- Email: [email protected]
1-21-01 Efficacy and tolerability of sumatriptan nasal spray: A review of United States studies
Headache
S32
21
tures and common precipitors diagnosis and treatment.
Headache
l-21 -04 l-21 -01 M. Asgharnejad, NC, USA
Efficacy and tolerability of sumatriptan A review of United States studies S. DeBussey.
Glaxo
We//come
Inc., Research
nasal spray: 7iiang/e Park,
Objective: This review summarizes experience with sumatriptan nasal spray in 3 double-blind, parallel-group, placebo-controlled studies conducted in the United States. Methods: Adult migraineurs used sumatriptan nasal spray (20 mg or 10 mg in all studies; 5 mg in the multiple-attack study) or placebo to treat a single migraine attack (two studies; n = 409 and 438) or up to 3 migraine attacks (one study; n = 1086) in 6 months. Reeults: Across studies, headache relief (moderate or severe predose pain reduced to mild or none) 2 hours pcstdose was experienced by 69% to 63% of patients treated with sumatriptan 20 mg compared with 43% to 54% and 29% to 35% of patients treated with sumatriptan 10 mg and placebo, respectively. Onset of relief relative to placebo began as early as 15 minutes postdose. Clinical disability scores of mild or none 2 hours postdose were reported for 70% to 74% of patients treated with sumatriptan 20 mg compared with 56% to 66% and 47% to 56% of patients treated with sumatrfptan IO mg and placebo, respectively. Similar efficacy rates at each study drug dose were observed in each study for nausea, photophobia, and phonophobia. In the multiple-attack study, individual-attack efficacy rates were comparable to across-attack efficacy rates. The most frequently reported adverse event in the active treatment groups was taste disturbance (bad, bitter, or unpleasant taste.) Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. Conclusions: Sumatrfptan nasal spray (10 mg and 20 mg) was rapidly effective and well-tolerated in the acute treatment of migraine across several studies. The dose offering the optimal efficacy-to-tolerability ratio is 20 mg.
11-21-021 -
Considerations migraine
on oral therapy. - with Sumatriptan
0. Bajenaru ‘, C. Tiu’, F. Antochi ‘, C. Panea’, D. Marfnescu ‘, A. Roceanu M. Gutu 2, N. Fabian 2. ’ University Hospital Bucharest, Bucuresti, Romania, 2 Glaxo- We//come-Bucharest, Bucuresti, Romania
in ‘,
The authors report the results of an open study including 30 patients, 16 males and 12 females, with mean age 32 f 12 years, with diagnostic of common migraine (18 patients - 60%) or neurologic migraine (12 patients - 40%). The patients were selected on clinical criterlas. We excluded the possibility of an intracranian aneurysm or ischaemic cardiopathy using the specific investigations. Arterial blood pressure of all patients ranged between: 105&Y?-160/100 mm Hg. They filled out a fonnular wiht the evolutive characteristics of pain and the associated symptoms before and after the administration of an oral dose of 100 mg Sumatriptan (Imigran) during the headache. The results showed that the headache disappeared in all patients after 90 f 10 minutes after the adminitration; in 60% of cases the headache ceased during the first 15 minutes after administration. It was also an improvement of the associated symptoms excepting one patient with nausea and vomiting at 60 minutes after the administration of Sumatriptan. None of the included patients had cardiac symptomatology after the administration of Sumatritan. The majority of cases, a facial rush and transient paresthesiae in the facial skin appeared. No electrocardiographic changes appeared after the administration of the drug.
