Articaine - Cloudfront.net

Transcription

ARTICAINE
June 2014
© 2014 Dr. Stanley F. Malamed!
All Rights Reserved
1
Today’s Menu
Part 2: Articaine HCl: Just the Facts
All Rights Reserved
2
Articaine HCl
All Rights Reserved
3
Articaine HCl
Availability
Mg /cartridge
MRTD
4%!
epi 1:100k
epi 1:200k
72
3.2 mg/lb!
7.0 mg/kg!
Absolute max = n/a
(USA)
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4
Articaine HCl
Onset
2 - 3 min
(textbook)
Duration! 60 min
(pulpal)
Duration! 3 - 5 hrs
(soft tissue)
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5
Articaine HCl
1976 Germany!
1985 Canada!
2000 USA!
2005 Australia
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6
Articaine HCl
Germany (2012) . . . 97% of ALL LAs used in dentistry*!
USA (2009) . . . 41% of ALL LAs used in dentistry
Australia (2012) . . . 70% of dentists use articaine**
* Daublander. Personnal communication February 2012
** Yapp, Hopcraft, Parashos. Australian Dent J 2012
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7
Why do doctors LIKE articaine?
Anecdotal comments from dentists:!
“It works faster”!
“It works better”!
“I don’t miss as often”!
“Hard to get ‘numb’ patients are easier to
numb with articaine”
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8
The SCIENCE of Articaine HCl
Since 1973 there have been more than 200
papers published in the dental / medical
literature on articaine HCl
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9
Articaine has been compared to lidocaine,
mepivacaine and prilocaine!
Virtually ALL studies have demonstrated that
articaine is AS SAFE and AS EFFECTIVE as
the drug it which it was compared.
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10
1999 - Three identical randomized, double-blind, parallel group,
active controlled, multicenter Phase 3 clinical trials!
Safety & efficacy of articaine HCl for USA Food & Drug
Administration (FDA) approval !
Patients aged 4 - 79 years!
JADA 2000 . . . Efficacy of articaine HCl!
JADA 2001 . . . Safety of articaine HCl!
Pediatric Dentistry 2001 . . . Safety & efficacy in pediatric dentistry
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11
1999 - Three identical randomized, double-blind, parallel group,
active controlled, multicenter Phase 3 clinical trials
Safety & efficacy of articaine HCl for USA Food & Drug
Administration (FDA) approval Because of the Haas 1995 paper we were asked to actively pursue
possible post-operative complications (e.g. paresthesia).
All patients were contacted 24-hours and 7-days following their
treatment and presented with a list of potential signs & symptoms
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12
29 sites !
in the !
USA & UK
Malamed SF, Gagnon S, Leblanc D
13
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Efficacy of articaine: a new amide local anesthetic
CONCLUSIONS!
!
Four percent articaine with epinephrine 1:100,000 is a safe and
effective local anesthetic for use in clinical dentistry. In this
investigation consisting of three randomized, double-blind
trials, we found articaine to be well tolerated in 882 subjects,
and that it provided clinically effective pain relief during most
dental procedures. Furthermore, we observed no significant
difference in pain relief between subjects in the 4 percent
articaine with epinephrine 1:100,000 group and those in the 2
percent lidocaine with epinephrine 1:100,000 group.!
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14
Efficacy of articaine: a new amide local anesthetic
CONCLUSIONS!
!
For 4 percent articaine with epinephrine 1:100,000, time to
onset of anesthesia and duration of anesthesia are
appropriate for clinical use and are comparable to those
observed for other commercially available local anesthetics.!
Articaine can be used effectively in both adults and children.!
!
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15
16
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Safety of articaine: a new amide local anesthetic
CONCLUSIONS:!
!
The incidence of complications (including paresthesia) was
equal for both of the tested local anesthetics, lidocaine &
articaine.!
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17
FDA-approved to age 4 years
18
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Virtually ALL studies have demonstrated that articaine
is AS SAFE and AS EFFECTIVE as the drug it which it
was compared.!
WHY?!
Because local anesthetics are VERY EFFECTIVE drugs
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19
Before Articaine HCl!
