Obesity
Obesity
Obesity
CONTENTS:
ABBREVIATIONS iii
FORWARD BY THE DIRECTOR GENERAL iv
WORD FROM SAUDI ARABIAN SOCIETY OF METABOLIC AND BARIATRIC SURGERY v
ACKNOWLEDGEMENT vi
INTRODUCTION 1
Magnitude of the problem in the Kingdom of Saudi Arabia (KSA) 1
GUIDELINES DEVELOPMENT PROCESS 2
Scope of guidelines 2
Aim of the guidelines 2
Clinical question to be answered 2
Development process 3
Implementation strategies 4
Update of the guidelines 4
HOW TO USE THE GUIDELINES 5
PRIMARY PREVENTION OF OBESITY IN CHILDREN, ADOLESCENTS AND ADULTS 6
Guidelines for Healthy Eating 7
Psychological/behavioral interventions 27
Long-term weight management 28
Referral for specialist support 28
PHARMACOLOGICAL TREATMENT 29
BARIATRIC SURGERY 35
ANNEX 1: KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS 43
ANNEX 2: MEMBERS OF ADOPTION GROUP OF FIRST DRAFT OF THE GUIDELINES 47
ANNEX 3: OBESITY CONTROL PROGRAM SCIENTIFIC COMMITTEE 48
ANNEX 4: GUIDELINES PREPARATION COMMITTEE 49
ANNEX 5: CHARTS FOR BMI TO AGE PERCENTILES AMONG CHILDREN 50
iii
ABBREVIATIONS:
ASBP American Society of Bariatric Physicians
ACEI Angiotensin-converting-enzyme inhibitor
ARB Angiotensin receptor blockers
BMI Body mass index
CVD Cardio-vascular disease
CCB Calcium-channel blocker
GAG Guidelines Adoption Group
HDL High- density lipoprotein
ICSI Institute for Clinical Systems Improvement
Kcal Kilo-calorie
Kg Kilo-gram
KSA Kingdom of Saudi Arabia
LDL Low-density lipoprotein
NICE National Institute for health and Care Excellence (UK)
NCD Non-Communicable Disease
NHMRC National Health and Medical Research Council (Australia)
SAGES Society of American Gastrointestinal and Endoscopic Surgeons
SASMBS Saudi Arabian Society of Metabolic and Bariatric Surgery
SIGN Scottish Intercollegiate Guidelines Network
SHIS Saudi Health Information Survey
TSH Thyroid-stimulating hormone
WC Waist circumference
iv
FORWARD :
The health system in KSA has witnessed enormous development and reforms during the last few decades; however, it
continues to face many emerging challenges. The country is already experiencing the demographic and epidemiologic
transitions, whereby the health scene is dominated by non-communicable diseases (NCDs).
In the Kingdom of Saudi Arabia, obesity and overweight has become one of the most common public health problems
affecting people of both sexes and all age groups. The prevalence is on the rise, which requires prompt actions and
efforts from health and related stakeholders.
We are putting forward these evidence based guidelines for obesity to health care workers in the Kingdom of Saudi
Arabia. The guidelines have been adapted by national experts who are also users of clinical guidelines in their own
practices. They are intended to provide health care professionals with the tools to effectively prevent and manage
overweight and obesity.
We are very grateful to H.E. the Minister of Health for his constant support and advice to the General Directorate for
Control of Genetic and Chronic Diseases to combat NCDs and its risk factors in the country.
Looking forward to see tangible results of this effort in combating obesity in the country.
Overweight and obesity affect more than 60% of the total population in Saudi Arabia. Almost all age groups are affected
in general and adults in particularly. In order to introduce high quality health-care for these individual, it is mandatory
to establish clinical guidelines that will help health-care providers to manage this common problems at all levels. These
guidelines are adapted from Scottish Intercollegiate Guidelines Network (SIGN) for management of obesity after taking
permission in this regard. The guidelines will cover preventive and curative aspects of overweight and obesity and could
be implemented at primary, secondary, and tertiary care levels in Saudi Arabia.
Finally we thank the Scientific Committee of Saudi Arabian Society of Metabolic and Bariatric Surgery for adapting these
guidelines and acknowledge the untiring efforts of our partner; the General Directorate for Control of Genetic and
Chronic Diseases, Ministry of Health, Kingdom of Saudi Arabia, for their major contribution in issuing the guidelines. We
hope that all health care providers will implement it in order to introduce the best quality health care for our community.
ACKNOWLEDGEMENT:
First and foremost I offer my sincerest gratitude to the Director General of the General Directorate for Control of Genetic
and Chronic Diseases, who has supported us throughout preparation process in developing these guidelines. His
guidance, enthusiastic encouragement and useful critiques were valuable.
I would also like to thank the Saudi Arabian Society of Metabolic and Bariatric Surgery (SASMBS) where these Guidelines
are based on their work which was published in the Saudi Journal of Obesity.
Special thanks are extended to the members of adoption group of first draft of the guidelines of obesity for their unlimited
help.
I would like to express my appreciation to obesity control program scientific committee and guidelines preparation
committee for their valuable and constructive suggestions during planning and development of this work. Their
willingness to give their time so generously has been very much appreciated.
Finally, I would also like to extend my thanks to the obesity program coordinators, doctors and nurses from all the regions
of the Kingdom for their dedicated work.
INTRODUCTION:
Obesity results from accumulation of body fats overtime. It occurs when the energy intake exceeds energy requirements.
