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1.  Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs. other triptans 
Neurological Sciences  2014;35(Suppl 1):99-105.
Migraine is three times as common in females as in males, and attacks may be more severe and difficult to treat in women. However, no study specifically addressed possible gender differences in response to antimigraine therapy. The objective of this study was to review the efficacy of frovatriptan vs. other triptans, in the acute treatment of migraine in subgroups of subjects classified according to gender (men vs. women) through a pooled analysis of three individual randomized Italian studies. 414 patients suffering from migraine with or without aura were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1–3 episodes of migraine in no more than 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, traditional migraine endpoints were compared between the 66 men and 280 women of the intent-to-treat population. At baseline, long-term and debilitating migraine attacks were more frequently reported by women than men. During the observation period, the proportion of pain-free attacks at 2 h did not significantly differ between frovatriptan and the comparators in either men (32 vs. 38 %, p = NS) or women (30 vs. 33 %, p = NS). Pain relief was also similar between treatments for both genders (men: 56 % frovatriptan vs. 57 % comparators; women: 55 vs. 57 %; p = NS for both). The rate of relapse was significantly lower with frovatriptan than with the comparators in men (24 h: 10 vs. 30 %; 48 h: 21 vs. 39 %; p < 0.05) as well as in women (24 h: 14 vs. 23 %; 48 h: 28 vs. 40 %; p < 0.05). The rate of adverse drug reactions was significantly larger with comparators, irrespectively of gender. Although migraine presents in a more severe form in women, frovatriptan seems to retain its good efficacy and favorable sustained antimigraine effect regardless of the gender.
doi:10.1007/s10072-014-1750-4
PMCID: PMC4035544  PMID: 24318560
Migraine; Gender; Frovatriptan; Rizatriptan; Zolmitriptan; Almotriptan
2.  Efficacy of early vs. late use of frovatriptan combined with dexketoprofen vs. frovatriptan alone in the acute treatment of migraine attacks with or without aura 
Neurological Sciences  2014;35(Suppl 1):107-113.
Early triptan use after headache onset may help improve the efficacy of acute migraine treatment. This may be particularly the case when triptan therapy is combined with a nonsteroidal anti-inflammatory drug (NSAID). The objective of this is to assess whether the combination of frovatriptan 2.5 mg + dexketoprofen 25 or 37.5 mg (FroDex25 and FroDex37.5) is superior to frovatriptan 2.5 mg alone (Frova) in the acute treatment of migraine attacks in patients who took the drug within 30 min from the onset of pain (early use) or after (late use). A total of 314 subjects with a history of migraine with or without aura were randomized into a double-blind, multicenter, parallel group, pilot study to Frova, FroDex25 or FroDex37.5 and were required to treat at least one migraine attack. In the present post hoc analysis, traditional migraine endpoints were compared across study drugs for subgroups of the 279 patients of the full analysis set according to early (n = 172) or late (n = 107) drug use. The proportion of patients pain free at 2 h in the early drug use subgroup was 33 % with Frova, 50 % with FroDex25 and 51 % with FroDex37.5 mg (p = NS combinations vs. monotherapy), while in the late drug use subgroup was 22, 51 and 50 % (p < 0.05 FroDex25 and FroDex37.5 vs. Frova), respectively. Pain-free episodes at 4 h were 54 % for early and 34 % for late use of Frova, 71 and 57 % with FroDex25 and 74 and 68 % with FroDex37.5 (p < 0.05 for early and p < 0.01 for late use vs. Frova). The proportion of sustained pain free at 24 h was 26 % under Frova, 43 % under FroDex25 mg and 40 % under FroDex37.5 mg (p = NS FroDex25 or 37.5 vs. Frova) in the early drug intake subgroup, while it was 19 % under Frova, 43 % under FroDex25 mg and 45 % under FroDex37.5 mg (p < 0.05 FroDex25 and FroDex37.5 vs. Frova) in the late drug intake subgroup. Risk of relapse at 48 h was similar (p = NS) among study drug groups (Frova: 25 %, FroDex25: 21 %, and FroDex37.5: 37 %) for the early as well as for the late drug use subgroup (14, 42 and 32 %). FroDex was found to be more effective than Frova taken either early or late. The intrinsic pharmacokinetic properties of the two single drug components made FroDex combination particularly effective within the 2–48-h window from the onset of the acute migraine attack. The efficacy does not seem to be influenced by the time of drug use relative to the onset of headache.