Pre-2005 (Australia)!
Pre-2000 (USA)
Lidocaine + epinephrine!
Mepivacaine + epinephrine!
Prilocaine + epinephrine! USA
Prilocaine + felypressin Australia
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20
Before Lidocaine HCl!
Pre-1948
Procaine + epinephrine!
Tetracaine + epinephrine!
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21
Procaine HCl
♥
Procaine HCl
♥
♥
Remains the most well-known local anesthetic in the
world by its proprietary name: NOVOCAIN.
Procaine was the 1st local anesthetic to be marketed in glass
dental cartridges (1922)
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22
Procaine HCl
Procaine
6-10 min
Onset -
2-3 hrs
Duration -
20-30 min
Duration -
Allergy
YES, rare
Overdose
Rare from
“too much”
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23
Procaine HCl
Lidocaine HCl
Procaine
Lidocaine
6-10 min
3-5 min
2-3 hrs
3-5 hrs
20-30 min
60 min
Allergy
YES, rare
Exceedingly rare
Overdose
Rare from
“too much”
More likely from ‘too
much’
Onset Duration Duration -
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24
So, What, if any, are the clinical
advantages of articaine HCl
compared with the other
amide LAs?
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25
Articaine HCl
Advantages
1. More lipid-soluble!
Diffuses through soft & hard tissues better!
Palatal anesthesia with buccal infiltration!
Mandibular anesthesia in adults via
infiltration!
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26
Maxillary Infiltration
Articaine
Articaine
More lipid-soluble
Flared palatal roots
Palatal soft tissue
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27
Articaine HCl by Mandibular Infiltration in Adults
Mandibular infiltration
John Meechan (UK)!
Al Reader (USA)
More lipid-soluble
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28
Articaine HCl
Advantages
!
2. Elimination half-life of 27 minutes (162 min = 2:42)
Lidocaine, mepivacaine, prilocaine ~ 90 minutes
(540 min = 9 hrs)
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29
Articaine HCl
Advantages
3. Pregnancy
All other amide local anesthetics
Elimination
half-life
Beta half-life ~90 minutes +
of
27
minutes
ARTICAINE
Beta half-life 27 minutes
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30
Articaine HCl
Advantages
4. Nursing
Elimination
half-life
All other local anesthetics
of
27
minutes
Pump & discard for 9 hours*
USA FDA
ARTICAINE
USA FDA
Pump & discard for 4 hours*
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31
Articaine HCl
Advantages
!
5. Pediatrics
- preferred
LA !
Elimination
half-life
!Decreased risk of overdose!
of
27
minutes
Elimination half-life of 27 minutes!
!
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32
Articaine HCl
Advantages
Articaine is the LEAST LIKELY
anesthetic to induce an overdose
caused by administration of
too many cartridges
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33
Articaine HCl
Advantages
6. Endodontics (infected / inflammed teeth)!
Greater lipid-solubility!
Thiophene ring = articaine!
Benzene ring = other LAs!
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34
Articaine HCl
Advantages
7. ‘Hard to ‘numb’ patients (anecdotal)
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35
Articaine HCl
Advantages
1. More lipid-soluble!
Diffuses through soft& hard tissues better!
Palatal anesthesia with buccal infiltration!
Mandibular anesthesia in adults via infiltration!
2. Elimination half-life of 27 minutes (162 min = 2:42)
Lidocaine, mepivacaine, prilocaine ~ 90 minutes (540 min = 9 hrs)!
3. Pregnancy - preferred LA!
4. Nursing - ‘Pump & dump’ for 4 hours (FDA)!
Lidocaine, mepivacaine, prilocaine P&D for 9 hours! !
5. Pediatrics - Lesser risk of OD!
6. Endodontics (infected/inflammed teeth)!
7. ‘Hard to ‘numb’ patients (anecdotal)
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36
Articaine 4% Epinephrine 1:100,000 or 200,000
•
Should I use articaine 4%
with 1:100,000 or 1:200,000
epineprine?
