Ergotamine, Dihydroergotamine: Current Uses and Problems

P. Tfelt-Hansen

Disclosures

Curr Med Res Opin. 2001;17(1s) 

In This Article

Results of Randomized, Clinical Trials with Ergotamine and Dihydroergotamine

The bioavailability of the oral form of ergotamine is <1% (see above). This extremely low bioavailability results in considerable inter-patient variability with regard to the amount of drug reaching the circulation. The oral route of administration of ergotamine is therefore not optimal. In randomized, clinical trials (RCTs), generally not carried out with current up-to-date methodology, oral ergotamine (1-5 mg) has, however, shown some efficacy compared with placebo[8]. The clinical relevance of the different efficacy parameters used in these old studies can be questioned, and no uniform picture of the effectiveness of oral ergotamine emerges from these RCTs. In recent RCTs, 2mg ergotamine + 200 mg caffeine were found to be inferior to 100 mg sumatriptan[8], and the rather small dose of 1mg ergotamine + 100 mg caffeine was inferior to the combination of calcium carbasalate (equivalent to 900 mg aspirin) + 10mg metoclopramide[8].

The rectal route of administration of ergotamine, which from a kinetic point of view should be more efficacious, has scarcely been investigated[8]. In a recent randomized, cross-over, double-blind trial including 251 patients[11], ergotamine + caffeine suppositories (2 mg + 200 mg) plus one optional suppository after 30 min were superior to 25 mg sumatriptan suppositories with response rates of 73% and 63% after 2 h and recurrence rates of 11% and 22%, respectively. Because of more side effects after ergotamine (27%) than after sumatriptan (8%), slightly more patients preferred sumatriptan (44%) than ergotamine (36%).

Intravenous dihydroergotamine was compared with placebo in one RCT, and the results indicated some superiority of dihydroergotamine[12]. Intranasal dihydroergotamine was compared with placebo in several RCTs with variable results[2,13]. An overview of four more recent RCTs, using current methodology, with intranasal and subcutaneous dihydroergotamine is shown in Table 1. Intranasal dihydroergotamine 2mg was superior to placebo with an effect after only 30 min[14]. In two comparative RCTs intranasal dihydroergotamine 1mg (plus an optional dose of 1mg after 30 min) was inferior to 6mg subcutaneous sumatriptan and 20 mg intranasal sumatriptan[15,16]. Subcutaneous dihydroergotamine 1mg was inferior to 6mg subcutaneous sumatriptan for the first 2 h, but apparently comparable thereafter[17]. In all three comparative RCTs, dihydroergotamine resulted in fewer recurrences than sumatriptan (Table 1).

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