doi:10.1007/s10072-014-1751-3
PMCID: PMC4035546  PMID: 24867846
Migraine; Frovatriptan; Dexketoprofen; Early intake; Late intake
3.  Efficacy of frovatriptan versus other triptans in the acute treatment of menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies 
Neurological Sciences  2012;33(Suppl 1):65-69.
The objective of this study was to review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), in women with menstrually related migraine (IHS criteria) through a pooled analysis of three individual studies. Subjects with a history of migraine with or without aura were randomized to F 2.5 mg or R 10 mg (study 1), F or Z 2.5 mg (study 2), and F or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double-blind, crossover design. After treating three episodes of migraine in no more than 3 months with the first treatment, patients had to switch to the next treatment for other 3 months. 346 subjects formed intention-to-treat population of the main study; 280 of them were of a female gender, 256 had regular menses and 187 were included in the menstrual migraine subgroup analysis. Rate of pain free at 2, 4 and 24 h was 23, 52 and 67 % with F and 30, 61 and 66 % with comparators (P = NS). Pain relief episodes at 2, 4 and 24 h were 37, 60 and 66 % for F and 43, 55 and 61 % for comparators (P = NS). Rate of recurrence was significantly (P < 0.05) lower under F either at 24 h (11 vs. 24 % comparators) or at 48 h (15 vs. 26 % comparators). Number of menstrual migraine attacks associated with drug-related adverse events was equally low (P = NS) between F (5 %) and comparators (4 %).
doi:10.1007/s10072-012-1044-7
PMCID: PMC3362699  PMID: 22644174
Almotriptan; Menstrually related migraine; Frovatriptan; Rizatriptan; Zolmitriptan
4.  Frovatriptan versus zolmitriptan for the acute treatment of migraine with aura: a subgroup analysis of a double-blind, randomized, multicenter, Italian study 
Neurological Sciences  2012;33(Suppl 1):61-64.
Migraine with aura affects ~20–30 % of migraineurs and it is much less common than migraine without aura. The aim of this study was to compare the efficacy of frovatriptan 2.5 mg and zolmitriptan 2.5 mg in the treatment of migraine with aura. Analysis was carried out in a subset of 18 subjects with migraine with aura (HIS criteria) out of the 107 enrolled in a multicenter, randomized, double-blind, cross-over study. According to the study design, each patient had to treat three episodes of migraine in no more than 3 months with one drug, before switching to the other treatment. The rate of pain-free episodes at 2 h was significantly (p < 0.05) larger under frovatriptan (45.8 %) than under zolmitriptan (16.7 %). Pain free at 4 h, pain relief at 2 and 4 h and recurrent episodes were similar between the two treatments, while sustained pain-free episode was significantly (p < 0.05) more frequent during frovatriptan treatment (33.3 vs. 8.3 % zolmitriptan). Our study suggests that frovatriptan is superior to zolmitriptan in the immediate treatment of patients with migraine with aura, and it is capable of maintaining its acute analgesic effect over 48 h.
doi:10.1007/s10072-012-1043-8
PMCID: PMC3362723  PMID: 22644173
Migraine with aura; Frovatriptan; Zolmitriptan
6.  Dorsolateral medullary ischemic infarction causing autonomic dysfunction and headache: a case report 
The Journal of Headache and Pain  2012;13(4):327-330.
