Safety and clinical effectiveness of iGlarLixi in people with type 2 diabetes mellitus in Mexico
Authors' conclusion
iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets.
Study context
- Population
- Adults with T2D prescribed iGlarLixi in routine clinical practice in Mexico; mean age 57.8 years, diabetes duration 14.1 years, 55.5% female
- Participants
- 330 adults
- Outcome
- Incidence proportion and incidence rate of adverse drug reactions (ADRs), serious ADRs and severity of suspected ADRs possibly related to iGlarLixi
- Follow-up
- 24 ± 1 months
Methodological detailsmulticentre
- Multicentre
Main finding
As reported in the abstract
Participants reporting adverse drug reactions (ADRs)
59
17.9%; 95% CI: 13.9–22.4
ADRs reported
95
Mean ADR events per participant-year
0.164
Observational data: associations, not effects.
Further findings
HbA1c · baseline to end of study
- HbA1c decreased from baseline to end of study
- 9.5% to 7.3%
Glycaemic targets achieved · end of study
- HbA1c < 7%
- 51.7%
- FPG < 110 mg/dL
- 64.6%
- PPG < 180 mg/dL
- 86.3%
7-point SMBG · baseline to 3, 6, 12 and 24 months
- Significant decrease in 7-point self-monitoring plasma or capillary blood glucose
- P < 0.0001
Safety
Most common ADRs · 24 months
- Gastrointestinal disorders
- 11.2%
- Nausea
- 7.3%
Original publication
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