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Hypoglycemia Among Type 2 Diabetics
Fasting Ramadan
Dr. Khaled Dr. Khaled Tayeb
To Fast during the month of Ramadan-Prayer and supplication to God-Discipline to be observed during the
month-Rights of property to be respected
ا ك�تب� ( 183) ي�ام� ك�م� � ك�تب� ع�ل�ي�ك�م� الص� ن�وا ا ال!ذين� آم� �ي#ه� ي�ا أون� ب�لك�م� ل�ع�ل!ك�م� ت�ت!ق� ع�ل�ى ال!ذين� من ق�
و� ع�ل�ى 184)
ا أ� ريض. نك�م م! م�ن ك�ان� م ع�د�ود�ات2 ف� ا م! �ي!ام. ( أد�ي�ة6 ون�ه� ف ر� و�ع�ل�ى ال!ذين� ي�طيق� �ي!ام2 أ�خ� عد!ة6 م�ن� أ ر2 ف� ف� س�
أ�ن ي�ر6 ل!ه� و� و� خ� ه� ا ف� ي�ر. م�ن ت�ط�و!ع� خ� كين2 ف� ط�ع�ام� مس�ي�ر6 ل!ك�م� إن ك�نت�م� ت�ع�ل�م�ون� وم�وا� خ� ت�ص�
د.ى 185) آن� ه� ر� يه ال�ق� ان� ال!ذي� أ�نزل� ف م�ض� ر� ر� ه� ( ش�
نك�م� د� م ه م�ن ش� ان ف� ق� ر� ال�ف� د�ى و� ب�ي�ن�ات2 م�ن� ال�ه� ل�لن!اس و�عد!ة6 ر2 ف� ف� و� ع�ل�ى س�
ا أ� ريض. ه� و�م�ن ك�ان� م� م� ل�ي�ص� ر� ف� ه� الش!ر� ر� و�ال� ي�ريد� بك�م� ال�ع�س� ر� ي�ريد� اللOه� بك�م� ال�ي�س� �ي!ام2 أ�خ� م�ن� أل�ع�ل!ك�م� د�اك�م� و� ا ه� � اللOه� ع�ل�ى م� وا لت�ك�ب�ر� � ال�عد!ة� و� ل�وا لت�ك�م و�
ون� ك�ر� ت�ش�
To Fast during the month of Ramadan-Prayer and supplication to God-Discipline to be observed during the
month-Rights of property to be respected
ا ك�تب� ( 183) ي�ام� ك�م� � ك�تب� ع�ل�ي�ك�م� الص� ن�وا ا ال!ذين� آم� �ي#ه� ي�ا أون� ب�لك�م� ل�ع�ل!ك�م� ت�ت!ق� ع�ل�ى ال!ذين� من ق�
و� ع�ل�ى 184)
ا أ� ريض. نك�م م! م�ن ك�ان� م ع�د�ود�ات2 ف� ا م! �ي!ام. ( أد�ي�ة6 ون�ه� ف ر� و�ع�ل�ى ال!ذين� ي�طيق� �ي!ام2 أ�خ� عد!ة6 م�ن� أ ر2 ف� ف� س�
أ�ن ي�ر6 ل!ه� و� و� خ� ه� ا ف� ي�ر. م�ن ت�ط�و!ع� خ� كين2 ف� ط�ع�ام� مس�ي�ر6 ل!ك�م� إن ك�نت�م� ت�ع�ل�م�ون� وم�وا� خ� ت�ص�
د.ى 185) آن� ه� ر� يه ال�ق� ان� ال!ذي� أ�نزل� ف م�ض� ر� ر� ه� ( ش�
نك�م� د� م ه م�ن ش� ان ف� ق� ر� ال�ف� د�ى و� ب�ي�ن�ات2 م�ن� ال�ه� ل�لن!اس و�عد!ة6 ر2 ف� ف� و� ع�ل�ى س�
ا أ� ريض. ه� و�م�ن ك�ان� م� م� ل�ي�ص� ر� ف� ه� الش!ر� ر� و�ال� ي�ريد� بك�م� ال�ع�س� ر� ي�ريد� اللOه� بك�م� ال�ي�س� �ي!ام2 أ�خ� م�ن� أل�ع�ل!ك�م� د�اك�م� و� ا ه� � اللOه� ع�ل�ى م� وا لت�ك�ب�ر� � ال�عد!ة� و� ل�وا لت�ك�م و�
ون� ك�ر� ت�ش�
Recommendations for Management of Diabetes
During Ramadan
Diabetes Care Volume 33, Number 8, August
2010
Major risk associated with Major risk associated with fasting in patients with fasting in patients with
diabetesdiabetes1.1. Hypoglycemia Hypoglycemia
2.2. HyperglycemiaHyperglycemia
3.3. Diabetic ketoacidosisDiabetic ketoacidosis
4.4. Dehydration and thrombosisDehydration and thrombosis
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
HypoglycaemiaHypoglycaemia
• 2 – 4% of mortality in patients 2 – 4% of mortality in patients with type 1 diabetes.with type 1 diabetes.
