Use of Mysimba in Patients With Weight Regain After Bariatric Surgery
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Although bariatric surgery is currently the most effective treatment for morbid obesity,
weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated
with antiobesity medications (AOMs).
Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone hydrochloride extended
release and bupropion hydrochloride extended release for the treatment of obesity, and is
used with lifestyle modification. Bupropion is a mild reuptake inhibitor of dopamine and
norepinephrine. Naltrexone, an opioid antagonist has minimum effect on weight loss on its
own. Naltrexone is thought to block the inhibitory effects of opioid receptors activated by
the β-endorphin released in the hypothalamus that stimulates feeding, thus allowing the
inhibitory effects of α-melanocyte stimulating hormone to reduce food intake. In patients
with obesity usage of Naltrexone/Bupropion (NB) results in up to 8.2% weight loss (2). There
is some evidence that also in bariatric patients with weight regain NB leads to additional
weight loss (3, 4).
At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is currently treated
with the Back on Track (BOT) program. The BOT program is an extra intervention our clinic
provides for the patients who have weight regain after surgery, this is part of our standard
care program.
The primary objective is to study the effect of naltrexone/bupropion in combination with the
BOT module on successful weight loss(>5% weight loss) after 22 weeks in patients with weight
regain after bariatric surgery, compared to the regular BOT module.