Background Diacerein is widely used in osteoarthritis (OA) management. Low risk of serious complications is considered to be one of its' major advantages. However, despite high acceptance of the medication, there were no large scale studies of diacerein safety in Russia.
Objectives To assess the incidence of adverse drug reactions (ADRs) in pts taking diacerein (Diaflex®, Romfarm) in real clinical practice
Methods 3479 (60.4% females and 39.6% males, mean age 57.6±12.6 y.) pts with OA or non-specific low back pain (LBP) taking diacerein were analyzed. Diacerein was administered at 100 mg/day, treatment outcomes were evaluated after 30 days of therapy. Apart from diacerein patients were also taking other drugs, including NSAIDs (62.6%), muscle relaxants, local glucocorticoid injections, slow-acting symptom-modifying drugs, and oths. Efficacy of the drug (VAS pain intensity dynamic and satisfaction with therapy), as well as incidence and type of ADRs were assessed.
Results The combined therapy including diacerein turned to be effective in the majority of pts: pain intensity decreased from 71.2±17.5 to 22.6±16.3 mm (VAS), pts were satisfied with 76% giving “excellent” or “good” mark to the treatment. Most common ADRs were associated with GI tract, i.e. approx 10% mentioned dyspepsia symptoms. Majority of pts stated more frequent stools with 5.91±1.9 bowel movements per week at baseline increasing to 7.3±2.8 bowel movements per week after 30 days of diacerein intake (p<0.001). Significant diarrhea developed only in 30 pts (0.86%). Clinically significant increase (>2-fold above the upper reference value) of ALT/AST levels was found in 20 pts (0.57%).
Conclusions The combined therapy including diacerein provides effective pain control in OA and LBP. Diacerein is well tolerated and is rarely associated with serious ADRs. Significant diarrhea and ALT/AST increase were registered in less than 1% of pts, taking diacerein for 30 days.
Disclosure of Interest None declared