Cw. Jones, A POSTMARKETING SURVEILLANCE STUDY OF (R)VOLTAROL 75 MG SR IN THE PRIMARY-CARE SETTING, British journal of clinical practice, 50(7), 1996, pp. 390-395
A total of 7438 patients suffering from a wide variety of painful cond
itions was included in the final analysis of a post-marketing surveill
ance (PMS) study monitoring the use of Voltarol 75 mg SR in a primary
care setting. Follow-up data were collected at visits conducted one, f
our and 12 months after the initial consultation, Improvement of sympt
oms was the most common reason for discontinuation of treatment (47% o
f patients who discontinued), Adverse events led to the withdrawal of
18% of patients overall. The rate of serious gastrointestinal complica
tions was low (0.4%) and deleterious hepatic or renal effects were not
apparent. There were significantly more events experienced by female
patients and there was a significant effect of age on severe gastroint
estinal events. In this PMS study Voltarol 75 mg SR was used successfu
lly once or twice daily without any unexpected adverse effects in a ma
nner consistent with current recommendations for the use of non-steroi
dal anti-inflammatory drugs.