il bambino allergico ed i farmaci farmaci... · ocular score during 3 years of open treatment with...
TRANSCRIPT
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Nuovi aspetti terapeutici
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
Neri Pucci SOD di Allergologia, AOU “A.Meyer”, Firenze
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Nuovi farmaci “intelligenti”
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
Neri Pucci SOD di Allergologia, AOU “A.Meyer”, Firenze
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Relovair
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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http://www.faqs.org/sec-filings/100114/THERAVANCE-INC_8-K/
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Fluticasone furoato
vilanterolo
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Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, in subjects with asthma and COPD.Kempsford R, Norris V, Siederer S.
Vilanterol produced a rapid and prolonged
bronchodilation over 24 h suggesting
the potential for once daily administration
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Mean FEV1 profile (0–24h) following single dose VILANTEROL
http://www.faqs.org/sec-filings/100519/THERAVANCE-INC_8-K/
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Respir Med. 2013 Apr;107(4):550-9.
Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: a randomised trial.
Martinez FJ, Boscia J, Feldman G, et al.
SourceUniversity of Michigan, Ann Arbor, MI, USA. [email protected]
CONCLUSIONS: FF/VI provides rapid and significant sustained improvement in FEV1 in subjects with moderate-to-severe COPD, which was not influenced by the dose of FF. These data suggest that FF/VI may offer clinical efficacy in COPD and warrants additional study.
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Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD Mark T Dransfield MD , et al.
InterpretationAddition of fluticasone furoate to vilanterol was associated with a decreased rate of moderate and severe exacerbations of COPD in patients with a history of exacerbation, but was also associated with an increased pneumonia risk.
Volume 1, Issue 3, Pages 210 - 223, May 2013
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Clin Transl Allergy. 2012 Jun 27;2(1):11..
Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial.Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M.
CONCLUSIONS: FF 100 alone and in combination with VI 25 provides significant bronchoprotection in subjects with mild asthma. That this protection is provided at 23 h post last dose, supports the utility of FF 100 and FF/VI 100/25 as viable once-daily therapies.
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Thorax. 2013 Jun;68(6):513-20. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial.Busse WW, O'Byrne PM, Bleecker ER, et al ED.
CONCLUSIONS: FF/VI (100/25 µg or 200/25 µg)
administered once daily over 52 weeks was well
tolerated by pa- tients ≥12 years with asthma. The overall
safety profile of FF/VI did not reveal any findings of signifi-
cant clinical concern.
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Clin Respir J. 2013 Apr 12. doi: 10.1111/crj.12026. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study.
Allen A, Schenkenberger I, Trivedi R, et al
FF/VI was found to be non-inferior to placebo on HPA axis function, with no indication of significant cortisol suppression after 42 days.
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Dymista
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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FLUTICASONE PROPIONATO AZELASTINA
Dymista : un farmaco intelligente
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Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension.
Dymista : un farmaco intelligente
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Meltzer E, et al. Int Arch Allergy Immunol 2013;161:369-77.
FPAZE
PLA
MP29-02
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Stemox
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Conservante Antimicrobico a base di acido benzoico (sostanza particolarmente tossica). Ha proprietà batte-riostatiche e fungistatiche, ed è utilizzato come additivo alimen-tare (E211) come conservante
benzoato di sodio è il sale di sodio dell‘ acido benzoico
Wikipedia
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
AMOXICILLINA + Ac CLAVULANICO
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
AMOXICILLINA + Ac CLAVULANICO
Le formulazioni di questi farmaci contengono circa 178.6mg/100ml di sodio benzoato
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Mori F, et al. Curr Drug Safety 2012;7:87-91.
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Sodium Benzoate
n.89 bambini con rea- zione cutanea (esantema, orticaria) nell’ultimo anno dopo assunzione di Amoxicillina-Clavulanico
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AMOXICLAV (8)
Na-BENZOATO (10)
AMOXICLAV + Na-Benz (3)
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Na-Benzoate
tot 89
Mori F, et al. Curr Drug Safety 2012;7:87-91.
15%
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COMPOSIZIONE amoxicillina triidrato corrispondente a amoxicillina 400mg, potassio clavulanato = acido clavulanico 57mg
ECCIPIENTI gomma antano, aspartame, silice colloidle anidra, acido citrico anidro, silicio diossido, ipromellosa, aroma arancia, aroma lampone, aroma golden syrup
NO SODIO BENZOATO !
