MARCIA A. TESTA, LINDA G. MARC, ALEXANDER TURCHIN, DONALD C. SIMONSON, Boston, MA

Impact of Subclinical Depression and Anxiety on Intensity and Frequency of Treatment-Related Side Effects and Symptoms. Author(s): MARCIA A. TESTA, LINDA MARC, ALEXANDER TURCHIN, DONALD C. SIMONSON, Boston, MA

Reaching glycemic treatment targets is hampered by emerging symptoms and side effects (SSE). While major depression and anxiety can exacerbate these adverse effects, subclinical psychiatric disease often goes unrecognized as a potential barrier to adherence. We analyzed associations between SSE distress and baseline levels of subclinical depression and anxiety using pooled data from 8 randomized clinical trials (2,927 patients, 413 clinics, 18 arms) including 12 regimens of insulin and oral agents (metformin, sulfonylureas, thiazolidinediones) alone or in combination during 24 – 52 wks. Socio-demographics and negative affect (anxiety, depression and loss of emotional and behavior control), SSE distress and incidence (54 symptom items of frequency and severity of distress) and other QOL outcomes (154 items) questionnaires were completed longitudinally. At baseline, patients were 22.6% T1D (53% male, age 32 ± 14 yrs, A1c 8.0 ± 1.0%), and 77.4% T2D (58% male, age 56 ± 10 yrs, A1c 9.2 ± 1.2%, BMI 31 ± 5 kg/m²). Greater baseline negative affect was correlated with higher baseline SSE distress (r = 0.51) and incidence (r = 0.53), and higher diabetes-specific symptom interference (r = 0.43), all p < 0.0001. When baseline negative affect was divided into quintiles, a strong logarithmically increasing relationship (R² = 0.98, p < 0.001) was observed between negative affect and SSE distress and incidence, with a percentile ordinal agreement gamma statistic of 0.47 (p < 0.001). In turn, reductions in SSE distress and incidence during treatment were predictive of lower endpoint A1c (p = 0.001) in addition to the probability of more patients achieving endpoint A1c < 8% (p = 0.031) and < 7% (p = 0.013). Patients with subclinical psychiatric disease are more susceptible to symptoms and side effects associated with diabetes treatments and should be screened accordingly to ensure that they receive appropriate attention during adjustments or changes in their therapeutic regimens.

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