Korean researchers have disclosed Asia’s first real-world data of Saxenda, a popular obesity treatment. It was the world’s second presentation of Saxenda’s real-world data after Canada.
Lim Soo, a professor at the Department of Endocrinology and Metabolism at Seoul National University Bundang Hospital (SNUBH), released Saxenda’s data after five months in a real-world clinical setting in nine local medical institutions at the International Congress on Obesity and Metabolic Syndrome & Asia-Oceania Conference on Obesity (ICOMES & AOCO) 2019, in Yeouido, Seoul, on Friday.
The real-world study took place at nine general hospitals, including SNUBH, from January 2018 to July 2019 to evaluate Saxenda’s clinical benefits in 406 patients. The research team has accumulated the data for five months from the start of the treatment and is still working on the follow-up.
In patients with body mass index (BMI) over 30kg/m2 or BMI at 27kg/m2 or more with weight-related accompanying diseases such as diabetes, dyslipidemia, and fatty liver, the researchers evaluated metabolic changes such as weight loss, glycated hemoglobin, and blood pressure two and five months after administering Saxenda. The study excluded patients who had previously received Saxenda or GLP-1 RA treatment or had a history of bariatric surgery.
The mean age of patients at the start of the study was 46.5 years, and 70 percent were female. The average BMI was 31.9kg/m2, the average weight, 86kg, and the average waist circumference, 102.9cm. About 44 percent of the patients were diabetic. At the beginning of the study, 406 patients started Saxenda treatment. Among them, 262 patients continued the medication for more than two months, and 111 patients, for over five months.
“The study was based on actual clinical data, which required patients to pay the full cost of the treatment,” Lim said, emphasizing that the expense was the primary reason for discontinuation of the treatment.
The study results showed that patients saw 2.9 kg or 3.5 percent weight reduction two months after the treatment on average. Five months after the treatment, they had 4.7 kg or 5.6 percent weight loss.
In terms of BMI, the two-month treatment led to a 1.06 kg/m2 or 3.4 percent decline in BMI, and the five-month one, a 1.97 kg/m2 or 6.1 percent slide.
“In Korea, Saxenda showed an average weight loss of 4.7 kg on the fifth month of treatment, with 56 percent of patients achieving at least 5 percent weight reduction compared to their baseline. And 29.8 percent had at least 10 percent weight loss compared to their baseline,” Lim said.
In Canada’s real-world study for the first time in the world, Saxenda showed an average 8.1 kg or 7.1 percent weight reduction six months after the treatment, Lim said. “In the case of Canada, baseline BMI was 40 kg/m2. In Korea, it was 31.9 kg/m2,” he added.
In particular, the patients’ average hemoglobin A1C (HbA1c), an indicator of diabetes, started at 7.3 percent but went down to 6.5 percent at the fifth month of treatment, Lim noted. “Considering that 44.1 percent of the patients were diabetic, this is a meaningful result,” he said.
The latest study showed that Saxenda not only improved blood sugar but blood pressure.
The patients’ average systolic blood pressure (SBP) was 131 mmHg at baseline but fell to 125 mmHg five months after Saxenda treatment. The average diastolic blood pressure (DBP) declined from 80.6 mmHg at baseline to 77.3 mmHg.
The researchers assessed adverse events based on patient reports, and about 32 percent of the patients reported side effects. The most common side effects were nausea (16.5 percent), vomiting (12.3 percent), diarrhea (8.9 percent), constipation (6.5 percent), and rash (5.1 percent). The drug compliance reported by the patients was 90 percent during the first two months of the treatment, and 81 percent for the next three months.
“The study showed that the efficacy and safety of Saxenda, which has been proven in randomized controlled trials (RCT), can be consistently applied in clinical settings,” Lim said.