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OPT : positivi con Na-benzoato e negativi con Amoxiclav
Mori F, et al. Curr Drug Safety 2012;7:87-91.
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
FK-506 e plasminogeno
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Cheratocongiuntivite Vernal severa
Papille giganti tarsali
Ulcera a scudo
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9 8 7 6 5 4 3 2 1
EYE 1
EYE 2
9 8 7 6 5 4 3 2 1
10
10
T0 3wk
p = 0.35
TACROLIMUS
p < 0.001
CYCLOSPORINE
CR
OS
S O
VE
R
7days washout
Score oculare in 30 bambini con VKC grave trattati con tacrolimus e ciclosporina per via oculare. N.Pucci, Caputo R, L.Di Grande, C.De Libero, et al. AOU “A.Meyer”, Firenze
FARM6FYZB3
p <
0.0
01
p < 0.001
p = 0.055
CYCLOSPORINE
TACROLIMUS
4wk 7wk
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1st y
ear
obje
ctiv
e sc
ore
10
5
0
65
63
42
p<0.001
p<0.001
15
base 1-3mts end
3.32 ± 2.01 months2nd
yea
r ob
ject
ive
scor
e
10
5
0
53
50
45
p<0.001
p<0.001
p<0.001
155.14 ± 1.89 months
3rdye
ar o
bjec
tive
scor
e
10
5
0
18
1816
p=0.003
p=0.002 p=0.27
155.36 ±1.62 months
base 1-3mts end base 1-3mts end
Fig 3. Ocular score during 3 years of open treatment with Tcr eyedrops in 65 patients .(mean±SD). In red : no. of patientsp<0.001
OP72
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50
40
30
20
10
00
1° year
2° year
34
3431
31
p<0.001
Qo
L
SC
OR
E START 2-4 MONTHS
Numbers within columns = number of patients
p=0.001
Qualità di vita prima e durante il trattamento con tacrolimus per via oculare
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Efficacia della ciclosporina per via oculare nella VKC
tacrolimus
87%100%
Efficacia del tacrolimus per via oculare nella VKC
AOU “A.Meyer”, 2013.
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prima dopo 3 settimane
Taddio A, Cimaz R, Pucci N, et al. 2009
Associazione tra Vernal KC e Uveite anteriore ed efficacia del trattamento con tacrolimus oculare
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LA CONGIUNTIVITE LIGNEA
• CONGIUNTIVITE MEMBRANOSA– MEMBRANE FORMATE
PREVALENTEMENTE DA FIBRINA
• ESTREMA GRAVITA’• PUO’ PORTARE ALLA PERDITA
FUNZIONALE E ANATOMICA DELL’OCCHIO
SEPTEMBER 2006
Caputo R, Pucci N, et al. 2009
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LA CAUSA
• 1994 trovata associazione tra IPOPLASMINOGEMIA TIPO 1 E CONGIUNTIVITE LIGNEA
• GENE PLASMINOGENO 6q26-q27
Caputo R, Pucci N, et al. 2009
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MECCANISMO
PLASMINOGENO
PLASMINA
TPA UPA
FIBRINOLISI RIMODELLAMENTO TISSUTALE
FIBRINA CICATRICI
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SEPTEMBER 2006
FIRST PATIENT• PLG EYE DROP
with Sodium Hyaluronate
• Surgery• No relapses• 5ys follow up
Caputo R, Pucci N,Mori F, Novembre E. Thromb Haemost
2008;100:1196-8
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SECOND PATIENT• 5 prior surgeries• Bulbar pseudomembrane covering completely
the LEFT eye• US: endophthalmitis total retinal detachment
Caputo R, Pucci N, et al. 2009
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SECOND PATIENT• PLG DROPS WITH SODIUM
HYALURONATE BOTH EYES
1 WEEK TREATMENTLEFT EYE
Caputo R, Pucci N, et al. 2009
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SECOND PATIENT
• SURGERY
LEFT EYE
TAPERING FROM 8/DAY TO 4/DAY WORSENING OF CLINICAL SITUATION
Caputo R, Pucci N, et al. 2009
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STUDY PROTOCOL PLG EYE DROPS
4 WEEK TREATMENT
SURGERY
SE
GM
EN
T 1
NOT SURGERY
8 WEEK TREATMENT
SE
GM
EN
T 2
Caputo R, Pucci N, et al. 2009
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Nanocapsule
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Nanoparticelle 10-1000nm di polimeri legati da forze elettrostatiche contenenti farmaco che viene rilasciato
Possono essere aggiunti recettori senza alterare la struttura del farmaco
BioImpacts 2012;2:71-81.
