Throughout the years it has become clear that lifestyle intervention is the cornerstone for
all types of bariatric treatment. Educating patients about behaviour, physical activity and
intake strategies will help built a skills set, which patients can fall back on throughout
their lives. Without additional lifestyle intervention a non-surgical, pharmacological or
surgical treatment will be less effective. (5, 6) Besides lifestyle interventions, adjuvant
pharmacological treatment has also proven to be effective in maintaining adequate weight
loss. Pharmacological treatment is mostly performed in patients who are not eligible for
bariatric surgery but do suffer from obesity and related comorbidities. Patients with a Body
Mass Index(BMI) of ≥ 30kg/m2 or a BMI ≥ 27kg/m2 with an obesity-related comorbidity are
advised to use pharmacological treatment. (7) In general the pharmacologic treatment affects
appetite and therefore causes weight loss, provided that lifestyle interventions are added to
the treatment.
For patients with a BMI of ≥ 40kg/m2 or a BMI ≥ 35kg/m2 with comorbid conditions bariatric
surgery is advised. There is a variety of surgical treatment options, with Sleeve Gastrectomy
(SG) and the Roux-en-Y gastric bypass (RYGB) being the most common. (8) An alteration of the
gastro-intestinal tract is performed, which causes a change in gut hormones, bile acids and
microbiota. These changes also have their effect on appetite and energy consumption causing
an even higher weight reduction. (9) Although lifestyle interventions are the cornerstone of
obesity treatment, bariatric surgery has proven to be a superior treatment. (9-11) Besides a
positive effect on weight, bariatric surgery also has a positive effect on comorbidities,
such as type 2 diabetes, hypertension, cancer incidence, cardiovascular events and
cardiovascular deaths. (9, 10, 12-14) All in all we can state that bariatric surgery
currently is the most effective treatment for patients suffering from morbid obesity.
Even though bariatric surgery is the most effective treatment, not all patients maintain
their weight loss. As mentioned before weight regain occurs in 16-37% of the patients. (1)
Currently these patients can be treated in our clinic with an extra module, the Back On Track
(BOT) module. The BOT module consists of 4 extra sessions, 3 with the physiotherapist,
psychologist or dietitian, and 1 with the medical doctor. During these sessions lifestyle
modifications will once again be the main focus. A study performed with data from our own
clinic shows an overall stabilisation of weight after this module. The regained weight will
not be lost with the help of this module. Therefore other options should be explored.
One of the possibilities is the use of medication, in combination with lifestyle
interventions (BOT module), to not only cause stabilisation of weight, but also weight loss
at the end of our module.
Pharmacological therapy with other medication in post-bariatric patients is described to be a
viable option. As described in the review performed by Sudlow et al, different medical
options are being investigated. (15) At the moment most research has been focussing on
pre-operative use of medication. In this review only four out of 20 studies described
post-operative use of medication. Of these four only two studies researched the effect of
naltrexone and bupropion combined in post-bariatric patients. Although these studies only
have a small amount of participants (e.g. n=10), they do show a possible positive effect on
weight loss. (3, 4, 15) Since there is a lack of research on the effect of pharmacotherapy as
an addition to lifestyle interventions in post-bariatric patients, no clear guidelines can be
created at the moment. (16)
Mysimba (Contrave in US) is Anti-Obesity Medication (AOM), it is a combination of naltrexone
hydrochloride extended release and bupropion hydrochloride extended release. Naltrexone,
mostly used for treatment of alcohol and opioid dependence, 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. Bupropion is a mild reuptake inhibitor of dopamine
and norepinephrine, which is used for treatment of depression and later for smoking
cessation. On their own the effect on weight loss is minimal, when combined their effect on
weight loss is synergistically positive. When combined with lifestyle interventions most
successful results will be obtained.
In patients with obesity usage of Naltrexone/Bupropion (NB) has a stronger effect and results
in up to 8.2% weight loss (2). A study performed by Apovian shows a significant difference in
successful weight loss after 4 weeks, when comparing patients who use NB to patients with
only lifestyle modifications. Their study had a follow-up period of 56 weeks with a extra
measure timepoint at 28 weeks. All patients were measured and monitored every 4 weeks. The
results at 4 weeks already showed a significant difference with the placebo group. (2)
Furthermore, in a study conducted by Greenway et al after 16 weeks of follow up a significant
difference in successful weight loss was observed. (17) So far not many studies have been
conducted in post-bariatric patients. Even though the results thus far are scarce, they are
promising. Two studies, both with a study population of 10, showed a positive result of
around 5% more weight loss in post-bariatric patients. (3, 4)
In this study we will examine the effect of 2 tablets of Mysimba 8/90mg 2 times daily as
addition to the Back On Track module for patients with weight regain after bariatric surgery.