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Biomedical subjects

H Massiou

Publications and source records attributed to H Massiou.

At least 19 recordsLinked to original sources
PubMed2002

Efficacy of oral ketoprofen in acute migraine: a double-blind randomized clinical trial.

BACKGROUND: Certain nonsteroidal anti-inflammatory drugs are effective in the acute treatment of migraine attacks. The authors report a double-blind, placebo-controlled, randomized cross-over trial of a dual-release formulation of oral ketoprofen in the acute treatment of migraine attacks. METHODS: The authors compared the efficacy of two doses of ketoprofen (75 or 150 mg) with that of placebo (primary analysis) and zolmitriptan 2.5 mg (secondary analysis) on one to four consecutive attacks in 235 intent-to-treat patients (out of 257 randomized patients) with migraine with or without aura. The principal efficacy outcome was headache relief (reduction in headache severity from severe or moderate to mild or absent at 2 hours). RESULTS: Results are based on 838 attacks with a severe or moderate headache that were evaluable at 2 hours. Relief was reported for 62.6% of headaches treated with ketoprofen 75 mg, 61.6% with ketoprofen 150 mg, and 66.8% with zolmitriptan. The difference between the three active treatments and placebo (27.8% relief) was highly significant, both tests of ketoprofen vs placebo being globally controlled at a 5% level for the type I error (primary analysis). Headaches at 2 hours disappeared more frequently for the active treatments than for placebo. The authors also demonstrated efficacy on most other secondary outcomes. The tolerance of ketoprofen was good (similar to that of placebo). CONCLUSIONS: Oral ketoprofen (75 mg or 150 mg) in a dual-release formulation is an effective and well-tolerated drug in the acute treatment of migraine attacks.

Acute Disease↗
PubMed2002

Efficacy and tolerability of acetazolamide in migraine prophylaxis: a randomised placebo-controlled trial.

BACKGROUND: Familial hemiplegic migraine and episodic ataxia type 2 (EA2) are allelic disorders with distinct types of mutations in the CACNA1A gene. EA2 attacks are remarkably sensitive to acetazolamide, a carbonic anhydrase inhibitor. The effectiveness of acetazolamide in migraine prophylaxis is unknown. OBJECTIVES: To evaluate the efficacy and the tolerability of acetazolamide in migraine prophylaxis. METHODS: We compared daily oral 500 mg acetazolamide and placebo in patients with migraine in a multicentre, double-blind, randomised trial of 12 weeks duration after a run-in period of 4 weeks without treatment. Frequency of attacks at the last trial period of 4 weeks was the primary efficacy criterion. Secondary efficacy criteria were the frequency of attacks per 4 weeks, the severity and duration of attacks, the number of hours with migraine as well as the number of responders with more than 50% reduction in attack frequency. RESULTS: 53 patients had been enrolled when the study was prematurely stopped because of a high number of withdrawals (34%), primarily linked to acetazolamide related side effects. Considering the primary and secondary efficacy criteria, among the 53 included patients (27 in the placebo group and 26 in the acetazolamide group), no difference between the 2 study groups could be demonstrated. The most frequent adverse events related to acetazolamide were paresthesias and asthenia. CONCLUSIONS: In this trial, migraine sufferers poorly tolerated acetazolamide given in an oral dose of 500 mg daily. No obvious prophylactic beneficial effect of acetazolamide appeared on migraine attacks.

Acetazolamide↗
PubMed2002

A negative trial of sodium valproate in cluster headache: methodological issues.

We report the result of a double-blind placebo controlled study of sodium valproate (SV) (1000-2000 mg/day) in the prophylaxis of cluster headache CH. Episodic and chronic CH were defined according to the International Headache Society classification. Ninety-six patients were included, 50 in the SV group and 46 in the placebo group. After a 7-day run-in period, patients were treated for 2 weeks. The primary efficacy criterion was the percentage of patients successfully improved, i.e having an at least 50% reduction in the average number of attacks per week between the run-in period and the last week of treatment. Whatever the type of CH, there was no difference between the two groups: 50% of subjects in the SV group and 62% in the placebo group were successfully improved (P = 0.23). This high success rate observed in the placebo group, which is likely to be due to the spontaneous remission of the episode, does not allow us to draw any valid conclusion with regard to the true efficacy of SV in the prophylaxis of CH.

Adult↗
PubMed2002

Almotriptan is an effective and well-tolerated treatment for migraine pain: results of a randomized, double-blind, placebo-controlled clinical trial.

Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo (P=0.493) and significantly better tolerated than sumatriptan (P<0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between almotriptan 25 mg and sumatriptan 100 mg (P=0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, almotriptan, is an effective and well-tolerated treatment for migraine pain.

Administration, Oral↗
PubMed2001

Dose finding, placebo-controlled study of oral almotriptan in the acute treatment of migraine.

