期刊
BMJ OPEN
卷 4, 期 12, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2014-005752
关键词
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资金
- Canadian Institutes for Health Research/Drug Safety and Effectiveness Network (CIHR/DSEN) [286941 DC0190GP]
- CIHR/DSEN New Investigator Awards in Knowledge Synthesis
- University of Ottawa Research Chair
- Roy and Vi Baay Chair in Kidney Research
- Faculty of Medicine and Dentistry
- Faculty of Pharmacy
- Faculty of Pharmaceutical Sciences
- Alberta Heritage Foundation for Medical Research
- Alberta Innovates-Health Solutions
- Tier 1 Canada Research Chair in Knowledge Translation
- NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS [F32DC000190] Funding Source: NIH RePORTER
Objective: To evaluate the effectiveness and safety of dipeptidyl peptidase-4 (DPP-4) inhibitors versus intermediate-acting insulin for adults with type 2 diabetes mellitus (T2DM) and poor glycaemic control despite treatment with two oral agents. Setting: Studies were multicentre and multinational. Participants: Ten studies including 2967 patients with T2DM. Interventions: Studies that examined DPP-4 inhibitors compared with each other, intermediate-acting insulin, no treatment or placebo in patients with T2DM. Primary and secondary outcome measures: Primary outcome was glycosylated haemoglobin (HbA1c). Secondary outcomes were healthcare utilisation, body weight, fractures, quality of life, microvascular complications, macrovascular complications, all-cause mortality, harms, cost and cost-effectiveness. Results: 10 randomised clinical trials with 2967 patients were included after screening 5831 titles and abstracts, and 180 full-text articles. DPP-4 inhibitors significantly reduced HbA1c versus placebo in network meta-analysis (NMA; mean difference (MD) -0.62%, 95% CI -0.93% to -0.33%) and meta-analysis (MD -0.61%, 95% CI -0.81% to -0.41%), respectively. Significant differences in HbA1c were not observed for neutral protamine Hagedorn (NPH) insulin versus placebo and DPP-4 inhibitors versus NPH insulin in NMA. In meta-analysis, no significant differences were observed between DPP-4 inhibitors and placebo for severe hypoglycaemia, weight gain, cardiovascular disease, overall harms, treatment-related harms and mortality, although patients receiving DPP-4 inhibitors experienced less infections (relative risk 0.72, 95% CI 0.57 to 0.91). Conclusions: DPP-4 inhibitors were superior to placebo in reducing HbA1c levels in adults with T2DM taking at least two oral agents. Compared with placebo, no safety signals were detected with DPP-4 inhibitors and there was a reduced risk of infection. There was no significant difference in HbA1c observed between NPH and placebo or NPH and DPP-4 inhibitors.
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