This could occur as a result of many factors including increased food intake, physical inactivity, and genetic factors1,2.
Obesity is a key risk factor for many non-communicable diseases (NCDs), including type 2 diabetes, hypertension, heart
disease and some cancers. The risk increases with increase in the level of obesity. Obesity and overweight are also strongly
associated with mental health and eating disorders2, 3, 4.
Obesity and overweight have become the most prevalent nutritional problems in the world putting an increased burden
on the health care system. They affect almost one third (2.1 billion people) of the global population and result in five
percent of all deaths worldwide3,4,5. The magnitude of the problem may reach almost half of the world’s adult population
by 2030 if the current trend persists6.
A comprehensive, systemic multi-sectoral program comprising of multiple interventions involves and includes broad
behavioral change component is required to produce positive impact in managing obesity among the population. Physical
activity and nutritional behavior are a vital part of any obesity control program. This necessitates the development of
multi-setting programs (e.g. schools and work-places). Prevention efforts should also invest in, and target all age groups
and individuals with parental and/or family involvement3,5.
Scope of guidelines:
The guidelines aim to provide recommendations for the prevention and management of overweight/obesity in children
and adults based on current evidence for best practices that is suitable for our target population, culture, health-care
system, and resources.
The following five items (PIPOH) were used to define the health question and cover different aspects 8:
(P) The Population concerned and characteristic of disease condition:
- The target population includes all sex and age groups.
(I) The Interventions of interest:
- Screening the population for overweight and obesity.
- Psychological, dietary and physical exercise interventions.
- Referral to secondary and tertiary care for further assessment and management.
(P) The Professionals to whom the guidelines will be targeted:
- These guidelines are intended for the use of healthcare professionals at all levels, including physicians, nurses,
dietitians, psychologists and physiotherapists.
3
(O) The expected Outcome including patients, public and system outcome:
- To reduce the prevalence of overweight and obesity and their co-morbidities.
- To reduce the expenditure on the health system.
- To decrease clinical practice variation.
(H) The Health care setting and context in which the guidelines are to be implemented:
- PHC centers and Hospitals.
Development process:
The General Directorate for Control of Genetic and Chronic diseases (NCDs) constituted a team to develop
“Saudi Guidelines for the Prevention and Management of Obesity”. The team operated under supervision of the
Director General of NCDs and headed by the Director of Obesity control Program (members of the team are listed at
annex 3). The assistance of the Obesity Control Programhs Scientific Committee was available for guidance during
the process.
The team reviewed the Clinical Practice Guidelines for the Prevention and Management of Obesity in Saudi Arabia
developed by the Saudi Arabian Society of Metabolic and Bariatric Surgery (SASMBS); and also conducted a rigorous
review of relevant evidenced based scientific literature. After a thorough assessment, a consensus was reached to use
the SIGN guideline as the main guideline based on the work of SASMBS and to fill the gap from the following guidelines9:
• Clinical Practice Guidelines for the Management of overweight and obesity in adults, adolescents and children in
Australia.
• 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children.
• NICE (National Institute for health and Care Excellence) guidelines - Obesity: identification, assessment and
management of overweight and obesity in children, young people and adults (November 2014).
• Institute for Clinical Systems Improvement (ICSI) guideline for Prevention and Management of Obesity for Children
and Adolescents.
4
To avoid duplication of efforts, the team adopted the grading of evidence used by different guidelines used in this
document (annex1).
The updated version was presented in a workshop, involving the Obesity Control Program Scientific Committee, in
addition to other relevant stakeholders and the recommendation of the participants were included.
The final draft was distributed for review by Obesity Control Program Scientific Committee and their comments were
included (annex 3 lists the membership of the Committee).
Implementation strategies:
Obesity Control Program will be responsible for implementation of the guidelines with the support of regional
directorates. The printed document will be distributed to all targeted health professionals. Training of Trainers (TOT)
will be organized at national level to train regional level trainers.
Wide scale training workshops will be conducted at regional level to train health professionals from primary and
secondary level health facilities.
Feedback will be obtained from health professionals trained on the guidelines, and their recommendations will be
considered in updating the future edition.
Chapter (1) is on primary prevention of obesity among children, young people and adults; the guidelines provide information
on preventing overweight and obesity through lifestyle modification program, focusing on recommendations for healthy
diet, physical activity and periodic medical examination.
Chapters (2&3) are about weight management in children and adults; where the guidelines introduce two algorithms to be
followed for assessment and management of obesity and overweight. The assessment is based on Body Mass Index (BMI) for
age percentiles for children and BMI and Waist Circumference (WC) for adult, in addition to a set of laboratory investigation
to assess for underlying causes, risk factors and co-morbidities.
Chapter (4) explains pharmacological management of obesity; it briefly presents a list of medications used for pharmacological
treatment. It provides brief description of each medication including mechanism of action, indications, contraindications,
maintenance dosage and mode of administration.
Chapter (5) on surgical management of obesity (bariatric surgery); it describes briefly the indications for considering bariatric
surgery as part of obesity management pass-way. It describes briefly the common types of bariatric surgery highlighting its
potential short term and long term complications.
Different grades are used in the document based on the source of evidence. In order to effectively use the document
the reader should refer to annex 1, which summarizes the grade of evidences used by different sources quoted in this
document.
