Reduced risk of NSAID gastropathy (GI mucosal toxicity) with nonacetylated salicylate (salsalate): an endoscopic study.
This randomized, investigator-blinded, parallel group endoscopic study evaluated the effects of salsalate and naproxen on the gastroduodenal mucosa over a 3-month period in patients with RA. Using therapeutic doses of the drugs, 8 of 21 patients (38%) in the naproxen group had endoscopically shown active ulcers (seven patients) or diffuse erosions (one patient), whereas none of the 18 patients treated with salsalate (0%) had such lesions (P = .003). Five of the eight naproxen-treated patients with evidence of GI damage were asymptomatic at the time of endoscopic verification of their lesions. The most significant disadvantage of salsalate was its higher incidence of otologic problems accounting for six of the nine discontinuations with salsalate. However, the findings of this study suggest that patients receiving salsalate are at lower risk for developing significant gastropathy than those treated with naproxen. The relative benefit-to-risk ratio of salsalate indicates that this drug should be considered as a significant alternative NSAID therapy.
Roth
S
S
Arthritis Center, Arizona Institutes, Phoenix 85102.
Bennett
R
R
Caldron
P
P
Hartman
R
R
Mitchell
C
C
Doucette
M
M
Ekholm
B
B
Goldlust
B
B
Lee
E
E
Wilson
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects*; D005773:Gastroscopy; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009288:Naproxen / Q000627:therapeutic use*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012459:Salicylates / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000139:chemically induced
D000894:Anti-Inflammatory Agents, Non-Steroidal; D012459:Salicylates; D009288:Naproxen; C014182:salicylsalicylic acid