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Vantaggi dell’utilizzo di nanocapsule :
minima degradazione del farmaco
aumento della
biodisponibilità riduzione
del dosaggio fino a10.000 volte
minima tossicità
BioImpacts 2012;2:71-81.
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Nanocapsule : applicazioni
Pavankumar K. BioImpacts 2012;2:71-81.
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Nanocapsule : applicazioni
Pavankumar K. BioImpacts 2012;2:71-81.
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GRAZIE PER L
’ATTENZIONE!
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•FINE
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Phase III study results
The companies presented top-line results from two Phase III studies comparing
Relovair over Advair in COPD treatment. Data from the first study showed superiority
of once daily Relovair over twice daily Advair on a pre-defined primary endpoint of 0-
24 hour weighted mean FEV1 (p<0.001) in COPD patients.
In the second study, Relovair demonstrated numerical improvements but not
statistical superiority over Advair on the 0-24 hour weighted mean FEV1 (p=0.267) in
COPD. In the 24-week Phase III registrational program (n=330) Relovair met the
primary endpoint of statistically-significant change from baseline in trough evening
FEV1 compared to placebo (p=0.009) in adults and adolescents with persistent
asthma. The most common adverse events were bronchitis, headache,
nasopharyngitis, upper respiratory tract infection, pharyngitis, and sinusitis
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AMOXICLAV (8)
Na-BENZOATO (10)
AMOXICLAV + Na-Benz (3)
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Na-Benzoate
tot 89
Mori F, et al. Curr Drug Safety 2012;7:87-91.
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Nuovi aspetti terapeutici
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
Neri Pucci SOD di Allergologia, AOU “A.Meyer”, Firenze
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Nuovi farmaci “intelligenti”
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
Neri Pucci SOD di Allergologia, AOU “A.Meyer”, Firenze
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Relovair
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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http://www.faqs.org/sec-filings/100114/THERAVANCE-INC_8-K/
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Fluticasone furoato
vilanterolo
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Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, in subjects with asthma and COPD.Kempsford R, Norris V, Siederer S.
Vilanterol produced a rapid and prolonged
bronchodilation over 24 h suggesting
the potential for once daily administration
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Mean FEV1 profile (0–24h) following single dose VILANTEROL
http://www.faqs.org/sec-filings/100519/THERAVANCE-INC_8-K/
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Respir Med. 2013 Apr;107(4):550-9.
Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: a randomised trial.
Martinez FJ, Boscia J, Feldman G, et al.
SourceUniversity of Michigan, Ann Arbor, MI, USA. [email protected]
CONCLUSIONS: FF/VI provides rapid and significant sustained improvement in FEV1 in subjects with moderate-to-severe COPD, which was not influenced by the dose of FF. These data suggest that FF/VI may offer clinical efficacy in COPD and warrants additional study.
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Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD Mark T Dransfield MD , et al.
InterpretationAddition of fluticasone furoate to vilanterol was associated with a decreased rate of moderate and severe exacerbations of COPD in patients with a history of exacerbation, but was also associated with an increased pneumonia risk.
Volume 1, Issue 3, Pages 210 - 223, May 2013
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Clin Transl Allergy. 2012 Jun 27;2(1):11..
Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23 h after dosing in adult asthma: a randomised, controlled trial.Oliver A, Quinn D, Goldfrad C, van Hecke B, Ayer J, Boyce M.
CONCLUSIONS: FF 100 alone and in combination with VI 25 provides significant bronchoprotection in subjects with mild asthma. That this protection is provided at 23 h post last dose, supports the utility of FF 100 and FF/VI 100/25 as viable once-daily therapies.
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Thorax. 2013 Jun;68(6):513-20. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial.Busse WW, O'Byrne PM, Bleecker ER, et al ED.
CONCLUSIONS: FF/VI (100/25 µg or 200/25 µg)
administered once daily over 52 weeks was well
tolerated by pa- tients ≥12 years with asthma. The overall
safety profile of FF/VI did not reveal any findings of signifi-
cant clinical concern.
