PMID- 27461213
OWN - NLM
STAT- MEDLINE
DCOM- 20170102
LR  - 20221207
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 36
IP  - 11
DP  - 2016 Nov
TI  - Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin 
      Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled 
      Analysis.
PG  - 925-933
AB  - BACKGROUND: In patients with type 2 diabetes mellitus (T2DM), dapagliflozin 
      improves glycemic control and has a safety profile typically related to its 
      mechanism of action. Hypersensitivity adverse events (AEs) have been reported in 
      some patients with sodium-glucose cotransporter 2 (SGLT2) inhibitors, including a 
      recent report of dermatological AEs in Japan. METHODS: We investigated the 
      frequency and characteristics of hypersensitivity AEs, including potentially 
      hypersensitivity-related skin AEs, across 21 phase IIb/III trials of 
      dapagliflozin (N = 5936) versus active or placebo comparators (N = 3403), 
      including the subpopulation of Asian patients (N = 1563). RESULTS: Overall, AEs 
      and serious AEs (SAEs) of hypersensitivity were infrequent and were reported in a 
      similar proportion of patients with dapagliflozin versus active or placebo 
      comparators (AEs: 4.5 vs. 4.3 %; SAEs: 0.2 vs. 0.1 %, respectively). The most 
      common events affected the skin or subcutaneous tissue: rash (dapagliflozin: 
      1.1 %, comparator: 1.1 %), eczema (0.6, 0.8 %), dermatitis (0.5, 0.4 %), and 
      urticaria (0.5, 0.2 %). Few patients discontinued as a result of hypersensitivity 
      AEs (</=0.2 %). In patients of Asian descent, a lower frequency of hypersensitivity 
      AEs was observed with dapagliflozin versus comparators (2.0 vs. 4.5 %). In the 
      subset of placebo-controlled trials, hypersensitivity AEs were slightly more 
      frequent with dapagliflozin than with placebo across the overall population (4.7 
      vs. 3.8 %), and less frequent with dapagliflozin in Asian patients (1.5 vs. 
      5.0 %). CONCLUSIONS: The findings of this post hoc analysis indicate that 
      dapagliflozin does not lead to an increased risk of serious hypersensitivity 
      reactions or potentially hypersensitivity-related skin events among patients with 
      T2DM, including Asian patients. Long-term outcome studies and postmarketing 
      surveillance will provide further information on hypersensitivity reactions with 
      SGLT2 inhibitors. CLINICALTRIALS. GOV IDENTIFIERS: NCT01042977, NCT01031680, 
      NCT00855166, NCT00984867, NCT01294423, NCT00673231, NCT00972244, NCT00680745, 
      NCT00660907, NCT01095653, NCT00831779, NCT00976495, NCT00859898, NCT00736879, 
      NCT00683878, NCT00663260, NCT00643851, NCT00528879, NCT00528372, NCT00357370, 
      NCT00263276.
FAU - Mellander, Annika
AU  - Mellander A
AD  - AstraZeneca Gothenburg, Patient Safety, Pepparredsleden 1, 43150, Molndal, 
      Sweden. annika.mellander@astrazeneca.com.
FAU - Billger, Martin
AU  - Billger M
AD  - AstraZeneca Gothenburg, Patient Safety, Pepparredsleden 1, 43150, Molndal, 
      Sweden.
FAU - Johnsson, Eva
AU  - Johnsson E
AD  - AstraZeneca Gothenburg, Patient Safety, Pepparredsleden 1, 43150, Molndal, 
      Sweden.
FAU - Traff, Anna Karin
AU  - Traff AK
AD  - AstraZeneca Gothenburg, Patient Safety, Pepparredsleden 1, 43150, Molndal, 
      Sweden.
FAU - Yoshida, Shigeru
AU  - Yoshida S
AD  - AstraZeneca, Osaka, Japan.
FAU - Johnsson, Kristina
AU  - Johnsson K
AD  - AstraZeneca Gothenburg, Patient Safety, Pepparredsleden 1, 43150, Molndal, 
      Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT00528372
SI  - ClinicalTrials.gov/NCT00263276
SI  - ClinicalTrials.gov/NCT00357370
SI  - ClinicalTrials.gov/NCT00528879
PT  - Journal Article
PT  - Meta-Analysis
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (SLC5A2 protein, human)
RN  - 0 (Sodium-Glucose Transporter 2)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
MH  - Asian People
MH  - Benzhydryl Compounds/administration & dosage/*adverse effects
MH  - Blood Glucose
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Hypersensitivity/etiology
MH  - Female
MH  - Glucosides/administration & dosage/*adverse effects
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/*adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Sodium-Glucose Transporter 2
MH  - Sodium-Glucose Transporter 2 Inhibitors
EDAT- 2016/10/22 06:00
MHDA- 2017/01/04 06:00
CRDT- 2016/07/28 06:00
PHST- 2016/10/22 06:00 [pubmed]
PHST- 2017/01/04 06:00 [medline]
PHST- 2016/07/28 06:00 [entrez]
AID - 10.1007/s40261-016-0438-3 [pii]
AID - 10.1007/s40261-016-0438-3 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.