• Rates of hypoglycaemia are some Rates of hypoglycaemia are some several-fold lower in patients with several-fold lower in patients with type 2 compared with type 1 type 2 compared with type 1 diabetesdiabetes
• Rates being lower in patients with Rates being lower in patients with type 2 diabetes treated with oral type 2 diabetes treated with oral agents.agents.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
Categories of risks in patients with Categories of risks in patients with type 1 or type 2 diabetes who fast type 1 or type 2 diabetes who fast
during Ramadanduring Ramadan
1. Very high risk1. Very high risk• Severe hypoglycaemiaSevere hypoglycaemia within the last 3 within the last 3
months prior to Ramadan.months prior to Ramadan.• A history of A history of recurrent hypoglycaemiarecurrent hypoglycaemia..• Hypoglycaemia unawarenessHypoglycaemia unawareness..• Sustained poor glycemic control.Sustained poor glycemic control.• Ketoacidosis within the last 3 months Ketoacidosis within the last 3 months
prior to Ramadan.prior to Ramadan.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
Breaking the FastBreaking the Fast
All patients must always and All patients must always and immediately end their fast if:immediately end their fast if:1.1. Hypoglycaemia (blood glucose of Hypoglycaemia (blood glucose of
<60mg/dl).<60mg/dl).2.2. Blood glucose reaches <70 mg in the Blood glucose reaches <70 mg in the
first few hours after the start of the fast, first few hours after the start of the fast, especially if insulin, sulfonylurea drugs, especially if insulin, sulfonylurea drugs, or neglitinide are taken at predawn.or neglitinide are taken at predawn.
3.3. Blood glucose exceeds 300 mg with Blood glucose exceeds 300 mg with symptoms of hyperglycaemia.symptoms of hyperglycaemia.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
(4.7 fold)
(7.5 fold)
10
Change in outcome measures during Ramadan in participants receiving both gliclazide and metformin1
0.27
0.92
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Hyp
og
lyca
emic
Eve
nts
per
p
erso
n
8.95
7.75
6.75
7.25
7.75
8.25
8.75
9.25
Hb
A1
c (
%)
Pre-Ramadan Post-Ramadan
Hypoglycaemia in study control group on Metfromin + Gliclazide Ramadan 2008
Int J Clin Pract 2009; 63: 1446–50
Hypoglycemia in Sulphonylurea-Hypoglycemia in Sulphonylurea-Treated Subjects with Type 2 Treated Subjects with Type 2
Diabetes Diabetes Undergoing Ramadan Fasting:Undergoing Ramadan Fasting:A Five-Country Observational A Five-Country Observational
StudyStudy
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
ObjectivesObjectives
• To determine the incidence of To determine the incidence of hypoglycemia during Ramadan in hypoglycemia during Ramadan in Muslim subjects with type 2 diabetes Muslim subjects with type 2 diabetes treated with a sulphonylurea.treated with a sulphonylurea.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & MethodsSubjects & Methods• Eligible subjectsEligible subjects
• Muslim patients with type 2 diabetes Muslim patients with type 2 diabetes treated with Sulphonylureastreated with Sulphonylureas( Glimiperide, ( Glimiperide, Glyclazide , or Glibenclamide)Glyclazide , or Glibenclamide)
• With or without MetforminWith or without Metformin• Age ≥ 18 years oldAge ≥ 18 years old
• Excluded subjects Excluded subjects • Patients with Type 1 diabetesPatients with Type 1 diabetes• Patients with Insulin treated type 2 Patients with Insulin treated type 2
diabetesdiabetes
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
• Subjects were recruited from 5 Subjects were recruited from 5 countries.countries.
