Abstract
Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac, containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.Areas covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee. In this review article, we summarize safety data from these studies.Expert opinion: The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1327-1339 |
| Number of pages | 13 |
| Journal | Expert Opinion on Drug Safety |
| Volume | 14 |
| Issue number | 8 |
| DOIs | |
| State | Published - Aug 1 2015 |
| Externally published | Yes |
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Keywords
- Acute pain
- Diclofenac
- Osteoarthritis
- Safety
- SoluMatrix
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
Low-dose SoluMatrix diclofenac : A review of safety across two Phase III studies in patients with acute and osteoarthritis pain. / Gibofsky, Allan; Altman, Roy D; Daniels, Stephen; Imasogie, Olaolu; Young, Clarence.
In: Expert Opinion on Drug Safety, Vol. 14, No. 8, 01.08.2015, p. 1327-1339.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Low-dose SoluMatrix diclofenac
T2 - A review of safety across two Phase III studies in patients with acute and osteoarthritis pain
AU - Gibofsky, Allan
AU - Altman, Roy D
AU - Daniels, Stephen
AU - Imasogie, Olaolu
AU - Young, Clarence
PY - 2015/8/1
Y1 - 2015/8/1
N2 - Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac, containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.Areas covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee. In this review article, we summarize safety data from these studies.Expert opinion: The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.
AB - Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac, containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.Areas covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee. In this review article, we summarize safety data from these studies.Expert opinion: The safety results from the Phase III studies indicate that all dosing regimens of low-dose SoluMatrix diclofenac up to 12 weeks are generally well tolerated. Few serious gastrointestinal, cardiovascular, renal, or hepatic adverse events commonly associated with NSAID use were reported in these studies. Although not directly compared, the safety of SoluMatrix diclofenac was similar to findings for other diclofenac drug products. The potential for safe and effective management of acute and chronic pain at reduced NSAID doses is attractive; definitive characterization of SoluMatrix diclofenac safety requires confirmation by long-term studies.
KW - Acute pain
KW - Diclofenac
KW - Osteoarthritis
KW - Safety
KW - SoluMatrix
UR - http://www.scopus.com/inward/record.url?scp=84937204307&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84937204307&partnerID=8YFLogxK
U2 - 10.1517/14740338.2015.1047760
DO - 10.1517/14740338.2015.1047760
M3 - Article
C2 - 26004029
AN - SCOPUS:84937204307
VL - 14
SP - 1327
EP - 1339
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
SN - 1474-0338
IS - 8
ER -