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PubMed2003

The triptan formulations : how to match patients and products.

The 5-HT(1B/1D) receptor agonists (the 'triptans') are migraine-specific agents that have revolutionised the treatment of migraine. They are usually the drugs of choice to treat a migraine attack in progress. Different triptans are available in various strengths and formulations, including oral tablets, orally disintegrating tablets, nasal sprays and subcutaneous injections. In Europe, sumatriptan is also available as a suppository. Specific differences among the triptans exist, as evidenced by different pharmacological profiles including half-life, time to peak plasma concentrations, peak plasma concentrations, area under the concentration-time curve, metabolism and drug-drug interaction profiles. How or whether these differences translate to clinical efficacy and tolerability advantages for one agent over another is not well differentiated. However, delivery systems may play an important role in onset of action. Given that the clinical distinctions among these agents are subtle, identification of the most appropriate triptan for an individual patient requires consideration of the specific characteristics of the patient and knowledge of patient preference, an accurate history of the efficacy of previous acute-care medications and individual features of the drug being considered. The selection of an acute antimigraine drug also depends upon the stratification of the patient's migraine attack by peak intensity, time to peak intensity, level of associated symptoms such as nausea and vomiting, time to associated symptoms, comorbid diseases and concomitant treatments that might cause drug-drug interactions. Individual patient response to the triptans seems to be idiosyncratic and possibly genetically determined. Therefore, a set of specific questions can be used to determine whether a currently used triptan is optimally effective, whether the dose needs to be increased or whether another triptan should be tried. The clinician has in his/her armamentarium an ever-expanding variety of triptans, available in multiple formulations and dosages, which have good safety and tolerability profiles. Continued clinical use will yield familiarity with the various triptans, and it should become possible for the interested physician to match individual patient needs with the specific characteristics of a triptan to optimise therapeutic benefit. Use of the methods outlined in this review in choosing a triptan for an individual patient is probably more likely to lead to migraine relief than making an educated guess as to which triptan is most appropriate.

Dose-Response Relationship, Drug↗
PubMed2004

Intranasal medications for the treatment of migraine and cluster headache.

Intranasal medications for the treatment of headache have recently received increased attention. This paper reviews intranasal formulations of a variety of available medications (dihydroergotamine mesylate [dihydroergotamine mesilate], sumatriptan, zolmitriptan, butorphanol, capsaicin and lidocaine [lignocaine]) and one experimental medication (civamide, a cis-isomer of capsaicin) for the treatment of migraine and cluster headache. Although the efficacy of intranasal agents varies with the product used, intranasal delivery may be both convenient and more effective than other modes of drug delivery for a variety of reasons: (i) intranasal administration bypasses small bowel gastrointestinal tract absorption, which is often significantly delayed during the acute phase of a migraine attack; (ii) nauseated patients may prefer non-oral formulations as they decrease the chance of vomiting and are more rapidly effective; (iii) intranasal administration causes no pain or injection site reaction and is easier and more convenient to administer than injection or suppository and so may be used earlier in a migraine attack, resulting in better efficacy; (iv) intranasal medication produces the same number or fewer adverse events than injections; and (v) intranasal formulations offer a more rapid onset of action than oral medications, for some of the above reasons and, as such, may be more useful in patients with cluster headache, although this needs to be verified. However, it is important to emphasise that a preference study showed that most patients prefer oral tablets to an intranasal formulation. Also, some nasal preparations have significant adverse effects or are not well absorbed and therefore do not work consistently; others are more challenging to administer as a result of their delivery apparatus. Nevertheless, it is our opinion that nasal preparations increase therapeutic options and may result in faster response times and better efficacy than oral formulations and better patient satisfaction than injectable preparations.

Administration, Intranasal↗
PubMed2005

The treatment of pediatric migraine.

The management of pediatric migraine requires a balance of biobehavioral measures coupled with agents for acute treatment and, if needed, daily preventive medicines. A recent American Academy of Neurology practice parameter has critically reviewed the limited data regarding the efficacy and safety of medicines for the acute and preventive therapy of pediatric migraine. The first step is to establish the headache frequency and degree to which the migraines impact upon lifestyle and performance. The next step is to institute nonpharmacologic measures such as regulation of sleep (improved sleep hygiene), moderation of caffeine, regular exercise, and identification of provocative influences (eg, stress, foods, social pressures). A wide variety of therapeutic options exist for patients whose migraine headaches occur with sufficient frequency and severity to produce functional impairment. The most rigorously studied agents for the acute treatment of migraine are ibuprofen, acetaminophen, and sumatriptan nasal spray, all of which have shown safety and efficacy in controlled trials. Daily preventive drug therapies are warranted in about 20% to 30% of young migraine sufferers. The particular drug selected for the individual patient requires an appreciation of comorbidities such as affective or anxiety disorders, co-existent medical conditions such as asthma or diabetes, and acceptability of potential toxicities such as weight gain, sedation, or tremor.

