smoking cessation in smokers motivated to quit presented at american college of cardiology...

Smoking Cessation in SmokersSmoking Cessation in SmokersMotivated to Quit Motivated to Quit

Smoking Cessation in SmokersSmoking Cessation in SmokersMotivated to Quit Motivated to Quit

Presented atPresented atAmerican College of CardiologyAmerican College of Cardiology

Scientific Sessions 2004Scientific Sessions 2004

Presented by Dr. Robert Anthenelli Presented by Dr. Robert Anthenelli

STRATUS-US TrialSTRATUS-US TrialSTRATUS-US TrialSTRATUS-US Trial

www. Clinical trial results.org

RimonabantA selective cannabinoid type 1

receptor antagonist

5 mg n=262

RimonabantA selective cannabinoid type 1

receptor antagonist

5 mg n=262

Endpoints (1 year): Smoking abstinence Change in body weight in patients who stopped smoking

Endpoints (1 year): Smoking abstinence Change in body weight in patients who stopped smoking

STRATUS-US TrialSTRATUS-US TrialSTRATUS-US TrialSTRATUS-US Trial

Presented at ACC Scientific Sessions 2004Presented at ACC Scientific Sessions 2004

787 patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking

Randomized, double-blind, multicenter

787 patients who smoked ≥10 cigarettes/day for at least 2 months and were motivated to stop smoking

Randomized, double-blind, multicenter

Placebo n=261

Placebo n=261

Rimonabant A selective cannabinoid type 1

receptor antagonist

20 mg n=261

Rimonabant A selective cannabinoid type 1

receptor antagonist

20 mg n=261

Treatment for 1 YearTreatment for 1 Year


36.2%

20.2% 20.6%

0%

20%

40%36.2%

20.2% 20.6%

0%

20%

40%

STRATUS-US Trial STRATUS-US Trial STRATUS-US Trial STRATUS-US Trial

27.6%

15.6% 16.0%

0%

10%

20%

30% Rimonabant 20 mg

Rimonabant 5 mg

Placebo

27.6%

15.6% 16.0%

0%

10%

20%

30% Rimonabant 20 mg

Rimonabant 5 mg

Placebo

Smoking abstinence at 7-10 weeks p < 0.001 for high-dose vs placebo

p = NS for low-dose vs placebo


Smoking abstinence at end of study p < 0.001 for high-dose vs placebo

p = NS for low-dose vs placebo



Change in weight from baseline among patients with a prolonged abstinence

from smokingp<0.001 for rimonabant 20 mg vs placebo

0.6

3.7

0

1

2

3

4

Rimonabant 20 mg Placebo

0.6

3.7

0

1

2

3

4

Rimonabant 20 mg Placebo

• Among patients with a prolonged abstinence from smoking, change in weight from baseline was significantly in high-dose group compared with placebo (Figure)

• In subgroup of patients who were overweight initially, BMI was significantly in high-dose group versus placebo (-0.1 vs. 1.7, p<0.001)


kg



• Among patients smoking ≥10 cigarettes per day and motivated to stop smoking, use of the selective cannabinoid type 1 receptor antagonist rimonabant in a 20 mg dose was associated with an increase in prolonged smoking abstinence compared with placebo, but there was no difference between the 5 mg dose of rimonabant and placebo

• Additionally, weight gain, which can be a negative side effect of smoking cessation, was lower in patients who received rimonabant 20 mg, with benefit seen even in obese patients

• Further evaluation warranted

• Among patients smoking ≥10 cigarettes per day and motivated to stop smoking, use of the selective cannabinoid type 1 receptor antagonist rimonabant in a 20 mg dose was associated with an increase in prolonged smoking abstinence compared with placebo, but there was no difference between the 5 mg dose of rimonabant and placebo

• Additionally, weight gain, which can be a negative side effect of smoking cessation, was lower in patients who received rimonabant 20 mg, with benefit seen even in obese patients

• Further evaluation warranted

smoking cessation in smokers motivated to quit presented at american college of cardiology...

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