5 vertin 24 & dhi

1. 1
Now available in India

2. 2
Vertin 24
•Assured patient compliance
•Convenient dosage
•Established efficacy & safety

3. 3
Dose of Betahistine
48 mg /day
Martindale, 2002, Coelho MH IN Basics on Vertigo, Dizziness & Imbalance, 1999

4. 4
P’K in general
•Min effective conc. -blood conc. of drug required to
show therap. Effect
•Lethal dose- Blood conc. of drug producing toxicity
•Therapeutic window- Range of blood conc. of drug
showing therapeutic effect but not toxic
•Half-life- Time required to achieve half of max.
blood levels of drug
•Duration for which drug remains in therap. Window
determines dosage schedule
Vertin half-life 3-4 hrs
•Various trials established that 16 mg needs to be given
tid & 24 mg need to be given bid- ensures blood conc.
in therapeutic window to exhibit therapeutic effect

5. 5
Vertin 24 reprint
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
RD, MC
147 pts recurrent vertigo
(Bouts of severe dizziness lasting for several
min to several hrs with / without
Cochlear symptoms
Grp I BH 16 mg t.i.d. (morn, noon, even)
Grp II BH 24 mg b.i.d. ( Morn, even)
for 3 months

6. 6
Efficacy
•Frequency of vertigo attacks
•Duration of vertigo attacks
1=mean duration betn 2 & 10 min
2=mean duration betn 11 & 60 min
3=mean duration betn 1 & 6 hrs
4= mean duration betn 6 & 24 hrs
•Severity (5-point scale)
0=nil, 1=mild, 2=moderate, 3=severe, 4=very severe
Tolerance
Spontaneous complaints betn day 45 & 90
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
Assessment Day 0, 45 & 90 of treatment

7. 7
Reduction in severity of vertigo attacks
with t.i.d. & b.i.d.
Reduction in severity of vertigo attacks
with t.i.d. & b.i.d.
Mild to zero severity in % pts
Day 45 Day 90
16 mg t.i.d. 78.1 92.7
24 mg b.i.d. 77.9 87.5
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV

8. 8
Global assessmentGlobal assessment
% pts with success
Day 45 Day 90
16 mg t.i.d. 82.8 92.8
24 mg b.i.d. 86.8 90.3
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV

9. 9
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
Equal efficacy of 16 mg tid & 24 mg bid
in reducing frequency of vertigo attacks
16 mg tid
24 mg bid

10. 10
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
Equal efficacy of 16 mg tid & 24 mg bid
in reducing duration of vertigo attacks
16 mg tid
24 mg bid

11. 11
Equal efficacy of 16 mg tid & 24 mg bid
in reducing severity of vertigo attacks
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
16 mg tid
24 mg bid

12. 12
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV
84.1 88.2
0
20
40
60
80
100
%ptswithnoS.E.
16 mg tid 24 mg bid
Comparable tolerance of Vertin 16 mg
tid & 24 mg bid

13. 13
•No significant difference in reduction of freq.,
duration & severity of vertigo attacks with 16 mg
t.i.d. & 24 b.i.d.
•Comparable tolerance with both grps
Results
Vertin 16 mg t.i.d. & 24 mg b.i.d.
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV

14. 14
Betahistine given as just 2 doses per day- easier
to Rx for patients not wishing to take medicine
in middle of day
Conclusion
-Tran Ba Huy, J Fr. Oto-Rhino-Laryngol (JFPRL), 1992, 41 (suppl 3), HV

15. 15
Recent
2003 study
Effect of Betahistine on
handicap induced by Dizziness

16. 16
Vertin DHI Reprint
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593
DB, RD, MC
69 pts recurrent vertigo of
peripheral vestibular origin
severely handicapped by vertigo
Either of treatments for 8 weeks
Vertin 16 mg t.i.d. /
Flunarizine 10 mg o.d. & placebo twice daily
Recent
2003 data

17. 17
•DHI- self assessment scale -evaluating handicap
associated with vertigo- Physical, functional,
emotional subscores in vertigo patients
•25 questions- 9 functional, 9 emotional, 7 physical
•Answer ‘yes’ 4 points, ‘sometimes’ 2 , ‘no’ 0
•Sum of all subscores- Total DHI score
•Total DHI score
“0”-No handicap, “100” significant handicap
•Patients included, total DHI score > 40
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593
Assessment by Dizziness Handicap Inventory (DHI)

18. 18
Assessment of
•Vegetative symptoms- nausea, vomiting, light
headedness, sweating, pallor, headache, cochlear
symptoms- tinnitus, hearing loss, fullness of ear
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593
Assessment of B.P., pulse rate

