PMID- 32753164
OWN - NLM
STAT- MEDLINE
DCOM- 20210519
LR  - 20221207
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 42
IP  - 9
DP  - 2020 Sep
TI  - Exenatide Once Weekly: Effectiveness, Tolerability, and Discontinuation 
      Predictors in a Real-world Setting.
PG  - 1738-1749.e1
LID - S0149-2918(20)30334-9 [pii]
LID - 10.1016/j.clinthera.2020.07.002 [doi]
AB  - PURPOSE: The goal of this study was to evaluate the effectiveness and safety of 
      exenatide once weekly (EOW) and to determine predictors of treatment response and 
      drug discontinuation in patients with type 2 diabetes mellitus (T2DM) followed up 
      for 18 months in a real-world setting. METHODS: This retrospective cohort study 
      included patients with T2DM who initiated EOW 2 mg between 2014 and 2019 in an 
      outpatient diabetes clinic in Italy. Data were collected at baseline and at 
      follow-up visits (6, 12, and 18 months after EOW). We estimated glycosylated 
      hemoglobin (HbA(1c)) and body weight mean changes from baseline to follow-up 
      visits and assessed the proportion of patients reaching HbA(1c) target </=7% and a 
      5% weight loss after 12 months of treatment. We then attempted to establish 
      predictors of glycemic and weight response, and compared patient characteristics 
      between subjects who persisted on treatment versus those who discontinued EOW. 
      FINDINGS: One-hundred eighty-six patients (46.2% male) were included in the 
      study. The mean (SD) age and diabetes duration were 63.2 (8.9) years and 10.7 
      years (18.3), respectively. Significant reductions in HbA(1c) values (-0.9%; 95% 
      CI, -1.1 to -0.8) and body weight (-2.8 kg; 95% CI, -3.4 to -2.2) were observed 
      after 6 months. Sixty-one percent of patients (87 of 143) achieved target HbA(1c) 
      values </= 7% after 12 months, and 34% (45 of 134) exhibited a weight loss of at 
      least 5% of baseline body weight. Blood glucose and weight reductions were 
      maintained after an 18-month follow-up. Predictors of adequate glycemic and 
      weight response were shorter diabetes duration and nonuse of a different GLP-1RA, 
      respectively. Patients on sulfonylureas failed to reach metabolic and body weight 
      targets. The most common adverse events were gastrointestinal side effects (7.5%) 
      and injection site reactions (6.4%), followed by headache (1.1%) and allergic 
      reactions (1.1%). Forty-three percent of patients (79 of 186) discontinued EOW. 
      The main reasons for discontinuation were insufficient HbA(1c) improvement and/or 
      limited weight reduction (19.9%), side effects (16.1%), or patient decision 
      (6.5%). Predictors of discontinuation were higher HbA(1c) levels at baseline and 
      use of basal insulin therapy before EOW treatment. IMPLICATIONS: EOW treatment, 
      in a real-world setting, offers sustained and effective glycemic control and 
      weight loss over 18 months in patients with T2DM. Diabetes duration and basal 
      insulin therapy, however, may affect the outcome of EOW treatment, suggesting 
      that early initiation of EOW could improve glycemic control and reduce the risk 
      of treatment discontinuation.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Di Dalmazi, Giulia
AU  - Di Dalmazi G
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Coluzzi, Sara
AU  - Coluzzi S
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Baldassarre, Maria P A
AU  - Baldassarre MPA
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Sorbo, Sofia Elena
AU  - Sorbo SE
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy.
FAU - Dell'Aquila, Stefania
AU  - Dell'Aquila S
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy.
FAU - Febo, Fabrizio
AU  - Febo F
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Ginestra, Federica
AU  - Ginestra F
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Graziano, Giusi
AU  - Graziano G
AD  - CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, Pescara, 
      Italy.
FAU - Rossi, Maria C
AU  - Rossi MC
AD  - CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, Pescara, 
      Italy.
FAU - Consoli, Agostino
AU  - Consoli A
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy.
FAU - Formoso, Gloria
AU  - Formoso G
AD  - Department of Medicine and Aging Sciences, G. D'Annunzio University, Chieti, 
      Italy; Center for Advanced Studies and Technology (CAST), G. D'Annunzio 
      University, Chieti, Italy. Electronic address: gloria.formoso@unich.it.
LA  - eng
PT  - Journal Article
DEP - 20200801
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Sulfonylurea Compounds)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Body Weight/drug effects
MH  - Cohort Studies
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Exenatide/*therapeutic use
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin/therapeutic use
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Sulfonylurea Compounds/therapeutic use
MH  - Time Factors
OTO - NOTNLM
OT  - clinical practice
OT  - exenatide once weekly
OT  - real-world evidence
OT  - type 2 diabetes mellitus
EDAT- 2020/08/06 06:00
MHDA- 2021/05/20 06:00
CRDT- 2020/08/06 06:00
PHST- 2020/04/27 00:00 [received]
PHST- 2020/06/19 00:00 [revised]
PHST- 2020/07/02 00:00 [accepted]
PHST- 2020/08/06 06:00 [pubmed]
PHST- 2021/05/20 06:00 [medline]
PHST- 2020/08/06 06:00 [entrez]
AID - S0149-2918(20)30334-9 [pii]
AID - 10.1016/j.clinthera.2020.07.002 [doi]
PST - ppublish
SO  - Clin Ther. 2020 Sep;42(9):1738-1749.e1. doi: 10.1016/j.clinthera.2020.07.002. 
      Epub 2020 Aug 1.