A new combination of two FDA-approved drugs has shown a remarkable 8.7% average weight loss and a reduction of 1 point for A1c in just 12 weeks…
Although the FDA has approved the two products separately, it has not approved the combination of the two. In a 3-month safety study, combination weight management (WM) pharmacotherapy with lorcaserin (LOR)(Belviq) and immediate release (IR) Phentermine (phen) did not exacerbate any serotonergic adverse effects seen with lorcaserin alone.
Pharmacotherapy for weight management (WM) may involve combining drugs targeting different signaling pathways. This pilot study was sized to assess the primary outcome of the impact of lorcaserin (LOR), a specific 5HT2c receptor agonist and phenteramine on pre-selected potentially serotonergic (5HT) adverse events (AEs) compared to LOR alone.
A total of 238 patients (pts) with BMI >30, or >27 with a comorbidity, but without T2DM, were randomized in a 12-week study comparing LOR 10mg BID alone, LOR 10mg BID with phenIR 15mg QD (LOR/phen QD) and LOR 10mg BID with phenIR 15mg BID (LOR/phen BD). All received a standard diet and exercise program with adherence self-reported by study subjects. The primary endpoint evaluated whether short-term LOR/phen treatment is associated with exacerbation of potential 5HT AEs compared to LOR alone. Secondary objectives included safety, tolerability, pharmacokinetics and weight loss (WL).
The results showed that 37.2% (LOR), 42.3% (LOR/phen QD), and 40.8% (LOR/phen BD) pts reported potential 5HT AEs. 5.1%.(LOR), 2.6% (LOR/phen QD) and 10.1% (LOR/phen BD) pts discontinued due to AEs. At wk 12 mean changes in BP (systolic/diastolic) and pulse (bpm) were -5.5/-2.5/-1.9 (LOR), -3.3/-1.4/1.1 (LOR/phen QD) and -3.4/-1.7/3.1 (LOR/phen BD). Mean change from baseline WL (kg/%) in 12-wk completers was 4.0/3.8 (LOR), 7.6/7.3 (LOR/phen QD) and 8.9/8.7 (LOR/phen BD). 33.3% (LOR), 68.2% (LOR/phen QD) and 84.2% (LOR/phen BD) pts achieved ≥5% WL (12-wk completers).
The researchers concluded that the treatment with LOR plus phen was not associated with exacerbation of potential 5HT AEs compared to LOR alone. Common AEs during the trial were consistent with prior experience with these agents. The combination of LOR BID and phen BID more than doubled weight loss achieved compared to LOR alone.
In another study on the same drug combination, a small 22-patient observational study conducted by Dr. Robert Huster and Dr. Louis Aronne, the results showed an amazing 1% weight loss per week for 12 weeks showing a final weight loss of 11.8% with no significant side effects. Dr. Arrone’s University was one of the sites for the Eisai study concluded in November 2014.
The synergistic effect of this combination was seen in pre-clinical animal tests as noted in the Arena patent covering this combination therapy. Given that animals and humans have the same pathways in play for food cravings and satiety, the Bel-Phen results seen by Dr. Huster and Dr. Aronne are to be expected and consistent or better than results seen with the fen-phen combination. An image of the results of the pre-clinical Belviq + phentermine studies is show below. (Compound B is the same chemical formulation as lorcaserin.)
Publisher’s comment: An 8.7% average weight loss in just 12 weeks and a reduction in HbA1c level of -1.0 in an FDA-monitored study has not made the news yet, as only the abstract has been published. These numbers would be very good at 1 year and are fantastic in 12 weeks. This is accomplished via the synergistic effects of combining Belviq and Phentermine. Patients were still losing weight at the end of the trial indicating over 20% weight loss in one year. The average numbers are remarkable especially with the minimal side effects of Belviq.
I know you hear about diet and exercise constantly but with 20 years of this being the solution obesity has doubled and diabetes has quadrupled. This Belviq Phentermine combination could become the new standard for weight loss treatment. Since there is a 90% overlap between obesity and diabetes both will be helped by this drug.
You can find out more from co-author Dr. Timothy Garvey (University of Alabama at Birmingham), who presented the findings at the Obesity Week 2014 meeting, on the current status of obesity medications in this recent exclusive interview with me for Diabetes In Control.
Obesity Week 2014: The American Society for Metabolic and Bariatric Surgery and the Obesity Society Joint Annual Scientific Meeting; November 4, 2013; Boston, MA. Abstract 2053P