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Management of IBS
Keys to treatment of IBS
Education/reassurance
Lifestyle/diet modification
Communication between patient and physician
Appropriate drug therapy
Follow-up with patient
Adjustment of therapy if necessary
Patient education in IBS
Education and reassurance are essential elements of clinical management
Patients need information about the nature of their condition, such as its high prevalence, the causes and symptoms
Patients should be made aware of the available treatment options, e.g. pharmacologic andnon-pharmacologic therapies
Dietary and lifestyle modification
Stress management/reduction techniques have been shown to improve patient well-being1
Diet diaries may be used to identify dietary factors that tend to trigger IBS symptoms
– elimination or reduction in intake of these foods may reduce the frequency and severity
of symptoms2
1Leahy A et al. J R Coll Physicians London 1988;32:552–62Burden S. J Hum Nutr Diet 2001:14:231–41
Drugs for individual symptoms in IBS
Abdominal pain Bloating Altered bowel motility
Anticholinergic/ anti-–spasmodics
Tricyclic antidepressants
Selective serotonin reuptake inhibitors
Antispasmodics
Antiflatulents
Loperamide
Cholestyramine
Psyllium
Methylcellulose
Calcium polycarbophil
Lactulose
70% sorbitol
Polyethylene glycol solution
Serotonergic agents (e.g. tegaserod, alosetron)
Psychologic treatments for IBS
Some patients with IBS may also benefit from
– referral to a psychologist or psychiatrist
– hypnotherapy
– biofeedback
– psychodynamic therapy
– stress management/relaxation
– cognitive behavioural programs
Drossman DA et al. The Functional GI Disorders, 2000
A comprehensive multi-component approach
Treatment program is based on dominant symptoms and their severity, and on psychosocial factors
Medication directed at the predominant symptoms
Diet/lifestyle modifications
Psychologic or behavioural options– psychotherapy– stress management
Complementary/alternative therapies
AGA medical position statement: Irritable Bowel Syndrome, 2002
Levels of evidence and grading of recommendations
Level I: high-quality randomized clinical trials
– Grade A recommendation
Level II: intermediate quality randomized clinical trials
– Grade B recommendation
Level III–IV: evidence from non-randomized trials or case studies
– Grade C recommendation
ACG Functional GI Disorders Task Force. Am J Gastroenterol 2002;97:S1–S26
Recommendations on traditional approaches
Antispasmodic agents: (Grade B recommendation)– overall, trials were of short duration, suboptimal quality and
demonstrated inconsistent effectiveness– antispasmodics should be used with caution in patients with
constipation
Bulking agents: (Grade B recommendation)– overall, trials contained small numbers of patients and were of
suboptimal quality
– fiber has been shown to exacerbate common IBS symptoms (gas, bloating, abdominal discomfort)
– fiber is appropriate treatment for the treatment of constipation, but may not be recommended for the treatment of IBS
ACG Functional GI Disorders Task Force. Am J Gastroenterol 2002;97:S1–S26
Recommendations on traditional approaches (cont’d)
Tricyclic antidepressants: (Grade B recommendation)
– overall, trials were of short duration, enrolled small numbers of patients, and were of suboptimal design
– the evidence is inadequate to support the effectiveness of TCAs for the improvement of global IBS symptoms
– there is limited evidence that TCAs may decrease abdominal pain
– TCAs may cause constipation and should be used with causation in IBS patients with constipation
ACG Functional GI Disorders Task Force. Am J Gastroenterol 2002;97:S1–S26
Recommendation on tegaserod
Tegaserod: (Grade A recommendation)
– overall, tegaserod trials consistently demonstrated high quality study methodology and effectiveness for the treatment of IBS with constipation
ACG Functional GI Disorders Task Force. Am J Gastroenterol 2002;97:S1–S26
THE IBS Market
Review
Defining an IBS Market
Many drugs prescribed Prescription data not available in all countries Created market (antispamodics + Laxatives)
Rationale behind the antispamodics
Relax smooth muscle of the colon Used with symptom of pain- May be used for the symptom of diarrhea
Antispasmodic drugs
Anticholinergic Muscle Relaxants Calcium channel blockers
Anticholinergic: Buscopan Hyoscine- B.Ingelheim
Advantages: Well established OTC use- cheap Well known Used in many indications
including dysmenorrhea Promoted by BI
Disadavantages Dry mouth Blurred vision May affect heart rhythm
Antispasmodic /Anticholinergic : Librax (clindinium+ chlordiazepoxide)
Advantages: Effective on the pain Well-established Inexpensive Generic forms available
Disadvantages Side effect profile (dry mouth
dizziness ) Constipation
Controlled prescription
Smooth Muscle relaxant: mebeverine
Duspatalin is the second most widely used drug on the market in UAE and Lebanon
Duspatalin from Solvay: number one brand in portfolio in Lebanon-
Number 2 in Portfolio in UAE
Duspatalin -Solvay
Present indication Symptomatic treatment of abdominal pain and discomfort and cramps, bowel disturbances and intestinal discomfort associated with IBS.
