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Solian (amisulpride)


Conclusion

Solian (amisulpride) is a new analogue in the group of atypical antipsychotics indicated for the treatment of schizophrenia. Solian displays an efficacy in the treatment of both positive and negative schizophrenia symptoms that is equal to or better than that of some of the traditional antipsychotics, but – like the other atypical antipsychotics – has fewer extrapyramidal effects.  In addition, Solian has been shown to be just as efficacious as risperidone against acute exacerbations of schizophrenia symptoms, but induced significantly less weight gain.
Thus Solian does not seem to differ substantially from the other atypical antipsychotics; whether or not it is a treatment option for a patient depends on the individual.

 

Background

Marketed in Denmark since 10 June 2002, Solian (amisulpride) is a new atypical antipsychotic for the treatment of schizophrenia. Amisulpride is a selective dopamine D2/D3 antagonist. Unlike most other typical and atypical antipsychotics, amisulpride has no affinity for the serotonergic, adrenergic, histaminergic and cholinergic receptors.

 

The recommended dose is 400-800 mg daily; doses in excess of 400 mg are divided into two doses a day. The daily dose can be increased to a maximum of 1200 mg. If symptoms are predominantly negative, the recommended daily dose is 50-300 mg. The tablets are available in strengths of 50 and 200 mg.

 

Efficacy

At daily doses of 400-800 mg, amisulpride has demonstrated the same efficacy as traditional antipsychotics (haloperidol 20 mg and flupentixol 25 mg) against the positive symptoms of schizophrenia (delusions, hallucinations, etc.)

 

Amisulpride has been compared with one other atypical antipsychotic: in a short-term study of 228 patients with acute exacerbations of schizophrenia symptoms, amisulpride 800 mg was just as efficacious as risperidone 8 mg against both positive and negative symptoms (BPRS and PANSS).

 

At doses of 100-300 mg, amisulpride displayed significantly greater efficacy against negative symptoms (affective blunting and emotional and social withdrawal) compared with placebo. Amisulpride has not been compared with other antipsychotics at its low dose.

 

Adverse drug reactions

Extrapyramidal effects are dose-dependent; in two studies their incidence was significantly lower than in patients receiving haloperidol or flupentixol. A meta-analysis in which amisulpride was indirectly compared with other atypical antipsychotics found no significant differences in the level of risk of extrapyramidal effects compared with risperidone 4-8 mg, olanzapine and quetiapine.

 

Weight gain in the order of 0.2-0.8 kg was observed in 16-21% of the patients. When amisulpride was compared with risperidone, significantly less weight gain was seen with the former. Aside from weight gain, the most common adverse effects were insomnia, anxiety and agitation (5-10%). There were no problems with QT-interval prolongation. See also the table below.

 

Drug interactions

Amisulpride increases the effect of alcohol. Caution should also be exercised in concomitant use of CNS suppressants or antihypertensives. Amisulpride may also reduce the efficacy of dopamine agonists.

 

Cost

Because dosages are so individual, it is difficult to make a direct price comparison (see the table below). However, Solian is no more expensive than the other newer atypical antipsychotics.

 

Atypical antipsychotics

 

Product  Contents Extrapyramidal effects (1) Sedation (1)  Weight gain (1) Recommended dosage interval  Cost (DKK)
Clozapine, Leponex clozapine - +++ +++ 200-450 (600)mg  11.95-26.89 (35.86)
Dogmatil  sulpiride + + + 600-1800 mg  11.65-34.94
Seroquel   quetiapine (+) ++ + 150-750 mg  22.57-85.70
Risperdal   risperidone +(+) (2) + + (+) 4-6 (16) mg  25.17-37.75 (100.67)
Solian  amisulpride + (+) + + 400-800 (1200) mg
50-300 mg3
33.48-66.96 (100.45)
 7.19-25.11
Zeldox   ziprasidone + (+) + (+) 40-160 mg  23.23-67.92
Zyprexa   olanzapine + + +++ 5-20 (40) mg  25.27-191.23 (382.46)

1 Based on Lægemiddelkataloget 2002 (“Medicinal Products Catalogue 2002”).
2 Risperdal only at 6 mg and above.
3 Dose for predominantly negative symptoms.

 

Additional information is available from the summary of product characteristics published by the Danish Medicines Agency (Danish only).


Last modified: July 10th 2002


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