Researchers recently studied the effects of the weight loss drug lorcaserin on obesity and diabetes in the CAMELLIA-TIMI 61 trial.
Obesity has tripled over the past 40 years and continues to be a growing problem worldwide. Body weight is directly linked to diabetes risk, with obesity being associated with the development of diabetes and worsening control of glucose in those with diabetes. Therefore, obesity and its related diabetes risk contribute to the risk of other diseases such as chronic kidney disease, heart disease, and stroke. As a result, weight management is a goal of therapy in diabetes. In addition to lifestyle modification recommendations, guidelines also recommend the use of weight loss drugs to help manage obesity and diabetes.
Weight loss drug studies have previously reported improvements in glucose control with their use, however, most were short-term studies of usually1-year study length. Researchers in the United States designed the CAMELLIA-TIMI 61 trial to study the long-term safety and efficacy of the weight loss drug, lorcaserin, in obesity and diabetes. Their results were published in The Lancet.
The CAMELLIA-TIMI 61 clinical trial was randomized, double-blinded, placebo-controlled, and done at over 400 sites in eight different countries. Eligible patients were overweight or obese with a high risk of a cardiovascular event. The trial had a study size of 12,000 patients who were randomly assigned to lorcaserin (10 mg twice daily) or a matched placebo.
Once assigned, diabetes medications could be started, discontinued or changed according to local standards, however, the use of other weight loss drugs was not allowed. Over half of the study population had diabetes, and about one-third had pre-diabetes. The patients were followed up for a median time of 3 years.
In study patients who were pre-diabetic, lorcaserin reduced the risk of diabetes by 19% when compared to the placebo group. In study patients without diabetes, lorcaserin reduced diabetes risk by 23%. The net weight loss in patients taking lorcaserin was significantly greater than placebo across all subgroups of patients with diabetes, pre-diabetes, and no diabetes.
A greater number of diabetic patients experienced remission to either pre-diabetes or normal glucose levels in the lorcaserin group versus placebo, and a greater proportion of patients with pre-diabetes taking lorcaserin were able to achieve normal glucose levels. Further in patients with diabetes, lorcaserin decreased the risk of diabetes-related complications, such as diabetic retinopathy or neuropathy, by 21%. Hypoglycemia (low blood sugar) was found to be more common with lorcaserin than placebo (6.6% versus 5.8%) in patients with diabetes. This highlights the importance of careful dose adjustments to drugs known to increase the risk of causing low blood sugar in patients who are losing weight.
The findings from the CAMELLIA-TIMI 61 trial support the approach that weight loss can improve cardiovascular health. This is consistent with existing literature that also reinforces the benefits of weight loss – through lifestyle, medication, or surgical methods – on glucose control. The researchers conclude that their study results support the potential for lorcaserin as an add-on therapy in the management of obesity and diabetes.
Written by Maggie Leung, PharmD
References:
- Bohula, E. A., Scirica, B. M., Inzucchi, S. E., Mcguire, D. K., Keech, A. C., Smith, S. R., . . . Ince, C. (2018). Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): A randomised, placebo-controlled trial. The Lancet. doi:10.1016/s0140-6736(18)32328-6
- St. Peter, E. (2018, October 4). Weight loss drug shows positive effect on diabetes. Retrieved from https://www.eurekalert.org/pub_releases/2018-10/bawh-wld100218.php