Biomedical subjects
V Pfaffenrath
Publications and source records attributed to V Pfaffenrath.
[Acute therapy of episodic and chronic cluster headache with sumatriptan s.c. Results of a one-year long-term study].
The aim of the open prospective study was to investigate the efficacy, safety and tolerability of subcutaneous sumatriptan in the acute treatment of cluster headache. Self-treatment with 6 mg sumatriptan subcutaneously was monitored over a period up to 1 year. Headache parameters were documented by the patients with a headache diary. A total of 2031 attacks in 52 patients were investigated. Treatment with sumatriptan was effective in 88% of the attacks and 57% of the patients were pain-free within 15 min after injection; 42% of the patients became painfree within 15 min after at least 90% of their attacks. During long-time treatment the efficacy remained unchanged. Of the patients 10% withdrew from the study due to lack of efficacy or adverse events. In total, 62% of the patients reported adverse events, which were serious in 3.8% of the cases. Subcutaneous self-treatment of cluster headache is both highly effective and well tolerated.
Efficacy and safety of sumatriptan tablets (25 mg, 50 mg, and 100 mg) in the acute treatment of migraine: defining the optimum doses of oral sumatriptan.
That sumatriptan tablets are effective and well tolerated in the acute treatment of migraine has been established, but the relationship between dose and efficacy has not been adequately defined to date in clinical trials. This multinational double-blind trial (N = 1003) in which patients treated up to three migraine attacks with sumatriptan 25 mg, 50 mg, 100 mg, or placebo, with a second independently randomized dose for headache recurrence, evaluated the efficacy and tolerability of three doses of sumatriptan. The results demonstrate that all doses of sumatriptan were superior (P < 0.05) to placebo in reducing moderate or severe predose headache to mild or no headache 4 hours postdose for each of the three treated attacks; sumatriptan 50 mg and 100 mg were each superior (P < 0.05) to sumatriptan 25 mg 4 hours postdose for two of three attacks. Sumatriptan (all doses) was similarly effective at relieving nausea and photophobia or phonophobia or both and at reducing clinical disability. Headache recurrence was experienced by similar proportions of patients across treatment groups (35% to 48% after placebo; 26% to 39% after sumatriptan). Relief of recurrent headache 2 hours after the second dose of study medication occurred in greater percentages of patients using any dose of sumatriptan compared with patients using placebo to treat recurrence. The incidence of adverse events with 25-mg and 50-mg sumatriptan tablets was similar to the incidence with placebo and lower than the incidence with 100-mg sumatriptan tablets. These data provide the first demonstration from a large well-controlled clinical trial that both the 50- and 100-mg doses are more effective than the 25-mg dose and that the 50-mg dose is associated with a lower incidence of adverse events than the 100-mg dose.
Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group.
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The D2 receptor NcoI allele: absence of allelic association with migraine with aura.
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Migraine in pregnancy: what are the safest treatment options?
The occurrence of migraine in women is influenced by hormonal changes throughout the lifecycle. A beneficial effect of pregnancy on migraine, mainly during the last 2 trimesters, has been observed in 55 to 90% of women who are pregnant, irrespective of the type of migraine. A higher percentage of women with menstrual migraine find that their condition improves when they are pregnant. However, in rare cases migraine may appear for the first time during pregnancy. The positive effects of pregnancy on migraine and the possible worsening post partum are probably related to the uniformly high and stable estrogen levels during pregnancy and the rapid fall-off thereafter. Nondrug therapies (relaxation, sleep, massage, ice packs, biofeedback) should be tried first to treat migraine in women who are pregnant. For treatment of acute migraine attacks 1000 mg of paracetamol (acetaminophen) preferably as a suppository is considered the first choice drug treatment. The risks associated with use of aspirin (acetylsalicylic acid) and ibuprofen are considered to be small when the agents are taken episodically and if they are avoided during the last trimester of pregnancy. The 'triptans' (sumatriptan, zolmitriptan, naratriptan), dihydroergotamine and ergotamine tartrate are contraindicated in women who are pregnant. Prochlorperazine for treatment of nausea is unlikely to be harmful during pregnancy. Metoclopramide is probably acceptable to use during the second and third trimester. Prophylactic treatment is rarely indicated and the only agents that can be given during pregnancy are the beta-blockers metoprolol and propranolol.
[Treatment of migraine attacks and migraine prophylaxis: recommendations of the German Migraine and Headache Society].