[l-21 -03 1 Post-lumbar
puncture
headache
L.M. Barea, R. Targa, D. Orsato, M. Ribeiro. Departament Medical Sciences University Port0 Alegre, RS, Brazil
of Neurology;
Headache is the most common complication of lumbar puncture (LP), ocurring in 15 to 30% of patients. A cross-sectional study was conducted to estimate the frequency and clinical features of headache among the patients that were admitted during a 6 months period in the Departament of Neurology of Complexo Hospitalar Santa Casa and were underwent a diagnostic LP. In this study 61 patients, aged 15-74 years (Means: 36 ys) were interviewed before the LP and in the 6th day after LP. A postural headache relieve by Lying Supine, occurs after 46% of LP procedure performed with 22 gauge Quincke needles. Patients reporting headache before LP were more likely to report post-LP headache. CSF opening pressure, cells, protein and the amount of CFS removed at the time of LP did not influence the ocurrence of headache. The knowledge of clinical fea-
of post-LP
Headache in Parkinson’s risk factors
headache
is of value for the correct
disease: An evaluation
of
Kemal Bayiilkem t , Mehmet Turgut’, Ali Akyol ’ , Hirlya Gene1 ’ ’ Dept. of Neurolog): Adnan Menderes University School of Medicine, Aydtn, Turk88 2Dept. of Neurosurgery; Adnan Menderes University School of Medicine, Aydm, Turkey Parkinson’s disease (PD) is characterized by degeneration of pigmented dopamine in the substantia nigra resulting in reduced levels of dopamine in the neostriatum. Headache is encountered in about one third of Parkinson’s patients and antidepressant drugs appears to be effective in treating it. In this study, the clinical features of 13 patients of PD were evaluated retrospectively. of the 13 patients, 8 were female and 5 were male, with mean age of 67.8. Headache was a dull, sometimes continous and it was located predominately in the nuchal region. Nuchal rigidity was present in 5 of 13 Parkinson’s patients with headaches. Four patients were treated with common analgesics such as aspirin or acetaminophen and the remaining 9 patients were treated with piroksikam. The total dose of piroksikam was 40 mg. Analgesic efficacy was assessed daily using a visual analogue scale and a qualitative scale. There was no consistent effect of levodopa on dopamine agonist treatment on the pain sensation of PD. The results of this study suggest that there is no correlation between headache and the degree of rigidity in the nuchal region.
1 l-21 -05 1 Headache prevalence and characteristics university students in Hungary Gy. Bozsik, I. Jelencsik, Semmelweis University
among
Cs. Ertsey, J. Afra. Department of Neurology Medical School, Budapest, Hungary
There is no sufficient data concerning the epidemiology of headache in Hungary. One recent survey assessing the prevalence of migraine in urban and rural communities has shown headache at 47.0 per cent and migraine at 9.6 per cent of subjects. There was no significant difference between rural and urban population in the occurrence and features of migraine. The aim of our present study was to evaluate the headache prevalence and characteristics among hungarian university students. 228 volunteers were involved (113 male, 115 female, aged between 23-28 years). The data were collected by self-administered questionnaire. 180 (78.9%) students reported headache during a one year period. Using the diagnostic criteria for headaches of International Headache Society we found that 36 (15.8%) of them had suffered from migraine, 113 (49.5%) had had episodic tension type headache and 31 (13.8%) mixed type headache. The headache characteristics, validity and reliability of the headache questonnaires are reviewed and discussed on the poster.
1 21 06 Lx-l
lsosorbide dinitrate effects on cerebral haemodynamics in migraine are potentiated by indomethacin: Possible pathogenetic implications?
P. Bellantonio, G. Micieli, M.G. Buzzi, A.E. Castellano, N. Bernareggi r, F. Rossi, G. Nappi. FECS Neuromed, Pozzi//i (E), Pavia, /ta/x ’ RCCS “C. Mondino” Pavia, /ta/y Haemodynamic changes induced by the NOdonor lsosorbide Dinitrate (IDN, 5 mg sublingually) have been demonstrated as greater and long-lasting among migraine patients who will develop a delayed response to the drug, thus sug gesting the existence of neuronal other than vascular mechanism mediating such response. The role of nitric oxide (NO) in the delayed phase of spontaneous-like migraine attack is still poorly understood. An interesting model for evaluating vascular mechanisms in nitrate-induced migraine is offered by lndomethacin (I) administration, a drug which is highly used and effective in aborting migraine pain. One of its mechanism of action is inhibition of vascular effects of prostaglandin E2 mediated via prostacyclin receptors coupled to adenyl cyclase. Cerebral vasomotor responses induced by I (50 mg/30’ i.v.). have been evaluated in migraine patients and in healthy controls during IDN test. I was given at different times of the test: before (group A), during the early stage (group 8) and during the delayed headache/vascular response (group C). Haemodynamic changes were followed with transcranial Doppler measurements at middle cerebral artery (MCA) level, along to heart rate, blood pressure and End-Tfdal CO2 changes. At least 9 patients and controls were studied for each group. I induced significant decrease in MCA mean velocity (Vm) when given either prior to or after IDN. In migraine patients l-induced Vm decrease appeared larger after IDN administration both in early and delayed phases, the occurrence of spontaneous-like headache being associated in these cases to a significant Vm decrease, as previously reported by us. I worsened this Vm decrease, inducing a therapeutic effect usually during the 30’ administration.
