Safety and tolerability of Empagliflozin use during the holy month of Ramadan by fasting patients with type 2 diabetes: A prospective cohort study

Safety and tolerability of Empagliflozin use during the holy month of Ramadan by fasting patients with type 2 diabetes: A prospective cohort study

Type 2 Diabetes Mellitus (T2DM) patients are exposed to a 7.5 times higher risk of hypoglycemia while fasting during Ramadan. Relevant diabetes guidelines prioritize the use of SGLT2 inhibitors over other classes. There is a great need to enrich data on their safe and effective use by fasting patien...

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Published in:Saudi pharmaceutical journal Vol. 31; no. 6; pp. 972 - 978
Main Authors: Samkari, Mayada M., Bokhari, Neda'a S., Alhajaji, Raghad, Ahmed, Malaz E., Al Raddadi, Ahmad, Bahget, Alaa K., Saleh, Sarah F., Aljehani, Faisal, Alzahrani, Saud H., Alsifyani, Sarah S., Samkari, May M., Badr, Aisha F., Alalawi, Mai, Al Sulaiman, Khalid
Format: Journal Article
Language:English
Published: Saudi Arabia Elsevier B.V 01-06-2023
Elsevier
Subjects:
Empagliflozin
Fasting
Hyperglycemia
Hypoglycemia
Muslims
Original
Ramadan
SGLT2 inhibitors
Sodium-glucose co-transporter 2 inhibitors
T2DM
T2DM
RCT
CDC
DM
GLP1RA
IDF
SGLT-2I
UTI
N
P
Hyperglycemia
DKA
HbA1c
CKD
SGLT2 inhibitors
WHO
Muslims
Empagliflozin
SU
Fasting
CI
DDP-4
Sodium-glucose co-transporter 2 inhibitors
Hypoglycemia
CVD
DAR
Ramadan
FPG
HE
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Summary:Type 2 Diabetes Mellitus (T2DM) patients are exposed to a 7.5 times higher risk of hypoglycemia while fasting during Ramadan. Relevant diabetes guidelines prioritize the use of SGLT2 inhibitors over other classes. There is a great need to enrich data on their safe and effective use by fasting patients at greater risk of hypoglycemia. Therefore, this study aims to assess the safety and tolerability of Empagliflozin in T2DM Muslim patients during Ramadan. A prospective cohort study was conducted for adult Muslim T2DM patients. Patients who met the inclusion criteria were categorized into two sub-cohorts based on Empagliflozin use during Ramadan (Control versus Empagliflozin). The primary outcomes were the incidence of hypoglycemia symptoms and confirmed hypoglycemia. Other outcomes were secondary. All patients were followed up to eight weeks post-Ramadan. A propensity score (PS) matching and Risk Ratio (RR) were used to report the outcomes. Among 1104 patients with T2DM who were screened, 220 patients were included, and Empagliflozin was given to 89 patients as an add-on to OHDs. After matching with PS (1:1 ratio), the two groups were comparable. The use of other OHDs, such as sulfonylurea, DPP4 inhibitors, and Biguanides, was not statistically different between the two groups. The risk of hypoglycemia symptoms during Ramadan was lower in patients who received Empagliflozin than in the control group (RR 0.48 CI 0.26, 0.89; p-value = 0.02). Additionally, the risk of confirmed hypoglycemia was not statistically significant between the two groups (RR 1.09 CI 0.37, 3.22; p-value = 0.89). Empagliflozin use during Ramadan fasting was associated with a lower risk of hypoglycemia symptoms and higher tolerability. Further randomized control trials are required to confirm these findings.
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content type line 23
ISSN:1319-0164
2213-7475
DOI:10.1016/j.jsps.2023.04.022