Most Read Articles
11 May 2020
This second issue revisits the impact EMPA-REG OUTCOME had on clinical practice and helps readers discover how it gives life back to patients through its cardiovascular indication. Learn how it was approved and the possible mechanisms for its cardiovascular benefits.
Pearl Toh, 15 Oct 2020
Cycling was associated with reduced risk for both all-cause and cardiovascular (CV) mortality in people with diabetes, according to a study presented at EASD 2020 Meeting — suggesting that cycling could be encouraged as an activity to prevent deaths in this population who are known to have a higher mortality risk than the general public.
Elaine Soliven, 15 Oct 2020

Higher levels of exercise appear to be associated with a lower risk of all-cause mortality in adults with type 2 diabetes (T2D) compared with no exercise at all, according to a study presented at EASD 2020.

Elvira Manzano, 12 Oct 2020
Taking regular hot baths may have a positive impact on glycaemia, blood pressure (BP), and body weight among Japanese patients with type 2 diabetes(T2D), according to a real-world study touted as the first to analyse the effect of heat therapy in T2D.

Real-world study shows benefits of semaglutide in GLP-1RA-naïve adults with T2D

Audrey Abella
01 Sep 2020

Once-weekly semaglutide significantly reduced HbA1c and weight in GLP-1RA*-naïve adults with type 2 diabetes (T2D), the retrospective SPARE** study reveals.

“[We] investigated real-world clinical outcomes during the first year of semaglutide availability in Canada, in patients with T2D attending a referral-based specialist practice,” said the researchers. “[Our findings showed] statistically and clinically significant 3- to 6-month reduction in HbA1c and weight, regardless of semaglutide dose or order of semaglutide therapy. Blood pressure (BP) and lipids also improved, and there was no change in reported incidence of hypoglycaemia.”

At a mean follow-up of 4.9 months, there were significant reductions in HbA1c (mean, 1.03 percent) and weight (mean, 3.9 kg; p<0.001 for both). [Diabetes Obes Metab 2020;doi:10.1111/dom.14117]

Marked HbA1c reductions were also seen with semaglutide 1.0 mg vs 0.25–0.5 mg (least squares [LS] mean change, 0.24 percent; p<0.001), among noninsulin vs insulin users (LS mean change,0.21 percent; p=0.003), and those who had a 6-month vs a 3-month follow-up (LS mean change,0.18 percent; p<0.01).

The HbA1c reductions were significant regardless whether semaglutide was added to one, two, or 3 OHAs*** (LS mean change, 1.35, 1.18, and 0.76 percent, respectively), or insulin (LS mean change, 0.87 percent; p<0.001 for all). A similar trend was seen for weight reduction (LS mean change, 4.4, 4.2, and 3.4 percent [one, two, and 3 OHAs, respectively] and –3.6 percent [insulin]; p<0.001 for all).

Body mass index (1.3 kg/m2), BP (4.0 mm Hg [systolic] and 1.5 mm Hg [diastolic]), and lipid profile (0.4 mmol/L [triglycerides], 0.2 mmol/L [LDL cholesterol], and 0.4 mmol/L [non-HDL cholesterol]; p<0.001 for all) also dropped significantly following initiation of semaglutide.

“Therapies for diabetes that improve not only glycaemia but also weight, BP, and lipids may have additional benefit in the risk reduction of cardiovascular and microvascular complications associated with diabetes,” said the researchers.

Baseline and follow-up rates of hypoglycaemia (at least one incidence weekly) were similar in the overall cohort (4.3 percent vs 4.7 percent; p=0.70), as well as among those on sulphonylurea (2.4 percent vs 3.4 percent; p=0.41) or insulin (7.5 percent vs 8.4 percent; p=0.65).

Nearly 20 percent discontinued semaglutide, which was lower than other real-world assessments of exenatide, dulaglutide, and liraglutide. [Diabetes Obes Metab 2019;21:1-10; Diabetes Obes Metab 2017;19:953-961; Curr Med Res Opin 2018;34:995-1003] “[Our] participants … were attending multidisciplinary specialist clinics operating in a well-resourced public health system, which may have improved persistence,” said the researchers.

 

Randomized vs real-world

SPARE comprised 937 participants (mean age 57.1 years) who initiated and maintained semaglutide during follow-up. Despite the significant findings, when compared against SUSTAIN 1 – an RCT comparing semaglutide against placebo – the drops in HbA1c (particularly with the 0.5- and 1.5-mg doses) in SPARE were smaller. [Lancet Diab Endocrinol 2017;5:251-260]

However, SUSTAIN 1 had younger and treatment-naïve participants with shorter disease duration and longer on-treatment time. “[Conversely, our participants had multiple OHAs] and comorbidities. Furthermore, RCTs provide additional healthcare provider support, as well as scheduled dispensing of a therapy [that is] not routinely available to the larger populations being assessed in real-world evaluations,” the researchers pointed out.

Nonetheless, real-world studies are now recognized by the US FDA as vital support for regulatory decision making. [N Engl J Med 2016;375:2293-2297; www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices, accessed September 1, 2020] “Real-world studies have the advantage of including people with a broad age range, different socio-economic backgrounds, multiple comorbidities, and using polytherapy, which may make the results more generalizable to real-world clinical practice,” they said.

However, the lack of randomization and having a select patient cluster from a specialist endocrinology practice may have limited generalizability of the findings, they pointed out. “We only reported outcomes in GLP-1RA-naïve individuals, and it is not known how the results would differ in those who switched from another GLP-1RA to semaglutide.”

Future trials with longer follow-ups are thus warranted to explore the impact of semaglutide in other patient subgroups and compare semaglutide against other diabetes drug classes, they said.

 

 

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Endocrinology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
11 May 2020
This second issue revisits the impact EMPA-REG OUTCOME had on clinical practice and helps readers discover how it gives life back to patients through its cardiovascular indication. Learn how it was approved and the possible mechanisms for its cardiovascular benefits.
Pearl Toh, 15 Oct 2020
Cycling was associated with reduced risk for both all-cause and cardiovascular (CV) mortality in people with diabetes, according to a study presented at EASD 2020 Meeting — suggesting that cycling could be encouraged as an activity to prevent deaths in this population who are known to have a higher mortality risk than the general public.
Elaine Soliven, 15 Oct 2020

Higher levels of exercise appear to be associated with a lower risk of all-cause mortality in adults with type 2 diabetes (T2D) compared with no exercise at all, according to a study presented at EASD 2020.

Elvira Manzano, 12 Oct 2020
Taking regular hot baths may have a positive impact on glycaemia, blood pressure (BP), and body weight among Japanese patients with type 2 diabetes(T2D), according to a real-world study touted as the first to analyse the effect of heat therapy in T2D.