• 300 subjects were selected per country.300 subjects were selected per country.• Diabetes Center in Holy Makkah and Diabetes Center in Holy Makkah and
other centers from (UAE, India, other centers from (UAE, India, Malaysia, and occupied Palestine ).Malaysia, and occupied Palestine ).
Subjects & MethodsSubjects & Methods
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & MethodsSubjects & MethodsPatients were given a daily dairy card to record ..Patients were given a daily dairy card to record ..• any hypoglycemic symptoms and complicationsany hypoglycemic symptoms and complications• The time from the start of hypoglycemic The time from the start of hypoglycemic
symptoms and the last meal and medicationssymptoms and the last meal and medications• Self monitor blood glucoseSelf monitor blood glucose• Need for assistance to treat hypos.Need for assistance to treat hypos.• The fasting was broken or not.The fasting was broken or not.• Cards to be filled daily regardless of symptomsCards to be filled daily regardless of symptoms
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & MethodsSubjects & Methods
• The hypoglycemic events were further The hypoglycemic events were further classified into..classified into..
-- Symptomatic : Symptomatic : (headache, sweating, (headache, sweating, tremors, palpitation, etc..)tremors, palpitation, etc..)
-- Documented: symptomatic with BG ≤ 70 Documented: symptomatic with BG ≤ 70 mg/dl.mg/dl.
-- Severe: requiring medical or non- Severe: requiring medical or non- medical medical
assistance. assistance.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Patients Characteristic in Patients Characteristic in the Studythe Study
Glimepiride (n=428)
Gliclazide (n=386)
Glibenclamide (n=535)
Glipizide (n=29)
Overall(N=1378)
Gender M229 (54 %)225 (58 %)263 (49 %)12 (41 %)729 (53 %)
Age at baseline, yrs
51.4 ± 10.153.7 ± 9.255.5 ± 10.058.1± 9.853.8 ± 10.0
BMI, kg/m228.4 ± 5.229.0 ± 5.329.4 ± 10.045.0 ± 18.546.6 ± 9.9
Age at diabetes diagnosis, yrs
45.3 ± 9.646.9 ± 8.947.5 ± 10.045.0 ± 18.546.6± 9.9
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Sulponylurea use by country Sulponylurea use by country in the studyin the study
CountryGlimepiride (n=428)
Gliclazide (n=386)
Glibenclamide (n=535)
Glipizide (n=29)
Overall(N=1378)
India239 (56%)50 (13%)107 (20%)0 (0%)396 (29%)
Occupied Palestine48 (11%)0 (0%)170 (32%)29 (100%)247 (18%)
Malaysia 29 (7%)182 (47%)144 (27%)0 (0%)355 (26%)
Saudi Arabia108 (25%)141 (37%)114 (37%)0 (0%)363 (26%)
UAE4 (1%)13 (3%)0 (0%)0 (0%)17 (1%)
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
ResultsResults• The daily dairy card were returned by 1378 The daily dairy card were returned by 1378
patients from total 1397 patients.patients from total 1397 patients.• Symptomatic hypoglycemia was 40% in Symptomatic hypoglycemia was 40% in
occupied Palestine and 10% in Saudi Arabia occupied Palestine and 10% in Saudi Arabia • Over all symptomatic hypoglycemic events Over all symptomatic hypoglycemic events
were recorded in 271 subjects were recorded in 271 subjects (19.7%)(19.7%)• Headache represent 14.5%, sweating Headache represent 14.5%, sweating
