18 month efficacy and safety results from EnteroMedics, Inc.’s 5 year ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity have been released. It seems it works, as the statistically significant results show.
We covered the story of EnteroMedics’ emerging nerve-blocking therapy back in July, here, when the U.S. FDA accepted for filing the Company’s Premarket Approval (PMA) application for its Maestro® Rechargeable System’s VBLOC® vagal blocking obesity treatment. Laparoscopically implanted leads intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. As such VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
The ReCharge Pivotal Trial of VBLOC® vagal blocking therapy is a prospective double-blind, sham-controlled clinical trial involving 239 randomized patients (233 implanted) at ten sites in the United States and Australia. All patients received an implanted device and were randomized in a 2:1 allocation to VBLOC treatment or sham control groups. Patients were surgically implanted with either a fully functional device with leads to the vagus nerve (treated) or received a sham surgical procedure and a sham device without leads to the vagus nerve (sham control).
Now the company has announced 18 month safety and efficacy results which point to a statistically significant 13% difference in Excess Weight Loss (EWL) as compared with a sham control (p < 0.001). Patients in the VBLOC group (n=117), achieved EWL of 25%, or 10% total body weight loss (TBL), compared to 12% EWL, or 4% TBL for sham control group patients (n=42).
In total, 54% of patients in the VBLOC group achieved at least 20% EWL and 41% achieved at least 25% EWL, compared to 26% and 17%, respectively, for the sham control group at the 18-month interval. Significantly, approximately 78% of the patients who reported for their 18-month visit remained under the clinical trial’s randomized blind.
The rate of device-related serious adverse events at 18 months was 4.3% for the VBLOC group, meaningfully lower than the 12 month threshold of 15% (p < 0.0001). The safety results continued to confirm VBLOC Therapy had no adverse cardiovascular effects. Overall, a reduction in blood pressure and heart rate was observed.
“Durable weight loss over time is a critical, if challenging, goal in bariatric medicine, one that plays a significant role in achieving long-term health benefits,” said Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer. “These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety, underscoring the attractive benefit risk profile of VBLOC Therapy. If approved, VBLOC may help to address the lifelong challenges associated with obesity by offering a treatment option that supports safe, long-term weight loss and a healthy lifestyle.”
Source: EnteroMedics, Inc., Marketwire