PMID- 22340363 OWN - NLM STAT- MEDLINE DCOM- 20121105 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 14 IP - 8 DP - 2012 Aug TI - The effect of linagliptin on glycaemic control and tolerability in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. PG - 694-708 LID - 10.1111/j.1463-1326.2012.01586.x [doi] AB - AIM: Linagliptin is a new dipeptidyl peptidase-4 inhibitor recently approved for use in the USA. The objective of this systematic review and meta-analysis was to assess effect of linagliptin on glycaemic control, biomarkers and incidence of adverse events (AEs) in patients with type 2 diabetes mellitus. METHODS: Five published and four unpublished randomized, clinical trials were identified from multiple databases. Qualitative assessments and quantitative analyses were performed. RESULTS: Nine studies included 4246 participants with 53% men, 59.4% Caucasians, 38.7% Asians, and age range 45-69 years. Linagliptin was given as monotherapy (vs. placebo) or combined with metformin (vs. metformin + placebo), sulphonylurea (vs. sulphonylurea + placebo) or pioglitazone (vs. pioglitazone + placebo). Linagliptin 5 mg/day for 12-24 weeks, significantly reduced haemoglobin A1c (HbA1c) (-0.63%, p < 0.00001), fasting plasma glucose (FPG) (-1.01 mmol/l, p < 0.00001) and improved disposition index (DI, product of insulin sensitivity and acute insulin secretion) (p = 0.0001). Linagliptin monotherapy was not more effective than metformin at reducing HbA1c or FPG. Similar proportion of patients in linagliptin and placebo groups reported AEs including upper respiratory tract infections, headaches, nausea, hypertension and back pain. CONCLUSIONS: Linagliptin was associated with modest but significant reduction in HbA1c and FPG and improved DI after 12-24 weeks. Patients who would probably benefit most are those with HbA1c <9%, already on an active agent, compliant with weight reduction strategies, and can recognize and manage hypoglycaemia, fluid retention and upper respiratory tract infections. Long-term studies are needed to determine durability of response, incidence of microvascular and macrovacular complications, cost-effectiveness and safety. CI - (c) 2012 Blackwell Publishing Ltd. FAU - Singh-Franco, D AU - Singh-Franco D AD - Pharmacy Practice, Nova Southeastern University, College of Pharmacy, FL 33324, USA. singh@nova.edu FAU - McLaughlin-Middlekauff, J AU - McLaughlin-Middlekauff J FAU - Elrod, S AU - Elrod S FAU - Harrington, C AU - Harrington C LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20120320 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Purines) RN - 0 (Quinazolines) RN - 0 (Thiazolidinediones) RN - 0 (hemoglobin A1c protein, human) RN - 3X29ZEJ4R2 (Linagliptin) RN - 9100L32L2N (Metformin) RN - X4OV71U42S (Pioglitazone) SB - IM CIN - Diabetes Obes Metab. 2012 Nov;14(11):1054-5. PMID: 23034010 MH - Aged MH - Biomarkers/blood MH - Blood Glucose/*metabolism MH - Cost-Benefit Analysis MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage MH - Drug Therapy, Combination MH - Female MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemic Agents/*administration & dosage MH - Linagliptin MH - Male MH - Metformin/*administration & dosage MH - Middle Aged MH - Pioglitazone MH - Purines/*administration & dosage MH - Quinazolines/*administration & dosage MH - Randomized Controlled Trials as Topic MH - Thiazolidinediones/*administration & dosage MH - Treatment Outcome MH - United States EDAT- 2012/02/22 06:00 MHDA- 2012/11/06 06:00 CRDT- 2012/02/21 06:00 PHST- 2012/02/21 06:00 [entrez] PHST- 2012/02/22 06:00 [pubmed] PHST- 2012/11/06 06:00 [medline] AID - 10.1111/j.1463-1326.2012.01586.x [doi] PST - ppublish SO - Diabetes Obes Metab. 2012 Aug;14(8):694-708. doi: 10.1111/j.1463-1326.2012.01586.x. Epub 2012 Mar 20.