6
Chapter 1
* 5= Encourage intake of daily 5 portions of fruits and vegetables (ICSI, strong recommendation, high
quality evidence).
* 2= Encourage eating with the child in a sociable atmosphere without distractions, separate eating from other
activities and keep recreational screen time to less than 2 hours, (ICSI, strong recommendation, high quality
evidence)10.
* 1= Include at least 1 hour or more of active play every day (see physical activity section below).
* 0= Skip sugar sweetened beverages, drink more water every day.
• Advise patients using medications associated with weight gain on weight management, as shown in table 3 (SIGN,
evidence grade B)11.
Children:
• Encourage children gradually to perform at least 60 minutes of moderate to vigorous exercise daily – continuous or
accumulated in short bouts (ICSI, Moderate Recommendation, High Quality Evidence)10,11.
• Encourage children to lead active daily life such as walking, cycling, skipping and using the stairs and support them to
practice regular physical activity appropriate to their age and ability such as football and swimming11.
• Discourage sedentary behavior of more than two hours for children particularly of screen time, like watching TV,
computer use and playing video games (ICSI, strong recommendation, high quality evidence)10,11.
• Encourage family approach to physical exercise (e.g. walking and cycling to school and shops, going to the park or for
swimming) 11.
Adults:
• Provide physical activity advice appropriate to specific individual situation. The focus should be on activities that can
fit easily into their everyday lives and are tailored to their individual preferences and circumstances. Attention should
be given to pregnant women, those at risk of post-natal weight retention, women reaching the age of menopause, or
while quitting smoking11.
• Inform the individuals about the benefits of physical activity on reducing the risk of Cardiovascular Disease (CVD) and
type 2 diabetes, even without evident weight reduction11.
• Encourage adults to do at least 30 minutes of moderate-intensity physical activity on 5 or more days a week. This
should be built up over time; start by walking 10 minutes a day on a few days during the first couple of weeks then
add more time and days gradually11.
10
Chapter 2
YES NO
PATIENT
Determine Goals WILLING TO
- Pre-pubertal: Weight maintenance rather than weight loss.. Offer lifestyle advice
- Post-pubertal: weight loss rather than weight maintenance CHANGE
Adapted from 2006 Canadian clinical practice guidelines & SIGN Guidelines
12
• Use the Saudi sex-specific BMI for age percentile chart for assessing overweight and obesity in infants and children
0-19 years of age (there are two sets of gender specific charts, Birth to 36 months and 2 to 19 years (see annex 5)).
The Growth Chart for Saudi Children and adolescents categorizes overweight as between the 85th and 95th
percentile and obesity as above the 95th percentile12,13,14 .
• Inquire about the presence of parental obesity, type 2 diabetes and CVD which are a strong predictor of a child’s
weight and co-morbidities (ICSI, Strong Recommendation, High Quality Evidence)4,10.
• Assess child developmental history, physical and mental health and assess for current health problems, co-
morbidities (e.g. raised blood pressure, joint pain, gastrointestinal symptoms, insulin resistance, intertrigo, dental
health) and risks for future disease (ICSI, Strong Recommendation, High Quality Evidence) 4,10.
Devise goals:
• In children and pre-pubertal adolescents the goal should be weight maintenance rather than weight loss.
Maintaining weight during growth will result in a declining BMI and will prevent potential adverse effects (NHMRC,
evidence grade D)4,5.
• In post-pubertal adolescents the goal is weight loss rather than weight maintenance4,5.
• Recommend early start of weight management in children and adolescents with the objectives of preventing
adulthood overweight or obesity, reducing risk of co-morbidities and enhancing healthy life style behaviors 4.
• Target weight management of the child or adolescent through family approach – addressing healthy lifestyle
behavior of the whole family (ICSI, Strong Recommendation, High Quality Evidence and NHMRC, evidence grade PP4.
• Recommend frequent contacts with health professionals for children and adolescents (NHMRC, evidence grade B)4.
• Consider child preference, ability and strength when choosing lifestyle activities. It is recommend that the activities
13
should be fun, recreational and tailored to the relative strengths of child and family (Canadian, evidence grade A,
level 2)3.
• Lifestyle interventions should focus on changing the health behaviors, consume healthy diet, and perform physical
activity 4,10 :
- Advise the reduction of screen time to less than 2 hours per day (ICSI, Strong Recommendation, High Quality
Evidence).
- Encourage daily 60 minutes of moderate and vigorous exercise, e.g. household tasks, walking to school, sports
clubs, swimming pool, walking tracks. etc (ICSI, Strong Recommendation, moderate Quality Evidence).
- Encourage children to have regular meals in a sociable atmosphere (ICSI, Strong Recommendation, High Quality
Evidence).
- Encourage children to eat a nutrient-dense breakfast daily (ICSI, High Quality Evidence).
- Discourage eating energy-dense food, like fast food (ICSI, High Quality Evidence).
- Encourage children to eat to appetite (ICSI, Moderate Quality Evidence).
- Advice on availing healthy food choices.
- Encourage drinking water instead of sugary drinks and energy drinks (ICSI, Strong Recommendation, High Quality
Evidence).
- Advice on separating eating from other activities, e.g. watching TV (ICSI, Moderate Quality Evidence).
• Weight management of obese child should include a family based behavior change components targeting lifestyle
change of the whole family (SIGN, evidence grade B)11.
• Sustained behavioral changes are essential to achieve weight maintenance and/or weight loss in children (SIGN,
evidence grade D)11.