Planned indication NA
Formul./dosages 135mg (30 tabs) t.id200mg (30 tabs) given twice dailySyrup 10mg/ml available for children
PositioningKey Messages
Reminder detailing – sampling etc…
Others High on services to key customers – pharmacist deals
Overview:
Duspatalin
Advantages Relatively inexpensive Well- established Long term relationship in GI
field –supporting portfolio Sold directly from the
pharmacy Mainly sold through pharmacy
deals
Disadvantages Old No new supporting data Grade B –according to ACG Only provides relief of one
symptom – pain Not highly effective Doctors level of satisfaction May cause constipation in
some cases
Calcium channel Blockers: Dicetel pinaverium bromide (Solvay)
Advantages: Treatment of pain May reduce intestinal spasms Solvay is still active in GI field
Disadvantage: May reduce response to food
in the colon Not effective in C-IBS
Muscle relaxants and CCB’s- last note
A recent review of 26 controlled clinical trials on muscle relaxant and CCB’s:
Improve the pain
No effect on constipation No effect on the bloating
Laxative: A6
Key laxatives used in Lebanon and UAE: Duphalac (Lactulose) Solvay Dulcolax (Bisacodyl) BI
Laxatives –in general
Advantages Inexpensive Direct relief Natural alternative
Disadvantages May cause cramps and pains Development of tolerance Loss of fluids in most cases May cause flatulence
TCA & SSRI TCA & SSRI rationale & effectiveness rationale & effectiveness
Psychological co-morbidity Psychological co-morbidity
Major depressionMajor depression History of abuse (physical, sexual)History of abuse (physical, sexual) Serious impairment of daily functionSerious impairment of daily function somatizationsomatization
Multiple organs symptomsMultiple organs symptoms
Numerous specialists consultationsNumerous specialists consultations
Antidepressants - side effectsAntidepressants - side effects
Drug Main side effects
Tryptizol, Saroten: amitriptyline MSD/ Lundbeck
Sedation,orthostasis,dry mouth,constipation
Tofranil Imipramine Novartis
Diaphoresis, dry mouth, orthostasis
PROZAC: Fluoxetine E.Lilly cramping, mild hyperactivity, diarrhea
Faverin:Fluvoxamine Solvay Weight gain, hyperactivity, diarrhea
Zoloft: Sertraline Pfizer Mild hyperactivity, nausea
TCA & SSRI - DoseTCA & SSRI - Dose
Found to increase transit time Given in lower than usual doses
Ex- Prozac psychiatric dose is 10-20 mg , dose in IBS 5mg
No indication for these drugs but used off label –
Reality check: would you like to take a psychiatric drug for a problem in your gut?
FOR YOUR INFORMATION
The Story of Lotronex from GSK
This drug is alosteron introduced in few markets for D-IBS.
This drug is a 5 HT3 antagonist
Serious side effects: withdrawn in 2001 Severe constipation, ischemic colitis
The Story of Pruplsid (Gastroprokinetic)cisapride (J.Cilag)
5HT4 agonist and 5 HT3 Antagonist (weka) Indicated in GERD Used off- label in D-IBS
Caused QT prolongation - withdrawn