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Clin Respir J. 2013 Apr 12. doi: 10.1111/crj.12026. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study.
Allen A, Schenkenberger I, Trivedi R, et al
FF/VI was found to be non-inferior to placebo on HPA axis function, with no indication of significant cortisol suppression after 42 days.
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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… a new dry powder device ?
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Dymista
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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FLUTICASONE PROPIONATO AZELASTINA
Dymista : un farmaco intelligente
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Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension.
Dymista : un farmaco intelligente
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Meltzer E, et al. Int Arch Allergy Immunol 2013;161:369-77.
FPAZE
PLA
MP29-02
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Stemox
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Conservante Antimicrobico a base di acido benzoico (sostanza particolarmente tossica). Ha proprietà batte-riostatiche e fungistatiche, ed è utilizzato come additivo alimen-tare (E211) come conservante
benzoato di sodio è il sale di sodio dell‘ acido benzoico
Wikipedia
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
AMOXICILLINA + Ac CLAVULANICO
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benzoato di sodio è il sale di sodio dell‘ acido benzoico
AMOXICILLINA + Ac CLAVULANICO
Le formulazioni di questi farmaci contengono circa 178.6mg/100ml di sodio benzoato
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Mori F, et al. Curr Drug Safety 2012;7:87-91.
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Sodium Benzoate
n.89 bambini con rea- zione cutanea (esantema, orticaria) nell’ultimo anno dopo assunzione di Amoxicillina-Clavulanico
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AMOXICLAV (8)
Na-BENZOATO (10)
AMOXICLAV + Na-Benz (3)
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Na-Benzoate
tot 89
Mori F, et al. Curr Drug Safety 2012;7:87-91.
15%
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COMPOSIZIONE amoxicillina triidrato corrispondente a amoxicillina 400mg, potassio clavulanato = acido clavulanico 57mg
ECCIPIENTI gomma antano, aspartame, silice colloidle anidra, acido citrico anidro, silicio diossido, ipromellosa, aroma arancia, aroma lampone, aroma golden syrup
NO SODIO BENZOATO !
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OPT : positivi con Na-benzoato e negativi con Amoxiclav
Mori F, et al. Curr Drug Safety 2012;7:87-91.
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
FK-506 e plasminogeno
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Cheratocongiuntivite Vernal severa
Papille giganti tarsali
Ulcera a scudo
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9 8 7 6 5 4 3 2 1
EYE 1
EYE 2
9 8 7 6 5 4 3 2 1
10
10
T0 3wk
p = 0.35
TACROLIMUS
p < 0.001
CYCLOSPORINEC
RO
SS
OV
ER
7days washout
Score oculare in 30 bambini con VKC grave trattati con tacrolimus e ciclosporina per via oculare. N.Pucci, Caputo R, L.Di Grande, C.De Libero, et al. AOU “A.Meyer”, Firenze
FARM6FYZB3
p <
0.0
01
p < 0.001
p = 0.055
CYCLOSPORINE
TACROLIMUS
4wk 7wk
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1st y
ear
obje
ctiv
e sc
ore
10
5
0
65
63
42
p<0.001
p<0.001
15
base 1-3mts end
3.32 ± 2.01 months2n
d ye
ar o
bjec
tive
scor
e
10
5
0
53
50
45
p<0.001
p<0.001
p<0.001
155.14 ± 1.89 months
3rdye
ar o
bjec
tive
scor
e
10
5
0
18
1816
p=0.003
p=0.002 p=0.27
155.36 ±1.62 months
base 1-3mts end base 1-3mts end
Fig 3. Ocular score during 3 years of open treatment with Tcr eyedrops in 65 patients .(mean±SD). In red : no. of patientsp<0.001
OP72
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50
40
30
20
10
00
1° year
2° year
34
3431
31
p<0.001Q
oL
S
CO
RE START 2-4 MONTHS
Numbers within columns = number of patients
p=0.001
Qualità di vita prima e durante il trattamento con tacrolimus per via oculare
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Efficacia della ciclosporina per via oculare nella VKC
tacrolimus
87%100%
Efficacia del tacrolimus per via oculare nella VKC
AOU “A.Meyer”, 2013.
