PMID- 36548746
OWN - NLM
STAT- MEDLINE
DCOM- 20221226
LR  - 20230125
IS  - 2072-6651 (Electronic)
IS  - 2072-6651 (Linking)
VI  - 14
IP  - 12
DP  - 2022 Dec 3
TI  - Real-World Evaluation of the Tolerability to Onabotulinum Toxin A: The RETO 
      Study.
LID - 10.3390/toxins14120850 [doi]
LID - 850
AB  - Onabotulinumtoxin A (onabotA) has shown efficacy in chronic migraine (CM), with 
      good tolerability and a low rate of adverse effects, most of them not severe. The 
      aim of this study is to evaluate tolerability and adverse effects of onabotA in 
      clinical practice and to analyze if there is a relationship between tolerability 
      to treatment administration, adverse effects' (AEs) occurrence and clinical 
      response. We included patients with CM that received treatment with onabotA for 
      the first time. Tolerability to treatment was evaluated by a 0-10 numeric rating 
      scale (0: worst possible, 10: optimal tolerability). We assessed the presence of 
      AEs by using a standardized questionnaire. Treatment response was based on the 50 
      and 75% responder rate between weeks 20 and 24, compared with the baseline, 
      according to headache diaries. We analyzed whether the tolerability was 
      associated with a higher frequency of AEs or a higher probability of clinical 
      response. We included 105 patients, 87.7% female, with an age of 43.9 +/- 10.7 
      years. Mean tolerability was 7.8/10 and 7.2/10 in the first and second onabotA 
      administration, respectively. AEs were reported by (first-second) 71.4-68.6% 
      patients. The percentage of patients with a 50% response was 56.3%. There was no 
      association between tolerability and AEs' occurrence or clinical response.
FAU - Garcia-Azorin, David
AU  - Garcia-Azorin D
AUID- ORCID: 0000-0002-3132-1064
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
AD  - Department of Medicine, University of Valladolid, 47002 Valladolid, Spain.
FAU - Martinez, Blanca
AU  - Martinez B
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
FAU - Gutierrez, Maria
AU  - Gutierrez M
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
FAU - Ruiz-Pinero, Marina
AU  - Ruiz-Pinero M
AUID- ORCID: 0000-0002-1508-0168
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
FAU - Echavarria, Ana
AU  - Echavarria A
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
FAU - Sierra, Alvaro
AU  - Sierra A
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
FAU - Guerrero, Angel L
AU  - Guerrero AL
AUID- ORCID: 0000-0001-7493-6002
AD  - Headache Unit, Neurology Department, Hospital Clinico Universitario de 
      Valladolid, 47005 Valladolid, Spain.
AD  - Department of Medicine, University of Valladolid, 47002 Valladolid, Spain.
LA  - eng
PT  - Journal Article
DEP - 20221203
PL  - Switzerland
TA  - Toxins (Basel)
JT  - Toxins
JID - 101530765
RN  - EC 3.4.24.69 (onabotulinum toxin A)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Humans
MH  - Female
MH  - Adult
MH  - Middle Aged
MH  - Male
MH  - *Botulinum Toxins, Type A/toxicity
MH  - Treatment Outcome
MH  - Chronic Disease
MH  - *Migraine Disorders/drug therapy
PMC - PMC9783903
OTO - NOTNLM
OT  - adverse effects
OT  - chronic migraine
OT  - onabotA
COIS- The authors declare no conflict of interest.
EDAT- 2022/12/23 06:00
MHDA- 2022/12/27 06:00
PMCR- 2022/12/03
CRDT- 2022/12/22 15:13
PHST- 2022/11/13 00:00 [received]
PHST- 2022/11/29 00:00 [revised]
PHST- 2022/11/30 00:00 [accepted]
PHST- 2022/12/22 15:13 [entrez]
PHST- 2022/12/23 06:00 [pubmed]
PHST- 2022/12/27 06:00 [medline]
PHST- 2022/12/03 00:00 [pmc-release]
AID - toxins14120850 [pii]
AID - toxins-14-00850 [pii]
AID - 10.3390/toxins14120850 [doi]
PST - epublish
SO  - Toxins (Basel). 2022 Dec 3;14(12):850. doi: 10.3390/toxins14120850.