RESUMO
Context: Collaborative care models for depression have been successful in a variety of settings, but their success may differ by patient engagement. We conducted a post-hoc analysis of the INDEPENDENT trial to investigate the role of differential engagement of participants on health outcomes over 3 years. Settings and Design: INDEPENDENT study was a parallel, single-blinded, randomised clinical trial conducted at four socio-economically diverse clinics in India. Participants were randomised to receive either active collaborative care or usual care for 12 months and followed up for 24 months. Method: We grouped intervention participants by engagement, defined as moderate (≤7 visits) or high, (8 or more visits) and compared them with usual care participants. Improvements in composite measure (depressive symptoms and at least one of three cardio-metabolic) were the primary outcome. Statistical Analysis: Mean levels of depression and cardio-metabolic measures were analysed over time using computer package IBM SPSS Statistics 25. Results: The composite outcome was sustained the highest in the moderate engagers [27.5%, 95% confidence interval (CI): 19.5, 36.7] and the lowest in high engagers (15.8%, 95% CI: 8.1, 26.8). This pattern was observed for individual parameters - depressive symptoms and glycosylated haemoglobin. Progressive reductions in mean depressive symptom scores were observed for moderate engagers and usual care group from baseline to 36 months. However, in high engagers of collaborative care, mean depressive symptoms were higher at 36 months compared to 12 months. Conclusion: Sustained benefits of collaborative care were larger in participants with moderate engagement compared with high engagement, although a majority of participants relapsed on one or more outcome measures by 36 months. High engagers of collaborative care for co-morbid depression and diabetes may need light touch interventions for longer periods to maintain health and reduce depressive symptoms.
RESUMO
BACKGROUND AND OBJECTIVES: Thiazolidinediones (pioglitazone and rosiglitazone) induce renal epithelial sodium channel (ENaC)-mediated sodium reabsorption, resulting in plasma volume (PV) expansion. Incidence and long-term management of fluid retention induced by thiazolidinediones remain unclear. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In a 4-week run-in period, rosiglitazone, 4 mg twice daily, was added to a background anti-diabetic therapy in 260 South Indian patients with type 2 diabetes mellitus. Patients with PV expansion (absolute reduction in hematocrit in run-in, ≥1.5 percentage points) entered a randomized, placebo-controlled study to evaluate effects of amiloride and spironolactone on attenuating rosiglitazone-induced fluid retention. Primary endpoint was change in hematocrit in each diuretic group versus placebo (control group). RESULTS: Of the 260 patients, 70% (n=180) had PV expansion. These 180 patients (70% male; mean age, 47.8 years [range, 30-80 years]) were randomly assigned to rosiglitazone, 4 mg twice daily, plus spironolactone, 50 mg once daily; rosiglitazone, 4 mg twice daily, plus amiloride, 10 mg once daily; or rosiglitazone, 4 mg twice daily, plus placebo for 24 weeks. Hematocrit continued to decrease significantly in control and spironolactone groups (mean absolute change, -1.2 [P=0.01] and -0.7 [P=0.02] percentage points, respectively), suggesting continued PV expansion. No change occurred with amiloride (mean change, 0.0 percentage points). Amiloride, but not spironolactone, was superior to control (mean hematocrit difference [95% confidence interval] relative to control, 1.27 [0.21-2.55] and 0.49 [-0.79-1.77] percentage points [P=0.04 and P=0.61], respectively). CONCLUSIONS: Prevalence of rosiglitazone-induced fluid retention in South Indian patients with type 2 diabetes is high. Amiloride, a direct ENaC blocker, but not spironolactone, prevented protracted fluid retention in these patients.