14
• Specialist services may be required for the following (NHMRC, evidence grade D) 4:
- Disordered eating,
- Poor body image,
- Depression and anxiety,
- Presence of co-morbidities (e.g. sleep apnea, orthopedic problems, risk factors for cardiovascular disease or type
2 diabetes and psychological distress),
- Suspected underlying medical or endocrine cause, and
- Concerns about height and development.
• Referral for pharmacologic or bariatric surgery may be considered in post-pubertal adolescents, with severe obesity
(a BMI > 40 kg/m2 or > 35 kg/m2 with obesity-related complications), who failed to respond to lifestyle interventions
(NHMRC, evidence grade D)4.
• Follow-up the cases regularly every 3 months (NHMRC, evidence grade PP)4.
15
Chapter 3
Adapted from 2006 Canadian clinical practice guidelines & SIGN Guideline
17
• Obtain a thorough history and a general physical examination to assess obesity, overweight and obesity related risks
and to exclude secondary causes of obesity (Canadian, evidence grade A, level 3)3,4. See tables 2 to 9 for details.
• Measure body mass index (BMI) (weight in kilograms divided by height in meters squared) to assess overweight or
obesity in adults - (Canadian, evidence grade A, level 3)3,4. Table 2 provides the reference for different BMI categories.
• Measure the waist circumference (WC) in addition to BMI to assess for abdominal fat and risk of obesity-related co-
morbidities particularly cardiovascular disease and diabetes (Canadian, evidence grade A, level 3)3. Males with WC ≥
102 cm and females with WC ≥88 cm are at high-risk of the above mentioned complications, see Table 3 11.
• Request/ Conduct laboratory tests when appropriate to assess for co-morbidities. Recommended tests include:
- Fasting plasma glucose level, lipid profile, including total cholesterol, triglycerides, low-density lipoprotein
cholesterol (LDL), high-density lipoprotein (HDL) and ratio of total cholesterol to HDL (Canadian, evidence grade A,
level 3)3.
- Liver enzyme tests, urinalysis and sleep studies (Canadian, evidence grade B, level 3)3.
• Refer for professional assessment as appropriate for eating disorders, depression and psychiatric disorders
(Canadian, evidence grade B, level 3)3.
18
Table 5: Medications that interfere with weight loss or induce weight gain15
Medication Class Alternatives
Antipsychotics/ Mood Stabilizers Ziprasidone, Aripiprazole
• Phenothiazines
• Atypical antipsychotics: Clozapine, olanzapine, risperidone, quetiapine
• Lithium
Antidepressants: Nefazodone, Bupropion, Venlafaxine
• Sedating tricyclics: Amitriptyline > imipramine
• Monoamine oxidase inhibitors (non-selective): Isocarboxazid, Phenelzine, tranylcypromine
• Selective serotonin reuptake inhibitors: Paroxetine > citalopram, fluvoxamine, sertraline
• Mirtazapine
Antiepileptics: Lamotrigine, Topiramate
• Gabapentin, Valproate, Carbamazepine, Pregabalin
Antiepileptics/antipsychotics used in bipolar disorder Lamotrigine, Topiramate, Ziprasidone
• Valproate, Carbamzepine, Clozapine, Olanzapine, Risperidone
• Hormonal contraceptives Barrier methods
• Corticosteroids NSAIDs
Progestational steroids: Weight loss Aromatase Inhibitors
• Megestrol acetate
Antidiabetic agents: Metformin, Acarbose
• Insulin
• Sulfonylureas
• Thiazolidinediones
Antihypertensives: ACEI, ARB, Diuretics, CCB
• Beta and alpha1- adrenergic blocking agents
Antihistamines: Diphenhydramine, Decongestants, inhaler
• Cyproheptadine
20
Table 8 : The following questions can help in discussing readiness to change lifestyle behaviors:
• How important do you think it is for you to make changes at the moment?
• How confident are you that you can change your eating patterns and increase your physical activity to improve health?
• Are there any stressful events in your life now that might get in the way?
• Do you feel you can succeed in changing health behaviors’, and how much do you believe it is worth the effort?
• Can you picture yourself changing health behaviors? How do you think your friends and family will react to your efforts?
• Are there people who can support you to change health behaviors’? Do you think they will help you in your efforts?
22
Table 10: Applying the Stages of Change Model to Assess Readiness to Lose Weight15
Management of obesity
Devise goals:
• The ultimate goal of weight management is to improve health and to reduce the risk of obesity related co-
morbidities 11.
- For adults with BMI 25-35 kg/m2 the target is to lose 5-10% of body weight (0.5-1 kg per week)3,11.
- For adults with BMI>35 kg/m2 and obesity-related co-morbidities the target is to lose a greater than 15-20% of
body weight 11.
Devise life style modification program for weight loss and reduction of risk factors:
• The focus of life style modification goals should be on improving health rather than reducing weight 4.
• Lifestyle modification should target at reducing energy intake, increasing energy expenditure and assisting in
behavioral change (NHMRC, evidence grade A) 4.
• Optimal dietary plan for achieving healthy body weight should be developed with a qualified and experienced
health professional team together with the individual and family 11.
• On discussing weight management with the patient and family, health professionals are encouraged to create a
nonjudgmental atmosphere and to address barriers to weight management (Canadian, evidence grade C, level 4) 3.
