Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1- naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS•HCl, which corresponds to a molecular weight of 333.88. 

Deze nieuwe stof lijkt in een grote meta-analyse even effectief als een ander modern middel, dat de artsen van ons centrum ook soms voorschrijven, Lyrica. ^[1] Maar de meta-analyse van de Cochrane groep van oktober 2009 was niet zo heel optimistisch, met een number needed to treat van 6 ^[2]

Lyrica® en Cymbalta® zijn beide de meest recente middelen die op de markt gekomen zijn voor de behandeling van neuropathische pijn, maar beide middelen zijn vermoedelijk niet de meest werkzame middelen tegen neuropathische pijn, omdat de NNT rond de 6 ligt, terwijl oudere middelen NNT tussen 3-5 hebben.

Verder bleek Cymbalta® kosteneffectief te zijn.^[3] Hoewel de Cochrane groep opmerkte:

Direct comparisons of duloxetine with other antidepressants and with other drugs already shown to be efficacious in neuropathic pain would be appropriate and should include unbiased economic analyses.

En in oudere patienten met neuropathische pijnen lijkt duloxetine (Cymbalta®) veilig genoeg en effectief.^[4]

Cymbalta® in neuropathische pijn 

Twee studies, samenvatting uit uitgebreide Amerikaanse bijsluiter:

The efficacy of Cymbalta® for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) was established in 2 randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in adult patients having diabetic peripheral neuropathy for at least 6 months.

Study 1 and 2 enrolled a total of 791 patients of whom 592 (75%) completed the studies. Patients enrolled had Type I or II diabetes mellitus with a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for at least 6 months. The patients had a baseline pain score of ≥4 on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Patients were permitted up to 4 g of acetaminophen per day as needed for pain, in addition to Cymbalta.

Patients recorded their pain daily in a diary. Both studies compared Cymbalta 60 mg once daily or 60 mg twice daily with placebo. Study 1 additionally compared Cymbalta 20 mg with placebo.

A total of 457 patients (342 Cymbalta, 115 placebo) were enrolled in Study 1 and a total of 334 patients (226 Cymbalta, 108 placebo) were enrolled in Study 2. Treatment with Cymbalta® 60 mg one or two times a day statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline.

For various degrees of improvement in pain from baseline to study endpoint, Figures 1 and 2 show the fraction of patients achieving that degree of improvement. The figures are cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.  

Auteurs: Prof.dr. Jan M. Keppel Hesselink, arts-farmacoloog, versie maart 2010

Referenties