Stroke can present, among other signs, with headache. Here, we describe the case of a man suffering from severe orbitary pain and autonomic dysfunction secondary to dorsolateral medullary ischemia. The anatomical relationship between lesion and symptomatology could be an indirect sign of hypothalamospinal tract involvement in the genesis of autonomic dysfunction and headache resembling a trigeminal autonomic cephalalgia.
doi:10.1007/s10194-012-0427-8
PMCID: PMC3356466  PMID: 22374177
Stroke; Secondary headache disorders; Autonomic diseases
7.  Chronic migraine classification: current knowledge and future perspectives 
The Journal of Headache and Pain  2011;12(6):585-592.
In the field of so-called chronic daily headache, it is not easy for migraine that worsens progressively until it becomes daily or almost daily to find a precise and universally recognized place within the current international headache classification systems. In line with the 2006 revision of the second edition of the International Classification of Headache Disorders (ICHD-2R), the current prevailing opinion is that this headache type should be named chronic migraine (CM) and be characterized by the presence of at least 15 days of headache per month for at least 3 consecutive months, with headache having the same clinical features of migraine without aura for at least 8 of those 15 days. Based on much evidence, though, a CM with the above characteristics appears to be a heterogeneous entity and the obvious risk is that its definition may be extended to include a variety of different clinical entities. A proposal is advanced to consider CM a subtype of migraine without aura that is characterized by a high frequency of attacks (10–20 days of headache per month for at least 3 months) and is distinct from transformed migraine (TM), which in turn should be included in the classification as a complication of migraine. Therefore, CM should be removed from its current coding position in the ICHD-2 and be replaced by TM, which has more restrictive diagnostic criteria (at least 20 days of headache per month for at least 1 year, with no more than 5 consecutive days free of symptoms; same clinical features of migraine without aura for at least 10 of those 20 days).
doi:10.1007/s10194-011-0393-6
PMCID: PMC3208036  PMID: 22028184
Chronic migraine; Transformed migraine; Chronic daily headache; Chronic headache; Headache; Migraine
8.  Chronic migraine classification: current knowledge and future perspectives 
The Journal of Headache and Pain  2011;12(6):585-592.
In the field of so-called chronic daily headache, it is not easy for migraine that worsens progressively until it becomes daily or almost daily to find a precise and universally recognized place within the current international headache classification systems. In line with the 2006 revision of the second edition of the International Classification of Headache Disorders (ICHD-2R), the current prevailing opinion is that this headache type should be named chronic migraine (CM) and be characterized by the presence of at least 15 days of headache per month for at least 3 consecutive months, with headache having the same clinical features of migraine without aura for at least 8 of those 15 days. Based on much evidence, though, a CM with the above characteristics appears to be a heterogeneous entity and the obvious risk is that its definition may be extended to include a variety of different clinical entities. A proposal is advanced to consider CM a subtype of migraine without aura that is characterized by a high frequency of attacks (10–20 days of headache per month for at least 3 months) and is distinct from transformed migraine (TM), which in turn should be included in the classification as a complication of migraine. Therefore, CM should be removed from its current coding position in the ICHD-2 and be replaced by TM, which has more restrictive diagnostic criteria (at least 20 days of headache per month for at least 1 year, with no more than 5 consecutive days free of symptoms; same clinical features of migraine without aura for at least 10 of those 20 days).
doi:10.1007/s10194-011-0393-6
PMCID: PMC3208036  PMID: 22028184
Chronic migraine; Transformed migraine; Chronic daily headache; Chronic headache; Headache; Migraine
9.  A transient third cranial nerve palsy as presenting sign of spontaneous intracranial hypotension 
The Journal of Headache and Pain  2011;12(4):493-496.
Spontaneous intracranial hypotension is an uncommon cause of sudden and persistent headache: associated symptoms are common, among which there are cranial nerve palsies, especially of the abducens nerve. We report a case of a 21-year-old man with a transient and isolated third nerve palsy due to spontaneous intracranial hypotension. To our knowledge, there are only few reports in the literature of such association.
doi:10.1007/s10194-011-0345-1
PMCID: PMC3139088  PMID: 21544649
Intracranial hypotension; Third cranial nerve palsy; MRI; Epidural blood patch
10.  A transient third cranial nerve palsy as presenting sign of spontaneous intracranial hypotension 
The Journal of Headache and Pain  2011;12(4):493-496.
