Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

Aman Goyal, Harmanjit Singh, Vijay Kumar Sehgal, C. R. Jayanthi, Renuka Munshi, K. Laxminarayana Bairy, Rakesh Kumar, Sandeep Kaushal, Ashish Kumar Kakkar, Sneha Ambwani, Chhaya Goyal, Goutameswar Mazumdar, Anjan Adhikari, Nina Das, Divya John Stephy, Pugazhenthan Thangaraju, D. C. Dhasmana, Shakil U. Rehman, Amit Chakrabarti, Basavaraj BhandareDinesh Kumar Badyal, Inderpal Kaur, K. Chandrashekar, Jagjit Singh, Puneet Dhamija, Sudhir Chandra Sarangi, Yogendra Kumar Gupta

Research output: Contribution to journalArticle

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Abstract

Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis. Results: Four hundred and sixteen (56.2%) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3%) were aware of recent regulatory events. However, only 333 (44.8%) changed their prescribing pattern. Seventeen of the 416 (4.1%) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM. Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

Original languageEnglish
Pages (from-to)468-475
Number of pages8
JournalIndian Journal of Medical Research
Volume146
Issue numberOctober
DOIs
Publication statusPublished - 01-10-2017
Externally publishedYes

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pioglitazone
Prescription Drugs
Hypoglycemic Agents
Observational Studies
India
Physicians
Medical problems
Type 2 Diabetes Mellitus
Urinary Bladder
Carcinoma
Pharmacovigilance
Surveys and Questionnaires
Pharmaceutical Preparations
Sales

All Science Journal Classification (ASJC) codes

  • Biochemistry, Genetics and Molecular Biology(all)

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Goyal, Aman ; Singh, Harmanjit ; Sehgal, Vijay Kumar ; Jayanthi, C. R. ; Munshi, Renuka ; Bairy, K. Laxminarayana ; Kumar, Rakesh ; Kaushal, Sandeep ; Kakkar, Ashish Kumar ; Ambwani, Sneha ; Goyal, Chhaya ; Mazumdar, Goutameswar ; Adhikari, Anjan ; Das, Nina ; Stephy, Divya John ; Thangaraju, Pugazhenthan ; Dhasmana, D. C. ; Rehman, Shakil U. ; Chakrabarti, Amit ; Bhandare, Basavaraj ; Badyal, Dinesh Kumar ; Kaur, Inderpal ; Chandrashekar, K. ; Singh, Jagjit ; Dhamija, Puneet ; Sarangi, Sudhir Chandra ; Gupta, Yogendra Kumar. / Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India : A multicentre questionnaire-based observational study. In: Indian Journal of Medical Research. 2017 ; Vol. 146, No. October. pp. 468-475.
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abstract = "Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis. Results: Four hundred and sixteen (56.2{\%}) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3{\%}) were aware of recent regulatory events. However, only 333 (44.8{\%}) changed their prescribing pattern. Seventeen of the 416 (4.1{\%}) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM. Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.",
author = "Aman Goyal and Harmanjit Singh and Sehgal, {Vijay Kumar} and Jayanthi, {C. R.} and Renuka Munshi and Bairy, {K. Laxminarayana} and Rakesh Kumar and Sandeep Kaushal and Kakkar, {Ashish Kumar} and Sneha Ambwani and Chhaya Goyal and Goutameswar Mazumdar and Anjan Adhikari and Nina Das and Stephy, {Divya John} and Pugazhenthan Thangaraju and Dhasmana, {D. C.} and Rehman, {Shakil U.} and Amit Chakrabarti and Basavaraj Bhandare and Badyal, {Dinesh Kumar} and Inderpal Kaur and K. Chandrashekar and Jagjit Singh and Puneet Dhamija and Sarangi, {Sudhir Chandra} and Gupta, {Yogendra Kumar}",
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Goyal, A, Singh, H, Sehgal, VK, Jayanthi, CR, Munshi, R, Bairy, KL, Kumar, R, Kaushal, S, Kakkar, AK, Ambwani, S, Goyal, C, Mazumdar, G, Adhikari, A, Das, N, Stephy, DJ, Thangaraju, P, Dhasmana, DC, Rehman, SU, Chakrabarti, A, Bhandare, B, Badyal, DK, Kaur, I, Chandrashekar, K, Singh, J, Dhamija, P, Sarangi, SC & Gupta, YK 2017, 'Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study', Indian Journal of Medical Research, vol. 146, no. October, pp. 468-475. https://doi.org/10.4103/ijmr.IJMR_1416_15

Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India : A multicentre questionnaire-based observational study. / Goyal, Aman; Singh, Harmanjit; Sehgal, Vijay Kumar; Jayanthi, C. R.; Munshi, Renuka; Bairy, K. Laxminarayana; Kumar, Rakesh; Kaushal, Sandeep; Kakkar, Ashish Kumar; Ambwani, Sneha; Goyal, Chhaya; Mazumdar, Goutameswar; Adhikari, Anjan; Das, Nina; Stephy, Divya John; Thangaraju, Pugazhenthan; Dhasmana, D. C.; Rehman, Shakil U.; Chakrabarti, Amit; Bhandare, Basavaraj; Badyal, Dinesh Kumar; Kaur, Inderpal; Chandrashekar, K.; Singh, Jagjit; Dhamija, Puneet; Sarangi, Sudhir Chandra; Gupta, Yogendra Kumar.

In: Indian Journal of Medical Research, Vol. 146, No. October, 01.10.2017, p. 468-475.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India

T2 - A multicentre questionnaire-based observational study

AU - Goyal, Aman

AU - Singh, Harmanjit

AU - Sehgal, Vijay Kumar

AU - Jayanthi, C. R.

AU - Munshi, Renuka

AU - Bairy, K. Laxminarayana

AU - Kumar, Rakesh

AU - Kaushal, Sandeep

AU - Kakkar, Ashish Kumar

AU - Ambwani, Sneha

AU - Goyal, Chhaya

AU - Mazumdar, Goutameswar

AU - Adhikari, Anjan

AU - Das, Nina

AU - Stephy, Divya John

AU - Thangaraju, Pugazhenthan

AU - Dhasmana, D. C.

AU - Rehman, Shakil U.

AU - Chakrabarti, Amit

AU - Bhandare, Basavaraj

AU - Badyal, Dinesh Kumar

AU - Kaur, Inderpal

AU - Chandrashekar, K.

AU - Singh, Jagjit

AU - Dhamija, Puneet

AU - Sarangi, Sudhir Chandra

AU - Gupta, Yogendra Kumar

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis. Results: Four hundred and sixteen (56.2%) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3%) were aware of recent regulatory events. However, only 333 (44.8%) changed their prescribing pattern. Seventeen of the 416 (4.1%) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM. Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

AB - Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis. Results: Four hundred and sixteen (56.2%) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3%) were aware of recent regulatory events. However, only 333 (44.8%) changed their prescribing pattern. Seventeen of the 416 (4.1%) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM. Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

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