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[Actions of pentaerithritol tetranitrate, isosorbide mononitrate and placebo on headache and ability to work of healthy subjects].
In a randomised, double-blind, four-way crossover study, 24 healthy volunteers received 240 mg/d pentaerithritol tetranitrate (PETN, CAS 78-11-5), 150 mg/d PETN, 60 mg/d isosorbide mononitrate slow release (ISMN, CAS 16051-77-7) or placebo in each study period for two days. Headache and disability to work were self-rated six times per day; individual measurements were combined to total scores. ISMN caused headaches more frequently (in approx. 90% of volunteers) and more severe (average total score 15.2) and a greater disability (average total score 6.0) than the high or low PETN-dosage (both in approx. 50%, headache score 4.9 or 6.4, disability score 1.1 or 2.1, resp.) and placebo (in approx. 10%, headache 0.8, disability 0), all these differences were statistically significant (p < 0.01, Wilcoxon). The high PETN-dosage showed a non-significant trend to produce fewer systemic side effects than the low PETN-dosage (not vice versa). With ISMN six volunteers prematurely terminated the study period and one volunteer who was replaced withdrew from the entire study due to side effects; all volunteers completed the study periods with the other medications.
Headache and the cervical spine: a critical review.
Headache related to the cervical spine is often misdiagnosed and treated inadequately because of confusing and varying terminology. Primary headaches such as tension-type headache and migraine are incorrectly categorized as "cervicogenic" merely because of their occipital localization. Cervicogenic headache as described by Sjaastad presents as a unilateral headache of fluctuating intensity increased by movement of the head and typically radiates from occipital to frontal regions. Definition, pathophysiology; differential diagnoses and therapy of cervicogenic headache are demonstrated. Ipsilateral blockades of the C2 root and/or greater occipital nerve allow a differentiation between cervicogenic headache and primary headache syndromes such as migraine or tension-type headache. Neither pharmacological nor surgical or chiropractic procedures lead to a significant improvement or remission of cervicogenic headache. Pains of various anatomical regions possibly join into a common anatomical pathway, then present as cervicogenic headache, which should therefore be understood as a homogeneous but also unspecific pattern of reaction.
[Medical therapy for menstrual migraine].
A menstrual migraine occurs in approximately 7-10 % of women suffering from migraine. The migraine occurs from 2 days before until 3 days after the end of the menstrual period. The choice of treatment depends on the duration of the attack, which ranges from 3 to 7 days. An attack of up to 3 days duration should be treated with acetylsalicylic acid, ergotamine tartrate or naproxen, each in combination with an antiemetic (domperidone, metoclopramide). If there is no response, sumatriptan can be administered orally (25-100 mg) or subcutaneously (6 mg). In the attacks continue for more than 3 days, short-term prophylaxis with naproxen or the application of an estrogen-containing patch is indicated. Neither ovulation inhibitors nor traditional migraine prophylaxis has an influence on menstrual migraine. Patients should keep a headache diary. Short-term prophylaxis with ergotamine tartrate or tamoxifen is obsolete.
[Headache and the cervical spine. A critical review].
Headache in association with the cervical spine is often misdiagnosed and treated inadequately due to confusing and varying terminology. Primary headaches such as tension-type headache and migraine are incorrectly categorized as "cervicogenic" merely because of their occipital localization. Cervicogenic headache described by Sjastaad presents as a unilateral headache of fluctuating intensity increased by movement of the head and typically radiating from occipital to frontal regions. Definition, pathophysiology, differential diagnosis and therapy of cervicogenic headache shall be demonstrated. Ipsilateral blockades of the C2/ C3 root and/or the major occipital nerve allow a differentiation between migraine and other primary headache syndromes. Neither pharmacological nor surgical or chiropractic procedures lead to an improvement or remission of cervicogenic headache. Pain of various anatomical regions possibly join into a common anatomical pathway then presenting as cervicogenic headache, which should therefore be understood as a homogeneous but also unspecific pattern of reaction.
Magnesium in the prophylaxis of migraine--a double-blind placebo-controlled study.
