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Summary

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. Phenylephrine Nasal Spray. n=15. n=16. n=10. Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310. . Symptom Scores.

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Summary

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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

  2. Phenylephrine Nasal Spray n=15 n=16 n=10 Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.

  3. Symptom Scores • NOSTRIL FEELS CLEAR – no difficulty at all in breathing through this nostril. • ALMOST CLEAR – can breathe through this nostril quite easily. • STUFFY – with some hindrance to breathing through this nostril, but not enough to make me uncomfortable. • QUITE STUFFY – nostril feels blocked, and it is not comfortable breathing through this nostril. • VERY STUFFY – can barely breathe through this nostril at all and have to breathe through my mouth much of the time. • COMPLETELY BLOCKED – cannot breathe through this nostril at all. Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.

  4. Symptom Score (% Difference) PL * * PE * * (47) (46) (54) (57) *p<0.005 PE v Pl Dressler et al. Ann Otol Rhinol Laryngol 1977;86:310.

  5. Bickerman. www.jacionline.org

  6. ○ -- PPA ● -- PE + -- PL Thomas et al. Br J Clin Pharmac 1991;32:705-11.

  7. IV PE Approx 0.2 – 1.6 mg Martinsson et al. Eur J Clin Pharmacol 1986;30:427-31.

  8. Dose Adjusted AUCFree 3H-Phenylephrine 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

  10. Hatton\PLAYER.HTM

  11. Jonathan Shuster, PhD Research Professor Division of Biostatistics Department of Epidemiology and Health Policy College of Medicine University of Florida Gainesville, FL

  12. Shuster\PLAYER.HTM

  13. Schering Protocol P04579 – Change inNasal Sx Score Over 6 hr in Vienna Chamber Placebo PE – 12 mg PSE – 60 mg p=0.6 % Change p=0.01 p=0.01 n=30 R,DB,CO Clinicalstudyresults.org (unique ID P04579)

  14. Schering Protocol P04822 – Average 6 hr Mean Change in Nasal Congestion in Canadian Chamber Placebo PE 10 M + L n=126 n=126 n=127 % Change p=0.2 p=0.001 p=0.007 n=379 subjects R,DB,PAR Clinicalstudyresults.org (unique ID P04822)

  15. 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

  16. Leslie Hendeles, Pharm.D. University of Florida Health Science Center (Box 100486) Gainesville, FL 32610-0486 Phone: (352) 273-6027 Fax: (352) 273-6120 Email: hendeles@cop.ufl.edu

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