PMID- 30049306
OWN - NLM
STAT- MEDLINE
DCOM- 20190503
LR  - 20190503
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 56
IP  - 9
DP  - 2018 Sep
TI  - Differences in baseline characteristics between type 2 diabetes mellitus patients 
      treated with dipeptidyl peptidase-4 inhibitors in randomized controlled trials 
      and those receiving the same treatment in real-world settings
.
PG  - 411-416
LID - 10.5414/CP203285 [doi]
AB  - AIMS: The goal was to analyze differences between the baseline characteristics of 
      type 2 diabetes mellitus (T2DM) patients treated with dipeptidyl peptidase-4 
      (DPP-4) inhibitors in three randomized clinical trials (RCTs) and those receiving 
      the same treatment in a German real-world setting. MATERIALS AND METHODS: Details 
      of the baseline characteristics of subjects with T2DM from three RCTs focusing on 
      DPP-4 inhibitors were obtained. The present study also included T2DM patients 
      receiving prescriptions for DPP-4 inhibitors who were followed between April 2007 
      and December 2016 in 1,246 general and diabetologist practices in Germany. Three 
      different DPP-4 inhibitors were considered in the subsequent statistical 
      analyses: sitagliptin, vildagliptin, and saxagliptin. The first outcome was the 
      difference in baseline characteristics between patients in RCTs and those 
      included in the real-world study for the three drugs. The second outcome was the 
      proportion of real-world patients who met exclusion criteria and who could not 
      have been included in RCTs. RESULTS: Patients being prescribed DPP-4 inhibitors 
      were younger in RCTs than in the real-world setting. RCT participants receiving 
      sitagliptin were also more likely to be men than the patients from the real-world 
      study, whereas the opposite was observed for vildagliptin and saxagliptin. The 
      share of real-world patients who met the exclusion criteria ranged from 20.7% for 
      vildagliptin to 38.1% for sitagliptin. In the case of the proportion of people 
      potentially not included in RCTs, figures ranged from 61.9% for sitagliptin to 
      79.3% for vildagliptin. CONCLUSION: Real-world studies should be included in the 
      evaluation of new drugs in the future.
.
FAU - Kostev, Karel
AU  - Kostev K
FAU - Schokker, Emile
AU  - Schokker E
FAU - Jacob, Louis
AU  - Jacob L
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptides)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 9GB927LAJW (saxagliptin)
RN  - EC 3.4.14.5 (DPP4 protein, human)
RN  - EC 3.4.14.5 (Dipeptidyl Peptidase 4)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adamantane/*analogs & derivatives/therapeutic use
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Biomarkers/blood
MH  - Blood Glucose/*drug effects/metabolism
MH  - Clinical Decision-Making
MH  - Databases, Factual
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/enzymology
MH  - Dipeptides/*therapeutic use
MH  - Dipeptidyl Peptidase 4/*metabolism
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Selection
MH  - Practice Patterns, Physicians'
MH  - Randomized Controlled Trials as Topic
MH  - Sex Factors
MH  - Sitagliptin Phosphate/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vildagliptin/*therapeutic use
EDAT- 2018/07/28 06:00
MHDA- 2019/05/06 06:00
CRDT- 2018/07/28 06:00
PHST- 2018/09/03 00:00 [accepted]
PHST- 2018/07/28 06:00 [pubmed]
PHST- 2019/05/06 06:00 [medline]
PHST- 2018/07/28 06:00 [entrez]
AID - 17348 [pii]
AID - 10.5414/CP203285 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2018 Sep;56(9):411-416. doi: 10.5414/CP203285.