Bladder cancer with pioglitazone: A case-control study.

BACKGROUND: Varied reports suggest a contentious relationship of bladder malignancy with pioglitazone in patients with type 2 diabetes. AIM: To study an association (prevalence and predictors) of bladder malignancy with pioglitazone therapy in Asian-Indian type 2 diabetes patients. METHOD: In this observational multicenter study, type 2 diabetic patients attending out-patient diabetes-clinic were evaluated. A detailed history of anti-diabetic medication, dose, duration, pioglitazone usage, time since initiation of pioglitazone, physical examination, biochemical tests and details pertaining to prevalent neuropathy, retinopathy and nephropathy were recorded. Details of bladder cancer or any malignancy (if present), time since diagnosis, risk factors for bladder cancer and histopathology records were noted. The study cohort was divided into two groups-pioglitazone ever users (Group A) and never users (Group B). RESULTS: A total of 8000 patients were screened out of which 1560 were excluded. Among 6440 included patients, 1056 (16.3%) patients were in group A and 5384 (83.6%) group B. Patients on pioglitazone were older (59.1 vs 57.7 years, p < 0.001), had longer duration of diabetes (12.7 vs 10.6 years, p < 0.001) with poor glycemic control (HbA1c 8.5 vs 8.3%, p < 0.01). A total of 74 patients had prevalent bladder cancer [16 (1.5%) in Group A and 58 in Group B (1.0%)]. Prevalent bladder cancer was not significantly greater in ever-users (odds ratio OR = 1.29, 95% confidence interval CI, 0.83-2.00) compared to never-users (odds ratio OR = 0.94, 95% confidence interval CI, 0.834-1.061) of pioglitazone (p = 0.207). However, history of hematuria in pioglitazone-users; while older age (>58 year), history of smoking and hematuria in the whole cohort were significant associated with bladder cancer. In the entire study cohort, 254 patients; 3.5% of males (128 out of 3575) and 4.6% of females (126 out of 2713) developed any malignancy. Age was significantly associated with prevalent malignancy in people with diabetes (odds ratio OR 1.036, 95% confidence interval CI: 1.022-1.051, p = 0.00) on multivariate forward regression. CONCLUSION: Pioglitazone use in Asian-Indians is not associated with an increased bladder cancer risk. However, pioglitazone should be restricted in individuals with history of hematuria. Age more than 58 years is a significant risk factor for development of any malignancy, particularly bladder cancer.

Virtual triage and outcomes of diabetic foot complications during Covid-19 pandemic: A retro-prospective, observational cohort study.

AIMS: Limb and patient outcomes in people with diabetic foot complications including diabetic foot ulcer (DFU) provided virtual triage and personalized video consultations during COVID-19 pandemic are not known. METHODS: Patients with foot complications attending the diabetic foot clinic prior to lockdown who sought teleconsultations during COVID-19 lockdown underwent virtual triage to include clinical history, visual inspection of feet, domiciliary wound care (community nurse assisted dressings) and offloading instructions. The subsequent ulcer, limb and mortality outcomes during the following 24 weeks of COVID-19 lockdown (April-September 2020, group 1) were assessed and compared with those who attended foot clinic during the same period in 2019 (April-September, group 2). RESULTS: Group 1 included 561 participants with foot complications provided with teleconsultations, median age 57 (51 to 63) years and diabetes duration of 10 (5 to 16) years. Twelve patients with severe DFU were excluded and 549 patients [357 (65%) neuropathic foot, 104 (18.9%) ischemic foot and 88 (16%) chronic Charcot foot with deformities] were evaluated. There were 227 (41.3%) participants with active DFU at start of lockdown, 32 (5.8%) with new onset ulcer during lockdown (47.1%) and 290 patients without ulcers. Group 2 included 650 participants; active foot ulcer was present in 366 patients. Wound closed or reduced in area in 78.4% of participants of group 1 compared to 76.0% (p = 0.318) in group 2. Fourteen (5.4%) patients required amputations [3 major and 11 minor] in group 1 during the study period compared to 6.8% in group 2 (p = 0.191). Twenty-one (3.8%) and 28 (4.3%) patients died (p = 0.532) during 24 weeks of follow up in group 1 and 2, respectively. CONCLUSIONS: Targeted foot-care service through virtual triage and teleconsultations during COVID-19 pandemic for people with foot complications have similar ulcer and limb outcomes compared to face-to-face foot care delivery.

Improved glycemic control amongst people with long-standing diabetes during COVID-19 lockdown: a prospective, observational, nested cohort study.

Background and aims: COVID-19 is likely to affect the lives of individuals with type 2 diabetes. However, the effect of COVID-19 lockdown on physical activity and glycemic control in such individuals is not known. We studied the physical activity and glycemic control during lockdown in comparison to pre-lockdown parameters in individuals with long-standing type 2 diabetes. Methods: This prospective, observational study includes 2240 people with T2DM regularly attending diabetes clinic prior to lockdown. Glycemic record, HbA1c, and physical activity assessed with Global Physical Activity Questionnaire (GPAQ) as metabolic equivalents (MetS min/week) were obtained during lockdown (minimum duration of 3 months). Results: A total of 422 out of 750 participants (nest) responded. The median (IQR) for age was 58 (52 to 64) years, duration of diabetes 11 (6 to 16) years, prevalent foot complications in 59.7%, and atherosclerotic cardiovascular disease in 21.3% of participants. There was a decrease in HbA1c from 7.8% (6.9 to 9.4) prior lockdown to 7.4% (6.6 to8.7) during lockdown [ΔHbA1c - 0.41 ± 0.27% (p = 0.005)] and postprandial blood glucose 200.0 mg/dl (152.0 to 252.0) to 158.0 (140.0 to 200.0) mg/dl (p < 0.001). The physical activity increased during lockdown from a GPAQ score 140 (0.0 to 1260) MetS to 840 (0.0 to 1680) MetS (p = 0.014). The improvement of glycemic control was observed in either gender and independent of the presence of foot complications or increase in physical activity. Conclusions: There is an overall improvement of glycemic control during COVID-19 lockdown independent of increase in physical activity in people with long duration of diabetes.