Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Skelid (Sanofi Winthrop)
200 mg tablets
Indication: Paget's disease
Tiludronate adds to the choice of biphosphonates available for the treatment of Paget's disease. The biphosphonates work by inhibiting the resorption of bone.
In clinical trials, the effectiveness of tiludronate has been objectively assessed by measuring concentrations of serum alkaline phosphatase. This enzyme is increased in Paget's disease. A 3-month course of tiludronate will at least halve alkaline phosphatase in over half the patients. The concentration of alkaline phosphatase may remain reduced for up to 18 months. In some patients, the concentration will fall to the normal range. Some patients will experience a reduction in bone pain.
Tiludronate has been compared with etidronate in a company-sponsored trial of 234 patients. After 6 months, significantly more patients had responded to tiludronate than etidronate. However, neither drug had an advantage over the other in the reduction of bone pain.1
Only 6-7% of a dose of tiludronate is absorbed. As food reduces absorption, the tablets should not be taken less than two hours before or after a meal. Absorption is also reduced by calcium, so the tablets should be swallowed with water, not milk.
Tiludronate binds to bone. This means that it has a long half-life. The drug is gradually excreted unchanged in the urine.
The most frequent adverse effects are gastrointestinal, including abdominal pain, nausea and diarrhoea. Other adverse effects include asthenia, headaches and rashes. Bone mineralisation is not affected at therapeutic doses.
