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and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013).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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U2 - 10.4103/ijmr.IJMR_1416_15
DO - 10.4103/ijmr.IJMR_1416_15
M3 - Article
AN - SCOPUS:85042085395
SN - 0971-5916
VL - 146
SP - 468
EP - 475
JO - Indian Journal of Medical Research
JF - Indian Journal of Medical Research
IS - October
ER -