Adrenergic beta-Antagonists↗
PubMed1994

Development and implementation of practice guidelines (Part 1).

Development and implementation of practice guidelines should be a team effort that includes pharmacists, the medical staff, and hospital administration. Described in this article are the steps involved in developing and successfully implementing practice guidelines. Also briefly presented are some practice guidelines developed by the staff at Cedars-Sinai Medical Center for the use of ondansetron in the post-op setting, colony stimulating factors, and sumatriptan for the treatment of migraine. Finally, discussion of a few practice guidelines that are in the implementation phase and future directions with regard to evolution of practice guidelines are presented.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Profiles of 5-HT 1B/1D agonists in acute migraine with special reference to second generation agents.

The efficacy of 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) agonists is related to their inhibitory effects on neurogenic inflammation, mediated through serotoninergic control mechanisms. Recently, a series of oral second generation 5-HT 1B/1D agonists (eletriptan, naratriptan, rizatriptan and zolmitriptan) have been developed and are reviewed in this paper. Their in vitro and in vivo pharmacological properties, clinical efficacy, drug interactions, and adverse effects are evaluated and compared to the gold standard in the treatment of acute migraine, sumatriptan.

Acute Disease↗
PubMed1999

[New therapies in neurology, but who benefits?].

In recent years several new treatments have been introduced in neurology, sumatriptan in migraine, riluzole in amyotrophic lateral sclerosis, interferon-beta in multiple sclerosis and rivastigmine in Alzheimer's disease. Doubts exist on the effects on functional outcome of these new treatments. Hardly effective drugs are not forced on physicians by the pharmaceutical industry, since physicians are involved in decisions from phase I studies to the final approval of the drugs. The problem is, however, that in clinical studies emphasis is still on statistically significant differences rather than on meaningful differences in the functional status of patients. In conclusion, in clinical studies outcome measures should be chosen more carefully and there is a need for sensitive linear functional scales.

Alzheimer Disease↗
PubMedDate not supplied

[Analgesic efficacy of Famalgin and Imigran in patients with acute migraine attacks].

Migraine is a syndrome clinically manifested in attacks which dominant symptom is unilateral, rarely generalized, recurrent headache that can last for hours, and occasionally, days. According to different sources, it is considered that about 10-15% of world population suffers from some type of this syndrome. Migraine is most frequently clinically revealed in the age of 30-40, therefore in the most productive period with significant share in treatment costs and a great influence to the working ability of those patients. The aim of this trial was to determine analgesic efficacy of Imigran (sumatriptan) and Famalgin in the treatment of acute attacks of migraine headache. Trial results revealed significant analgesic efficacy of both preparations without significant differences in analgesic effect, with significantly better tolerability of Famalgin. It was concluded that both preparations were efficacious drugs for the treatment of headache as the most prominent clinical symptom of migraine, with significantly rarer and less pronounced adverse effects of Famalgin.

Acute Disease↗
PubMedDate not supplied

New anti-migraine drugs: present and beyond the millennium.

A fast growing new class of anti-migraine drugs has recently been introduced for the acute treatment of migraine: the serotonin (5-HT) 1B/D-agonists. Since the introduction of its first representative, sumatriptan, in 1993, several new compounds of this class have been or are about to be approved. The following review introduces this class of compounds and focuses on indications, differences, advantages and disadvantages of each member. It further discusses new indications of established drugs for the use in migraine, including prophylaxis. For the use of analgesics and ergotamine, the reader is referred to recent reviews.

Forecasting↗
PubMed2000

Newer intranasal migraine medications.

Two new intranasal migraine medications, sumatriptan and dihydroergotamine mesylate, may offer specific advantages for patients who are seeking alternatives to various oral or parenteral migraine abortive therapies. Placebo-controlled clinical studies demonstrate that both intranasal forms are effective in relieving migraine headache pain, but published clinical trial information comparing these two intranasal medications with current abortive therapies is lacking. Both agents are generally well tolerated by patients, with the exception of mild, local adverse reactions of the nose and throat.

Administration, Intranasal↗
PubMed2000

Rizatriptan versus usual care in long-term treatment of migraine.

