Alogliptin benzoate
Adults with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products, including insulin, when these together with diet and exercise do not provide adequate control.
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
53%
47%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No clinically relevant differences in glycaemic efficacy were observed between men and women; reductions in HbA1c were similar across gender subgroups.
Sex-specific posology
No sex-specific data
No sex- or gender-specific dose adjustments are required; the recommended adult dose for men is 25 mg alogliptin once daily, with renal dose adjustments based on kidney function rather than sex.
No sex- or gender-specific dose adjustments are required; the recommended adult dose for women is 25 mg alogliptin once daily, with renal dose adjustments based on kidney function rather than sex.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
There are no data on the use of alogliptin in pregnant women. Animal studies do not indicate harmful effects with respect to reproductive toxicity, but as a precautionary measure its use during pregnancy should be avoided. It is unknown whether alogliptin is excreted in human milk; a decision should be made to discontinue breast-feeding or discontinue therapy, considering the benefit for the child and the woman.
Sex-specific non-clinical findings
No human data are available on the effects of alogliptin on male or female fertility; animal studies showed no adverse effects on fertility.
No human data are available on the effects of alogliptin on female fertility; animal studies showed no adverse effects on fertility.
Disease prevalence by sex
Men
53%
Women
47%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No clinically relevant differences in glycaemic efficacy were observed between men and women; reductions in HbA1c were similar across gender subgroups.
Sex-specific posology
No sex-specific data
Men
No sex- or gender-specific dose adjustments are required; the recommended adult dose for men is 25 mg alogliptin once daily, with renal dose adjustments based on kidney function rather than sex.
Women
No sex- or gender-specific dose adjustments are required; the recommended adult dose for women is 25 mg alogliptin once daily, with renal dose adjustments based on kidney function rather than sex.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
There are no data on the use of alogliptin in pregnant women. Animal studies do not indicate harmful effects with respect to reproductive toxicity, but as a precautionary measure its use during pregnancy should be avoided. It is unknown whether alogliptin is excreted in human milk; a decision should be made to discontinue breast-feeding or discontinue therapy, considering the benefit for the child and the woman.
Sex-specific non-clinical findings
Men
No human data are available on the effects of alogliptin on male or female fertility; animal studies showed no adverse effects on fertility.
Women
No human data are available on the effects of alogliptin on female fertility; animal studies showed no adverse effects on fertility.
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
Across 13 studies involving 9,405 patients with type 2 diabetes mellitus, overall incidences of adverse events, serious adverse events, and discontinuations were comparable between alogliptin (25 mg and 12.5 mg), active control, and placebo; the most common adverse reaction with 25 mg alogliptin was headache. No adverse reactions were classified as very common (≥1/10). Common adverse reactions (≥1/100 to <1/10) included upper respiratory tract infections, nasopharyngitis, hypoglycaemia, headache, abdominal pain, gastroesophageal reflux disease, diarrhoea, pruritus, and rash. Important serious or clinically significant adverse reactions (frequency not known) included acute pancreatitis, hepatic dysfunction including hepatic failure, hypersensitivity reactions (including anaphylactic reactions and angioedema), exfoliative skin conditions such as Stevens‑Johnson syndrome and erythema multiforme, urticaria, bullous pemphigoid, and interstitial nephritis. Pooled analyses showed overall hypoglycaemia rates were low and similar or lower with alogliptin 25 mg compared to active control or placebo, with severe hypoglycaemia rare (0.1%).
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source