Unlike Vioxx, Vioxxalt is registered for the treatment of acute pain and primary dysmenorrhoea. No significant difference in efficacy and adverse drug reactions has been observed in short-term use (one to five days) compared with ibuprofen and naproxen. Vioxxalt can be administered in a single daily dose, but 24 hours of treatment with Vioxxalt costs ten times more than ibuprofen 400 mg three times a day.
Other studies have found the short-term use of ibuprofen 400 mg to be well tolerated, so this should continue to be the first-line treatment for acute pain in patients who do not obtain sufficient efficacy from paracetamol, unless the patient has ulcer-related problems.
The COX-2 inhibitor Vioxxalt (rofecoxib) has been marketed in Denmark since 18 February 2002. Vioxxalt differs from its market predecessor Vioxx in two ways: indication and strength. Vioxxalt is indicated for the relief of acute pain and pain due to primary dysmenorrhoea. Vioxxalt is sold in the form of 25 and 50 mg tablets, since new studies have shown that 25 and 50 mg are the doses that provide optimal efficacy against primary dysmenorrhoea or acute pain. Vioxxalt does not have a more rapid onset of action than Vioxx.
Vioxx is available in 12.5 mg and 25 mg tablets; the recommended dose for the symptomatic treatment of osteoarthritis and rheumatoid arthritis is still 12.5-25 mg daily. Please see the information on Vioxx in the 1 March 2000 issue of Rational Farmakoterapi (Danish only).
There are five studies that compare the efficacy of Vioxxalt and older medicinal products for the treatment of acute pain. The results of another study, one that compares rofecoxib with diclofenac, will be published soon.
A study of 151 patients with moderate to severe postoperative pain after dental surgery compared rofecoxib 50 mg with ibuprofen 400 mg. Both treatments were given in a single administration. The efficacy of the two drugs was found to be the same measured over a period of eight hours. A study of 272 patients found similar results: that there was no significant difference in the efficacy of rofecoxib and ibuprofen after 12 hours. On the other hand, rofecoxib was better after 24 hours, but only a single dose of ibuprofen 400 mg had been given, and the normal dosage is three times daily.
One study of 127 patients with primary dysmenorrhoea compared rofecoxib 25 and 50 mg with naproxen 500 mg. Naproxen had a significantly faster onset of action than rofecoxib (time to significant difference from placebo was one and two hours respectively). Otherwise, there was no significant difference in the efficacy of the three therapies measured over eight hours. The recommended dose for primary dysmenorrhoea is 25 mg.
One study of 218 patients with postoperative pain after orthopaedic surgery compared the efficacy of rofecoxib 50 mg with that of naproxen 500 mg. No significant difference in efficacy was found.
Finally, a study of 393 patients with postoperative pain compared rofecoxib 50 mg with codeine 60 mg combined with paracetamol 600 mg: rofecoxib was significantly more efficacious and induced fewer adverse effects. It should be remembered, however, that the optimal dose of paracetamol is 1000 mg and not 600 mg.
Adverse drug reactions
According to the summary of product characteristics published by the Danish Medicines Agency, 1%-10% of the roughly 1200 patients involved in studies experienced dizziness, diarrhoea, increased sweating, or dyspepsia during treatment with rofecoxib 25-50 mg daily for five days.
It has previously been shown that the incidence of gastrointestinal complications in long-term treatment was lower with rofecoxib than other NSAIDs. In the above-mentioned studies, no significant differences were found in the adverse effects seen with rofecoxib 25 and 50 mg, ibuprofen 400 mg and naproxen 500 mg, when the drugs were given in the form of a single administration. On the other hand, codeine plus paracetamol induced more adverse effects than rofecoxib.
As with Vioxx, there is a potential for interaction with warfarin, rifampicin and other drugs. Other possible interactions have less clinical relevance in the case of short-term use.
Vioxxalt is marketed in packs of five and ten tablets. When the largest pack is compared with the same size pack of the most commonly used NSAIDs, it is apparent that Vioxxalt is ten times more expensive than ibuprofen. In addition, Vioxxalt does not currently fall under the general reimbursement scheme.
|Least expensive product
||No. of tablets
||Cost per tablet (DKK)
||Cost per day (DKK)|
|Ibuprofen 400 mg
|Diclon 50 mg
|Naproxen 500 mg
|Vioxx 25 mg
|Vioxxalt 25 mg
|Vioxxalt 50 mg
Additional information can be found in the summary of product characteristics published by the Danish Medicines Agency (Danish only).
Last modified: February 18th 2002