Because of the recurrent nature of migraine, a major concern with pharmacologic therapy is whether it will remain effective, safe, and tolerable over the long term. The development of sumatriptan offered an improvement in migraine therapy, although concerns remain about chest symptoms associated with this class of drugs. In early clinical trials, rizatriptan was shown to have good bioavailability and favorable effects on quality of life. Long-term extension trials ran for up to 12 months and compared rizatriptan with "usual care" (i.e., medications used for acute therapy). These studies showed that the 10-mg rizatriptan dose was consistently superior to usual care with regard to pain relief and complete pain relief (pain-free). Side effects were generally mild and transient in all treatment groups. Nausea, dizziness, and somnolence were the most commonly reported adverse effects.

Humans↗
PubMed1999

[Emergency treatment of migraine attacks with particular reference to agonists of 5-HT1B/1D receptor].

The author discusses the modern methods of emergency controlling of migraine attacks, especially the recently introduced drugs agonists of the 5-HT 1B/1D receptor /Sumatriptan, Zolmitriptan/ and prophylactic treatment. In light and moderately severe attacks analgesics are usually effective as well as non-steroid antiinflammatory drugs /paracetamol, acetylsalicylic acid, naproxen, diclofenac, ibuprofen, ketoprofen etc./ with or without addition of caffeine and codeine, and metoclopramide /for suppression of nausea and vomiting/ or Torecan. Ergotamine is still in use, although it can produce serious adverse effects. An essential advance in the treatment of more severe attacks was achieved with the introduction of Sumatriptan, a selective 5-HT1D receptor agonist in 1988. In pursuing this direction further indole derivatives /so called triptans/ were introduced. Zolmitriptan introduced in 1994 is an agonists of 5-HT 1B/1D receptor, is active both peripherally and centrally, is well absorbed from the digestive tract and has a good bioavailability index /40%/. In 2.5 mg doses it causes regression or marked alleviation of migraine attack within 2 hours in 70% of cases. Administration of a second dose after that time increases the percentage of successes. Adverse effects are usually mild, coronary complication have not yet been described. Prophylactic treatment is given to patients with attack frequency over 2 in a month. For that treatment usually dihydroergotamine, pisotifen, propranolol, metoprolol, flunarizin, valproic acid, iprasochrom and oxetoron are given.

Analgesics↗
PubMed2000

[Patients with cluster headache in a neurological department].

BACKGROUND: Cluster headache is a devastating disorder which needs intensive drug treatment in the cluster periods. MATERIAL AND METHODS: All patients hospitalised for cluster headache (n = 37) at the Department of Neurology, Haukeland University Hospital 1988-1998 were studied. Data were retrieved from patient files and all patients were asked to fill in a postal questionnaire, which were returned by 27 (73%). RESULTS: Median age was 47 years, range 22-78 years. 28 patients were male. Ten of the patients had chronic cluster headache, all men. 20 out of 27 patients who answered the questionnaire used sumatriptan for acute attacks, 15 of them as subcutaneous injection. 17 patients had tried oxygen inhalation during an attack. Ten of the patients had tried prednisone as prophylactic treatment during a cluster, half of them with effect. Only two patients had tried verapamil and four had tried lithium. None of the patients had ever used valproate as drug prophylaxis. 18 of the patients smoked more than five cigarettes per day. INTERPRETATION: The treatment of cluster headache patients is at present suboptimal, both regarding symptomatic and prophylactic drugs.

Adult↗
PubMed2000

[Diagnosis and recent treatment of migraine].

This lecture discusses prevalence, diagnosis and recent treatment of migraine in Japan. It particularly emphasizes the necessity for better medical delivery to patients with migraine. The nationwide population study showed that migraine is just as common a disorder as in other countries. The overall prevalence of migraine was 8.4% among people aged 15 years or older. Severity of migraine was similar to previous reports from other countries. Migraine sufferers in Japan do not consult a physician regularly for the problem. Yet, approximately 70% of the migraine sufferers complained that migraine headache disturbed their daily activity to a major degree. With many migraine sufferers who deserve medical care, the necessity for improved medical care is beginning to be widely recognized. New medicine such as sumatriptan is on market now and its proper clinical use is important.

Adolescent↗
PubMed2002

Unexplained fitting in three parturients suffering from postdural puncture headache.

We present the cases of three women who, within a 6-month period, suffered post-partum generalized tonic-clonic seizures. All had received an epidural in labour for analgesia and were subsequently diagnosed as suffering from postdural puncture headache. All were treated for that headache with Synacthen and one also received sumatriptan before her seizures. All made satisfactory recoveries and were discharged home. None displayed classical patterns suggestive of pre-eclampsia, meningitis, cortical venous thrombosis or any other pathological process that might explain these events adequately, and the specific precipitating factors were left unidentified.

Adult↗
PubMed2003

Expression of serotonin receptors in mouse oocytes and preimplantation embryos.

