Bariatric Surgery vs. Medical Ther apy in Diabetes
Table 2. Primary and Secondary End Points at 12 Months.* Medical Therapy (N = 41)
End Point
Gastric Bypass (N = 50)
Sleeve Gastrectomy (N = 49)
P Value Gastric Sleeve Gastric Bypass Gastrectomy Bypass vs. Medical vs. Medical vs. Sleeve Therapy Therapy Gastrectomy
Glycated hemoglobin ≤6% — no. (%)
5 (12)
21 (42)
18 (37)
0.002
0.008
0.59
≤6% with no diabetes medications — no. (%)
0
21 (42)
13 (27)
<0.001
<0.001
0.10
9.3±1.4
9.5±1.7
Baseline — % Month 12 — %
8.9±1.4 7.5±1.8
6.4±0.9
6.6±1.0
<0.001
0.003
0.23
−1.4±1.5
−2.9±1.6
−2.9±1.8
<0.001
<0.001
0.85
Baseline
104.4±14.5
106.7±14.8
100.6±16.5
Month 12
99.0±16.4
Change from baseline
−5.4±8.0
Change from baseline — percentage points Body weight — kg
77.3±13.0 −29.4±8.9
75.5±12.9 −25.1±8.5
<0.001
<0.001
0.50
<0.001
<0.001
0.02
High-density lipoprotein cholesterol Percent change from baseline
11.3±25.7
28.5±22.7
28.4±21.9
0.001
0.001
0.98
−14 (−40 to 3)
−44 (−65 to −16)
−42 (−56 to 0)
0.002
0.08
0.17
Median percent change from baseline −33.2 (−71 to 0) (interquartile range)
−84 (−91 to −59)
−80 (−90 to −63)
<0.001
<0.001
0.59
Triglycerides Median percent change from baseline (interquartile range) High-sensitivity C-reactive protein
* Plus–minus values are means ±SD. Post-randomization data were not available for nine patients in the medical-therapy group and one patient in the sleeve-gastrectomy group. P<0.05 for the comparisons with baseline values in all listed categories. To convert the values for cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for triglycerides to millimoles per liter, multiply by 0.01129.
gastrectomy (81%) was superior to that of medical therapy (13%) (P<0.001 for both comparisons). Both surgical groups had a significantly greater decrease in BMI over time than did the medicaltherapy group (P<0.001 for both comparisons) (Fig. 1D).
bypass, but not after sleeve gastrectomy, as compared with medical therapy. There was a marked increase in high-density lipoprotein (HDL) cholesterol and a significant decrease in the highsensitivity CRP level after the two surgical procedures, as compared with medical therapy alone.
Other Health Outcomes
Use of Cardiovascular Medications
Table 2 shows changes in clinical and laboratory outcomes at 12 months. The reduction in prevalence of the metabolic syndrome was significantly greater in the two surgical groups than in the medical-therapy group (Table S3 in the Supplementary Appendix). Rates of hyperinsulinemia and the HOMA-IR index improved markedly after each of the two surgical procedures, as compared with medical therapy alone. A significant decrease in triglycerides occurred at 12 months after gastric
Although levels of total and LDL cholesterol did not differ significantly among groups after 12 months, there was a significant reduction in the number of medications needed to treat hyperlipidemia in the two surgical groups (Table 3). For example, lipidlowering drugs were required at baseline in 86% and 78% of patients assigned to undergo gastric bypass and sleeve gastrectomy, respectively, but use declined to 27% and 39% after 12 months, as compared with 92% for medical therapy (P<0.001
10.1056/nejmoa1200225 nejm.org
The New England Journal of Medicine Downloaded from nejm.org on March 29, 2012. For personal use only. No other uses without permission. From the NEJM Archive. Copyright © 2010 Massachusetts Medical Society. All rights reserved.
5