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Biomedical subjects

M Frontoni

Publications and source records attributed to M Frontoni.

At least 19 recordsLinked to original sources
PubMed2003

Interferon beta treatment of MS in the daily clinical setting: a 3-year post-marketing study.

We performed a post-marketing study of patients with multiple sclerosis (MS) attending the outpatient service to evaluate the impact of interferon beta-1b (IFNbeta-1b) in the daily clinical setting. The absolute changes in relapse frequency and in the mean EDSS score over a three-year period were compared between 83 patients with relapsing remitting MS treated with IFNbeta-1b and 83 RRMS patients who did not take the drug. Annualized relapse frequency significantly decreased in patients undergoing therapy while no statistically significant changes in EDSS score were observed. These findings point out the role of post-marketing studies in evaluating the impact of approved drugs in the daily clinical setting in terms of safety and tolerability. Furthermore, our results confirm the positive effect of immunomodulatory treatment in decreasing the occurrence of inflammatory events.

Adult↗
PubMed2003

Can the Expanded Disability Status Scale be assessed by telephone?

Information from patients who are unable to continue their visits to a study centre may be of major importance for the interpretation of results in multiple sclerosis (MS) clinical trials. To validate a questionnaire based on the Expanded Disability Status Scale (EDSS), patients in five different European centres were assessed independently by pairs of trained EDSS raters, first by telephone interview and a few days later by standardized neurological examination. Seventy women and 40 men with an average age of 43.7 years (range 19-74 years) were included in the study. Mean EDSS score at the last visit was 4.5 (0-9). EDSS assessment by telephone was highly correlated with the EDSS determined by physical examination (Pearson's correlation coefficient = 0.95). An intraclass correlation coefficient (ICC) of 94.8% was found for the total sample; 77.6% and 86%, respectively, for patients with EDSS < 4.5 (n = 46) and > 4.5 (n = 64). Kappa values for full agreement were 0.48; for variation by +0.5 steps and +1.0 steps, 0.79 and 0.90, respectively. Best agreement could be found in higher EDSS scores, where assessment by telephone interview might be needed most. The telephone questionnaire is a valid tool to assess EDSS score in cases where the patient is unable to continue visiting a study centre or in long-term follow-up of trial participants.

Adult↗
PubMed1999

MRI in multiple sclerosis during the menstrual cycle: relationship with sex hormone patterns.

We investigated MRI activity in MS during the menstrual cycle in relation to physiologic sex hormone fluctuations. Eight women with relapsing-remitting MS were submitted to serial brain gadolinium-enhanced MRI examinations over a 3-month period in two alternate follicular and luteal phases of the menstrual cycle. The ratio of progesterone/17-beta-estradiol during the luteal phase was significantly associated with both number (r = 0.6, p = 0.03) and volume (r = 0.7, p = 0.009) of enhancing lesions, providing support for a role of these hormones as immunomodulatory factors in MS.

Adult↗
PubMed1999

Magnetic resonance imaging outcome of new enhancing lesions in relapsing-remitting multiple sclerosis patients treated with interferon beta1a.

We investigated whether interferon-beta1a modifies the course of new enhancing lesions in relapsing-remitting multiple sclerosis. Sixty-eight patients were studied by monthly magnetic resonance imaging (MRI) in a pretest-posttest design including 6 months of observation and 6 months of treatment. We examined the course of new Gd-enhancing lesions on two consecutive scans during observation and during treatment. Lesions detected during treatment were also analyzed by MRI 1 year later for persistence of enhancement, persistence of T2 hyperintensity, development of T1 hypointensity, or disappearance. Among the enhancing lesions detected by observation and treatment MRI, respectively, Gd-enhancement persisted at 2 months in 20% and 3% (P < 0.001), T2 hyperintensity persisted in 86% and 63% (P < 0.03), and T1 hypointensity developed in 49% and 15% (P < 0.01). Progression to T1 hypointensity was significantly more frequent in larger lesions during both the observation and treatment periods (P < 0.01). No reenhancement of plaques was present at 1-year follow-up; a further reduction in T2 hyperintensity (63% vs. 39%) was observed while T1 hypointensity remained unchanged. Both the duration of Gd enhancement and the short-term MRI course of new enhancing lesions benefited by treatment with recombinant interferon-beta1a treatment.

Adjuvants, Immunologic↗
PubMed1998

Cardiac autonomic dysfunction in patients with Alzheimer disease: possible pathogenetic mechanisms.

We studied a possible correlation between autonomic cardiac activity and the level of the red blood cell acetylcholinesterase (AChE) in patients with probable Alzheimer disease (AD). The influence of cholinesterase inhibitor treatment on this autonomic activity was evaluated. Twelve patients satisfying the NINCDS-ADRDA criteria of probable AD and 10 healthy controls were studied. Autonomic cardiac activity was evaluated by means of power spectral analysis (PSA) of heart rate variability (HRV) using an autoregressive algorithm on 250 consecutive electrocardiographic R-R intervals. All patients received oral eptastigmine, a new cholinesterase inhibitor, for 1 month. Before treatment, a simultaneous recording of the electrocardiographic and respiratory activities was performed at rest and subsequently during head-up tilt test at 700. Recording was repeated on the last day of treatment. The level of AChE activity during each recording was also evaluated. Spectrum power was calculated in three main frequency bands: high frequency (HF), 0.15-0.4 Hz; low frequency (LF), 0.04-0.15 Hz; very low frequency (VLF), <0.04 Hz. In addition, we calculated the total spectrum power (TSP) and the LF/HF ratio. The TSP and the absolute value of each spectral component were significantly lower in AD patients than in controls. In contrast with controls, AD patients did not show any significant change before treatment in either the LF and HF components or in the LF/HF ratio during the tilt test. However, the modification in the LF component, induced by tilting, showed a significant correlation with the level of AChE activity (p < 0.03). During the tilt test, the treatment caused changes in LF and HF components and in the LF/HF ratio similar to those observed in controls. These results suggest that the presence of autonomic cardiac dysfunction in AD patients might be due to a cholinergic deficit in the peripheral autonomic nervous system. Some aspects of this autonomic dysfunction can be normalized by cholinesterase inhibitor treatment.