Serotonin receptors have been found in several reproductive organs as well as in the central nervous system. Serotonin-binding sites have been demonstrated in duck ovarian follicles and the testis, hamster ovaries, human granulosa cells and mouse placenta. Local production of serotonin by the rat ovary, oviduct, uterus and testis has also been reported. We analyzed the expression of three types of serotonin receptors: 5-HT1B, 5-HT2C and 5-HT1D by reverse transcription-polymerase chain reaction in mouse unfertilized oocytes and preimplantation embryos from zygotes to the blastocyst stage in vivo. Transcripts for 5-HT1B and 5-HT2C serotonin receptors were detected neither in unfertilized oocytes nor at any stages of in vivo developing preimplantation embryos. Serotonin 5-HT1D receptor mRNA was present in unfertilized oocytes, zygotes, 2-cell embryos, compacted morulae and in vivo produced expanded blatocysts. The expression of the mRNA 5-HT1D serotonin receptor was also detected in blastocysts cultured in vitro. When added to the culture medium, specific serotonin 5-HT1D agonist sumatriptan (1 microM) significantly inhibited the development of mouse embryos cultured in vitro. Demonstration of the expression of 5-HT1D serotonin receptor in mouse oocytes and preimplantation embryos supports the idea of a functional serotonin (5-HT1D) receptor in early mammalian development.

Animals↗
PubMed2003

Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses.

The placebo and nocebo effect is believed to be mediated by both cognitive and conditioning mechanisms, although little is known about their role in different circumstances. In this study, we first analyzed the effects of opposing verbal suggestions on experimental ischemic arm pain in healthy volunteers and on motor performance in Parkinsonian patients and found that verbally induced expectations of analgesia/hyperalgesia and motor improvement/worsening antagonized completely the effects of a conditioning procedure. We also measured the effects of opposing verbal suggestions on hormonal secretion and found that verbally induced expectations of increase/decrease of growth hormone (GH) and cortisol did not have any effect on the secretion of these hormones. However, if a preconditioning was performed with sumatriptan, a 5-HT(1B/1D) agonist that stimulates GH and inhibits cortisol secretion, a significant increase of GH and decrease of cortisol plasma concentrations were found after placebo administration, although opposite verbal suggestions were given. These findings indicate that verbally induced expectations have no effect on hormonal secretion, whereas they affect pain and motor performance. This suggests that placebo responses are mediated by conditioning when unconscious physiological functions such as hormonal secretion are involved, whereas they are mediated by expectation when conscious physiological processes such as pain and motor performance come into play, even though a conditioning procedure is performed.

Aged↗
PubMedDate not supplied

[New aspects of therapy in hemicrania].

Within the pharmacological treatment of migraine it is possible to distinguish treatment of attacks and prevention therapy. The aim of attack treatment is to stop pain and accompanying symptoms, or at least to make them more tolerable, whereas the aim of prophylaxis is to reduce the frequency and possibly the severity and duration of the residual episodes. The choice to initiate either treatment, or both, is based on quantitative criteria, such as attack frequency (if greater than 2-3 per month, prophylaxis treatment is recommendable) and on qualitative features, like the degree of disability, the response and the tolerance of the patient to attack treatment. Prophylaxis treatment has not achieved any improvement since 1981, when propranolol was first utilized. The knowledge of the mechanisms of action of drugs used in prophylaxis, as well as their results, are at a standstill. Even with the newer calcium channel antagonists and beta-blockers we achieve a 50% reduction of attacks in less than half of subjects treated. On the other hand, we had important news in the treatment of migraine attacks. Sumatriptan, a selective agonist of serotonin receptors, represents a therapeutic novelty due both to the results obtained and to the studies that have been stimulated on the pathogenesis of migraine. New therapeutic perspectives are now opening and hopefully thanks to the cooperation of basic and clinical scientists, they might become a reality in a short time.

Adrenergic beta-Antagonists↗
PubMed1992

The pathophysiology of migraine: a tentative synthesis.

It is proposed that the migraine attack is explicable by an interaction between the brain and the cranial circulation in subjects with unstable vascular and pain-control mechanisms. While peptides are undoubtedly involved in vasodilatation, there is strong evidence that 5-HT plays an important part in the genesis of migraine. Whether the place of 5-HT lies in central pain-control pathways, in the serotonergic project to the cerebral cortex, in a direct action on the cranial blood vessels or in its action at all three sites remains uncertain. It seems probable that the primary action of sumatriptan or ergotamine in terminating migraine headache is exerted on the cerebral and extracranial circulation whereas medications employed in prophylaxis may act centrally.

Brain Stem↗