Efficacy Varenicline in Smoking Cessation Programme A Randomized, Single-Blind, Placebo Controlled Trial

· Biomolecular, Tobacco Control

Mirsyam Ratri Wiratmoko,1,2 Agus Dwi Susanto,1,3 Faisal Yunus,1 Tribowo Tuahta Ginting3,4
1Departemen Pulmonologi dan Kedokteran Respirasi Fakultas Kedokteran Universitas Indonesia, RSUP Persahabatan, Jakarta
2Departemen Ilmu Penyakit Dalam Program Studi Pendidikan Dokter Fakultas Kedokteran dan Kesehatan Universitas Muhammadiyah Jakarta
3Klinik Berhenti Merokok, RSUP Persahabatan
4Satuan Medis Fungsional Ilmu Kesehatan Jiwa, RSUP Persahabatan, Jakarta

Background: Smoking has increased risk of morbidity and mortality. World Health Organization predicts that by 2020, disease caused by smoking will result in the deaths of around 8.4 million people in the world and half of these deaths from Asia. Varenicline, a partial agonist at the α4β2 nicotinic acetylcholine receptor, has the potential to aid smoking cessation by relieving nicotine withdrawal symptoms and reducing the rewarding properties of nicotine.
Methods: A randomized, single-blind, placebo controlled trial conducted between July to December 2012 with a 12 week treatment period and 12 week follow-up of smoking status at Persahabatan Hospital, Jakarta. Eighty male adult smokers who volunteered for the study assigned into varenicline and placebo group. Varenicline titrated to 1 mg twice daily (n=40) or placebo (n=40) for 12 weeks, plus weekly smoking cessation counseling.
Results: During the first 4 weeks (weeks 1-4)after 12 weeks of treatment, 55% of participants in the varenicline group were continuously abstinent from smoking compared with 27.5% in the placebo group (Prevalence Ratio [PR] 2,0). For weeks 5 – 8, 52.5% of participants in the varenicline group were continuous abstinent compared with 20% in the placebo group (PR, 2,6). For weeks 9-12, 47.5% of participants in the varenicline group were continuous abstinent compared with 17.5% in the placebo group (PR, 2,7). Mean of first day free of smoking used Varenicline was 40,63 days and mean of first day free of smoking used placebo was 56.43 days. The most adverse event with varenicline was nausea, which occurred in 9 participants (22.5%). Mean of CO level was 18.46 ppm, mean of Fagerstrom score for nicotine dependence was 6,4, and mean of Brinkman index was 317.9.
Conclusion: Varenicline is an efficacious, safe, and well-tolerated smoking cessation pharmacotherapy. (J Respir Indo. 2017; 37: 145-56)
Keywords: Varenicline, counseling, smoking cessation

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