Safety and efficacy of skin patches containing loxoprofen sodium in diabetic patients with overt nephropathy.
BACKGROUND
Because oral nonsteroidal anti-inflammatory drugs (NSAIDs) have adverse effects on kidney function, patients with kidney diseases are administered these drugs as transdermal patches. Little is known about the effects of NSAID patches on renal function. We therefore assessed the effects of topical loxoprofen sodium on kidney function in type 2 diabetic patients with overt nephropathy.


METHODS
Twenty patients with type 2 diabetes and overt proteinuria and with knee and/or low back pain were treated with skin patches containing 100 mg loxoprofen on the knee or back for 24 h per day for 5 consecutive days. The degree of pain was assessed using a visual analogue scale (VAS). Blood and 24-h urine samples were obtained at baseline and at the end of the study. Glomerular filtration rate (GFR) was estimated from serum creatinine and cystatin C concentrations.


RESULTS
The 20 patients consisted of 11 males and 9 females, of mean age 61.6 ± 13.9 years. Loxoprofen-containing patches significantly reduced VAS pain without affecting blood pressure, GFR or urinary prostaglandin E2 concentration. Serum concentrations of loxoprofen and its active trans-OH metabolite did not correlate with GFR.


CONCLUSIONS
Loxoprofen-containing patches do not affect renal function in type 2 diabetic patients with overt nephropathy over a short-term period. Long-term studies are needed to clarify the safety of loxoprofen-containing patches in patients with chronic kidney diseases.
Department of Medicine, Shiga University of Medical Science, Otsu, Shiga, 520-2192, Japan, haraki@belle.shiga-med.ac.jp.
Hisazumi
H
Araki
Shogo
S
Kuwagata
Mariko
M
Soumura
Kosuke
K
Yamahara
Yoshikata
Y
Morita
Shinji
S
Kume
Keiji
K
Isshiki
Shin-ichi
S
Araki
Atsunori
A
Kashiwagi
Hiroshi
H
Maegawa
Takashi
T
Uzu
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001794:Blood Pressure / Q000502:physiology; D003404:Creatinine / Q000097:blood; D055316:Cystatin C / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D015232:Dinoprostone / Q000652:urine; D004305:Dose-Response Relationship, Drug; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006801:Humans; D007668:Kidney / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D057968:Transdermal Patch; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D055316:Cystatin C; D010666:Phenylpropionates; C040656:loxoprofen; D003404:Creatinine; D015232:Dinoprostone