S32
21
tures and common precipitors diagnosis and treatment.
Headache
l-21 -04 l-21 -01 M. Asgharnejad, NC, USA
Efficacy and tolerability of sumatriptan A review of United States studies S. DeBussey.
Glaxo
We//come
Inc., Research
nasal spray: 7iiang/e Park,
Objective: This review summarizes experience with sumatriptan nasal spray in 3 double-blind, parallel-group, placebo-controlled studies conducted in the United States. Methods: Adult migraineurs used sumatriptan nasal spray (20 mg or 10 mg in all studies; 5 mg in the multiple-attack study) or placebo to treat a single migraine attack (two studies; n = 409 and 438) or up to 3 migraine attacks (one study; n = 1086) in 6 months. Reeults: Across studies, headache relief (moderate or severe predose pain reduced to mild or none) 2 hours pcstdose was experienced by 69% to 63% of patients treated with sumatriptan 20 mg compared with 43% to 54% and 29% to 35% of patients treated with sumatriptan 10 mg and placebo, respectively. Onset of relief relative to placebo began as early as 15 minutes postdose. Clinical disability scores of mild or none 2 hours postdose were reported for 70% to 74% of patients treated with sumatriptan 20 mg compared with 56% to 66% and 47% to 56% of patients treated with sumatrfptan IO mg and placebo, respectively. Similar efficacy rates at each study drug dose were observed in each study for nausea, photophobia, and phonophobia. In the multiple-attack study, individual-attack efficacy rates were comparable to across-attack efficacy rates. The most frequently reported adverse event in the active treatment groups was taste disturbance (bad, bitter, or unpleasant taste.) Aside from this event, the pattern and incidence of adverse events did not differ among treatment groups. Conclusions: Sumatrfptan nasal spray (10 mg and 20 mg) was rapidly effective and well-tolerated in the acute treatment of migraine across several studies. The dose offering the optimal efficacy-to-tolerability ratio is 20 mg.
11-21-021 -
Considerations migraine
on oral therapy. - with Sumatriptan
0. Bajenaru ‘, C. Tiu’, F. Antochi ‘, C. Panea’, D. Marfnescu ‘, A. Roceanu M. Gutu 2, N. Fabian 2. ’ University Hospital Bucharest, Bucuresti, Romania, 2 Glaxo- We//come-Bucharest, Bucuresti, Romania
in ‘,
The authors report the results of an open study including 30 patients, 16 males and 12 females, with mean age 32 f 12 years, with diagnostic of common migraine (18 patients - 60%) or neurologic migraine (12 patients - 40%). The patients were selected on clinical criterlas. We excluded the possibility of an intracranian aneurysm or ischaemic cardiopathy using the specific investigations. Arterial blood pressure of all patients ranged between: 105&Y?-160/100 mm Hg. They filled out a fonnular wiht the evolutive characteristics of pain and the associated symptoms before and after the administration of an oral dose of 100 mg Sumatriptan (Imigran) during the headache. The results showed that the headache disappeared in all patients after 90 f 10 minutes after the adminitration; in 60% of cases the headache ceased during the first 15 minutes after administration. It was also an improvement of the associated symptoms excepting one patient with nausea and vomiting at 60 minutes after the administration of Sumatriptan. None of the included patients had cardiac symptomatology after the administration of Sumatritan. The majority of cases, a facial rush and transient paresthesiae in the facial skin appeared. No electrocardiographic changes appeared after the administration of the drug.
