1 summary oral pe at 10 mg: no more effective than placebo no systemic effects poor oral...
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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
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Phenylephrine Nasal Spray
Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.
n=10
n=16
n=15
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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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Bickerman. www.jacionline.org
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Thomas et al. Br J Clin Pharmac 1991;32:705-11.
○ -- PPA● -- PE+ -- PL
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Approx 0.2 – 1.6 mg
Martinsson et al. Eur J Clin Pharmacol 1986;30:427-31.
IV PE
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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.
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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
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Hatton\PLAYER.HTM
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Jonathan Shuster, PhD
Research Professor
Division of Biostatistics
Department of Epidemiology and Health Policy
College of Medicine
University of Florida
Gainesville, FL
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• Shuster\PLAYER.HTM
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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
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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
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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]