1 summary oral pe at 10 mg: no more effective than placebo no systemic effects poor oral...
TRANSCRIPT
1
Summary
Oral PE at 10 mg:
• No more effective than placebo• No systemic effects• Poor oral bioavailability• Dose-response studies needed• TV ads – grossly misleading
3
Symptom Scores
1. NOSTRIL FEELS CLEAR – no difficulty at all in breathing through this nostril.
2. ALMOST CLEAR – can breathe through this nostril quite easily.
3. STUFFY – with some hindrance to breathing through this nostril, but not enough to make me uncomfortable.
4. QUITE STUFFY – nostril feels blocked, and it is not comfortable breathing through this nostril.
5. VERY STUFFY – can barely breathe through this nostril at all and have to breathe through my mouth much of the time.
6. COMPLETELY BLOCKED – cannot breathe through this nostril at all.
Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.
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Symptom Score (% Difference)
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
0 15 30 60 120
** * *
PL
PE
*p<0.005 PE v Pl
Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.
(57)
(54)(47) (46)
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Dose Adjusted AUCFree 3H-Phenylephrine
0
100
200
300
400
500
600
700
IV Oral
ng.min mL
F=38%
n=4 n=3
Hengstmann et al. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol 1982;21:335-41.
9
Randy C. Hatton, PharmD, FCCP, BCPS Co-Director, Drug Information and Pharmacy Resource Center
Shands at the University of Florida
Clinical Professor, College of Pharmacy
University of Florida
Gainesville, FL
11
Jonathan Shuster, PhD
Research Professor
Division of Biostatistics
Department of Epidemiology and Health Policy
College of Medicine
University of Florida
Gainesville, FL
13
Schering Protocol P04579 – Change inNasal Sx Score Over 6 hr in Vienna Chamber
-25
-20
-15
-10
-5
0Placebo PE – 12 mg PSE – 60 mg
% C
han
ge p=0.6
p=0.01
n=30
p=0.01
Clinicalstudyresults.org (unique ID P04579)R,DB,CO
14
Schering Protocol P04822 – Average 6 hr Mean Change in Nasal Congestion in Canadian Chamber
-35
-30
-25
-20
-15
-10
-5
0Placebo PE 10 M + L
% C
han
ge
p=0.2
n=127
p=0.007
Clinicalstudyresults.org (unique ID P04822)R,DB,PAR
n=126n=126
p=0.001
n=379 subjects
16
Summary
Oral PE at 10 mg:
• No more effective than placebo• No systemic effects• Poor oral bioavailability• Dose-response studies needed• TV ads – grossly misleading
17
Leslie Hendeles, Pharm.D.Leslie Hendeles, Pharm.D.University of Florida
Health Science Center (Box 100486)Gainesville, FL 32610-0486
Phone: (352) 273-6027Fax: (352) 273-6120
Email: [email protected]