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APEX Trial

Duration of T2DM associated with an increased remission

Greater %EWL also linked with resolution or improvement in T2DM

Patients who had diabetes for a shorter period of time before having a LAGB, and those who lost more excess weight afterwards, are both associated with an increased likelihood of remission or improvement in T2DM status, according to the a two-year interim analysis of type 2 diabetics from the AP Early Experience Trial (APEX).

The authors claim that the outcomes, published online in the journal Postgraduate Medicine, demonstrate that LAGB is a potential adjunctive treatment for obese patients with T2DM with 95.5% of patients experiencing remission or improvement in T2DM status.

APEX is a five-year, open-label, prospective, observational trial designed to examine the effect of LAGB in 517 severely obese patients. This interim analysis examined the effect of LAGB in 395 patients who has received a LAGB and had been followed for two years. There were 288 patients who did not have T2DM and 89 severely obese T2DM patients who required daily hypoglycemic medication at baseline.

In the T2DM groups, 66 (74%) patients met the two-year post-intervention criteria, requiring that they had T2DM at baseline and sufficient information available to assess changes in weight, T2DM status, and concomitant comorbidity status.

Results

Two years after the procedure, 48.5% (32/66) experienced T2DM remission, 47% (31/66) experienced improvement in T2DM, 4.5% (3/66) experienced no change in T2DM (stable), and no patients experienced worsening of T2DM. Overall, 95.5% of patients experienced remission or improvement in T2DM In No new cases of T2DM were reported in the group of patients who did not have T2DM at baseline.

The 66 patients with T2DM at baseline also showed a reduction in mean BMI from 43.9kg/m2 (standard deviation [SD] ± 5.9kg/m2) to 34.6 kg/m2 (SD ± 5.8 kg/m2) after two years, and a mean %WL of 20.6% (SD ± 11.2%).

The overall population of patients with T2DM at baseline (n=89) experienced a mean change in BMI of −8.5kg/m2 (SD ± 5.3 kg/m2) and %WL of −18.8% (SD ± 10.7%), compared with a mean change in BMI of −8.5kg/m2 (SD ± 4.8kg/m2; p=0.618) and %WL of −19.4% (SD ± 10.5%; P = 0.499), respectively, in patients who did not have T2DM at baseline.

In patients with T2DM at baseline, there were no statistically significant differences in mean change in BMI or mean %WL between response groups after two years.

Patients with remitted or improved T2DM after two years had mean T2DM duration of 48.1 months and 80.5 months, respectively (p=0.082 between response groups); in patients whose T2DM status did not change, duration of disease was 106.7 months (8.9 years). Therefore, the duration of T2DM was associated with change in T2DM status (logistic regression, p=0.069).

After two years, the mean average duration of disease for the combined remitted and improved response groups was 64.6 months. Several comorbidities associated with obesity were remitted or improved after two years, including hypertension (90.8%), hyperlipidemia (76.9%), obstructive sleep apnoea (86.0%), gastroesophageal reflux disease (91.0%), osteoarthritis (92.7%), and depression (75.4%).

In patients with T2DM at baseline, device-related events were reported in 22.5% (20/89) of patients. In comparison, device-related events were reported in 20.5% (59/288) of patients who did not have T2DM at baseline after two years (p=0.687). In patients with T2DM at baseline, serious device-related events were reported in 5.6% (5/89) of patients, compared with 2.8% (8/288) of patients who did not have T2DM at baseline after two years (p=0.197).

Medical device complications (eg, gastric band slippage or erosion) were experienced by 3.4% (3/89) of patients with T2DM at baseline, 2 (2.2%) patients required revisional surgery and 1 (1.1%) patient required explantation.

In comparison, 2.4% (7/288) of patients had complications, 7 (2.4%) patients required revisional surgery and 1 (0.3%) patient required explantation (a single patient required revisional surgery and explantation) in the population of patients who did not have T2DM at baseline (revisional surgery, p>0.999; explantation, p=0.417).

Conclusion

The authors conclude that two-year data from the prospective APEX trial, resulted in clinically meaningful weight loss, remission or improvement of T2DM, and reduction of multiple obesity-related comorbidities in the majority of patients with T2DM at baseline whose status was evaluable at two years.

“The amount of weight lost and duration of T2DM contributed to the likelihood of disease remission, suggesting that early weight loss intervention facilitated by LAGB may have significant effects on β-cell health and insulin sensitivity,” they write. “In this study, weight loss appears to be the most likely mechanism to explain T2DM remission, resulting in increased liver, fat, and muscle insulin sensitivity and glucose disposal… earlier intervention through significant weight loss, which improves insulin resistance, is more likely to affect remission of T2DM.”

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