100,000
200,000
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37
Articaine 4% Epinephrine 1:100,000 or 200,000
•
100,000
Less epinephrine is, of course, better
for the patient, therefore MY
RECOMMENDATION is the use of
articaine 4% with 1:200,000
epinephrine for optimal depth and
duration of pain control
200,000
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38
So, Malamed,
you think articaine’s a
great drug, but . . .
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39
Are there any concerns, out there in the community, regarding articaine HCl?
YES
Prolonged anesthesia!
(paresthesia)
40
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A basic truism regarding ANATOMY:
Everybody is different
!
We teach ‘normal’ anatomy:
Insert the needle here
Advance 25 mms
Aspirate
Deposit the drug
We HOPE the nerve is in the area
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41
A basic truism regarding INJECTIONS:
Once a needle penetrates the
skin or mucous membrane,
every injection is
BLIND
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42
A basic truism regarding LOCAL ANESTHETICS:
LAs are chemicals that
interrupt nerve conduction
(producing anesthesia)
transiently (hopefully)
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43
Another truism regarding LOCAL ANESTHETICS
!
ALL LAs are neurotoxic
(they can damage nerves)
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44
A basic truism regarding PARESTHESIA:
!
Paresthesia has existed
ever since injections
were first administered
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45
Articaine !
and !
Paresthesia
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46
Canada
Articaine introduced in Canada in 1983
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47
Haas, D A. Lennon, D.!
!
A 21 year retrospective study of
reports of paresthesia following
local anesthetic administration.!
!
J. Canadian Dental Association
61(4):319-20, 323-6, 329-30, 1995 Apr
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48
A 21 year retrospective study of reports of paresthesia
following local anesthetic administration.!
J. Canadian Dental Association). 61(4):319-20, 323-6, 329-30, 1995
Overall incidence of paresthesia (all LAs) = 1:785,000!
2% and 3% LAs = 1:1,250,000!
4% prilocaine = 1:588,235!
4% articaine = 1:440,529
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49
J. Canadian Dental Association). 61(4):319-20, 323-6, 329-30, 1995
70.6% involve!
LINGUAL nerve
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50
A 21 year retrospective study of reports of paresthesia following local anesthetic administration.!
J. Canadian Dental Association). 61(4):319-20, 323-6, 329-30, 1995 Apr
This was NOT a scientific study:!
1. Duration of paresthesia was NOT documented!
2. In > 30% of incidents the LA used was not identified!
3. The reports of paresthesia did not include cases
where the LA might have been used for surgical
procedures!
**** Surgery is THE most common cause of paresthesia
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51
4. The gauge and length of the needle used was
documented in only 26% of the reviewed cases (n = 143) !
5. The injection technique used during each incident
was not identified!
6. It was a review of voluntary reports reviewed by the
Provincial Insurance Commission.!
7. Conclusions are quite subjective.!
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52
Yet this paper has taken on a life of its
own . . . has become THE most cited paper
purporting to demonstrate that 4% LAs are
associated with a higher risk of paresthesia!
Virtually all papers reporting increased risk of
paresthesia from articaine ultimately use this
paper as their initial source.!
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53
The DANISH experience
Articaine introduced in Denmark in 2001
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54
Articaine introduced in Denmark in 2001!
Prof. S. Hillerup 2006 IJOMS
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55
77%!
Lingual N.
77% (42/54) cases involved LINGUAL nerve
56
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57
2004 . . . Danish Dental Association
recommended that articaine not be used
by inferior alveolar nerve block!
Sales of articaine declined significantly
© 2014
Dr. Dr.
Stanley
F. Malamed!
© 2013
Stanley
F. Malamed!
All All
Rights
Reserved
Rights
Reserved
58
Pharmacovigilance Working Party of the European Union
EU equivalent to
Canada’s TGA!
