Incidence of spontaneous notifications of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after marketing in the United Kingdom

Figures & data

Table 1 WHO-ART preferred terms included in the groups assessed

Group	WHO-ART preferred terms
Gastrointestinal bleeding	Duodenal ulcer hemorrhagic, duodenal ulcer perforated, gastric ulcer hemorrhagic, gastric ulcer perforated, gastrointestinal hemorrhage, hematemesis, hemorrhage rectum, melaena, esophageal ulceration hemorrhage, peptic ulcer perforated.
Abdominal pain	Abdominal pain
Liver toxicity	Bilirubinemia, gamma-GT increased, hepatic function abnormal, hepatitis, hepatitis cholestatic, hepatocellular damage, jaundice, SGPT increased.
Renal toxicity	Nephrosis, oliguria, renal failure acute, renal function abnormal, urine flow decreased.
Edema	Angioedema, face edema, edema, edema mouth, edema peripheral, edema periorbital, papilloedema, tongue edema.
Arterial hypertension	Hypertension, hypertension aggravated.
Thromboembolic cardiovascular events	Angina pectoris aggravated, myocardial infarction, embolism arterial, cerebrovascular disorder, peripheral ischemia, thrombophlebitis, thrombophlebitis deep, transient ischemic attack.

Abbreviations: ART, adverse reactions terminology; GT, glutamyl transferase; SGPT, serum glutamic pyruvic transaminase; WHO, World Health Organisation.

Table 2 Incidence rates (95% confidence interval [CI]) of spontaneous reports of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after introduction to the UK market

Adverse reaction group	Incidence rate (95% CI)	Adjusted incidence rate (95% CI)
Gastrointestinal bleeding
Aceclofenac	0.000 (0.000–0.888)
Meloxicam	1.421 (1.033–1.908)
Rofecoxib	3.247 (2.604–4.000)	2.656 (2.078–3.345)
Abdominal pain
Aceclofenac	0.000 (0.000–0.888)
Meloxicam	1.356 (0.978–1.833)
Rofecoxib	3.837 (3.135–4.649)	3.136 (2.505–3.878)
Liver toxicity
Aceclofenac	0.241 (0.006–1.342)
Meloxicam	0.032 (0.001–0.180)
Rofecoxib	0.775 (0.480–1.184)	0.627 (0.365–1.004)
Renal toxicity
Aceclofenac	0.723 (0.149–2.112)
Meloxicam	0.097 (0.020–0.283)
Rofecoxib	0.627 (0.365–1.004)	0.517 (0.282–0.867)
Thromboembolic cardiovascular events
Aceclofenac	0.241 (0.006–1.342)
Meloxicam	0.065 (0.008–0.233)
Rofecoxib	0.664 (0.394–1.050)	0.553 (0.310–0.913)
Arterial hypertension
Aceclofenac	0.000 (0.000–0.888)
Meloxicam	0.097 (0.020–0.283)
Rofecoxib	0.701 (0.422–1.095)	0.590 (0.337–0.959)
Edema
Aceclofenac	1.204 (0.391–2.810)
Meloxicam	1.130 (0.787–1.572)
Rofecoxib	4.833 (4.041–5.735)	3.948 (3.235–4.77)

Table 3 Incidence rate ratios (95% confidence intervals [CI]) of adverse reactions with aceclofenac versus meloxicam, and with aceclofenac versus rofecoxib

Adverse reaction group	Incidence rate ratio (95% CI)	Adjusted incidence rate ratio (95% CI)
Gastrointestinal bleeding
Aceclofenac/meloxicam	0.00 (0.00–0.65)
Aceclofenac/Rofecoxib	0.00 (0.00–0.28)	0.00 (0.00–0.34)
Abdominal pain
Aceclofenac/meloxicam	0.00 (0.00–0.68)
Aceclofenac/rofecoxib	0.00 (0.00–0.24)	0.00 (0.00–0.29)
Liver toxicity
Aceclofenac/meloxicam	7.46 (0.10–585.39)
Aceclofenac/rofecoxib	0.31 (0.01–1.93)	0.38 (0.01–2.45)
Renal toxicity
Aceclofenac/meloxicam	7.46 (1.00–55.68)
Aceclofenac/rofecoxib	1.15 (0.22–3.98)	1.40 (0.26–5.01)
Thromboembolic cardiovascular events
Aceclofenac/meloxicam	3.73 (0.06–71.62)
Aceclofenac/rofecoxib	0.36 (0.01–2.30)	0.43 (0.01–2.83)
Arterial hypertension
Aceclofenac/meloxicam	0.00 (0.00–18.05)
Aceclofenac/Rofecoxib	0.00 (0.00–1.40)	0.00 (0.00–1.69)
Edema
Aceclofenac/meloxicam	1.07 (0.33–2.73)
Aceclofenac/rofecoxib	0.25 (0.08–0.60)	0.31 (0.10–0.73)