Hypoglycemia among Type 2 Diabetics Fasting Ramadan
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Transcript Hypoglycemia among Type 2 Diabetics Fasting Ramadan
Hypoglycemia
Among Type 2 Diabetics
Fasting Ramadan
Dr. Khaled Tayeb
[email protected]
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
الصيام َكَما ُكتِب َعلَ الَّ ِ
)(183يا أَيُّ َها الَّ ِذين آمنُواْ ُكتِ
ين ِمن ََ ْْلِ ُك ْم لَ َعلَّ ُك ْم تَ تَّ ُقو َن
ذ
م
ك
ي
ل
ع
ب
َ
ِّ
ُ
َ
ْ
ُ
َ
َ َ
َ
َ
َ َ
َ
ُ
ات فََمن َكا َن ِ
ضا أَو َعلَ س َف ٍر فَ ِع َّدةٌ ِّمن أَيَّ ٍام أُ َخر و َعلَ الَّ ِ
ود ٍ
ِ
ين
ذ
ي
ر
م
م
ك
ن
م
َّ
ُ
ً
( )184أَيَّ ًاما َّم ْع ُد َ
َ
ْ
ْ
َ َ
َ
َ
ي ِطي ُقونَه فِ ْديةٌ طَعام ِ
ِ
َّ
ٍ
ومواْ َخ ْي ٌر لَّ ُك ْم ِن ُكنتُ ْم تَ ْعلَ َُمو َن
ص
ت
َن
أ
و
ه
ل
ر
ي
خ
و
ه
ف
ا
ر
ي
خ
ع
و
ط
ت
ن
َم
ف
ن
ي
ك
س
م
َ
َ
َ
َّ
َ
َ
َ
َ
َ ًْ َُ ٌْ ُ َ ُ ُ
َ
ُ ُ َ َُ ْ
ِِ
(َ )185ش ْهر رم َ َّ ِ
ات ِّمن ال ُْه َدى والْ ُفرََ ِ
اس وب يِّ نَ ٍ
ان فَ ََمن َش ِه َد
ُ ََ
ي أُن ِز َل فيه الْ ُق ْرآ ُن ُه ًدى لِّلنَّ ِ َ َ
َ ْ
َ
ضا َن الذ َ
ِمن ُك ُم َّ
ضا أ َْو َعلَ َس َف ٍر فَ ِع َّدةٌ ِّم ْن أَيَّ ٍام أُ َخ َر يُ ِري ُد اللّهُ بِ ُك ُم الْيُ ْس َر َوالَ
ص َْمهُ َوَمن َكا َن َم ِري ً
الش ْه َر فَ لْيَ ُ
يُ ِري ُد بِ ُك ُم ال ُْع ْس َر َولِتُ ْك َِملُواْ ال ِْع َّد َة َولِتُ َكِّْ ُرواْ اللّهَ َعلَ َما َه َدا ُك ْم َولَ َعلَّ ُك ْم تَ ْش ُك ُرو َن
Recommendations for Management
of Diabetes During Ramadan
Diabetes Care
Volume 33, Number 8, August 2010
Major risk associated with
fasting in patients with diabetes
1. Hypoglycemia
2. Hyperglycemia
3. Diabetic ketoacidosis
4. Dehydration and thrombosis
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
Hypoglycaemia
• 2 – 4% of mortality in patients with
type 1 diabetes.
• Rates of hypoglycaemia are some
several-fold lower in patients with
type 2 compared with type 1 diabetes
• Rates being lower in patients with type
2 diabetes treated with oral agents.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
Categories of risks in patients with type 1 or
type 2 diabetes who fast during Ramadan
1. Very high risk
• Severe hypoglycaemia within the last 3
months prior to Ramadan.
• A history of recurrent hypoglycaemia.
• Hypoglycaemia unawareness.
• Sustained poor glycemic control.
• Ketoacidosis within the last 3 months prior to
Ramadan.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
Breaking the Fast
All patients must always and immediately
end their fast if:
1. Hypoglycaemia (blood glucose of <60mg/dl).
2. Blood glucose reaches <70 mg in the first few
hours after the start of the fast, especially if
insulin, sulfonylurea drugs, or neglitinide are
taken at predawn.