10.2%, tremors 8.5% and palpitation 7%.10.2%, tremors 8.5% and palpitation 7%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Incidence of symptomatic Incidence of symptomatic hypoglycemia during hypoglycemia during
Ramadan by countriesRamadan by countriesCountries N of Patients
Occupied Palestine 40%
Malaysia24%
United Arab Emirates18%
India13%
Saudi Arabia10%Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Incidence of hypoglycemia Incidence of hypoglycemia during Ramadan by typeduring Ramadan by type
Type of hypoglycemiaPercentage (%)
Symptomatic hypoglycemic events86
Documented hypoglycemic events3.6
Severe hypoglycemic events3.7
Severe hypoglycemic events requiring medical assistance
6.7
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Incidence of hypoglycemia Incidence of hypoglycemia during Ramadan by typeduring Ramadan by type
0
20
40
60
80
100
Symptomatic hypoglycemic
events
Documented hypoglycemic
events
Severe hypoglycemic
events
Severe hypoglycemic
events requiring medical assistance
86%
3.6% 3.7% 6.7%
Type of hypoglycemia
Incidence of hypoglycemia Incidence of hypoglycemia during during
Ramadan by types of drugRamadan by types of drug
N of patients (%)Glimepiride (n=428)
Gliclazide (n=386)
Glibenclamide (n=535)
Glipizide (n=29)
Overall(N=1378)
Symptomatic hypoglycemic events72 (16.8%)54 (14 %)137 (25.6%)8 (27.6%)271
19.7%
Documented hypoglycemic events17 (4.0%)11 (2.8%)21 (3.9%)0 (0.0%)49
3.6%
Severe hypoglycemic events22 (5.1%)10 (2.6%)58 (10.8%)2 (6.9%)92
6.7%
Severe hypoglycemic events requiring medical assistance
10 (2.3%)6 (1.6%)36 (6.5%)0 (0.0%)51 3.7%
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
ResultsResults
• Symptomatic hypoglycemia events 1095Symptomatic hypoglycemia events 1095
• Documented hypoglycemic events were similar Documented hypoglycemic events were similar
across all sulphonylurea groups 3.6%, .across all sulphonylurea groups 3.6%, .
• Events not requiring medical assistance 3.7% Events not requiring medical assistance 3.7%
• Events requiring assistance 6.7% .Events requiring assistance 6.7% .
• Subjects experienced a serious complication Subjects experienced a serious complication
1.2% .1.2% .
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
DiscussionDiscussion• The incidence of severe hypoglycemia requiring The incidence of severe hypoglycemia requiring
medical or non medical assistance or hospitalization medical or non medical assistance or hospitalization
were less than other studies.were less than other studies.
• In the EPIDAR study, 2% of patients hospitalized in In the EPIDAR study, 2% of patients hospitalized in
comparison to 0.5% in this study. (comparison to 0.5% in this study. (Diabetes Care 2004; Diabetes Care 2004;
2306-11)2306-11)
• Health care resources utilization, was less in this Health care resources utilization, was less in this
study. The less severe hypoglycemia events or better study. The less severe hypoglycemia events or better
education regarding the symptoms could explain this.education regarding the symptoms could explain this.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
The incidence of Hypoglycaemia in The incidence of Hypoglycaemia in Muslim Type 2 Diabetics treated with Muslim Type 2 Diabetics treated with Sitagliptin or a Sulphoylurea during Sitagliptin or a Sulphoylurea during
Ramadan.Ramadan.