Dietary interventions
• Target energy deficit of 500-1000 kilo-calorie per day (3,500 kcal/week). Attention should be given to the dietary
preferences of the individual (NHMRC, evidence grade A) 4.
• Provide advice on dietary modification appropriate to the patient condition (type, quantity and/or frequency) to
achieve and maintain a hypo-caloric intake (a high-protein or a low-fat diet with acceptable macronutrient
distribution range). Patients should be advised to:
26
- choose low energy-dense foods (e.g. whole-grains, cereals, fruits, vegetables, and salads) and reduce intake of
energy-dense foods (e.g. animal fats, sugary drinks (SIGN, evidence grade B) 11.
- reduce consumption of junk food 11.
- undertake regular self-weighing (SIGN, evidence grade B) 11.
• Strictly supervise patients on very low calorie diets prescribed for rapid weight loss, (SIGN, evidence grade D) 11.
Psychological/behavioral interventions
• Psychological interventions should be part of any weight management program (SIGN, evidence grade A) 11.
• It should be adjusted to circumstances of the individuals or their families. The objectives are to decrease dietary
energy intake, increasing physical activity, and decreasing sedentary behaviors (SIGN, evidence grade B) 11.
• Devise strategies appropriate to specific individual situations to prevent or minimize weight regain in adults who
successfully achieved weight loss (NHMRC, evidence grade A) 4.
• Advise the adults who successfully achieved weight loss, to consult health professionals if they observed small
amount of weight regain (approximately 3 kg). Health professionals should reassess the lifestyle modification
maintenance program for the individual (NHMRC, evidence grade PP) 4.
• Encourage motivation for long-term weight management through approaches including self-management (e.g.
manage hunger, reviewing goals, and regular self-weighing), continuing contact with health professionals and
behavioral strategies (NHMRC, evidence grade PP) 4.
Chapter 4
PHARMACOLOGICAL TREATMENT
30
PHARMACOLOGICAL TREATMENT:
Currently there is a list of medications used for pharmacological treatment (see table 12), however, there is no enough
evidence regarding the efficacy of different drugs, the benefit of combination therapy, weight regain after withdrawal
of medications or the benefits of continuing treatment beyond 1 year. However, the following are recommended 11,16:
• Consider adding pharmacologic agent with lifestyle interventions on an individual case basis after assessment of
risks and benefits:
- In obese adults (BMI ≥30 kg/m2) who failed to achieve or maintain weight loss with lifestyle modification program,
(Canadian, evidence grade B level 23 and SIGN, Evidence grade A) 11.
- In obese or overweight individuals (BMI ≥28 kg/m2 with co-morbidities) to assist in reducing obesity-related co-
morbidities, like type 2 diabetes, impaired glucose tolerance or the risk factors for type 2 diabetes (Canadian,
evidence grade B level 23 and SIGN, Evidence grade A) 11.
- In pre-pubertal obese children Pharmacological therapy is generally not recommended, however, it can be
considered only (treatment with Orlistat) under supervision of specialized team, if severe co-morbidities are
present, e.g. orthopedic problems, sleep apnea, severe psychological disease or within the context of a supervised
clinical trial (Canadian, evidence grade C, level 4 and NICE, 2006, amended 2014) 3,17.
• Discuss with the patient the potential benefits, limitations, drug’s side effects, and the temporary nature of the
weight loss achieved with medications before initiating therapy (NICE, 2006, amended 2014) 17.
• Discontinue use if the drug is ineffective, or if there are serious adverse effects 18.
31
Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Route of Primarily renal Primarily renal Primarily renal No single organ as major route Primarily fecal excretion of
Elimination of elimination unabsorbed drug
Limitations of Use • Safety and • Effect on CV morbidity • Effect on CV morbidity andmortality • Should not be used in
efficacy of co- and mortality has not has not beenestablished combination with any
administration been established • Safety and effectiveness in otherGLP1- receptor agonist
with other • Safety and effectivenessin combination with other products • Should not be used with
products for combination with other for weight loss, including insulin
weightloss products for weight loss, prescription and OTC drugs, and • Effect on CV morbidity and
have not been including prescription herbal preparations have not been mortality have not been
established and OTC drugs, and established established
• Effect on CV herbal preparations have • Safety and efficacy of co-
morbidity and not been established administration with other
mortality has not products for weight loss have
been established not been established
• Not been studied in patients
with a history of pancreatitis
Contraindications Pregnancy • Uncontrolled • Pregnancy Personal or family history of Pregnancy, chronic mal-
hypertension • Glaucoma MTC or MEN2,hypersensitivity absorption syndrome,
• Seizure disorders, • Hyperthyroidism to liraglutide cholestasis, known
anorexia nervosa or • during or within 14 days of taking or any product components, hypersensitivity to the
bulimia, or undergoing MAOIs pregnancy medication or to any product
abrupt discontinuation of • known hypersensitivity or components
alcohol, benzodiazepines, idiosyncrasy to sympathomimetic
barbiturates, and amines