3. Blood glucose exceeds 300 mg with
symptoms of hyperglycaemia.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010
(4.7 fold)
(7.5 fold)
Change in outcome measures during Ramadan in
participants receiving both gliclazide and metformin1
Hypoglycaemia in study control group on Metfromin + Gliclazide
Ramadan 2008
9.25
8.95
0.92
8.75
HbA1c (%)
Pre-Ramadan
Post-Ramadan
8.25
7.75
7.75
7.25
6.75
Hypoglycaemic Events per
person
1
0.9
0.8
0.7
0.6
0.5
0.4
0.27
0.3
0.2
0.1
0
Int J Clin Pract 2009; 63: 1446–50
10
Hypoglycemia in SulphonylureaTreated Subjects with Type 2 Diabetes
Undergoing Ramadan Fasting:
A Five-Country Observational Study
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Objectives
• To determine the incidence of
hypoglycemia during Ramadan in Muslim
subjects with type 2 diabetes treated with a
sulphonylurea.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
• Eligible subjects
• Muslim patients with type 2 diabetes
treated with Sulphonylureas( Glimiperide,
Glyclazide , or Glibenclamide)
• With or without Metformin
• Age ≥ 18 years old
• Excluded subjects
• Patients with Type 1 diabetes
• Patients with Insulin treated type 2
diabetes
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
• Subjects were recruited from 5 countries.
• 300 subjects were selected per country.
• Diabetes Center in Holy Makkah and other
centers from (UAE, India, Malaysia, and
occupied Palestine ).
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
Patients were given a daily dairy card to record ..
• any hypoglycemic symptoms and complications
• The time from the start of hypoglycemic
symptoms and the last meal and medications
• Self monitor blood glucose
• Need for assistance to treat hypos.
• The fasting was broken or not.
• Cards to be filled daily regardless of symptoms
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
• The hypoglycemic events were further classified
into..
- Symptomatic : (headache, sweating,
tremors, palpitation, etc..)
- Documented: symptomatic with BG ≤ 70 mg/dl.
- Severe:
requiring medical or non- medical
assistance.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Patients Characteristic in the Study
Glimepiride
(n=428)
Gliclazide
(n=386)
Glibenclamide
(n=535)
Glipizide
(n=29)
Overall
(N=1378)
Gender M
229 (54 %) 225 (58 %)
263 (49 %)
12 (41 %)
729 (53 %)
Age at baseline,
yrs
51.4 ± 10.1
53.7 ± 9.2
55.5 ± 10.0
58.1± 9.8
53.8 ± 10.0
BMI, kg/m2
28.4 ± 5.2
29.0 ± 5.3
29.4 ± 10.0
45.0 ± 18.5
46.6 ± 9.9
Age at diabetes
diagnosis, yrs
45.3 ± 9.6
46.9 ± 8.9
47.5 ± 10.0
45.0 ± 18.5
46.6± 9.9
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Sulponylurea use by country in the
study
Country
Glimepiride
(n=428)
Gliclazide
(n=386)
Glibenclamide
(n=535)
Glipizide
(n=29)
Overall
(N=1378)
India
239 (56%)
50 (13%)
107 (20%)
0 (0%)
396 (29%)
Occupied
Palestine
48 (11%)
0 (0%)
170 (32%)
29 (100%)
247 (18%)
Malaysia
29 (7%)
182 (47%)
144 (27%)
0 (0%)
355 (26%)
108 (25%)
141 (37%)
114 (37%)
0 (0%)
363 (26%)
4 (1%)
13 (3%)
0 (0%)
0 (0%)
17 (1%)
Saudi Arabia
UAE
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
• The daily dairy card were returned by 1378
patients from total 1397 patients.