Australia’s TGA
and the USA’s
FDA
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59
Forside > Bivirkninger > Meddelelser om bivirkninger >
er om bivirkninger
ning af bivirkninger hos
er
ning af bivirkninger hos dyr
ning af bivirkninger ved
orsøg
indberetning
gsrådet
dsopdatering
lance
Konklusioner på vurdering af bivirkninger ved
lokalbedøvelsesmidler brugt til tandbehandling
Produktresumé for Septanest®
EU´s Bivirkningskomité har på et møde d. 17. oktober 2006 igen vurderet forekomst af
bivirkninger, især mistanke om nerveskader (paræstesier, føleforstyrrelser), ved brug af
lokalbedøvelsesmidler anvendt i forbindelse med tandbehandling.
Produktresumé for Septocaine®
Vurderingen er en opfølgning på en undersøgelse, der indledtes i 2005. Undersøgelsen blev sat i
værk, fordi der i Danmark var rejst mistanke om, at ét af lokalbedøvelsesmidlerne, articain,
indebar øget risiko for nerveskader, set i forhold til risikoen ved anvendelse af andre
lokalbedøvelsesmidler (mepivacain, prilocain, lidocain).
Produktresumé for Ubistesin Forte®
Undersøgelsen er foretaget i tæt samarbejde med indehaveren af markedsføringstilladelsen for
lægemidlerne Septanest® og Septocain®. I undersøgelsen indgår de samlede internationale
erfaringer indhentet fra 57 lande. Det anslås at ca. 100 millioner patienter årligt behandles med
articain.
Septanest® og Septocain® og risiko
for føleforstyrrelser
Undersøgelsen omfatter en gennemgang af eksperimentelle studier samt af kliniske forsøg med
raske frivillige samt patienter. Gennemgangen omfatter de almindeligst anvendte
lokalbedøvelsesmidler og altså ikke kun articain. Endvidere er samtlige bivirkningsrapporter
indsamlet på verdensplan gennemgået.
Produktresumé for Ubistesin®
Undersøgelse af bivirkninger ved
bedøvelsesmidler ved tandbehandling
20 October 2006
Med hensyn til articain er konklusionen, at der ikke er sket afgørende ændringer i dette
lægemiddels sikkerhedsprofil siden tidspunktet for påbegyndelse af markedsføringen (1988). Der
er således intet grundlag for at afvige fra at bruge articain efter de gældende retningslinier, som
fremgår af produktresumeet.
Konklusionen er endvidere at
alle lokalbedøvelsesmidler kan forårsage nerveskade (er neurotoksiske).
o Forekomsten af føleforstyrrelser forekommer tilsyneladende med lidt større hyppighed
efter anvendelse af articain og prilocain. Set i forhold til antallet af behandlede patienter
er føleforstyrrelserne imidlertid sjældent forekommende. Eksempelvis anslås
forekomsten af føleforstyrrelser ved anvendelse af articain at være et tilfælde pr. 4.5
millioner behandlede patienter.
nerveskader kan have flere årsager
o mekanisk forårsaget skade ved nåleindstikket
o direkte toksisk påvirkning af lægemidlet
o utilstrækkelig ilttilførsel til nerven
der er ikke umiddelbart behov for yderligere eksperimentelle undersøgelser eller kliniske
forsøg
der bør gøres en indsats for yderligere at mindske forekomsten af nerveskader
o Indehaveren af markedsføringstilladelsen har fremsat forslag til, hvorledes risikoen for
nerveskader kan nedsættes yderligere; forslaget indebærer bl.a. undervisningstilbud for
tandlæger, forbedret information i produktresumeet samt øget rapportering i en periode
til myndighederne.
I Danmark er følgende lokalbedøvelsesmidler med indhold af articain markedsført: Septanest®,
Septocaine®, Ubistesin® og Ubistesin Forte® (se link til produktresumeer for de fire lægemidler
i faktaboksen øverst til højre på siden).
Yderligere oplysninger kan fås ved henvendelse til overlæge Doris I. Stenver,
Forbrugersikkerhed, tlf. 44 88 92 47, mobil 22 46 09 79.
Lægemiddelstyrelsen, d. 23. oktober 2006
All Rights Reserved
et d. 27.11.2006
60
Pharmacovigilance Committee of the European Union
Regarding articaine, the conclusion is that safety profile of the
drug has not significantly evolved since its initial launch (1998).