antiepileptic drugs
• Use of other bupropion
containing products
• Chronic opioid use
• During or within 14 days
of taking MAOIs
• Known allergy to any
ingredients in the product
• Pregnancy
33
Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Maintenance 10 mg oral BID, The dose should be 7.5 mg/46 mg oral QD every morning 3 mg SC QD at any time of 120 mg oral TID with each
Dosage and with or without escalated starting with with or without food the day, independent of main meal containing
Administration food. Discontinue 1tablet in the morning. Maximum dose is 15 mg/92 meals. Discontinue if patient fat(during or up to 1 hour
if patient has A total dosage of two Mg has not lost ≥4% of baseline after the meal)
not lost ≥5% of 8mg/90 mg tablets oral Discontinue or escalate the dose bodyweight by week 16
baseline body BID in the morning and if the patient has not lost ≥3% of
weight by week evening is reached at the baseline body weight by week 12 on
12 start of Week 4. 7.5mg/46 mg dosage, If the patient
Should not be taken with a has not lost ≥5% of baseline body
high fat meal. Discontinue weight on 15 mg/92 mg dosage after
if patient has not lost ≥5% an additional 12 weeks discontinue
of baseline body weight by treatment
week 12
Warnings and Serotonin • Suicidal behavior and • Fetal toxicity • Risk of thyroid C-cell tumors • Can decrease cyclosporine
Precautions syndrome or thoughts • Increase in HR • Acute pancreatitis exposure
neuroleptic • Risk of seizure may be • Suicidal behavior and thoughts • Acute gallbladder disease • Patient should be strongly
malignant minimized by adhering • Acute myopia and secondary angle • Risk of hypoglycemia with encouraged to take
syndrome-like to recommended dosing closure glaucoma concomitant use of anti- multivitamin supplement
reactions schedule and avoiding • Mood and sleep disorders diabetic therapy that contains fat-soluble
• Valvular heart co-administration with • Cognitive impairment • Heart rate increase vitamins
disease high-fat meal • Metabolic acidosis • Renal impairment • Rare cases of severe liver
• Cognitive • Increase in BP and HR • Elevated creatinine • Hypersensitivity reactions injury with hepatocellular
impairment • Hepato-toxicity • Use of anti-diabetic medications • Suicidal behavior and necrosis or acute hepatic
• Psychiatric • Angle-closure glaucoma thoughts failure have been reported
disorders, • Use of anti-diabetic • Patients may develop
including medications increased levels of urinary
euphoria and oxalate following treatment.
dissociation Monitor renal function
• Monitor for in patients at risk for renal
depression or insufficiency
suicidal thoughts • Substantial weight loss can
• Use of anti- increase risk of cholelithiasis
diabetic • Exclude organic causes of
medications obesity before prescribing
• Priapism • GI events may increase when
orlistat is taken with a high
at diet (>30%total daily
calories from fat)
34
Active Ingredient Lorcaserin HCl Naltrexone HCl and Phentermine and topiramate Extended-release Liraglutide* Orlistat*
buproprion HCl extended extended-release
release
Common Adverse Non-diabetic Nausea, constipation, Paraesthesia, dizziness, dysgeusia, Nausea, hypoglycemia, Oily spotting, flatus with
Reactions patients: headache, vomiting, insomnia, constipation, and dry diarrhea, constipation, discharge, fecal urgency fatty/
Headache, dizziness, insomnia, dry mouth vomiting, headache, decreased oil stool, oily evacuation,
dizziness, fatigue, mouth, and diarrhea appetite, dyspepsia, fatigue, increased defecation and fecal
nausea, dry dizziness, abdominal pain incontinence
mouth, and
constipation
Diabetic patients:
Hypoglycemia,
headache, back
pain, cough, and
fatigue
How Supplied 10 mg tablets 8 mg/90 mg tablets 3.75 mg/23 mg, 7.5 mg/46 Disposable, pre-filled, multi- 120 mg capsules
mg, 11.25 mg/69 mg and 15mg/92 dose pen that delivers 0.6mg,
mg capsules 1.2 mg, 1.8 mg, 2.4 mg or 3 mg
(6 mg/mL, 3mL).
Storage Store at 77°F Store at 77°F (25°C), Store at 59-77°F (15-25°C) Unopened pens: store in the Store at 77°F (25°C),with
(25°C), with permitted excursions refrigerator between 36-6°F permitted excursions of59-
with permitted of 59-86°F (15-30°C) (2-8°C) 86°F (15-30°C)
excursions of In-use pens: store in the
59-86°F (15-30°C) refrigerator 36-46°F (2-8°C)
OR at room temperature
between 59-86°F (15-30°C)
After initial use, the Liraglutide
3mg pen must be used within
30 days
GLP-1: glucagon-like peptide-1; AMPA: α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate; BMI: body mass index; HTN: hypertension; CV: cardiovascular; OTC:
over-the-counter; MAOI: monoamine oxidase inhibitors; MTC: medullary thyroid carcinoma; MEN2: Multiple Endocrine Neoplasia syndrome type 2; BID: twice daily;
QD: once daily; SC: subcutaneously; TID: three times daily; BP: blood pressure; HR: heart rate; GI: gastrointestinal
*Only Orlistat and LiraglutideBSFUIFPOMZ registered drugs in the Saudi Food & Drug Authority
35
Chapter 5
BARIATRIC SURGERY
36
BARIATRIC SURGERY:
• Consider Bariatric surgery as part of an overall clinical pathway for adult weight management.(SAGES evidence level I,
grade A) 26.
• Consider bariatric surgery on an individual case basis after assessing the risks and benefits (SIGN, evidence grade C) 11.
• Consider bariatric surgery:
- In adults with clinically severe obesity (BMI > 40 kg/m2). It is the most effective treatment for morbid obesity, it leads
to durable weight loss and improvement of co-morbidities (SAGES evidence level I, grade A) 26.