• Symptomatic hypoglycemia was 40% in
occupied Palestine and 10% in Saudi Arabia
• Over all symptomatic hypoglycemic events
were recorded in 271 subjects (19.7%)
• Headache represent 14.5%, sweating 10.2%,
tremors 8.5% and palpitation 7%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Incidence of symptomatic
hypoglycemia during Ramadan by
countries
Countries
N of Patients
Occupied Palestine
40%
Malaysia
24%
United Arab Emirates
18%
India
13%
Saudi Arabia
10%
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Incidence of hypoglycemia during
Ramadan by type
Type of hypoglycemia
Percentage (%)
Symptomatic hypoglycemic events
86
Documented hypoglycemic events
3.6
Severe hypoglycemic events
3.7
Severe hypoglycemic events requiring
medical assistance
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
6.7
Incidence of hypoglycemia during
Ramadan by type
100
80
60
86%
40
20
0
3.6%
Symptomatic
hypoglycemic
events
Documented
hypoglycemic
events
3.7%
Severe
hypoglycemic
events
Type of hypoglycemia
6.7%
Severe
hypoglycemic
events requiring
medical assistance
Incidence of hypoglycemia during
Ramadan by types of drug
N of patients (%)
Glimepiride
(n=428)
Gliclazide
(n=386)
Glibenclamide
(n=535)
Glipizide
(n=29)
Overall
(N=1378)
Symptomatic
hypoglycemic events
72 (16.8%)
54 (14 %)
137 (25.6%)
8 (27.6%)
271
19.7%
Documented
hypoglycemic events
17 (4.0%)
11 (2.8%)
21 (3.9%)
0 (0.0%)
49
3.6%
Severe hypoglycemic
events
22 (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
Results
• Symptomatic hypoglycemia events 1095
• Documented hypoglycemic events were similar
across all sulphonylurea groups 3.6%, .
• Events not requiring medical assistance 3.7%
• Events requiring assistance 6.7% .
• Subjects experienced a serious complication 1.2% .
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Discussion
• The incidence of severe hypoglycemia requiring medical
or non medical assistance or hospitalization were less
than other studies.
• In the EPIDAR study, 2% of patients hospitalized in
comparison to 0.5% in this study. (Diabetes Care 2004; 2306-11)
• Health care resources utilization, was less in this study.
The less severe hypoglycemia events or better education
regarding the symptoms could explain this.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
The incidence of Hypoglycaemia in Muslim
Type 2 Diabetics treated with Sitagliptin or a
Sulphoylurea during Ramadan.
Aim
• To compare the incidence of symptomatic
hypoglycaemia with Sitagliptin or A
Sulphonylurea during Ramadan.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Patients and study design
• A prospective, open-label, randomised study.
• 6 countries, 43 clinical sites.
• 1243 patients of whom 1066 randomized to treatment.
• Muslim Type 2 diabetics willing to fast Ramadan.
• Age : > 18 Yrs.
• Treated with a sulphonylurea for at least 3 months
before study with or without metformin and had
HbA1c < 10%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Pre-Randomization Treatment
Sitagliptin
( n = 507 )
Sulphonylurea
( n = 514 )
Glibenclamide
158 (31%)
181
(35%)
Glimepiride
189
(37%)
178
(35%)
Glicalazide
159
(32%)
152
(30%)
41
(8%)
41
(8%)
Monotherapy
Dual ( SU + MET ), n (%)
465 (92%)
471 (92%)
4.0
4.0
Duration of SU Therapy* yrs
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
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
• 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
*n/N (%)
Sitagliptin
25
*n/N (%)
Sulphonylurea
22.1%
20
21.2%
20.0% 20.0%
18.6%
15
11.9%
10.3%
9.9%
10
6.7%
5.1%
7.1%
5
0%
0
Overall
Egypt
0.5%
Palestien
Jordan
Lebanon
Saudi
Arabia
*no of patients experiencing event
/N overall or in each country by treatment. (%)
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
0.5%
UAE
Results
Sitagliptin
( n = 507 )
n ( %) of patients
Experiencing event
Symptomatic or
asymptomatic
hypoglycemic events
35
Severe hypoglycemic events
Hypoglycemic events
requiring non-medical
assistance
Hypoglycemic events
requiring medical assistance
( 6.9% )
Sulphonylurea
( n = 514 )
n (%) of patients
Experiencing event
84
0
1
( 0.2% )
0
* Types of hypoglycemic event defined in Methods
Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
( 16.3% )
0
3
( 0.6% )
0
Fear of hypoglycemia
is a major concern for patients
Male Female
Severe hypoglycemia
Male Female
Mild hypoglycemia
Male Female
Kidney problems
Male Female
Blindness
Blindness
Not worried
Very
worried
1. Pramming S et al. Diabet Med 1991;8:217–222
Hypoglycaemic Events
36
40
35
X4 increase
30
25
20
15
9
9
5
10
5
0
Education
No education
Pre-Ramadan
HE
•
•
•
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)
VECTOR: HbA1c
The between group difference was −0·6%
(p = 0·0262)
(7·7% to 7·2%)
(7·2% vs 7·3%)
:Adherence
Only 1 patient in the Vildagliptin group missed at least one
dose, compared with 10 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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