Thus, no medical evidence exists to prohibit the use of articaine
according to the current guidelines listed the summary of
product characteristics.
20 October 2006
61
All Rights Reserved
Pharmacovigilance Committee of the European Union
All local anaesthetics may cause nerve injury (they are neurotoxic in nature).!
The occurrence of sensory impairment is apparently slightly more
frequent following the use of articaine and prilocaine. However,
considering the number of patients treated, sensory impairments rarely
occur. For example, the incidence of sensory impairment following the
use of articaine is estimated to be 1 case in 4.8 million treated patients.!
!
Nerve injuries may result from several incidents:!
Mechanical injury due to needle insertion!
Direct toxicity from the drug!
Neural ischaemia!
!
There is no need for new experimental studies or clinical trials
20 October 2006
62
All Rights Reserved
Danish Medicines Agency (Laegemiddel Styrelsen) 25 October 2011!
!
The Danish Medicines Agency's database of side effects
contain 160 reports on adverse reactions from
articaine that occurred from 2001-2005. The adverse
reactions are mainly sensory impairment and nerve
damage.
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63
Danish Medicines Agency (Laegemiddel Styrelsen)
25 October 2011!
!
Since 2005, we have seen a drop in the number of
reports of new adverse reactions.!
Up until 1 October 2011, we have received 2 reports on
suspected adverse reactions from articaine which
occurred in 2011. In both cases, the patients have
experienced sensory impairment after treatment with
articaine.
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64
t
c
e
f
f
E
Danish Medicines Agency (Laegemiddel Styrelsen)
25 October 2011!
r
e
b
e
W
e
h
T
2001 - 2005 . . . 160 reported cases!
2005 - 2011 . . . 2 reported cases
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65
The AMERICAN experience
Articaine introduced in USA in 2000
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66
2010
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67
FDA Adverse Event Reporting System (AERS)!
Average number of adverse reports received by the FDA
is currently over 400,000/year… !
“For the 159 of the 248 cases (of dental paresthesia) for
which no procedure was listed, we assumed that they
involved nonsurgical dentistry.”
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68
Mepivacaine
1:623,112,900
Lidocaine
1:181,076,673
Bupivacaine
1:124,286,050
OVERALL
1:13,800,970
Articaine
1:4,159,848
Prilocaine
1:2,070,678
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69
USA
Ontario - 1993
Mepivacaine
1:623,112,900
1:1,125,000
Lidocaine
1:181,076,673
1:1,125,000
Bupivacaine
1:124,286,050
OVERALL
1: 13,800,970
Articaine
1:
4,159,848
Prilocaine
1:
2,070,678
70
1:
785,000
(2.27:1,000,000)!
1:
440,529
(1.7:1,000,000)!
1:
588,235
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Annual risk of being struck by lightning (USA) = 1:750,000
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71
Anaphylaxis to penicillin = 1:50,000
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72
Risk of paresthesia following mandibular implant = 37%!
Long term neuropathy = 13%
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73
92.7%!
involve!
LINGUAL!
nerve
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74
FDA - AERS website
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75
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF POST-MARKETING DRUG RISK ASSESSMENT
revised 9 January 2009
AERS data do have limitations. !
First there is no certainty that the reported event was actually due to the
product . . .!
FDA does not require that a causal relationship between the product and
event be proven . . .!
Furthermore, FDA does not receive all adverse event reports that occur
with a product.!
Estimated ~10% of all ADRs are reported
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76
Many factors can influence whether or not
an event will be reported, such as the time a
product has been marketed (Weber Effect)
and publicity about an event.
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77
Therefore, AERS cannot be used
to calculate the incidence of an
adverse event in the US population
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78
the WEBER effect
Dr JCP Weber!
Epidemiology of adverse reactions to
nonsteroidal antiinflammatory drugs. !
Rainsford KD, Velo GP, eds. Advances in
inflammation research. Vol. 6. New York:
Raven Press, 1984: 1-7.