The migraine prophylactic effect of 10 mmol magnesium twice-daily has been evaluated in a multicentre, prospective, randomized, double-blind, placebo-controlled study. Patients with two to six migraine attacks per month without aura, and history of migraine of at least 2 years, were included. A 4-week baseline period without medication was followed by 12 weeks of treatment with magnesium or placebo. The primary efficacy end-point was a reduction of at least 50% in intensity or duration of migraine attacks in hours at the end of the 12 weeks of treatment compared to baseline. With a calculated total sample size of 150 patients, an interim analysis was planned after completing treatment of at least 60 patients, which in fact was performed with 69 patients (64F, 5M), aged 18-64 years. Of these, 35 had received magnesium and 34 placebo. The number of responders was 10 in each group (28.6% under magnesium and 29.4% under placebo). As determined in the study protocol, this was a major reason to discontinue the trial. With regard to the number of migraine days or migraine attacks there was no benefit with magnesium compared to placebo. There were no centre-specific differences, and the final assessments of treatment efficacy by the doctor and patient were largely equivocal. With respect to tolerability and safety, 45.7% of patients in the magnesium group reported primarily mild adverse events like soft stool and diarrhoea in contrast to 23.5% in the placebo group.
Migraine and cluster headache--their management with sumatriptan: a critical review of the current clinical experience.
Sumatriptan is a potent and selective agonist at the vascular 5HT1 receptor which mediates constriction of certain large cranial blood vessels and/or inhibits the release of vasoactive neuropeptides from perivascular trigeminal axons in the dura mater following activation of the trigeminovascular system. The mode of action of this drug in migraine and cluster headache is discussed. On the basis of a detailed review of all published trials and available data from post-marketing studies, the efficacy, safety, tolerability and the place of oral and subcutaneous sumatriptan in the treatment of both conditions are assessed. A number of double-blind clinical trials have demonstrated that sumatriptan 100 mg administered orally is clearly superior to placebo in the acute treatment of migraine headache and achieves significantly greater response rates than ergotamine or aspirin. In other studies, 70 to 80% of patients receiving sumatriptan 6 mg sc experienced relief of migraine headaches by 1 or 2 h after administration, and patients consistently required less rescue medication for unresolved symptoms. Sumatriptan was also effective in relieving associated migraine symptoms like nausea and vomiting. Sumatriptan was equally effective regardless of migraine type or duration of migraine symptoms. Overall, approximately 40% of patients who initially responded to oral or subcutaneous sumatriptan experienced recurrence of their headache usually within 24 h, effectively treated by a further dose of this drug. In 75% of patients with cluster headache treated with sumatriptan 6 mg sc, relief was achieved within 15 min. Based on pooled study data, sumatriptan is generally well tolerated and most adverse events are transient. Adverse events following oral administration include nausea, vomiting, malaise, fatigue and dizziness. With the subcutaneous injection, injection site reactions occur in approximately 30%. Chest syumptoms are reported in 3 to 5% but have been associated with myocardial ischaemia only in rare isolated cases. The recommended dosage of sumatriptan at the onset of migraine symptoms is 100 mg orally or 6 mg subcutaneously. The recommended dosage for cluster headache is 6 mg sumatriptan sc. Sumatriptan must not be given together with vasoconstrictive substances, e.g., ergotamines, or with migraine prophylactics with similar properties, e.g., methysergide. Sumatriptan should not be given during the migraine aura. It is contraindicated in patients with ischaemic heart disease, previous myocardial infarction, Prinzmetal (variant) angina and uncontrolled hypertension.
Analgesics and NSAIDs in the treatment of the acute migraine attack.
In the treatment of migraine attacks, an antiemetic in combination with an analgesic or ergot alkaloid is widely recommended. Medication should be introduced as early as possible, but only when there is no doubt that the headache is due to migraine. The antiemetic provides relief from the nausea and vomiting and also enhances the resorption of analgesics or ergot preparations. Domperidone 20 mg orally and 20 mg metoclopramide as suppository or 10-20 mg orally are mostly used as antiemetics. Analgesics such as 1000 mg acetylsalicylic acid as effervescent tablets, or 1000 mg paracetamol as effervescent tablets or suppositories should be given 15-20 min later. If this treatment fails, NSAIDs can be tried. In some studies naproxen in doses between 500 and 1000 mg and ibuprofen in doses between 400 and 800 mg have been shown to be effective, as well as NSAIDs like diclofenac, mefenamic acid, ketoprofen, tolfenamic acid and pirprofen. NSAIDs have been found to be superior to placebo and to standard reference drugs in the majority of the reviewed double-blind trials. Nevertheless, these effects are marginal in some studies or even without clinical relevance. Accordingly, there is still a need for further comparative studies.