Spontaneous intracranial hypotension is an uncommon cause of sudden and persistent headache: associated symptoms are common, among which there are cranial nerve palsies, especially of the abducens nerve. We report a case of a 21-year-old man with a transient and isolated third nerve palsy due to spontaneous intracranial hypotension. To our knowledge, there are only few reports in the literature of such association.
doi:10.1007/s10194-011-0345-1
PMCID: PMC3139088  PMID: 21544649
Intracranial hypotension; Third cranial nerve palsy; MRI; Epidural blood patch
11.  Gingkolide B as migraine preventive treatment in young age: results at 1-year follow-up 
Neurological Sciences  2011;32(Suppl 1):197-199.
Primary headaches, migraine and tension-type headaches are some of the most frequent conditions in young age. Even before pharmacological treatment, it is mainly useful in these patients to adopt an appropriate lifestyle, with regular sleep, meals, computer and TV, sport, and avoiding triggers. Any specific and effective pharmacological treatment for migraine and tension-type headache is never lacking in side effects. Gingkolide B, an herbal constituent extract from Ginko biloba tree leaves, is a natural anti platelet activating factor (PAF). PAF is a potent pro inflammatory and nociceptive agent released during the inflammation process. Therefore, Gingkolide B can be considered a promising non pharmacological tool for treatment of migraine with and without aura. In an earlier clinical report, we described our initial attempts to assess the clinical utility of Gingkolide B in a small group of young migraine patients. A small sample of 30 young patients suffering from migraine without aura entered the open-label prospective trial. Migraine without aura was diagnosed according to International Headache Society (IHS) criteria. The treatment was well tolerated and the compliance was good. Despite the uncontrolled open-label design of this study and the small sample of patients, these data show that Gingkolide B seems to be effective as preventive treatment in reducing migraine attack frequency and in attenuating the use of symptomatic medication in our small series of children with primary headache.
doi:10.1007/s10072-011-0522-7
PMCID: PMC3084934  PMID: 21533745
Headache; Young age; Gingkolide B; Preventive treatment
12.  Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan 
Neurological Sciences  2011;32(Suppl 1):99-104.
Menstrually related migraine (MRM) is a particularly difficult-to-treat pain condition, associated with substantial disability. Aim of this study was to compare the efficacy and safety of frovatriptan and zolmitriptan in the treatment of MRM attacks, analyzing data from a multicenter, randomized, double blind, cross-over study. We analyzed the subset of 76 regularly menstruating women who participated in one head-to-head multicenter, randomized, double blind, cross-over clinical trial and who took the study drugs to treat MRM attacks. In a randomized sequence, each patient received frovatriptan 2.5 mg or zolmitriptan 2.5 mg: after treating three episodes of migraine in no more than 3 months with the first treatment, the patient had to switch to the other treatment. MRM was defined according to the criteria listed in the Appendix of the last Classification of Headache disorders of the International Headache Society. A total of 73 attacks, classified as MRM, were treated with frovatriptan and 65 with zolmitriptan. Rate of pain relief at 2 h was 52% for frovatriptan and 53% for zolmitriptan (p = NS), while rate of pain free at 2 h was 22 and 26% (p = NS), respectively. At 24 h, 74 and 83% of frovatriptan-treated and 69 and 82% of zolmitriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.05) lower with frovatriptan (15 vs. 22% zolmitriptan). Frovatriptan proved to be effective in the immediate treatment of MRM attacks, similarly to zolmitriptan, but showed lower recurrence rates, and thus a better sustained relief.
doi:10.1007/s10072-011-0547-y
PMCID: PMC3084939  PMID: 21533723
Frovatriptan; Migraine attacks; MRM; Zolmitriptan
13.  Almotriptan 12.5 mg in menstrually related migraine: A randomized, double-blind, placebo-controlled study 
Cephalalgia  2011;31(2):144-151.