- In adults with BMI > 35 kg/m2 and severe co-morbidities (SIGN, evidence grade C3 and Canadian, evidence grade B,
level 2) 11.
- In adults with BMI > 30 kg/m2 who have poorly controlled type 2 diabetes and are at increased cardiovascular risk
(NHMRC, evidence grade PP) 4.
- In post pubertal adolescents with very severe to extreme obesity and severe co-morbidities (SIGN, evidence grade
D)11. Bariatric surgery in adolescents is to be limited to exceptional cases and performed only by experienced teams
(Canadian, evidence grade C, level 4) 3.
• It should be performed by an experienced and well trained multidisciplinary team, including surgeons, anesthetists,
dietitians, nurses, psychologists and physicians (SAGES evidence level III, grade C). However, types of surgery,
anesthetic practice and immediate post-operative care are out of the scope of these guidelines 26.
• Assess for psychological disorders preoperatively (SAGES evidence level III, grade C). Treated psychopathology does
not prevent patients to undergo bariatric surgery (SAGES evidence level II, grade B) 26.
• Intra-gastric balloon is a safe and effective procedure in weight reduction, but, unfortunately, the results are temporal
and almost all patients return to their initial weights after balloon removal 27,28.
37
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ashx?id=10075&p=0
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cmaj.061409
4- Australian Government: Department of Health and Aging. Clinical Practice Guidelines for the Management of
overweight and obesity in adults, adolescents and children in Australia http://www.healthyactive.gov.au/internet/
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www.healthyactive.gov.au/internet/main/publishing.nsf/Content/obesityguidelines-index.htm
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obesity in primary care. Canberra, Commonwealth of Australia, 2013 Available: http://www.nhmrc.gov.au/_files_
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from url: http://www.mckinsey.com/search.aspx?q=Overcoming+obesity
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Edinburgh: SIGN; 2010. Available from url: http://www.sign.ac.uk/pdf/sign115.pdf.
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obesity-in-children-young-people-and-adults-pdf
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1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomized, double-blind, placebo-controlled
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Bariatric Surgery. SAGES Guidelines Committee endorsed by the ASMBS Received: 20 March 2008 / Accepted: 25
March 2008 ©SAGES 2008. Available from url:http://www.sages.org/publications/guidelines/guidelines-for-clinical-
application-of-laparoscopic-bariatric-surgery/
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Bays HE. Obesity Algorithm, presented by the American Society of Bariatric Physicians, 2014-2015.
43
ANNEXES:
1 - Level of evidence and grade of recommendations used by Scottish Intercollegiate Guidelines Network (SIGN).
Levels of evidence
1++ High quality meta-analyses, systematic reviews of RCTs or RCTs with a very low risk of bias
1+ Well-conducted meta-analyses, systematic reviews or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort studies/high quality case control or cohort studies with a very low risk
of confounding or bias and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the
relationship is causal
2- Case control or cohort studies with a high-risk of confounding or bias and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g., case reports, case series
4 Expert opinion
Grades of recommendation
A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population;
or A body of evidence consisting principally of studies
rated as 1+, directly applicable to the target population,
and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating
overall consistency of results; or extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating
overall consistency of results; or extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+
RCT: Randomized controlled trials
2 - Grade of recommendations used by National Health and Medical Research Council (NHMRC) - Australia
Grade Description
A Body of evidence can be trusted to guide the practice
B Body of evidence can be trusted to guide the practice in most situations
C Body of evidence provides some support for recommendation(s) but care should be taken in its application
D Body of evidence is weak and recommendation must be applied with caution
CBR Consensus-based recommendation formulated in the absence of quality evidence
PP Developed by the Obesity Guidelines Development Committee for areas beyond the scope of the systematic review.
3 - Classification of evidence used in the 2006 Canadian clinical practice guidelines on the management and prevention of
obesity in adults and children
Criteria
Level of for assigning a grade to recommendations
Grade Criteria
A Strong recommendation (action can apply to most individuals in most circumstances)
• benefits clearly outweigh risks (or vice versa)
• evidence is level 1, 2 or 3
B Intermediate recommendation (action may vary depending on the person’s characteristics or other circumstances)
• unclear whether benefits outweigh risks
• evidence is level 1, 2 or 3
C Consensus (weak) recommendation (alternative actions may be equally reasonable)
• unclear whether benefits outweigh risks
• evidence is level 3 or 4
4 - Definition of grades of recommendations used by Institute for Clinical Systems Improvement (ICSI), Minnesota (USA)
Category Quality Definitions Strong Recommendation Weak Recommendation
High Quality Further research is very unlikely The work group is confident that The work group recognizes that the
Evidence to change our confidence in the the desirable effects of adhering to evidence, though of high quality, shows a
estimate of effect this recommendation outweigh the balance between estimates of harms and
undesirable effects. This is a strong benefits. The best action will depend on local
recommendation for or against. This circumstances, patient values or preferences.
applies to most patients
Moderate Further research is likely to The work group is confident that The work group recognizes that there is a
Quality have an important impact on the benefits outweigh the risks but balance between harms and benefits, based
Evidence our confidence in the estimate recognizes that the evidence has on moderate quality evidence, or that there is
of effect and may change the limitations. Further evidence may uncertainty about the estimates of the harms
estimate. impact this recommendation. This is a and benefits of the proposed intervention that
recommendation that likely applies to may be affected by new evidence. Alternative
most patients. approaches will likely be better for some
patients under some circumstances.
