Table 6.

Clinical trials of Naltrexone/Bupropion SR

Clinical trialPatientsDoseTreatment, placebo from baseline% of patients losing ≥5% of baseline weightComment
COR I
1-year randomized, double-blind, placebo-controlled trial
(2010)
1742 patients randomly categorized in a 1:1:1 ratioi.16/360mg po
ii.32/360mg po
iii. placebo
i.-5.0%
ii.-6.1%
iii.-1.3%
i.39%
ii.48%
iii.16%
COR II
1-year randomized, double-blind, placebo-controlled trial
(2013)
1496 patients randomly categorized in a 2:1 ratio to NB 32/360mg or placebo; patients on NB with <5% weight loss in 28-44 week were reassigned to continue 32/360mg or increase daily dose to NB 48/360mgi.32/360mg (or increased daily dose 48/360mg)
ii.placebo
i.-6.4%
ii.-1.2%
i.50.5%
ii.17.1%
Random reassignment to higher dose did not change weight loss results
COR-BMOD
1-year randomized, double-blind, placebo-controlled trial
(2011)
793 patients with obesity randomly categorized in a 1:3 ratio
i.

BMOD+ NB (32/350mg)

ii.

BMOD+ placebo

i.-11.5%
ii.-7.3%
i.66.4%
ii.42.5%
The efficacy of NB is obvious, and a lifestyle change can increase weight loss
COR-DIABETES
1-year randomized, double-blind, placebo-controlled trial
(2013)
505 patients overweight/obese and T2DM with/without oral anti-hypoglycemic agents randomly categorized in a 2:1 ratioi.32/360mg
ii. placebo
i.-5.0%
ii.-1.8%
i.44.5%
ii.18.9%
↓HbA1c, certain improvements in CVD risk factors.
↑ nausea, constipation, vomiting

From: Existing and Emerging Molecular Targets for the Pharmacotherapy of Obesity

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