Real-world efficacy of prescription and over-the-counter nicotine replacement therapy

  • Shiffman, Saul
  • Rolf, Clyde N.
  • Hellebusch, Stephen J.
  • Gorsline, Jane
  • Gorodetzky, Charles W.
  • Chiang, Yu-Kun
  • Schleusener, Debra S.
  • Di Marino, Michael E.

  • 1Pinney Associates, Inc., Pittsburgh, PA, USA

    2University of Pittsburgh, Smoking Research Group, Pittsburgh, PA, USA

    3Marion Merrell Dow Pharmaceuticals, Cincinnati, OH, USA

    4Q2 Marketing Research, Inc., Cincinnati, OH, USA

    5ALZA Corporation, Encinitas, CA, USA

    6Quintiles, Inc., Kansas City, MO, USA

    7Essence Sciences, Inc., San Jose, CA USA

    8Aventis Pharmaceuticals, Bridgewater, NJ, USA

Correspondence to: Saul Shiffman PhD, Pinney Associates, 201 North Craig Street, Suite 320, Pittsburgh, PA 15213, USA, Tel: + 1 412 687 5677, Fax: + 1 412 687 4855, E-mail: [email protected]

Submitted 10 July 2001; initial review completed 15 September 2001; final version accepted 27 November 2001

Addiction 97(5):p 505-516, May 2002.

Aims

To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.

Design

Separate open-label studies with gum and patch in OTC and Rx settings.

Participants

There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.

Interventions

All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette®) or patch (21, 14 or 7 mg NicoDerm® CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.

Measurements

Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months.

Findings

OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05–1.98)] and gum [OR = 2.92 (1.58–5.40)], and remained significant at 6 months for patch [OR = 3.63; (1.74–7.61)] but not gum [OR = 1.37; (0.73–2.58)]. Among OTC gum users, 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch, abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.

Conclusions

Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.

Copyright © 2002 Blackwell Science Ltd.