AimAim
• To compare the incidence of To compare the incidence of symptomatic hypoglycaemia with symptomatic hypoglycaemia with
Sitagliptin or A Sulphonylurea during Sitagliptin or A Sulphonylurea during Ramadan.Ramadan.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Patients and study designPatients and study design
• A prospective, open-label, randomised study.A prospective, open-label, randomised study.• 6 countries, 43 clinical sites.6 countries, 43 clinical sites.• 1243 patients of whom 1066 randomized to 1243 patients of whom 1066 randomized to treatment.treatment.• Muslim Type 2 diabetics willing to fast Muslim Type 2 diabetics willing to fast Ramadan.Ramadan.• Age : > 18 Yrs.Age : > 18 Yrs.• Treated with a sulphonylurea for at least 3 Treated with a sulphonylurea for at least 3 months before study with or without metformin months before study with or without metformin and had HbA1c < 10%.and had HbA1c < 10%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Sitagliptin( n = 507 )
Sulphonylurea( n = 514 )
Glibenclamide158 (31%)181 (35%)
Glimepiride189 (37%)178 (35%)
Glicalazide159 (32%)152 (30%)
Monotherapy41 (8%)41 (8%)
Dual ( SU + MET ), n (%)465 (92%)471 (92%)
Duration of SU Therapy* yrs4.04.0
Experienced hypoglycaemia in 3 M before Ramadan
81 ( 16%)76 (15%)
Data are expressed as frequency, n(%) or mean ± standard deviation unless otherwise indicated. *median
Pre-Randomization Treatment
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
ResultsResults
• 1066 patients randomised, • 1021 enrolled in the study as they
returned at least one complete diary.• Incidence of symptomatic
hypoglycaemic events - Sitagliptin group (5.1%) - Sulphonylurea group (11.9).
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
0
5
10
15
20
25
Overall Egypt Palestien Jordan Lebanon Saudi Arabia
UAE
*n/N (%) Sitagliptin
*n/N )%( Sulphonylurea
5.1%
11.9%
0%
18.6%
10.3%
22.1%
6.7% 7.1%
9.9%
21.2%
0.5% 0.5%
20.0%20.0%
*no of patients experiencing event /N overall or in each country by treatment. (%) Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Sitagliptin) n = 507 (n ) %( of patients
Experiencing event
Sulphonylurea) n = 514 (
n )%( of patientsExperiencing event
Symptomatic or asymptomatic hypoglycemic events
35 (6.9%) 84 (16.3%)
Severe hypoglycemic events
00
Hypoglycemic events requiring non-medical assistance
1 (0.2%) 3 (0.6%)
Hypoglycemic events requiring medical assistance
00
* Types of hypoglycemic event defined in Methods
Results
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Fear of hypoglycemiais a major concern for patients
1 .Pramming S et al. Diabet Med 1991;8:217–222
Not worried Very worried
Male Female
Male Female
Male Female
Blindness
Male Female
Hypoglycaemic Events
X4 increase
• Main aim• To determine the incidence of hypoglycaemic events in 100 Muslim patients
with T2D fasting during Ramadan, who are treated with dual therapy of metformin plus vildagliptin or metformin plus sulphonylurea (SU)
• Primary objectives• the incidence of hypoglycaemic events defined as:
• Any reported symptoms by the patient and/or any blood glucose measurement of less than 3.9 mmol/L (also defined as mild or Grade 1 hypoglycaemia)
• The need for third party assistance (also defined as severe or Grade 2 hypoglycaemia);
• Secondary objectives• the change in weight;• the change in HbA1c levels; and• the treatment adherence during Ramadan.
VECTOR: Results - Hypoglycaemic events )HE( Mean between-group difference in patients who
experienced at least one HE was –41·7% )p = 0·0002(
(7·7% to 7·2%) (7·2% vs 7·3%)
VECTOR: HbA1cVECTOR: HbA1c
The between group difference was −0·6% The between group difference was −0·6% )p = 0·0262()p = 0·0262(
::AdherenceAdherence
Only 1 1 patient in the Vildagliptin group missed at least one dose, compared with 1010 patients in the SU group .
p = 0·0204
* There are an estimated 325,000 Muslims with type 2 diabetes in the UK** Hypoglycemic event (defined as blood glucose < 3.5 mmol ⁄ l with or without symptoms)
References:1. Devendra D et al. Vildagliptin therapy and hypoglycaemia in Muslim type 2 diabetes patients during Ramadan. Int J Clin Pract, October 2009, 63, 10, 1446–1450.
How to Help Patients Fast Safely
• Patient Education Program.• Select more safe drugs.• Adjust dose if needed• Ensure good non – sugar fluid intake.• Avoid heavy physical exercise at
afternoon.• Ensure good calorie distribution.
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