Background: Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM.
Methods: Premenopausal women with MRM were randomized to almotriptan (N = 74) or placebo (N = 73), taken at onset of the first perimenstrual migraine. Patients crossed over to the other treatment for the first perimenstrual migraine of their second cycle, followed by a two-month open-label almotriptan treatment period.
Results: Significantly more patients were pain-free at two hours (risk ratio [RR] = 1.81; p = .0008), pain-free from 2–24 hours with no rescue medication (RR = 1.99; p = .0022), and pain-free from 2–24 hours with no rescue medication or adverse events (RR = 1.94; p = .0061) with almotriptan versus placebo. Nausea (p = .0007) and photophobia (p = .0083) at two hours were significantly less frequent with almotriptan. Almotriptan efficacy was consistent between three attacks, with 56.2% of patients pain-free at two hours at least twice. Adverse events were similar with almotriptan and placebo.
Conclusion: Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.
doi:10.1177/0333102410378048
PMCID: PMC3057443  PMID: 20660540
Almotriptan; headache; menstrually related migraine; placebo; randomized controlled trial
14.  Evolution of migraine-associated symptoms in menstrually related migraine following symptomatic treatment with almotriptan 
Neurological Sciences  2010;31(Suppl 1):115-119.
In addition to headache, migraine is characterized by a series of symptoms that negatively affects the quality of life of patients. Generally, these are represented by nausea, vomiting, photophobia, phonophobia and osmophobia, with a cumulative percentage of the onset in about 90% of the patients. From this point of view, menstrually related migraine—a particularly difficult-to-treat form of primary headache—is no different from other forms of migraine. Symptomatic treatment should therefore be evaluated not only in terms of headache relief, but also by considering its effect on these migraine-associated symptoms (MAS). Starting from the data collected in a recently completed multicentre, randomized, double-blind, placebo-controlled, cross-over study with almotriptan in menstrually related migraine, an analysis of the effect of this drug on the evolution of MAS was performed. Data suggest that almotriptan shows excellent efficacy on MAS in comparison to the placebo, with a significant reduction in the percentages of suffering patients over a 2-h period of time.
doi:10.1007/s10072-010-0302-9
PMCID: PMC2869014  PMID: 20464599
Acute treatment; Almotriptan; Menstrual migraine; Migraine-associated symptoms
15.  An innovative approach for migraine prevention in young age: a preliminary study 
Neurological Sciences  2010;31(Suppl 1):181-183.
Headache is one of the commonest conditions to affect children and adolescents in industrialized countries. Effective pharmacological treatments without side effects are still lacking. Ginkgolide B, an herbal constituent extract from ginkgo biloba tree leaves, is a natural antiplatelet activating factor (PAF). PAF is a potent proinflammatory and nociceptive agent released during the inflammation process. Therefore, Ginkgolide B can be considered a promising non-pharmacological tool for treatment of migraine with and without aura. We propose to determine the efficacy of Ginkgolide B as preventive treatment in a group of young patients suffering from migraine without aura. A small sample of 24 young patients suffering from migraine without aura entered the open-label prospective trial. Migraine without aura was diagnosed according to International Headache Society criteria. The treatment was well tolerated and the compliance was good. These preliminary data show that Ginkgolide B seems to be effective as preventive treatment in reducing migraine attack frequency and in attenuating the use of symptomatic medication in our small series of children with primary headache.
doi:10.1007/s10072-010-0321-6
PMCID: PMC2869015  PMID: 20464618
Headache; Young age; Ginkgolide B; Preventive treatment
16.  Frovatriptan versus zolmitriptan for the acute treatment of migraine: a double-blind, randomized, multicenter, Italian study 
Neurological Sciences  2010;31(Suppl 1):51-54.