OBJECTIVE: To assess the efficacy and tolerability of oral almotriptan, a selective serotonin receptor (5-HT1B/1D) agonist, when used at different doses in the treatment of acute migraine. METHODS: This was a placebo controlled, double-blind, parallel-group, dose-finding study. Patients satisfying International Headache Society criteria for acute migraine were randomized to a single dose of placebo or oral almotriptan 2, 6.25, 12.5, or 25 mg at the onset of moderate or severe pain. Patients graded pain intensity on a 4-point verbal scale from 0 (no pain) to 3 (severe pain) and recorded adverse events. The primary efficacy variable was headache response at 2 hours. Data were analyzed on an intent-to-treat basis. RESULTS: Nine hundred and three patients were randomized, and 742 were included in the evaluation of the efficacy and tolerability. Headache response at 2 hours was 32.5% with placebo, and 30%, 56.3%, 58.5%, and 66.5% with almotriptan 2, 6.25, 12.5, and 25 mg doses (p < 0.05 for 6.25, 12.5, and 25 mg vs placebo). A dose-dependent decrease in the incidence of migraine-associated symptoms and the need for escape medication was observed. The incidence of adverse events with the almotriptan 2-mg, 6.25-mg, and 12.5-mg groups was comparable to that with the placebo group. CONCLUSION: Almotriptan 12.5 mg demonstrated the most favorable ratio between efficacy and tolerability, offering equivalent efficacy and better tolerability compared with the 25 mg dose. The minimum effective dose of almotriptan was 6.25 mg.

Acute Disease↗
PubMed2001

Effect of rizatriptan and other triptans on the nausea symptom of migraine: a post hoc analysis.

OBJECTIVE: To compare the effects of oral rizatriptan, sumatriptan, naratriptan, and zolmitriptan on the relief and emergence of nausea during a migraine attack. METHODS: Data from five randomized, placebo-controlled, double-blind clinical trials in which oral rizatriptan 10 mg was directly compared with oral sumatriptan 100 mg (N = 772), 50 mg (N = 1168), 25 mg (N = 1180), naratriptan 2.5 mg (N = 406), or zolmitriptan 2.5 mg (N = 571) for the acute treatment of a migraine attack were retrospectively analyzed. Migraine was diagnosed according to International Headache Society criteria. Presence or absence of nausea was recorded at baseline and at 0.5, 1, 1.5, and 2 hours after dosing. The end points analyzed were relief of nausea in those who had it at baseline and emergence of nausea in those who were free of it at baseline. Treatments were compared using odds ratios estimated from logistic regression models at 2 hours, and averaged odds ratios for the first 2 hours posttreatment. RESULTS: Approximately 60% of patients in each treatment group had nausea at baseline. In those patients with nausea at baseline, significantly more patients treated with rizatriptan 10 mg were free of nausea at 2 hours compared with sumatriptan 100 mg (66% versus 58%, P =.043), sumatriptan 50 mg (68% versus 57%, P =.010), sumatriptan 25 mg (68% versus 59%, P =.017), and naratriptan 2.5 mg (59% versus 45%, P =.014). Averaging over the four posttreatment time points in the first 2 hours, significantly more patients treated with rizatriptan 10 mg were free of nausea compared with sumatriptan 100 mg (P =.004), sumatriptan 50 mg (P =.001), and naratriptan 2.5 mg (P =.015). No significant differences in nausea relief were seen between rizatriptan 10 mg and zolmitriptan 2.5 mg, either at 2 hours (65% versus 61%, P =.210) or over the first 2 hours (P =.781). Rates of treatment-emergent nausea at 2 hours ranged from 11% to 18% with placebo, from 5% to 13% with rizatriptan 10 mg, and from 10% to 20% with other comparator triptans. CONCLUSIONS: Oral rizatriptan 10 mg was more effective than oral sumatriptan and naratriptan at eliminating nausea within 2 hours in patients who had it at baseline. Rates of emergent nausea in patients who were free of it at baseline were low, and no consistent differences were observed between active treatments.

Administration, Oral↗
PubMed2001

Naratriptan.

Naratriptan is a selective 5-HT(1B/1D) receptor agonist, with a high affinity at the 5-HT(1B), 5-HT(1D) and 5-HT(1F) receptor subtypes. Naratriptan contracts a number of large isolated cerebral arteries from several species, and has little contractile effect on peripheral blood vessels. It has an inhibitory effect on the cranial neurogenic inflammation model. The clinically recommended dose is 2.5 mg. It was found significantly superior to placebo on headache relief and pain free at 2 and 4 hours, and in relieving nausea, photophobia and phonophobia. It also has a good within-patient consistency, and a low recurrence rate. The side-effect profile is that of the triptan class, wih an incidence no different from placebo at the 25 mg dose. The contraindications are similar to any triptan, including coronary disease. Naratriptan is unlikely to affect metabolism of other drugs. In comparison sumatriptan 100 mg, naratriptan 2.5 mg has a slower onset of action and a lower response rate at 4 h, but it has a lower recurrence rate, and is better tolerated.