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79
the WEBER effect
The Weber Effect is an epidemiologic phenomenon
which states that the number of reported adverse
reactions for a drug rises until about the middle to end
of the 2nd year of marketing, peaks, and then steadily
declines despite steadily increasing prescribing rates.
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80
the WEBER effect
Pharmacotherapy 24(6):743-749, 2004
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81
Weber!
Effect
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82
Hillerup paper
Publicity!
!
EU report
Negative!
!
Positive
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83
The Australian experience
Articaine introduced in Australia in 2005
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84
ARTICAINE HCL
e
n
i
a
ic
t
r
a
e
s
u
0%
>7
ARTICAINE HCL
85
ARTICAINE HCL
ARTICAINE HCL
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Australian Dental
Journal!
56:348-351, 2011
5 case reports
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86
Kingon A, Sambrook P, Goss A. Australian Dent J 56:348-351, 2011
Electric shock sensation
Lingual nerve involvement
4% LA
Restorative dentistry
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87
4% LA
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88
Mental nerve involvement
4% LA
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89
Electric shock sensation
4% LA
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3% LA
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91
4 of 5 cases involve LINGUAL NERVE!
2 cases experienced ‘electric shock’
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92
Professor Dr. Stanley F. Malamed
In my opinion . . .!
If paresthesia involves the distribution of
the inferior alveolar and/or mental nerves . . .!
Possible etiologies:!
Direct needle trauma!
LA neurotoxicity!
Edema!
Hemorrhage!
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93
However,
IF it’s the lingual nerve . . .!
!
It’s MECHANICAL!
!
Not chemical
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94
Paresthesia in dentistry
> 95% of reported cases occur in the MANDIBLE!
!
Of these the overwhelming percentage
involve only the lingual nerve
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95
Is rarely observed in the maxilla!
< 5%!
Yet 1/2 of all dental care is in the upper arch!
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96
Is rarely (no reported cases) observed following:!
Gow-Gates mandibular nerve block!
Vazirani-Akinosi mandibular nerve block!
!
No lingual nerve in area
Only occasionally following mental/incisive nerve block!
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97
Paresthesia and 4% Anesthetics
Articaine is used in medicine:!
Ophthalmology!
Orthopedic surgery!
Arthroscopic, hand, foot!
Plastic and reconstructive surgery
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98
Articaine is used in medicine:!
NO reports of paresthesia from
articaine following use in medicine
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99
Question:!
Is it possible that articaine is so
specifically neurotoxic that it only
affects nerves within the mouth and
more specifically the lingual nerve?
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100
M. Anthony Pogrel, DDS, MD
101
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Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks JADA 2000;131:901-907
Prior to articaine’s introduction in the USA
Estimates PERMANENT nerve damage at
1:26,762 !
Inferior Alveolar Nerve Block’s
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102
Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks JADA 2000;131:901-907
Prior to articaine’s introduction in the USA
“It is reasonable to suggest that during a career, each dentist may
encounter at least one patient with an inferior alveolar nerve block
resulting in permanent nerve involvement”!
“The mechanisms are unknown and there is no known prevention
or treatment”
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103
Pogrel MA
CDAJ 35(4):271-273, 2007
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104
Pogrel MA!
J. Calif Dent Assoc 35(4):271-273, 2007
Study covered 1 January 2003 through 31 December 2005
U. California San Francisco School of Dentistry
n = 57!
All NON-surgical
‘We were aware of the discussion in dental circles as to the use of
articaine for inferior alveolar nerve blocks, and are aware of
recommendations suggesting that it not be used for IANBs.!
!
This was the predominant reason for submitting this paper at this time.”
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105
Pogrel MA!
J. Calif Dent Assoc 35(4):271-273, 2007
Study covered 1 January 2003 through 31 December 2005
U. California San Francisco School of Dentistry
n = 57!
All NON-surgical
ALL patients evaluated!
Dental records reviewed!
Treating dentists consulted!
