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LETTER TO EDITOR
Year : 2019  |  Volume : 10  |  Issue : 2  |  Page : 87-88

Effect of sudden ban of pioglitazone on glycaemic control of type 2 diabetes mellitus patients in a tertiary care hospital in South India


1 Department of Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore, Karnataka, India
2 Department of Medicine, Yenapoya Medical College, Yenepoya Deemed to be University, Mangalore, Karnataka, India
3 Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore, Karnataka, India

Date of Web Publication26-Apr-2019

Correspondence Address:
Dr. Sheetal Vasundara Mathai
Department of Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jod.jod_10_18

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How to cite this article:
Mathai SV, Adhikari PM, Kotian SM. Effect of sudden ban of pioglitazone on glycaemic control of type 2 diabetes mellitus patients in a tertiary care hospital in South India. J Diabetol 2019;10:87-8

How to cite this URL:
Mathai SV, Adhikari PM, Kotian SM. Effect of sudden ban of pioglitazone on glycaemic control of type 2 diabetes mellitus patients in a tertiary care hospital in South India. J Diabetol [serial online] 2019 [cited 2019 May 19];10:87-8. Available from: http://www.journalofdiabetology.org/text.asp?2019/10/2/87/257202



Reports on the incidence of bladder cancer led to a ban being imposed on the use of pioglitazone in the treatment of Type 2 diabetes mellitus (T2DM) in India on 18 June, 2013 which was revoked on 31 July, within 1.5 months of its imposition. However, drug sales did not begin for another 2 months and the use of pioglitazone therapy for 2–12 months. This retrospective study, carried out in a tertiary care hospital attached to a medical college at Mangalore, Karnataka, assesses the effect of the ban of pioglitazone, the alternative drugs introduced in its place and the reinstitution of the drug after the ban had been lifted, on the glycaemic control of T2DM by comparing various glycaemic parameters such as glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG) and physical parameters such as weight, body mass index and blood pressure. Data were analysed using statistical software Stastical Package for the Social Sciences version 11.5. P < 0.05 was considered statistically significant.

A total of 32 cases (14 (43.8) men; 18 (56.3) women) were studied. The mean age (years) was 62.50 ± 8.64 and mean duration of T2DM, 10.97 ± 4.14. All the participants were on a baseline therapy of sulphonylurea and metformin of 1–1.5 g. The alternate therapies used during the ban were metformin or voglibose or DPP-4 inhibitors (25 (78.1)), insulin only (5 (15.6)) or a combination of both (2 (6.3)).

Values of HbA1c, FPG and PPPG were compared among the three groups [Table 1]. HbA1c and FPG values are significantly lesser in the group on pioglitazone therapy than in the group on alternative therapy (P = 0.009, 0.05, respectively). When the HbA1c levels were compared between patients on pioglitazone therapy (n = 10), alternate therapy (n = 9) and reinstitution of pioglitazone therapy (n = 5), the usage of pioglitazone seemed to reduce HbA1c as compared to other groups of drugs, but this needs to be confirmed in a larger sample size. Similar findings were reported in earlier studies where the effect of use of pioglitazone (as monotherapy or combination therapy) was compared to that of the effect of metformin and insulin-based therapies.[1],[2],[3] However, another study showed that both the groups were equal in efficacy.[4] This study did not show statistically significant results for the PPPG values and physical parameters. This is in contrast to findings in some other studies which showed the reduction of weight in the groups on metformin-based therapy by 2.5 kg and 1.7 kg, compared to groups of patients on pioglitazone therapy.[4],[5] The glycaemic control of the groups was assessed as follows:
Table 1: Glycosylated haemoglobin, fasting plasma glucose, postprandial plasma glucose values of the cases before onset of ban, with the use of alternative therapy and when (if) reinstitution of the drug was done

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  1. Good – HbA1c <7.5 and/or FPG <140 mg/dl and/or PPPG <200 mg/dl
  2. Average – HbA1c 7.5–9 and/or FPG 140–200 mg/dl and/or PPPG 200–300 mg/dl
  3. Poor – HbA1c >9 and/or FPG >200 mg/dl and/or PPPG >300 mg/dl.


It was seen that good glycaemic control was more in patients on pioglitazone therapy before onset of ban (59.4%) and on reinstitution of pioglitazone therapy following the period of ban compared to alternate therapy (P = 0.03). The limitations of this study were a small sample size. However, these results prove the usefulness of the drug in the control of T2DM. The small risk of bladder cancer and other side effects of pioglitazone should, however, be kept in mind while using this drug.

Financial support and sponsorship

This study was supported by the Manipal Academy of Higher Education UG Students Research Grant, 2015.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Rosenblatt S, Miskin B, Glazer NB, Prince MJ, Robertson KE; Pioglitazone 026 Study Group, et al. The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus. Coron Artery Dis 2001;12:413-23.  Back to cited text no. 1
    
2.
Mattoo V, Eckland D, Widel M, Duran S, Fajardo C, Strand J, et al. Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: Results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study. Clin Ther 2005;27:554-67.  Back to cited text no. 2
    
3.
Hirose H, Kawai T, Yamamoto Y, Taniyama M, Tomita M, Matsubara K, et al. Effects of pioglitazone on metabolic parameters, body fat distribution, and serum adiponectin levels in Japanese male patients with type 2 diabetes. Metabolism 2002;51:314-7.  Back to cited text no. 3
    
4.
Schernthaner G, Matthews DR, Charbonnel B, Hanefeld M, Brunetti P; Quartet [corrected] Study Group, et al. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: A double-blind, randomized trial. J Clin Endocrinol Metab 2004;89:6068-76.  Back to cited text no. 4
    
5.
Charbonnel B, Schernthaner G, Brunetti P, Matthews DR, Urquhart R, Tan MH, et al. Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes. Diabetologia 2005;48:1093-104.  Back to cited text no. 5
    



 
 
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