Humans↗
PubMed2001

[Idiopathic SUNCT (short lasting unilateral neuralgiform headache attacks with conjunctival injection, tearing, sweating and rhinorrhea) syndrome: 2 new cases].

The syndrome of short-lasting unilateral, neuralgiform attacks of pain in the peri orbital area associated with conjunctival injection and tearing (SUNCT) is a rare disorder affecting mainly males. We report two French patients (1 male and 1 female) with SUNCT syndrome, 27 and 28 years of age respectively. Both patients had short (30 sec), frequent (30-100/day) excruciating pain located at the peri orbital area, associated with conjunctival injection, tearing, rhinorrhea, ptosis and others vasomotor symptoms. Clinical examination and imaging were normal. Most drugs used in the treatment of migraine, cluster headache, trigeminal neuralgia, and other short-lasting headaches were not successful.

Adult↗
PubMed2000

[Quality of life of migraine patients after treatment with 2.5 mg oral naratriptan].

OBJECTIVES: The primary objective of this prospective, open, non controlled, multicenter study was to collect data on migraine patient's health related quality of life before and after treatment of their migraine attacks b naratriptan orl 2.5 mg over a 12 week period. METHODS: The impact on health related quality of life was evaluated by the mean change from pre-treatment scores on the French migraine health related quality of life specific questionnaire (QVM). RESULTS: 244 patients have been included in the study. A statistically significant score improvement in health related quality of life, as measured by the global score and the four scores related to the four dimensions of the QVM questionnaire (functional, psychological, social and therapeutic) was observed compared to the pre-treatment score values. At the end of the treatment period, 67% of patients preferred naratriptan oral 2.5 mg to their usual treatment. CONCLUSION: Those data suggest that the use of naratriptan oral 2.5 mg for the treatment of migraine attacks during a 12 week period may be associated with a significant improvement in migraine patient's quality of life.

Administration, Oral↗
PubMed2000

Rizatriptan in the treatment of menstrual migraine.

OBJECTIVE: To determine the efficacy of oral rizatriptan 10 mg and 5 mg for treating menstrually associated migraine attacks. METHODS: Data from two large clinical trials with identical designs were included in a retrospective analysis. The studies were randomized, double-masked, placebo-controlled, incomplete block, two-period, crossover designs. Women with migraines were randomly assigned to one of five treatment sequences for the treatment of two migraine attacks. Only data from the first attack in women with migraines who were treated with rizatriptan or placebo were included in the analysis. A menstrually associated attack was defined as one that occurred within 3 days before or after the onset of the last menstrual period. RESULTS: In the subgroup of 335 women with menstrually associated migraine, rizatriptan was effective compared with placebo. At 2 hours after dosing, 68% of 139 women taking rizatriptan 10 mg and 70% of 115 women taking rizatriptan 5 mg with a menstrually associated migraine had pain relief compared with 44% of 81 patients taking placebo (P <.05). In all women, rizatriptan was as effective in treating menstrual as well as nonmenstrual migraine: 68% of 139 patients taking rizatriptan 10 mg with a menstrually associated migraine had pain relief at 2 hours after dosing compared with 69% of 393 patients with nonmenstrually associated attacks (test of menstrual association = nonsignificant; the analysis had 80% power to detect a difference of six percentage points between groups). Similar results were found for rizatriptan 5 mg (menstrual = 70%, nonmenstrual = 66%; not statistically significant). CONCLUSION: Rizatriptan is effective in the treatment of menstrually associated migraine attacks.

Administration, Oral↗
PubMed2000

Migraine and headache in childhood and adolescence.

Headache is one of the most common physical complaints of children and adults. The authors have provided definitions of headache, a classification system, diagnostic evaluations appropriate for children, and treatment options for patients with acute and chronic headache. Also, this article has emphasized the importance of diagnosing and treating migraine headache, a painful malady that is extensively underestimated and misdiagnosed in the pediatric population and one that can be treated acutely and when appropriate prophylactically with great success. Lack of a specific biologic marker, specific investigation, or brain imaging reduce these clinical entities too often to a psychological illness. Nonpharmacologic treatments are pivotal to manage chronic headaches. Migraine therapy, if administered early and through the appropriate route, could provide important and rapid relief.

Adolescent↗
PubMed2000

[Female hormones and migraine].

