PMID- 24456313
OWN - NLM
STAT- MEDLINE
DCOM- 20140922
LR  - 20230823
IS  - 1944-706X (Electronic)
IS  - 1083-4087 (Print)
IS  - 1083-4087 (Linking)
VI  - 20
IP  - 2
DP  - 2014 Feb
TI  - Tolerability of saxagliptin in patients with inadequately controlled type 2 
      diabetes: results from 6 phase III studies.
PG  - 120-9
LID - 10.18553/jmcp.2014.20.2.120
AB  - BACKGROUND: Oral antihyperglycemic drugs used to treat type 2 diabetes mellitus 
      (T2DM) vary in safety and tolerability. Treatment-related hypoglycemia and weight 
      gain can exacerbate underlying disease.  OBJECTIVE: To evaluate the tolerability 
      of saxagliptin using data from phase III clinical trials.  METHODS: Six 24-week 
      randomized studies in 4,214 patients with T2DM were assessed. Saxagliptin 2.5 mg 
      or 5 mg was compared with placebo in 2 trials of monotherapy in treatment-naive 
      patients and in 3 trials of add-on therapy to metformin, glyburide, or a 
      thiazolidinedione; initial combination therapy with saxagliptin 5 mg plus 
      metformin was compared with metformin monotherapy in treatment-naive patients. 
      Data from the monotherapy and add-on studies were pooled; data from the initial 
      combination study were analyzed separately. No statistical analyses of 
      between-group comparisons across studies were conducted for these safety analyses 
      because of multiplicity of end points and relative lack of statistical power and 
      because small differences not reaching statistical significance have the 
      potential to be clinically relevant.   RESULTS: In the pooled analysis, incidence 
      rates for adverse events (AEs) with saxagliptin 2.5 mg, 5 mg, and placebo were 
      72.0% (635/882), 72.2% (637/882), and 70.6% (564/799), respectively; rates for 
      serious AEs (SAEs) were 3.5% (31/882), 3.4% (30/882), and 3.4% (27/799); rates of 
      discontinuation due to AEs were 2.2% (19/882), 3.3% (29/882), and 1.8% (14/799). 
      AEs reported in >/= 2% of patients receiving saxagliptin and occurring >/= 1% more 
      frequently with saxagliptin than with placebo were sinusitis, gastroenteritis, 
      abdominal pain, and vomiting. In the initial combination study, AE incidence 
      rates with saxagliptin 5 mg plus metformin and metformin monotherapy were 55.3% 
      (177/320) and 58.5% (192/328), respectively; incidence rates for SAEs were 2.5% 
      (8/320) and 2.4% (8/328); and rates of discontinuation due to AEs were 2.5% 
      (8/320) and 3.4% (11/328).  CONCLUSION: Saxagliptin 2.5 mg or 5 mg was generally 
      well tolerated as monotherapy, add-on combination therapy with other oral 
      antihyperglycemic drugs, and initial combination with metformin.  
FAU - Davidson, Jaime A
AU  - Davidson JA
AD  - The University of Texas Southwestern Medical Center, 323 Harry Hines Blvd., 
      K5.246, Dallas, TX 75390-4854, USA. jaime.davidson@UTSouthwestern.edu.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - United States
TA  - J Manag Care Pharm
JT  - Journal of managed care pharmacy : JMCP
JID - 9605854
RN  - 0 (Dipeptides)
RN  - 0 (Hypoglycemic Agents)
RN  - 9GB927LAJW (saxagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacology
MH  - Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptides/administration & dosage/*adverse effects/pharmacology
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC10437547
EDAT- 2014/01/25 06:00
MHDA- 2014/09/23 06:00
PMCR- 2014/02/01
CRDT- 2014/01/25 06:00
PHST- 2014/01/25 06:00 [entrez]
PHST- 2014/01/25 06:00 [pubmed]
PHST- 2014/09/23 06:00 [medline]
PHST- 2014/02/01 00:00 [pmc-release]
AID - 2014(20)2: 120-129 [pii]
AID - 10.18553/jmcp.2014.20.2.120 [doi]
PST - ppublish
SO  - J Manag Care Pharm. 2014 Feb;20(2):120-9. doi: 10.18553/jmcp.2014.20.2.120.