The efficacy and safety of diacerein in the treatment of painful osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled study with primary end points at two months after the end of a three-month treatment period
Status odvoláno Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem, odvolaná publikace
PubMed
18050202
DOI
10.1002/art.23056
Knihovny.cz E-zdroje
- MeSH
- anthrachinony škodlivé účinky terapeutické užití MeSH
- antiflogistika škodlivé účinky terapeutické užití MeSH
- artróza kolenních kloubů farmakoterapie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- lidé středního věku MeSH
- lidé MeSH
- měření bolesti MeSH
- následné studie MeSH
- senioři MeSH
- stanovení cílového parametru MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- odvolaná publikace MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- anthrachinony MeSH
- antiflogistika MeSH
- diacerein MeSH Prohlížeč
OBJECTIVE: To determine whether the efficacy of diacerein persists at 2 months after the end of a 3-month treatment period, compared with placebo, in patients with painful knee osteoarthritis (OA). METHODS: After a 1-week nonsteroidal antiinflammatory drug washout period, patients received either diacerein or placebo for 3 months, followed by an off-treatment period of 3 months to determine the carryover effects of the drug. Although patients were followed up through month 6, the primary efficacy end point was the percent change from baseline in pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A) at month 5 (i.e., 2 months after the end of treatment) compared with placebo. The co-primary efficacy end point was the percent change from baseline in the total WOMAC score, also at month 5 versus placebo. RESULTS: Two hundred three patients were screened, and 168 patients with painful knee OA were randomized. One hundred sixty-five patients were analyzed in an intent-to-treat analysis. At month 5, diacerein showed statistically significant superiority versus placebo as assessed with both the WOMAC A (P < 0.0001) and the total WOMAC (P < 0.0001), demonstrating the carryover effect of the drug. This superiority was already evident from month 2 for pain (P = 0.001) and month 1 for total WOMAC (P = 0.0021). Diacerein was safe and well tolerated. No serious or previously undocumented adverse events were observed during the study. CONCLUSION: This is the first published study of a symptomatic slow-acting OA drug in which the time of assessment of the primary outcome end points was 2 months after the end of a 3-month treatment period. The results show that diacerein is safe and effective for the treatment of knee OA and has a long carryover effect.
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