PMID- 32316581
OWN - NLM
STAT- MEDLINE
DCOM- 20210113
LR  - 20210113
IS  - 2072-6643 (Electronic)
IS  - 2072-6643 (Linking)
VI  - 12
IP  - 4
DP  - 2020 Apr 17
TI  - Efficacy and Safety of Polaprezinc (Zinc Compound) on Zinc Deficiency: A 
      Systematic Review and Dose-Response Meta-Analysis of Randomized Clinical Trials 
      Using Individual Patient Data.
LID - 10.3390/nu12041128 [doi]
LID - 1128
AB  - Zinc intake is recommended for zinc deficiency. In clinical practice, polaprezinc 
      has been used as a zinc replacement therapy for zinc deficiency. However, the 
      efficacy of polaprezinc has not been established. To confirm the efficacy on zinc 
      deficiency of polaprezinc and provide additional information on an appropriate 
      regimen, we conducted a systematic review using individual patient data (IPD). We 
      searched PubMed, the Japanese database Ichushi, and the database owned by the 
      marketing authorization holder of polaprezinc. Randomized placebo-controlled 
      trials that reported the serum zinc concentration were eligible. The mean 
      difference of the change from baseline in serum zinc concentration was estimated 
      using a fixed-effects model. The linear dose-response relationship and the 
      subgroup effects were also assessed. Out of 54 unique randomized clinical trials 
      (RCTs), four studies met the eligibility criteria, and we could access IPD for 
      all of them. All three doses of polaprezinc (75 mg, 150 mg, and 300 mg) and the 
      placebo group were examined. The dose-combined overall polaprezinc increased the 
      change from baseline by a mean of 9.08 microg/dL (95% confidence interval: 5.46, 
      12.70; heterogeneity: I2 = 0.61%) compared to the placebo. A significant 
      dose-response relationship was confirmed (p < 0.001). Baseline serum zinc 
      concentration was considered an effect modifier in polaprezinc 300 mg. All doses 
      of polaprezinc were tolerable, but a dose-response relationship with adverse 
      events (AEs) was observed in gastrointestinal disorders. The dose of 300 mg may 
      be useful among patients with baseline serum zinc concentration of less than 70 
      microg/dL, and 150 mg for 70 microg/dL or more.
FAU - Furihata, Kei
AU  - Furihata K
AD  - Biostatistics, Data Science, Clinical Administration, Zeria Pharmaceutical Co., 
      Ltd., 10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo 103-8351, Japan.
FAU - Tsuchikawa, Masaru
AU  - Tsuchikawa M
AD  - Biostatistics, Data Science, Clinical Administration, Zeria Pharmaceutical Co., 
      Ltd., 10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo 103-8351, Japan.
FAU - Miwa, Takaki
AU  - Miwa T
AD  - Department of Otorhinolaryngology, Kanazawa Medical University, 1-1 Daigaku, 
      Uchinada, Ishikawa 920-0293, Japan.
FAU - Naito, Yuji
AU  - Naito Y
AD  - Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural 
      University of Medicine, Graduate School of Medical Science, 465 Kajii-chi, 
      Kawaramachi-Hirokoji Kamigyo-ku, Kyoto 602-8566, Japan.
FAU - Oba, Koji
AU  - Oba K
AD  - Department of Biostatistics, School of Public Health, Graduate School of 
      Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, 
      Japan.
FAU - Sakagami, Masafumi
AU  - Sakagami M
AD  - Department of Otolaryngology-Head and Neck Surgery, Hyogo College of Medicine, 
      1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan.
LA  - eng
GR  - NA/Zeria Pharmaceutical Co., Ltd./
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20200417
PL  - Switzerland
TA  - Nutrients
JT  - Nutrients
JID - 101521595
RN  - 0 (Organometallic Compounds)
RN  - 0 (Zinc Compounds)
RN  - 0WA1B15A1Z (polaprezinc)
RN  - 8HO6PVN24W (Carnosine)
RN  - J41CSQ7QDS (Zinc)
SB  - IM
MH  - Carnosine/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Gastrointestinal Diseases
MH  - Humans
MH  - Male
MH  - Organometallic Compounds/*administration & dosage/adverse effects/*therapeutic 
      use
MH  - Randomized Controlled Trials as Topic
MH  - Safety
MH  - Treatment Outcome
MH  - Zinc/*deficiency
MH  - Zinc Compounds/administration & dosage/adverse effects/therapeutic use
PMC - PMC7230469
OTO - NOTNLM
OT  - IPD meta-analysis
OT  - polaprezinc
OT  - serum zinc concentration
OT  - systematic review
OT  - zinc L-carnosine
OT  - zinc deficiency
COIS- K.F. and M.T. are employees of Zeria Pharmaceutical Co., Ltd., T.M., Y.N. and 
      M.S. received consultant fee and travel expenses on this review from Zeria 
      Pharmaceutical Co., Ltd. K.O. received travel expenses on this review from Zeria 
      Pharmaceutical Co., Ltd.
EDAT- 2020/04/23 06:00
MHDA- 2021/01/14 06:00
PMCR- 2020/04/01
CRDT- 2020/04/23 06:00
PHST- 2020/03/13 00:00 [received]
PHST- 2020/04/15 00:00 [revised]
PHST- 2020/04/15 00:00 [accepted]
PHST- 2020/04/23 06:00 [entrez]
PHST- 2020/04/23 06:00 [pubmed]
PHST- 2021/01/14 06:00 [medline]
PHST- 2020/04/01 00:00 [pmc-release]
AID - nu12041128 [pii]
AID - nutrients-12-01128 [pii]
AID - 10.3390/nu12041128 [doi]
PST - epublish
SO  - Nutrients. 2020 Apr 17;12(4):1128. doi: 10.3390/nu12041128.