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prima dopo 3 settimane
Taddio A, Cimaz R, Pucci N, et al. 2009
Associazione tra Vernal KC e Uveite anteriore ed efficacia del trattamento con tacrolimus oculare
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LA CONGIUNTIVITE LIGNEA
• CONGIUNTIVITE MEMBRANOSA– MEMBRANE FORMATE
PREVALENTEMENTE DA FIBRINA
• ESTREMA GRAVITA’• PUO’ PORTARE ALLA PERDITA
FUNZIONALE E ANATOMICA DELL’OCCHIO
SEPTEMBER 2006
Caputo R, Pucci N, et al. 2009
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LA CAUSA
• 1994 trovata associazione tra IPOPLASMINOGEMIA TIPO 1 E CONGIUNTIVITE LIGNEA
• GENE PLASMINOGENO 6q26-q27
Caputo R, Pucci N, et al. 2009
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MECCANISMO
PLASMINOGENO
PLASMINA
TPA UPA
FIBRINOLISI RIMODELLAMENTO TISSUTALE
FIBRINA CICATRICI
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SEPTEMBER 2006
FIRST PATIENT• PLG EYE DROP
with Sodium Hyaluronate
• Surgery• No relapses• 5ys follow up
Caputo R, Pucci N,Mori F, Novembre E. Thromb Haemost
2008;100:1196-8
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SECOND PATIENT• 5 prior surgeries• Bulbar pseudomembrane covering completely
the LEFT eye• US: endophthalmitis total retinal detachment
Caputo R, Pucci N, et al. 2009
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SECOND PATIENT• PLG DROPS WITH SODIUM
HYALURONATE BOTH EYES
1 WEEK TREATMENTLEFT EYE
Caputo R, Pucci N, et al. 2009
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SECOND PATIENT
• SURGERY
LEFT EYE
TAPERING FROM 8/DAY TO 4/DAY WORSENING OF CLINICAL SITUATION
Caputo R, Pucci N, et al. 2009
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STUDY PROTOCOL PLG EYE DROPS
4 WEEK TREATMENT
SURGERY
SE
GM
EN
T 1
NOT SURGERY
8 WEEK TREATMENT
SE
GM
EN
T 2
Caputo R, Pucci N, et al. 2009
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•
•
•
•
•
Nuovi farmaci “intelligenti”
Relovair
Dymista
Stemox
FK-506 e
plasminogeno
Nanocapsule
Nanocapsule
Il bambino allergico ed i farmaci Firenze, 31 maggio – 1 giugno 2013
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Nanoparticelle 10-1000nm di polimeri legati da forze elettrostatiche contenenti farmaco che viene rilasciato
Possono essere aggiunti recettori senza alterare la struttura del farmaco
BioImpacts 2012;2:71-81.
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Vantaggi dell’utilizzo di nanocapsule :
minima degradazione del farmaco
aumento della
biodisponibilità riduzione
del dosaggio fino a10.000 volte
minima tossicità
BioImpacts 2012;2:71-81.
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Nanocapsule : applicazioni
Pavankumar K. BioImpacts 2012;2:71-81.
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Nanocapsule : applicazioni
Pavankumar K. BioImpacts 2012;2:71-81.
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GRAZIE PER L
’ATTENZIONE!
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•FINE
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Phase III study results
The companies presented top-line results from two Phase III studies comparing
Relovair over Advair in COPD treatment. Data from the first study showed superiority
of once daily Relovair over twice daily Advair on a pre-defined primary endpoint of 0-
24 hour weighted mean FEV1 (p<0.001) in COPD patients.
In the second study, Relovair demonstrated numerical improvements but not
statistical superiority over Advair on the 0-24 hour weighted mean FEV1 (p=0.267) in
COPD. In the 24-week Phase III registrational program (n=330) Relovair met the
primary endpoint of statistically-significant change from baseline in trough evening
FEV1 compared to placebo (p=0.009) in adults and adolescents with persistent
asthma. The most common adverse events were bronchitis, headache,
nasopharyngitis, upper respiratory tract infection, pharyngitis, and sinusitis
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AMOXICLAV (8)
Na-BENZOATO (10)
AMOXICLAV + Na-Benz (3)
Cutaneous Adverse Reactions to Amoxicillin-Clavulanic Acid Suspension in Children: The Role of Na-Benzoate
tot 89
Mori F, et al. Curr Drug Safety 2012;7:87-91.
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