19. 19
Results of Vertin treatment on DHI scaleResults of Vertin treatment on DHI scale
Total
score
Physical
subscore
Functional
subscore
Emotional
subscore
Baseline 54.4
(100%)
18.1
(100%)
21.1
(100%)
15.2
(100%)
Week 8 17.8
(33%)
5.7
(32%)
7.3
(35%)
6.4
(32%)
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593

20. 20
•Mean total DHI score & 3 subscores with VTN
•VTN 48 mg /d slightly quicker in handicap
induced by vertigo
•All vegetative symptoms (nausea most frequently
reported)improved significantly except headache
Results
Conclusion
•Vertin reduces handicap induced by vertigo
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593

21. 21
Tolerance of Vertin 16 mg t.i.d.
•Mean values of B.P., pulse remained unchanged
•Well tolerated & safe
2003 study
-Albera E et al, Acta Otolaryngol, 2003, 123, 588-593

22. 22
Which antivertigo drug to choose
Betahistine or Cinnarizine ?

23. 23
Betahistine Cinnarizine
Does not sedate Sedation-side effect
Facilitates compensation slows down compensation
Suitable for use with should not be used with
vestibular habituation therapy vestibular habituation
therapy
Kirtane MV, Ind. J. Otolaryngol H N S, 1999, 51 (2), , Colletti V, Acvta Otolaryngol Suppl 5444
Betahistine vs. Cinnarizine

24. 24
Betahistine vs. Cinnarizine
Tolerance
Vertin Cinnarizine
No extrapyramidal side Extrapyramidal side
effects on long term since effects (Parkinson’s)
no antidopaminergic effects common due to anti-
dopaminergic effects
•No caution required Caution in elderly
in the elderly Ref.(Collin Dollery Drugs)

25. 25
Betahistine vs. Cinnarizine
Tolerance
Betahistine Cinnarizine
No caution in Hypotensive High dose-caution
patients since no effect in hypotensive-due
on B.P . to possibility
(Stough study) of lowering of B.P.
(Martindale ref)

26. 26
Betahistine vs. Cinnarizine
Vertin Cinnarizine
•Increases alertness Causes drowsiness
(Coelho ref) (Deering study)
•No effect on driving Should not drive or
performance (Betts operate machinery
Study) Ref(Collin Dollery Drugs)

27. 27
•Efficacy (Deering study)
•Safety/ tolerance (Deering study)
•Facilitates compensation unlike Cinnarizine (Colletti study)
•No drowsiness unlike Cinnarizine (Kirtane)
•Suitable for use with Vestibular Habituation
Therapy (VHT) unlike Cinnarizine (Kirtane)
Betahistine superior to Cinnarizine in

28. 28
Which antivertigo drug to choose
Betahistine or Prochlorperazine ?

29. 29
Vertin vs. Prochlorperazine Vs. PlaceboVertin vs. Prochlorperazine Vs. Placebo
12 healthy volunteers
High dosage of Vertin used ( 72 mg tds for 3 days)
Subjects performed driving tests
weaving in & out of traffic cones
driving through a narrow gap between traffic
cones
Assessed carelessness (Hitting cones!), errors of judgement
& slowing of response
12 healthy volunteers
High dosage of Vertin used ( 72 mg tds for 3 days)
Subjects performed driving tests
weaving in & out of traffic cones
driving through a narrow gap between traffic
cones
Assessed carelessness (Hitting cones!), errors of judgement
& slowing of response
Betts,Brit. J. Clin. Pharmacol, 1991, 32, 455-8
DB, C

30. 30
Driving test: mean no. of cones hit
Vertin no hampering of driving performance unlike Prochlorperazine
Driving test: mean no. of cones hit
Vertin no hampering of driving performance unlike Prochlorperazine
»
»9
5.5
4.0
Prochlorperazine
Placebo
Bettts, Brit. J. Clin. Pharmacol, 1991, 32, 455-8
Vertin

31. 31
Aantaa, Ann Clin. Res., 1976
Drug % preferences
BH 53%
Prochlor 17%
No prefer 30%
DB, CO 30 Meniere's disease pts
BH 8 mg tid/ Prochlor 5 mg tid

32. 32
Improvement of associated symptoms in
vertigo patients with BH
Improvement of associated symptoms in
vertigo patients with BH
15
7
1
0
6
0
0
2
4
6
8
10
12
14
16No.ofvertigopatients
Tinnitus nausea/ vomiting
wk 0 wk 1 wk 2 wk 3
Bradoo RA, Ind. J. Otolaryngol H N S, 2000 June, 52 (2), 151-8
No need for an antiemetic with BH in vertigo pts

33. 33
•Efficacy (Aantaa study)
•No drowsiness, No impairment of driving performance
( Betts) unlike Prochlorperazine
•Vertin- relieves N/V associated with vertigo- No need to
add antiemetic
•Suitable for use with VHT- facilitates compensation
Betahistine superior to Prochlorperazine

34. 34