[l-21 -03 1 Post-lumbar
puncture
headache
L.M. Barea, R. Targa, D. Orsato, M. Ribeiro. Departament Medical Sciences University Port0 Alegre, RS, Brazil
of Neurology;
Headache is the most common complication of lumbar puncture (LP), ocurring in 15 to 30% of patients. A cross-sectional study was conducted to estimate the frequency and clinical features of headache among the patients that were admitted during a 6 months period in the Departament of Neurology of Complexo Hospitalar Santa Casa and were underwent a diagnostic LP. In this study 61 patients, aged 15-74 years (Means: 36 ys) were interviewed before the LP and in the 6th day after LP. A postural headache relieve by Lying Supine, occurs after 46% of LP procedure performed with 22 gauge Quincke needles. Patients reporting headache before LP were more likely to report post-LP headache. CSF opening pressure, cells, protein and the amount of CFS removed at the time of LP did not influence the ocurrence of headache. The knowledge of clinical fea-
of post-LP
Headache in Parkinson’s risk factors
headache
is of value for the correct
disease: An evaluation
of
Kemal Bayiilkem t , Mehmet Turgut’, Ali Akyol ’ , Hirlya Gene1 ’ ’ Dept. of Neurolog): Adnan Menderes University School of Medicine, Aydtn, Turk88 2Dept. of Neurosurgery; Adnan Menderes University School of Medicine, Aydm, Turkey Parkinson’s disease (PD) is characterized by degeneration of pigmented dopamine in the substantia nigra resulting in reduced levels of dopamine in the neostriatum. Headache is encountered in about one third of Parkinson’s patients and antidepressant drugs appears to be effective in treating it. In this study, the clinical features of 13 patients of PD were evaluated retrospectively. of the 13 patients, 8 were female and 5 were male, with mean age of 67.8. Headache was a dull, sometimes continous and it was located predominately in the nuchal region. Nuchal rigidity was present in 5 of 13 Parkinson’s patients with headaches. Four patients were treated with common analgesics such as aspirin or acetaminophen and the remaining 9 patients were treated with piroksikam. The total dose of piroksikam was 40 mg. Analgesic efficacy was assessed daily using a visual analogue scale and a qualitative scale. There was no consistent effect of levodopa on dopamine agonist treatment on the pain sensation of PD. The results of this study suggest that there is no correlation between headache and the degree of rigidity in the nuchal region.
1 l-21 -05 1 Headache prevalence and characteristics university students in Hungary Gy. Bozsik, I. Jelencsik, Semmelweis University
among
Cs. Ertsey, J. Afra. Department of Neurology Medical School, Budapest, Hungary
There is no sufficient data concerning the epidemiology of headache in Hungary. One recent survey assessing the prevalence of migraine in urban and rural communities has shown headache at 47.0 per cent and migraine at 9.6 per cent of subjects. There was no significant difference between rural and urban population in the occurrence and features of migraine. The aim of our present study was to evaluate the headache prevalence and characteristics among hungarian university students. 228 volunteers were involved (113 male, 115 female, aged between 23-28 years). The data were collected by self-administered questionnaire. 180 (78.9%) students reported headache during a one year period. Using the diagnostic criteria for headaches of International Headache Society we found that 36 (15.8%) of them had suffered from migraine, 113 (49.5%) had had episodic tension type headache and 31 (13.8%) mixed type headache. The headache characteristics, validity and reliability of the headache questonnaires are reviewed and discussed on the poster.
1 21 06 Lx-l
lsosorbide dinitrate effects on cerebral haemodynamics in migraine are potentiated by indomethacin: Possible pathogenetic implications?
P. Bellantonio, G. Micieli, M.G. Buzzi, A.E. Castellano, N. Bernareggi r, F. Rossi, G. Nappi. FECS Neuromed, Pozzi//i (E), Pavia, /ta/x ’ RCCS “C. Mondino” Pavia, /ta/y Haemodynamic changes induced by the NOdonor lsosorbide Dinitrate (IDN, 5 mg sublingually) have been demonstrated as greater and long-lasting among migraine patients who will develop a delayed response to the drug, thus sug gesting the existence of neuronal other than vascular mechanism mediating such response. The role of nitric oxide (NO) in the delayed phase of spontaneous-like migraine attack is still poorly understood. An interesting model for evaluating vascular mechanisms in nitrate-induced migraine is offered by lndomethacin (I) administration, a drug which is highly used and effective in aborting migraine pain. One of its mechanism of action is inhibition of vascular effects of prostaglandin E2 mediated via prostacyclin receptors coupled to adenyl cyclase. Cerebral vasomotor responses induced by I (50 mg/30’ i.v.). have been evaluated in migraine patients and in healthy controls during IDN test. I was given at different times of the test: before (group A), during the early stage (group 8) and during the delayed headache/vascular response (group C). Haemodynamic changes were followed with transcranial Doppler measurements at middle cerebral artery (MCA) level, along to heart rate, blood pressure and End-Tfdal CO2 changes. At least 9 patients and controls were studied for each group. I induced significant decrease in MCA mean velocity (Vm) when given either prior to or after IDN. In migraine patients l-induced Vm decrease appeared larger after IDN administration both in early and delayed phases, the occurrence of spontaneous-like headache being associated in these cases to a significant Vm decrease, as previously reported by us. I worsened this Vm decrease, inducing a therapeutic effect usually during the 30’ administration.