All the hormonal events of the female life may modify the course of the migrainous disease. Their influence is slightly different on migraine with and without aura. Development of migraine at menarche and menstrually-related migraine attacks are principally observed in migraine without aura. Percutaneous estradiol is often effective for the prevention of pure menstrual migraine. Migraine usually improves during pregnancy; a worsening or a first development of attacks may nevertheless occur during this period, especially for migraine with aura. Oral contraception is not contraindicated in most migraine sufferers; it may worsen, improve or leave unchanged their disease. Migraine represents a risk factor of ischaemic stroke in young women; though a low one, some caution is necessary: tobacco should be forbidden, and the use of low-dose estrogen pills is recommended. Oral contraceptives should be interrupted in case of worsening of migraine, especially with aura. Estrogen replacement therapy is allowed after menopause in migraine sufferers; it may sometimes exacerbate migraine, which is in most cases controlled by therapeutic adjustment.

Contraceptives, Oral↗
PubMed2000

[Migraine and chronic headache in children].

In childhood and adolescence, migraine is the main essential chronic headache. This diagnosis is extensively underestimated and misdiagnosed in pediatric population. Lacks of specific biologic marker, specific investigation or brain imaging reduce these clinical entities too often to a psychological illness. Migraine is a severe headache evolving by stereotyped crises associated with marked digestive symptoms (nausea and vomiting); throbbing pain, sensitivity to sound, light are usual symptoms; the attack is sometimes preceded by a visual or sensory aura. During attacks, pain intensity is severe, most of children must lie down. Abdominal pain is frequently associated, rest brings relief and sleep ends often the attack. The prevalence of the migraine varies between 5p.100 and 10p.100 in childhood. At childhood, headache duration is quite often shorter than in adult population, it is more often frontal, bilateral (2/3 of cases) that one-sided. Migraine is a disabling illness: children with migraine lost more school days in a school year, than a matched control group. Migraine episodes are frequently triggered by several factors: emotional stress (school pressure, vexation, excitement: upset), hypoglycemia, lack of sleep or excess (week end migraine), sensorial stimulation (loud noise, bright light, strong odor, heat or cold.), sympathetic stimulation (sport, physical exercise). Attack treatments must be given at the early beginning of the crisis; oral dose of ibuprofen (10mg/kg) is recommended. If the oral route in not available when nausea or vomiting occurs, the rectal or nasal routes have then to be used. Non pharmacological treatments (biofeedback and interventions combining progressive muscle relaxation) have shown to have good efficacy as prophylactic measure. Daily prophylactic pharmacological treatments are prescribed in second line after failure of non-pharmacological treatment.

Adolescent↗
PubMed2000

[Prophylactic treatments of migraine].

Prophylactic treatment is mainly intended to reduce the frequency of migraine attacks. It is usually proposed to patients who suffer from two or more attacks per month. It should also be considered in patients who suffer from less frequent, but prolonged, disabling attacks with a poor response to abortive treatment, and who consider that their quality of life is reduced between attacks. Excessive intake of acute medication, more than twice a week, is a strong indication for prophylactic treatment. In order to obtain a good compliance to treatment, the patient must be informed of the expected efficacy of the drugs, and of their most frequent side effects. Thus, the choice of a prophylactic drug is made together with the patient. Based on the results of published controlled trials, the main prophylactic drugs are some betablockers, methysergide, pizotifene, oxetorone, flunarizine, amitriptyline, NSAIDs, and sodium valproate. Some less evaluated drugs such as aspirin, DHE, indoramine, verapamil, may be useful. Other substances such as riboflavin and new antiepileptic dugs are being evaluated. The choice of the drug to start with depends on several considerations. The first step is to make sure that there are no contra indications, and no possible interaction with the abortive medications. Then, possible side effects will be taken into account, for example, weight gain is a problem for most young women and patients who practice sports may not tolerate betablockers. Associated pathologies have to be checked. For example, a hypertensive migraine sufferers may benefit from betablockers; in a patient who suffers both from migraine and tension type headaches or from depression, amitriptyline is the first choice drug. The type of migraine should also be considered; for instance, in frequent attacks with aura, aspirin is recommended and betablockers avoided. In most cases, prophylaxis should be given as monotherapy, and it is often necessary to try successively several drugs before finding the most appropriate one. Doses should be increased gradually, in order to reach the recommended daily dose, only if tolerance permits. The treatment efficacy has to be assessed after 2 or 3 months, during which the patient must keep a headache diary. If the drug is judged ineffective, an overuse of symptomatic medications should be checked, as well as a poor compliance, either of which may be responsible. In case of a successful treatment, it should be continued for 6 or 12 months, and then, one should try to taper off the dose in order to stop the treatment or at least to find the minimum active dose. Relaxation, biofeedback, stress coping therapies, acupuncture are also susceptible to be effective in migraine prophylaxis.

Adrenergic beta-Antagonists↗