Needle, type of injection(s), drug used and treatment known for ALL 57
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106
If all LAs were equally neurotoxic
the % of cases of paresthesia would be
equal to the drugs % market share
50% of market share = 50% of cases of paresthesia
25% of market share = 25% of cases of paresthesia
Ratio should be 1.0
% Cases of paresthesia
% Market share
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107
Pogrel MA
J Calif Dent Assoc 35(4):271-273, 2007
Anesthetic
# of cases (%)
Approximate share
of LA market in
USA
Lidocaine HCl
20 (35%)
54%
0.64
Prilocaine HCl
17 (29.8%)
6%
4.96
Articaine HCl
17 (29.8%)
25%
1.19
Articaine HCl +
Lidocaine HCl
Lidocaine HCl +
Prilocaine HCl
Ratio
(1.0 =
expected)
1 (1.75%)
1 (1.75%)
Bupivacaine HCl
1 (1.75%)
Mepivacaine HCl
0 (0%)
108
15%
All Rights Reserved
Pogrel MA
J Calif Dent Assoc 35(4):271-273, 2007
“Therefore, using our previous assumption
that approximately half of all local anesthetic
used is for inferior alveolar nerve blocks,
then on the figures we have generated from
our clinic we do not see disproportionate
nerve involvement from articaine”
All Rights Reserved
109
Pogrel MA
J. Calif Dent Assoc 40:795-797, 2012 (October)
All Rights Reserved
110
Pogrel MA
N = 38!
January 2006 - December 2011
Articaine is still causing
permanent inferior alveolar
and lingual nerve damage
(36%), which is proportionate
to its market share (37%)
Carbocaine: 11% of cases with
a market share of 5%
Prilocaine: However, by causing
26% of all cases seen since 2005
with a local market share of only
8% is somewhat disproportionate
to its market share
Lidocaine: The number of cases
caused by lidocaine, on the
other hand, appears to be only
around 50% of its market share
All Rights Reserved
111
Pogrel MA
N = 38!
January 2006 - December 2011
Ratio!
(1.0 = expected)
Lidocaine
0.5
Articaine
0.97
Mepivacaine
2.2
Prilocaine
3.25
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112
2007
2011
Lidocaine
0.64
0.5
Articaine
1.19
0.97
Mepivacaine
Prilocaine
2.2
4.96
3.25
M. Anthony Pogrel, DDS, MD
All Rights Reserved
113
The German experience
Articaine introduced in Germany in 1976
All Rights Reserved
114
Synthesized articaine (carticaine) in 1973 - as a DENTAL LA !
Introduced into dentistry in 1976!
2010 . . . 97% of LA used in German dentistry is articaine!
Deutscher Dentalmarkt Jahresbericht (DDM) 2010 (German Dental
Market Annual Report 2010) GfK HealthCare, Nuremberg, Germany
All Rights Reserved
115
Dr. Wolfgang Jakob!
Dr. Monika Daublander!
!
E-mail (1 February 2012):!
“. . . the problem of neurosensory disturbances was
never a big issue in the German speaking Countries.”
All Rights Reserved
116
Dr. Wolfgang Jakob:!
Beside the ongoing about articaine in
Dänemark the problem of neurosensory
disturbances was never a big issue in the
German speaking countries.!
Hillerup reports 80 percent of all neurosensory
after IANB with articaine in Europe. (Denmark =
5,6 million people; while the EU has a
population of 501 million)
All Rights Reserved
117
Dr. Wolfgang Jakob:!
!
!
!
!
!
!
!
Denmark . . . Population 5.6 million!
EU . . . . . . Population 501 million!
!
!
Denmark . . . 80% of all reports of neurosensory
disturbance (Hillerup)!
All Rights Reserved
118
Journal of
Dentistry!
April 2010!
Volume 38, No. 4!
307-317
All Rights Reserved
119
Journal of
Dentistry!
April 2010!
Volume 38, No. 4!
307-317
All Rights Reserved
120
Conclusion:
The results suggest that articaine is
not toxic to the nervous structure
and further studies are necessary to
explain the possible relation between
articaine injection and paresthesia.
All Rights Reserved
121
So, why is it that the lingual nerve
is primarily involved in cases of
paresthesia?
All Rights Reserved
122
Dr. Anthony Pogrel
E-mail 2 February 2012
Malamed to Pogrel:!