The objective of this study is to assess patients’ satisfaction with migraine treatment with frovatriptan (F) or zolmitriptan (Z), by preference questionnaire. 133 subjects with a history of migraine with or without aura (IHS criteria) were randomized to F 2.5 mg or Z 2.5 mg. The study had a multicenter, randomized, double-blind, cross-over design, with each of the two treatment periods lasting no more than 3 months. At the end of the study, patients were asked to assign preference to one of the treatments (primary endpoint). The number of pain-free (PF) and pain-relief (PR) episodes at 2 h, and number of recurrent and sustained pain-free (SPF) episodes within 48 h were the secondary study endpoints. Seventy-seven percent of patients expressed a preference. Average score of preference was 2.9 ± 1.3 (F) versus 3.0 ± 1.3 (Z; p = NS). Rate of PF episodes at 2 h was 26% with F and 31% with Z (p = NS). PR episodes at 2 h were 57% for F and 58% for Z (p = NS). Rate of recurrence was 21 (F) and 24% (Z; p = NS). Time to recurrence within 48 h was better for F especially between 4 and 16 h (p < 0.05). SPF episodes were 18 (F) versus 22% (Z; p = NS). Drug-related adverse events were significantly (p < 0.05) less under F (3 vs. 10). In conclusion, our study suggests that F has a similar efficacy of Z, with some advantage as regards tolerability and recurrence.
doi:10.1007/s10072-010-0273-x
PMCID: PMC2869037  PMID: 20464583
Migraine; Frovatriptan; Zolmitriptan; Patient preference
17.  Hypothalamic deep brain stimulation in the treatment of chronic cluster headache 
Cluster headache (CH) is a short-lasting unilateral headache associated with ipsilateral craniofacial autonomic manifestations. A positron emission tomography (PET) study has shown that the posterior hypothalamus is activated during CH attacks, suggesting that hypothalamic hyperactivity plays a key role in CH pathophysiology. On this basis, stimulation of the ipsilateral posterior hypothalamus was hypothesized to counteract such hyperactivity to prevent intractable CH. Ten years after its introduction, hypothalamic stimulation has been proved to successfully prevent attacks in more than 60% of 58 hypothalamic implanted drug-resistant chronic CH patients. The implantation procedure has generally been proved to be safe, although it carries a small risk of brain haemorrhage. Long-term stimulation is safe, and nonsymptomatic impairment of orthostatic adaptation is the only noteworthy change. Microrecording studies will make it possible to better identify the target site. Neuroimaging investigations have shown that hypothalamic stimulation activates ipsilateral trigeminal complex, but with no immediate perceived sensation within the trigeminal distribution. Other studies on the pain threshold in chronically stimulated patients showed increased threshold for cold pain in the distribution of the first trigeminal branch ipsilateral to stimulation. These studies suggest that activation of the hypothalamus and of the trigeminal system are both necessary, but not sufficient to generate CH attacks. In addition to the hypothalamus, other unknown brain areas are likely to play a role in the pathophysiology of this illness. Hypothalamus implantation is associated with a small risk of intracerebral haemorrhage and must be performed by an expert neurosurgical team, in selected patients.
doi:10.1177/1756285610370722
PMCID: PMC3002651  PMID: 21179610
chronic cluster headache; deep brain stimulation; drug-resistant; hypothalamus; neuromodulation; neurostimulation; trigeminal autonomic cephalgias
18.  Headache, anxiety and depressive disorders: the HADAS study 
The Journal of Headache and Pain  2010;11(2):141-150.
