Suppository naproxen reduces incidence and severity of post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial

Table 1 Patient characteristics n (%)

Characteristic	Naproxen (n = 162)	Placebo (n = 162)
Age, yr	46.3 ± 8.3	44.7 ± 9.7
Female	78 (48.1)	73 (45.1)
Pancreatitis severity
Mild	8 (20.0)b	18 (45.0)
Moderate	4 (10.0)b	10 (25.0)
Severe	0 (0)b	0 (0)

^bP < 0.01 vs Placebo. Data are presented as mean ± SD or n (%).

Table 2 Incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis

Variable	Naproxen1	Placebo2
Sex
Female	9/12b	19/28
Male	3/12	9/28
Age (yr)
< 40	5/12	10/28
> 40	7/12	18/28
Sphincterotomy
Yes	8/129	23/119
No	4/33	5/43
Precut required	2/31	2/31
Pancreatic duct injection
Yes	6/75b	23/84
No	6/82	5/83
Pancreatic duct cannulations
≥ 3	2/6b	10/23
≤ 2	3/6	14/23
ERCP duration (min)
> 40	4/12b	12/28
< 40	8/12	16/28
Biliary duct injection
Yes	9/134	24/135
No	3/23	4/25

¹Pancreatitis/naproxen (12/162, 7.4%);

²Pancreatitis/placebo (28/162, 17%).

^bP < 0.01 vs Placebo.

Table 3 Risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis

Variable		Pancreatitis, n		OR	RR (95%CI)	RRR (%)	AR (%)
		Yes	No
Group				0.4b	0.42 (0.22-0.81)	58	-138
	Naproxen	12	150
	Placebo	28	134
Sex				3b	2.67 (1.40- 5.07)	167	62.54
	Female	28	123
	Male	12	161
Age (yr)				2.4b	2.2 (1.22-3.96)	120	54.54
	< 40	15	63
	> 40	25	261
Sphincterotomy				1	1.05 (0.52-2.11)	5	4.76
	Yes	31	217
	No	9	67
Pancreatic duct injection				2.1b	1.88 (1.06-3.32)	88	46.81
	Yes	29	130
	No	16	149
Pancreatic duct cannulations				2.1	1.87 (0.93-3.74)	87	46.52
	≥ 3	12	37
	≤ 2	14	93
ERCP duration (min)				2.6b	2.30 (1.29-4.09)	130	56.52
	> 40	16	54
	< 40	24	218
Biliary duct injection				1.7	1.66 (0.76-3.63)	66	39.75
	Yes	33	236
	No	7	88

^bP < 0.01 vs Placebo. OR: Odds ratio; RR: Relative risk; RRR: Relative risk reduction; AR: Absolute risk.