Low Quality Further research is very likely to The work group feels that the evidence The work group recognizes that there is
Evidence have an important impact on consistently indicates the benefit of significant uncertainty about the best
our confidence in the estimate this action outweighs the harms. This estimates of benefits and harms.
of effect and is likely to change. recommendation might change when
The estimate or any estimate of higher quality evidence becomes
effect is very uncertain. available.
46
5 - Definition of grades of recommendations used by the Society of American Gastrointestinal and Endoscopic
Surgeons(SAGES)
Level of evidence Criteria
Level I Evidence from properly conducted randomized controlled trials
Level II Evidence from controlled trials without randomization
Or Cohort or case-control studies Or Multiple time series, dramatic uncontrolled experiments
Level III Descriptive case series, opinions of expert panels
The members of the adoption group of first version of the Clinical Saudi Obesity Guidelines.
• Fahad S. Al-Shehri, Consultant of Family Medicine, Department of Family Medicine and Research, Health Affairs,
Aseer Region,
• Mohammed M. Moqbel, Consultant of family medicine, Department of Family Medicine and Research, Health Affairs,
Aseer Region,
• Abdullah M. Al-Shahrani, Departments of Family Medicine and Public Health, Ministry of Health Affairs, Southern
Region
• Yahia M. Al-Khaldi, Department of Family Medicine and Research, Health Affairs, Aseer Region,
• Waleed S. Abu-Melha, Department of Preventive Medicine, Armed Forced Hospital, Southern Region, Saudi Arabia
48
• Prof. Aayed R. Alqahtani - MD, FRCSC, FACS, Director of KSU Obesity Chair, Professor of Bariatric and MIS Surgery,
College of Medicine, King Saud University
• Dr Fahad Shar Alshehri - Consultant of family medicine and diabetes, Member of Saudi Arabian Society of Metabolic
& Bariatric Surgery (SASMBS)
• Dr. Haitham Alfalah, Consultant Bariatric Surgery, Kind Saud Medical City, Riyadh
• Dr. Khalid I. Alqumaizi - Consultant Family and Community Medicine, Dean, College of Medicine, ImamU
• Dr. Mohammad Y. Saeedi -Consultant Family and Community Medicine -Director General for Genetic and Chronic
Diseases , MOH , KSA
• Dr. Mohammed Y. Alharbi - Consultant of Pediatric Endocrinology, Dialectology and Obesity, Director of Diabetes
Centers and units Administration ,MOH, KSA
• Prof. Mourad Elmourad - Consultant Endocrinologist, Senior Advisor for Genetics & Chronic Directorate, MOH
• Dr. Mustafa Salih Mustafa, MBBS, MD Community Medicine, MA Health Management, Policy and Planning, General
Directorate for Genetic and Chronic Diseases , MOH , KSA
• Dr. Omar A. Alobaid - Associate Professor of Surgery, College of Medicine, King Saud University.
49
• Dr. Saleh M. AlRajhi - , DO, FAAFP, EMHA Candidate Bariatric and Family medicine consultant ,Chairman of Obesity
Department Obesity Metabolic And Endocrine Center ,King Fahad Medical City Riyadh, KSA
• Dr. Shaker A. Alomary - Consultant Family Medicine -Director of Obesity Control Program , MOH , KSA
• Dr. Shaker A. Alomary - Consultant Family Medicine -Director of Obesity Control Program , MOH , KSA
• Dr. Mustafa Salih Mustafa, MBBS, MD Community Medicine, MA Health Management, Policy and Planning, General
Directorate for Genetic and Chronic Diseases , MOH , KSA
• Dr. Syed Arif Hussain, MBBS, DPH, MSc Epidemiology, Epidemiologist/Public Health Specialist, General Directorate for
Genetic and Chronic Diseases , MOH , KSA
• Dr. Yassin Hassan Alsafi, MBBCH,MRCGP, General Directorate for Genetic and Chronic Diseases , MOH , KSA
• Dr. Mohamed E. Ibrahim - MBBS, Mph, MPhil Clinical Epidemiology, General Directorate for Genetic and Chronic
Diseases , MOH , KSA
• Dr. Fahad A. Alamri - Consultant Family Medicine, General Directorate for Genetic and Chronic Diseases , MOH , KSA
• Dr. Ahmed Jafar Al Eid, BSc, MD, SDFM, EMHCA. Family Physician, Coordinator of Obesity Control Program in Eastern
Province, MOH, KSA
BMI for age-percentiles: boys, birth to 36 months 43 x 55 mm BMI for age-percentiles: boys, 2 to 19 years 43 x 55 mm
Source: Al Herbish AS, El Mouzan MI, Al Salloum AA, Al Qureshi MM, Al Omar AA, Foster PJ, Kecojevic T. Body mass index in Saudi Arabian children and adolescents: a national reference and
comparison with international standards.
51
BMI for age-percentiles: girls, birth to 36 months BMI for age-percentiles: girls, 2 to 19 years
Source: Al Herbish AS, El Mouzan MI, Al Salloum AA, Al Qureshi MM, Al Omar AA, Foster PJ, Kecojevic T. Body mass index in Saudi Arabian children and adolescents: a national reference and
comparison with international standards.
For any inquiries or suggestions please feel free to contact us at: OCP@moh.gov.sa