Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon‐like peptide‐1 receptor agonists: A systematic analysis of published clinical trials

Bettge, Karolin; Kahle, Melanie; Aziz, Mirna S. Abd El; Meier, Juris J.

doi:10.1111/dom.12824

Cited by 235 publications

(205 citation statements)

References 59 publications

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“…Discontinuation due to nausea was low and not dose dependent. The incidence reported in this study was comparable to the incidence reported with other GLP-1 RAs (17,18).…”

Section: Discussionsupporting

confidence: 86%

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

et al. 2017

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OBJECTIVEITCA 650 (exenatide in osmotic mini-pump) continuously delivers exenatide subcutaneously for 3-6 months. Two doses of ITCA 650 were compared with placebo in patients with uncontrolled type 2 diabetes. RESEARCH DESIGN AND METHODSThis 39-week, phase 3, double-blind, placebo-controlled trial randomized 460 patients aged 18-80 years with glycated hemoglobin (HbA 1c ) 7.5-10% [58-86 mmol/mol] 1:1:1 to placebo, ITCA 650 40 mg/day, or ITCA 650 60 mg/day. Primary end point was change in HbA 1c at 39 weeks. was attained in 37%, 44%, and 9% of ITCA 650 40 mg/day, ITCA 650 60 mg/day, and placebo groups, respectively (P < 0.001 each dose vs. placebo). LS mean change from baseline body weight was 22.3 kg and 23.0 kg for ITCA 650 40 and 60 mg/day, respectively (P £ 0.015 vs. placebo 21.0 kg). Nausea was the most common adverse event (AE) and subsided over time. Discontinuation for gastrointestinal AEs occurred in 7.2% with ITCA and 1.3% with placebo. Most AEs associated with procedures to place and remove ITCA 650 were mild and transient. RESULTS Least squares (LS) mean change from baseline CONCLUSIONSITCA 650 significantly reduced HbA 1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.

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“…Discontinuation due to nausea was low and not dose dependent. The incidence reported in this study was comparable to the incidence reported with other GLP-1 RAs (17,18).…”

Section: Discussionsupporting

confidence: 86%

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

et al. 2017

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“…Although improvement in glucose metabolism has been repeatedly confirmed in 724 numerous preclinical and clinical studies, higher doses of GLP-1 are required to achieve a meaningful decrease in body weight. Furthermore, GLP-1 agonism confers dose-dependent gastrointestinal adverse effects that serve to limit the therapeutic intensity (Peters, 2013;Bettge et al, 2017). Nevertheless, when used as an adjunct to lifestyle changes, Saxenda (3 mg liraglutide; Novo Nordisk) is approved by the FDA for treatment of obesity.…”

Section: A Optimized Glucagon-like Peptide 1 Monoagonistsmentioning

confidence: 99%

Anti-Obesity Therapy: from Rainbow Pills to Polyagonists

et al. 2018

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“…В одном метаанализе АР ГПП-1, вводимые 1 р/нед, были более эффективны, чем эксенатид, вводимый 2 р/сут, в снижении уровня HbA 1c и сопровождались сравнимой динамикой массы тела и частотой гипогликемии [22]. В другом метаанализе АР ГПП-1 (включая лираглутид) были ассоциированы с более низкой частотой тошноты и рвоты, но с более высокой частотой диареи, чем АР ГПП-1 короткого действия [45]. Еще в одном метаанализе было показано, что снижение массы тела по сравнению с инсулинотерапией при применении АР ГПП-1 длитель-ного действия (включая лираглутид) обычно меньше, чем при применении АР ГПП-1 короткого действия [46].…”

Section: сравнение ар гпп-1unclassified

Evolution of glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes

Galstyan¹,

Karataeva²,

Yudovich³

2017

Diabetes mellitus

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Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon‐like peptide‐1 receptor agonists: A systematic analysis of published clinical trials

Abstract: GLP-1 RAs are associated with gastrointestinal AEs that are related to dose and background medications (especially metformin) and may vary in a compound-specific manner. Long-acting agents are associated with less nausea and vomiting but with more diarrhoea.

Cited by 235 publications

References 59 publications

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial

Anti-Obesity Therapy: from Rainbow Pills to Polyagonists

Evolution of glucagon-like peptide-1 receptor agonists for the treatment of type 2 diabetes

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