study evaluated the effectiveness and safety of 
      SPC of OLM/AML/HCTZ in a real practice setting in Korean patients with essential 
      hypertension. METHODS: This was an observational, retrospective, multi-center, 
      non-comparative cohort study. Medical records of 9749 patients with essential 
      hypertension who had been prescribed OLM/AML/HCTZ within 1 year of the study were 
      analyzed. The primary outcome was the achievement rate (%) of the target blood 
      pressure goal of a systolic blood pressure (SBP) of < 140 mmHg and a diastolic 
      blood pressure (DBP) of < 90 mmHg following administration of OLM/AML/HCTZ. The 
      secondary outcomes included the rate of BP control measured at each visit, the 
      amount of BP reduction compared to the index date, and the prescribing patterns 
      of OLM/AML/HCTZ. Safety and tolerability were assessed by the incidence rate of 
      adverse events (AEs) and discontinuation. RESULTS: In the effectiveness analysis 
      set (n = 9604), the overall achievement rate of target BP was 82.56%. The mean 
      SBP/DBP was significantly reduced compared to baseline at all visits (all 
      p < 0.0001), with the greatest reduction occurring at week 2. The achievement 
      rate of target BP was above 71%, regardless of the presence of risk factors 
      (diabetes mellitus, DM; cardiovascular disease, CVD; chronic kidney disease, 
      CKD). Patients with CVD and aged > 65 years showed a significantly higher 
      achievement rate (p < 0.05). A significant relationship existed between the 
      primary outcome and age (p < 0.0001). The achievement rate exceeded 74% in all 
      different age groups. In the safety analysis set (n = 9661), AEs were reported in 
      8.46% of patients, with the most frequent AE being dizziness. Serious adverse 
      events (SAEs) and unexpected adverse events (UAEs) occurred in 0.96% and 3.73% 
      patients, respectively. This was consistent with the previously reported safety 
      profile of OLM/AML/HCTZ. The majority of AEs were mild to moderate and resolved 
      during the observation period. The discontinuation rate of OLM/AML/HCTZ due to 
      AEs was 1.67%. CONCLUSION: This study demonstrated significant effectiveness of 
      OLM/AML/HCTZ in achieving target BP in Korean patients with essential 
      hypertension. OLM/AML/HCTZ was well tolerated.
FAU - Park, Sung-Ji
AU  - Park SJ
AUID- ORCID: 0000-0002-7075-847X
AD  - Division of Cardiology, Department of Medicine, Cardiovascular Imaging Center, 
      Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Republic of Korea. sungji.park@samsung.com.
FAU - Rhee, Si Jae
AU  - Rhee SJ
AD  - Medical Affairs Department, Daiichi Sankyo Korea Co., Ltd., Seoul, Republic of 
      Korea.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200618
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Imidazoles)
RN  - 0 (Tetrazoles)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 1J444QC288 (Amlodipine)
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Amlodipine/*therapeutic use
MH  - Antihypertensive Agents/*therapeutic use
MH  - Asian People
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Essential Hypertension/*drug therapy
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/*therapeutic use
MH  - Imidazoles/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Republic of Korea
MH  - Retrospective Studies
MH  - Tetrazoles/*therapeutic use
OTO - NOTNLM
OT  - Achievement of target blood pressure
OT  - Effectiveness
OT  - Essential hypertension
OT  - Observational study
OT  - Olmesartan
OT  - Real-world
OT  - Retrospective
OT  - Safety
OT  - Single pill combination
EDAT- 2020/06/20 06:00
MHDA- 2021/02/09 06:00
CRDT- 2020/06/20 06:00
PHST- 2020/04/22 00:00 [received]
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/02/09 06:00 [medline]
PHST- 2020/06/20 06:00 [entrez]
AID - 10.1007/s12325-020-01404-z [pii]
AID - 10.1007/s12325-020-01404-z [doi]
PST - ppublish
SO  - Adv Ther. 2020 Aug;37(8):3500-3514. doi: 10.1007/s12325-020-01404-z. Epub 2020 
      Jun 18.