Efficacy of diacerein in reducing liver steatosis and fibrosis in patients with type 2 diabetes and non-alcoholic fatty liver disease: A randomized, placebo-controlled trial.

The aim was to assess, in a randomized, double-blinded, placebo-controlled trial, the efficacy of diacerein, an anti-inflammatory drug, in improving liver fibrosis and steatosis in patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Sixty-nine diabetic patients with NAFLD were randomized to 24-month treatment with placebo (35 patients) or diacerein 100 mg/day (34 patients). Liver stiffness and steatosis were assessed by transient elastography (Fibroscan®) at baseline, and 12 and 24 months of follow-up. The primary outcome was the difference in mean liver stiffness and steatosis changes during treatment. Adjusted differences in mean changes on intention-to-treat analyses were estimated by generalized repeated-measures mixed-effects regressions. Diacerein significantly reduced liver stiffness in contrast to placebo by 1.6 kPa (95% CI: -2.6 to -0.5 kPa; p = 0.003), whereas no significant difference in mean changes in liver steatosis was observed. The reduction in liver stiffness was already evident at the 12-month examination, and accentuated at the 24-month examination. Eight patients reduced liver fibrosis stage during treatment, seven of whom were in the diacerein group (p = 0.020). In conclusion, a 2-year treatment with diacerein significantly reduced liver fibrosis in diabetic patients with NAFLD.

Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial.

OBJECTIVE: To assess, in a randomized, double-blind, and placebo-controlled trial, the efficacy and safety of diacerein, an immune modulator anti-inflammatory drug, in improving glycemic control of patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Eighty-four patients with HbA1c between 7.5 and 9.5% (58-80 mmol/mol) were randomized to 48-week treatment with placebo (n = 41) or diacerein 100 mg/day (n = 43). The primary outcome was the difference in mean HbA1c changes during treatment. Secondary outcomes were other efficacy and safety measurements. A general linear regression with repeated measures, adjusted for age, sex, diabetes duration, and each baseline value, was used to estimate differences in mean changes. Both intention-to-treat (ITT) analysis and per-protocol analysis (excluding 10 patients who interrupted treatment) were performed. RESULTS: Diacerein reduced HbA1c compared with placebo by 0.35% (3.8 mmol/mol; P = 0.038) in the ITT analysis and by 0.41% (4.5 mmol/mol; P = 0.023) in the per-protocol analysis. The peak of effect occurred at the 24th week of treatment (-0.61% [6.7 mmol/mol; P = 0.014] and -0.78% [8.5 mmol/mol; P = 0.005], respectively), but it attenuated toward nonsignificant differences at the 48th week. No significant effect of diacerein was observed in other efficacy and safety measures. Diarrhea occurred in 65% of patients receiving diacerein and caused treatment interruption in 16%. Seven patients in the diacerein group reduced insulin dosage, whereas 10 in the placebo group increased it; however, mild hypoglycemic events were equally observed. CONCLUSIONS: Diacerein reduced mean HbA1c levels, with peak of effect at the 24th week of treatment. The drug was well tolerated and may be indicated as adjunct treatment in patients with type 2 diabetes, particularly in those with osteoarthritis.

Is home blood pressure monitoring useful in the management of patients with resistant hypertension?

BACKGROUND: Ambulatory blood pressure (BP) monitoring (ABPM) is a cornerstone in resistant hypertension (RHT) management. However, it has higher cost and lower patients' acceptance than home BP monitoring (HBPM). Our objective was to evaluate HBPM usefulness in the management of patients with RHT. METHODS: A total of 240 patients were submitted to 24-hour ABPM and 5-day HBPM (triplicate morning and evening measurements). Patients with uncontrolled office BP (≥140/90mm Hg) were classified as true RHT (daytime or home BP ≥135/85mm Hg) or white-coat RHT (daytime or home BP <135/85mm Hg), and patients with controlled office BP were classified as masked RHT (daytime or home BP ≥135/85mm Hg) or controlled RHT (daytime or home BP <135/85mm Hg). Sensitivity, specificity, predictive values, and likelihood ratios for HBPM were calculated. Agreement between the procedures was evaluated using kappa coefficients and the Bland-Altman method. RESULTS: Mean office BP was 157±26/84±16mm Hg, mean daytime BP was 134±18/77±13mm Hg, and mean home BP was 143±20/76±14mm Hg. The ABPM and HBPM diagnoses were 35% and 48%, respectively, for true RHT; 36% and 23%, respectively, for white-coat RHT; 7% and 17%, respectively, for masked RHT; and 22% and 13%, respectively, for controlled RHT. HBPM overestimated systolic BP by 8.8 (95% confidence interval (CI) = 6.8-10.7) mm Hg and diastolic BP by 0.2 (95% CI = -1.0 to 1.4) mm Hg. The specificity, sensitivity, and positive and negative predictive values of HBPM in detecting controlled ambulatory BP were 91%, 55%, 89%, and 59%. CONCLUSIONS: HBPM presented good agreement with ABPM and can be used as a complementary method in the follow-up of resistant hypertensive patients, particularly in those with controlled ambulatory BPs.