The objective of this paper was to assess prevalence and characteristics of anxiety and depression in migraine without aura and tension-type headache, either isolated or in combination. Although the association between headache and psychiatric disorders is undisputed, patients with migraine and/or tension-type headache have been frequently investigated in different settings and using different tests, which prevents meaningful comparisons. Psychiatric comorbidity was tested through structured interview and the MINI inventory in 158 adults with migraine without aura and in 216 persons with tension-type headache or migraine plus tension-type headache. 49 patients reported psychiatric disorders: migraine 10.9%, tension-type headache 12.8%, and migraine plus tension-type headache 21.4%. The MINI detected a depressive episode in 59.9, 67.0, and 69.6% of cases. Values were 18.4, 19.3, and 18.4% for anxiety, 12.7, 5.5, and 14.2%, for panic disorder and 2.3, 1.1 and 9.4% (p = 0.009) for obsessive–compulsive disorder. Multivariate analysis showed panic disorder prevailing in migraine compared with the other groups (OR 2.9; 95% CI 1.2–7.0). The association was higher (OR 6.3; 95% CI 1.4–28.5) when migraine (with or without tension-type headache) was compared to pure tension-type headache. This also applied to obsessive–compulsive disorder (OR 4.8; 95% CI 1.1–20.9) in migraine plus tension-type headache. Psychopathology of primary headache can reflect shared risk factors, pathophysiologic mechanisms, and disease burden.
doi:10.1007/s10194-010-0187-2
PMCID: PMC3452290  PMID: 20108021
Migraine; Tension-type headache; Depression; Anxiety; Prevalence
19.  Topiramate in the prevention of migraine: a review of its efficacy, tolerability, and acceptability 
This paper reviews the results of placebo-controlled trials on topiramate (TPM) in the prophylaxis of migraine, focusing particularly on efficacy and tolerability of the target dose (100 mg/day). Data from well-conducted trials and analyses of pooled data show that TPM is effective against migraine, confirming the experience of physicians in various countries. High responder rate and good tolerability following slow titration suggest TPM as a first-line option for migraine prophylaxis. Patient acceptability may be enhanced by lack of weight gain, lack of major contraindications, and positive effects on quality of life.
PMCID: PMC2671823  PMID: 19412473
migraine; topiramate; prophylaxis; clinical trials; tolerability; acceptability
20.  Disability and migraine: recent outcomes using an Italian version of MIDAS 
The Journal of Headache and Pain  2003;4(Suppl 1):s42-s46.
Migraine is associated with functional impairment. The migraine disability assessment (MIDAS) questionnaire is a scientific instrument which captures headache-related disability. The Italian version of MIDAS was developed through a multistep standardized methodology. Studies on Italian clinical samples confirmed that migraine patients are disabled in all activity domains. Migraine exhibits a peculiar disability pattern: non-work activities are more affected than work activities; among patients in paid work, most continue working with a headache attack. We also found that MIDAS disability grades correlate with health-related quality of life scores at the SF-36 survey, namely with the extent to which physical health, emotional state and pain interfere with functioning in different roles. We conclude that MIDAS (also in its Italian version) is a reliable and useful instrument for assessing the impact of migraine on patients' daily activities, and that it can used not only in clinical practice but also in clinical research.
doi:10.1007/s101940300008
PMCID: PMC3611676
Key words Migraine; Disability; Migraine disability assessment questionnaire (MIDAS); Italian version; Disability pattern; Health-related quality of life
21.  The serotonergic system in migraine 
The Journal of Headache and Pain  2001;2(Suppl 1):s43-s46.
Serotonin (5–HT) and serotonin receptors play an important role in migraine pathophysiology. Changes in platelet 5–HT content are not casually related, but they may reflect similar changes at a neuronal level. Seven different classes of serotoninergic receptors are known, nevertheless only 5–HT2B–2C and 5HT1B–1D are related to migraine syndrome. Pharmacological evidences suggest that migraine is due to an hypersensitivity of 5–HT2B–2C receptors. m–Chlorophenylpiperazine (mCPP), a 5–HT2B–2C agonist, may induce migraine attacks. Moreover different pharmacological preventive therapies (pizotifen, cyproheptadine and methysergide) are antagonist of the same receptor class. On the other side the activation of 5–HT1B–1D receptors (triptans and ergotamines) induce a vasocostriction, a block of neurogenic inflammation and pain transmission.
doi:10.1007/s101940170008
PMCID: PMC3451809
Serotonin; Migraine; Triptans; m–Chlorophenylpiperazine; Pathogenesis
22.  Disability in migraine patients: Italian experience 
The Journal of Headache and Pain  2001;2(Suppl 1):s29-s31.
