PMID- 23961491
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130820
LR  - 20211021
IS  - 2230-8210 (Print)
IS  - 2230-9500 (Electronic)
IS  - 2230-9500 (Linking)
VI  - 17
IP  - 4
DP  - 2013 Jul
TI  - Efficacy and safety of pioglitazone in type 2 diabetes in the Indian patients: 
      Results of an observational study.
PG  - 709-15
LID - 10.4103/2230-8210.113766 [doi]
AB  - OBJECTIVE: This study was undertaken to assess the efficacy and safetyof 
      pioglitazone in combination with other oral antidiabetics (OADs) in Indian 
      patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This was an 
      openlabel, prospective, no-randomized, single-center observational study 
      conducted at a single center in India. A total of 958 adult patients with T2DM on 
      OADs, with uncontrolled fasting (FBG) or postprandial blood glucose (PPG), were 
      enrolled. Pioglitazone (7.5/15/30 mg) was added to existing therapy as a 
      combination treatment with other OAD. Body weight (BW), body mass index (BMI), 
      FBG and postprandial plasma glucose (PPPG) and glycosylated hemoglobin (HbA1c) 
      were measured at the beginning (week 0) and at every follow-up treatment visit, 
      i.e., 6 months (week 24), 1 year (week 48) and 2 years (week 96). Changes from 
      baseline to each visit were analyzed using the Wilcoxon test. All patients also 
      went through a urinalysis at baseline, and after 6 months, 1 year and 2 years of 
      treatment, to assess for any abnormalities in the urine (pH, pus or protein), 
      suggestive of bladder abnormalities. RESULTS: The combined analysis was carried 
      out on 958 completed patients in this study who were treated with pioglitazone 
      7.5 mg, 15 mg and 30 mg tablet and other OADs. The difference in mean value of 
      FBG showed a highly significant decrease (P < 0.0001) from baseline to end of 
      treatment, i.e., from 167.0, (59.16) 172.6 (58.51) and 171.0 (39.47) to 140.2, 
      (26.46) 143.8 (22.04) and 138.5 (27.82) mg/dL. Similarly, PPG showed a 
      significant (P < 0.0001, 0.002 and 0.008) decrease from baseline to end of the 
      treatment, i.e., from 256.0, (61.79) 222.9 (67.88) and 223.6 (69.11) to 195.9, 
      (46.92) 204.0 (48.03) and 187.6 (53.36) mg/dL, and there was a highly significant 
      (P < 0.0001) decrease in HbA1c levels, i.e., from 8.46, 8.34 and 8.42% to 7.781, 
      7.78 and 7.73%, respectively. However, gain in mean BW was also observed from 
      baseline to end of the treatment, i.e., from 69.90, (9.44) 68.29 (8.62) and 67.64 
      (7.75) kg to 71.69, (8.35) 70.08 (7.96) and 69.70 (7.99) kg, respectively, and 
      BMI increased from 26.74 (14.18-53.04) kg/m(2) at baseline to 27.45 (12.87-53.73) 
      kg/m(2) at the end of the treatment, respectively (P < 0.0001). No significant 
      changes were found in urine in patients even after 2 years of treatment with 
      pioglitazone. There was little variation in pH or presence of pus and proteins in 
      the urine, indicating no increased risk of bladder-related abnormalities across 
      all treated age groups even after 2 years of treatment with pioglitazone. 
      CONCLUSION: Pioglitazone in combination with other OADs in Indian patients was an 
      effective treatment protocol in glycemic control, reduction in FBG, PPPG and 
      HbA1c and also helps in controlling weight gain in patients with T2DM. In this 
      patient population, there was no increased risk of bladder-related abnormalities. 
      Pioglitazone was therefore found to be a safe and efficacious addition to 
      treatment in patients with poorly controlled diabetes.
FAU - Balaji, Vijayam
AU  - Balaji V
AD  - Director and Senior Consultant Diabetologist, Dr. Balaji Diabetes Care Centre 
      and, Dr. V. Seshiah Diabetes Research Institute, Aminjikarai, Chennai, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Endocrinol Metab
JT  - Indian journal of endocrinology and metabolism
JID - 101555690
PMC - PMC3743375
OTO - NOTNLM
OT  - Indian patients
OT  - Pioglitazone
OT  - oral antidiabetics
OT  - type 2 diabetes
COIS- Conflict of Interest: None declared
EDAT- 2013/08/21 06:00
MHDA- 2013/08/21 06:01
PMCR- 2013/07/01
CRDT- 2013/08/21 06:00
PHST- 2013/08/21 06:00 [entrez]
PHST- 2013/08/21 06:00 [pubmed]
PHST- 2013/08/21 06:01 [medline]
PHST- 2013/07/01 00:00 [pmc-release]
AID - IJEM-17-709 [pii]
AID - 10.4103/2230-8210.113766 [doi]
PST - ppublish
SO  - Indian J Endocrinol Metab. 2013 Jul;17(4):709-15. doi: 10.4103/2230-8210.113766.