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\begin{document}

\title{Incidence of hypoglycemia with glimepiride/metformin fixed-dose
combination in patients with type 2 diabetes inadequately controlled on
metformin monotherapy in Peru: a prospective, active pharmacovigilance
cohort study Short running title: Hypoglycemia with glimepiride plus
metformin in Peru}



\author[1]{Miguel Pinto-Valdivia}%
\author[2]{Lourdes Loyola}%
\author[3]{Jorge Jara}%
\author[4]{Lucy Damas-Casani}%
\author[5]{Miguel Guillén}%
\author[6]{Cecilia A. Medina}%
\affil[1]{Clínica Delgado Auna}%
\affil[2]{Instituto del Cáncer Y Diabetes del Callao}%
\affil[3]{Clínica San Juan Bautista}%
\affil[4]{Universidad Maria Auxiliadora}%
\affil[5]{Clinica Ricardo Palma}%
\affil[6]{Sanofi}%


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  \date{May 24, 2024}


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\begin{abstract}
Purpose ---~To evaluate hypoglycemia incidence rate during treatment
with a fixed-dose combination of glimepiride and metformin in patients
non-responders to metformin monotherapy. Data were collected during
customary specialized practice in Peru where access to effective and
safe, but low-cost medications, is needed. Methods---~This was an
observational, prospective, active pharmacovigilance, cohort study with
in-person medical assessments. Medical assessments were conducted every
3-months, with monthly follow-up through phone calls. Data regarding use
and administration of treatment were recorded by patients. Adverse
events (AE) reported by patients and/or ascertained by attending
physicians during the period of 18 months along with treatment-related
events were identified. Cumulative incidence and hypoglycemia incidence
rate were estimated. Poisson and logistic regression models were applied
to study their relationship with risk factors and patterns of use.
Results--- 206 patients were enrolled in the study from 10 centers and
were followed for a median duration of 12 months (range, 2-18 months).
Forty treatment-related AEs were reported (cumulative incidence =
19.4\%). No severe hypoglycemic events were observed. Most common AE
found was non-severe hypoglycemia (cumulative incidence = 2.4\%;
incidence rate = 2.6/100 person/years). Self-administration of a higher
dose than prescribed was associated with a higher probability of an AE
(p=0.03). Conclusions---~Administration of a fixed-dose combination of
glimepiride plus metformin was associated with low incidence of
non-severe hypoglycemia, and no incidence of severe hypoglycemia. These
results advocate the use of fixed-dose combination of glimepiride plus
metformin in low- and middle-income countries with limited resources,
even more so in wake of COVID-19 pandemic.%
\end{abstract}%



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