Migraine is associated with functional impairment. The migraine disability assessment (MIDAS) scale is a scientific instrument which captures headache–related disability. The Italian version of MIDAS was developed through a multi–step standardized methodology. Studies on Italian clinical samples showed that migraine patients were disabled in all activity domains. Non–work activities were more affected than work activities. Among patients in paid work, most continued working with a headache attack, although productivity was significantly reduced. The Italian MIDAS was used also in patients with transformed migraine and drug overuse. These patients were markedly disabled. MIDAS scores were higher than those found in migraine patients. When disability was assessed after 6 months from withdrawal therapy, MIDAS scores were significantly lower than at baseline. Our results confirmed the negative impact of the lives of headache patients, and suggest the use of MIDAS as a sensitive outcome measure for monitoring patients’ progress.
doi:10.1007/s101940170006
PMCID: PMC3451815
Migraine; Disability; Transformed migraine; Migraine disability assessment (MIDAS); Outcome measure
23.  Disability and migraine: MIDAS 
The Journal of Headache and Pain  2001;2(Suppl 1):s25-s27.
Migraine is an heterogeneous disorder. Most patients are disabled both in work and in non–work activities. Different instruments to assess migraine–related disability have been developed. Among these, the migraine disability assessment (MIDAS) questionnaire is the most studied. Population–based studies have shown that MIDAS is a simple but reliable and scientifically sound instrument. This instrument improves patient–physician communication. It can help healthcare professionals to understand migraine severity in individual patients, and rapidly assess treatment needs (screening instrument). Furthermore, reduction in headache–related disability is a major goal of migraine treatment. Change in MIDAS score after treatment intervention may be a useful end point, both in everyday practice and in clinical trials. Ongoing studies will confirm the potential of MIDAS as a valid outcome measure.
doi:10.1007/s101940170005
PMCID: PMC3451820
Migraine; Disability; Migraine disability assessment (MIDAS) questionnaire; Communication; Outcome measure
24.  Menstrual migraine 
The Journal of Headache and Pain  2001;2(Suppl 1):s117-s119.
An association between migraine and menstruation can be ascertained by use of a diary for a minimum of three cycles. The pathophysiological and clinical peculiarities of menstrual migraine indicate that its management should differ from that of non–menstrual migraine. NSAIDS or migraine-specific medications (e.g. triptans) are often effective for the acute management of menstrual migraine. Preventive treatment is indicated when the attacks are long–lasting, severe and disabling and do not respond to acute treatments. Short–term prophylaxis (at the time of headache vulnerability) employs standard drugs such as magnesium, ergotamine or NSAIDs; triptans are currently being evaluated for short–term prophylaxis. If severe menstrual migraine attacks cannot be controlled by these, hormone therapy (percutaneous or transdermal estrogen) may be indicated. Antiestrogen agents (danazol, tamoxifen) are indicated only in rare resistant cases.
doi:10.1007/s101940170023
PMCID: PMC3451824
Menstruation; Migraine; Therapy; Sex hormones
25.  New strategies for the treatment of migraine attacks 
The Journal of Headache and Pain  2001;2(Suppl 1):s113-s115.
There is no consensus on which treatment strategy should be used in the acute therapy of migraine. A stratified care approach based on patient’s disabilty assessed by a valid instrument (the MIDAS questionnaire) has been proposed. An international controlled study, the DISC trial, showed that stratified care provided better clinical outcomes than step care across attacks or within attacks. An Italian study invited migraine patients with moderate– severe disability to treat 9 attacks according to one of two strategies: stratified care (i.e. triptans from the outset) or step care across attacks (i.e. with drug escalation from non–specific drugs to triptans, if the response was not satisfactory). This study should provide data useful for assessing the optimal treatment strategy in migraine.
doi:10.1007/s101940170022
PMCID: PMC3451825
Migraine;  Acute treatment; Step care; Stratified care; Triptans

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