Can you provide me with a summary of just
why it appears that the lingual nerve is involved
in this problem so much more so than others?!
How much LA does a dentist deposit to
anesthetize the lingual nerve when doing the
IANB? !
Very little, if any. So why do 'they' cast
blame on the drug?
123
All Rights Reserved
Why LINGUAL nerve?
Dr. Pogrel’s reply:!
“I do think there is also a genuine difference in the
incidence, and as you say,!
It is not due to the local anesthetic itself since the vast
majority (volume) is deposited close to the inferior
alveolar nerve and not the lingual nerve. !
If it was a neurotoxic phenomenon, you would expect the
inferior alveolar nerve to be affected much more.”
All Rights Reserved
124
Why LINGUAL nerve?
!
The fact that the lingual nerve is stretched when
the mandible is open to an the inferior alveolar
block probably does give it less opportunity to
get out of the way and makes it much more likely
that this phenomenon is traumatic.
All Rights Reserved
125
“The Lingual
Nerve
is In the Way”
All Rights Reserved
126
Perth
Perth
Sydney
Adelaide
Adelaide
Sydney
All Rights Reserved
127
Fascicle
Fascicle
Fascicle
Fascicle
Fascicle
Fascicle
All Rights Reserved
128
Pogrel, MA, Schmidt, BL, Sambajon, V, and Jordan, RCK !
Lingual Nerve Damage from Inferior Alveolar Nerve Blocks - A Possible Explanation, !
J Amer Dent Assoc 134, 195-199, 2003
The Inferior Alveolar Nerve usually had 5-7 fascicles
whereas the Lingual Nerve in that area usually had
around three but in the third of the cases was actually
unifascicular in the area where the inferior alveolar nerve
block was given. © 2014 Dr. Stanley F. Malamed!
All Rights Reserved
129
Fascicle
Normal
Damaged
All Rights Reserved
130
IMO . . . IF it’s the distribution of the lingual
nerve (loss of taste, paresthesia) . . .!
!
It’s MECHANICAL!
!
Not chemical
131
All Rights Reserved
70.6% involve!
LINGUAL nerve
All Rights Reserved
132
Hillerup, 2006
77%
(42/54)
cases involved LINGUAL nerve
133
All Rights Reserved
Kingon, 2011
4 of 5 cases involve LINGUAL NERVE!
2 cases experienced ‘electric shock’
80%
All Rights Reserved
134
Garisto, 2010
92.7%!
involve!
LINGUAL!
nerve
All Rights Reserved
135
Author
Country
Year
%!
Lingual
Haas,
Lennon
Canada
1995
70.6
Hillerup
Denmark 2006
77
Kingon,
Australia 2011
Sambrook
80
Garristo,
Haas
USA
2010
92.7
All Rights Reserved
136
So, what should YOU do?
All Rights Reserved
137
Articaine has been claimed to be more
effective, but there are reports of an
increased risk of neurotoxicity,
presenting as prolonged numbness in
the areas of distribution, often with pain.
This may be due to the high
concentration of the solution rather
than to the anesthetic itself.*
Consequently, it is recommended that
articaine should not be used for
regional blocks (eg inferior alveolar).
*Kingon A, Sambrook P, Goss A
138
All Rights Reserved
Benefit v. Risk
!
The doctor MUST always consider the BENEFIT to
be gained from use of a procedure or drug versus
the RISK involved in the procedure or drug.!
!
ONLY when the benefit to be gained CLEARLY
OUTWEIGHS the risk should the procedure be
done or the drug administered
All Rights Reserved
139
ALL reports claiming an increased risk
of paresthesia with articaine are
ANECDOTAL
There is absolutely NO scientific
evidence articaine has a greater risk of paresthesia than other LAs
All Rights Reserved
140
malamed@usc.edu
141
All Rights Reserved
www.elsevier.com
OR
142
www.drmalamed.com
All Rights Reserved
malamed@usc.edu
Thank you for
listening . . .
All Rights Reserved
143

Articaine - Cloudfront.net

Transcription

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