Acetylcholinesterase↗
PubMed1998

Determinants of Gd-enhanced MRI response to IFN-beta-1a treatment in relapsing-remitting multiple sclerosis.

The decision to use interferon beta (IFN-beta) as a treatment for relapsing-remitting multiple sclerosis (RRMS) is based on both clinical characteristics and course of the disease. To better identify the profile of responders, the relationships between baseline clinical/MRI characteristics and therapeutical response was analyzed in 49 patients with RRMS randomly assigned to receive subcutaneously 3 or 9 MIU of IFN-beta-1a. The therapeutical response was evaluated as a per cent change in the mean number and volume of monthly Gd-enhancing lesions in both first (early response) and second (late response) 6-month period of treatment, compared to the 6-month pre-treatment period. A better early response was seen in patients with a lower number of relapses during the pre-treatment period, while the late response was favourably influenced by a lower baseline EDSS and the high dose. Our findings suggest that the effect of IFN-beta-1 a on disease MRI activity is dose-related and dependent on the relapse rate and the level of disability before treatment.

Adjuvants, Immunologic↗
PubMed1997

No increase of serum autoantibodies during therapy with recombinant human interferon-beta1a in relapsing-remitting multiple sclerosis.

OBJECTIVES: The present investigation was aimed at establishing whether interferon (IFN)-beta would induce the synthesis of autoantibodies in patients affected by multiple sclerosis (MS). MATERIALS AND METHODS: The titres of different autoantibodies were measured in a group of 68 relapsing-remitting MS patients before and during treatment with human recombinant IFN-beta1a (3 MIU or 9 MIU subcutaneously 3x a week). ANA, anti-thyroid, anticardiolipin serum autoantibodies were assayed in all cases: when patients were found positive to ANA > 1 : 40, they were also tested for anti-DNA and anti-ENA antibodies. RESULTS: No increase was found in autoantibodies synthesis during 6 months of r-hIFNbeta1a therapy, either at low or high dosages. The percentage of patients positive to different types of autoantibodies varied between 0 and 29%, which are values similar to those already reported in untreated MS patients. CONCLUSION: Our data indicate that the short-term use of IFN-beta1a in MS is safe in terms of the induction of humoral autoimmune responses: however, further follow-up is needed to confirm these findings during long-term treatments.

Adjuvants, Immunologic↗
PubMed1997

MRI measures and their relations with clinical disability in relapsing-remitting and secondary progressive multiple sclerosis.

To further evaluate the relationship between clinical disability and Magnetic Resonance Imaging (MRI) lesion burden, we examined 85 patients with clinically definite multiple sclerosis (54 relapsing-remitting and 31 secondary progressive). This cross-sectional study reports on the correlations between total and infratentorial lesion volume on both T1 and T2 weighted images, and overall physical disability measured by Expanded Disability Status Scale, ambulation index and individual functional systems. Assessment of the hypointense lesion load on T1 weighted images rather than the hyperintense lesion load on T2 weighted images at brain MRI was shown to be useful for differentiating relapsing-remitting from secondary progressive Multiple Sclerosis. A weak relationship between disability and total lesion volume on both T1 and T2 weighted images was found in relapsing-remitting Multiple Sclerosis. In secondary progressive Multiple Sclerosis, infratentorial lesion volume on T2 weighted images represents the only marker of disability. Finally, the presence of cerebellar, brainstem and mental impairment was significantly associated to a greater total lesion volume on MRI, while no relationship was found with other functional systems.

Adolescent↗
PubMed1996

Power spectrum analysis contribution to the detection of cardiovascular dysautonomia in multiple sclerosis.

In multiple sclerosis (MS) autonomic cardiovascular dysfunction is an uncommon, but potentially dangerous event, to which studies of spectral analysis of heart rate variability have not been applied, yet. MATERIAL AND METHODS--We studied 16 patients with definite MS (11 women and 5 men, mean age 30.3 +/- 7.4 yrs., mean EDSS 2.06 +/- 1.42) and 16 sex- and age-matched healthy controls. Besides cardiovascular reflex tests (valsalva manoeuvre, deep breathing, lying to standing, Blood Pressure response to standing and sustained handgrip), each underwent spectral analysis of the R-R interval short-term variability at rest and after tilting, to detect three components: very low frequency (VLF), low frequency (LF) and high frequency (HF). A recent brain MRI was obtained from patients, to compare plaque characteristics with spectral parameters. RESULTS--At cardiovascular reflexes, only four patients (25%) showed an impairment, mostly of a mild degree. VLF and LF at rest were lower in MS subjects than in controls (p < 0.01). No significant correlation was found between spectral parameters and lesion area or localization as detected on MRI. CONCLUSIONS--Spectral analysis could usefully flank reflex tests to detect autonomic subclinical cardiovascular abnormalities.

Adult↗
PubMed1996

Cardiac autonomic dysfunction in relapsing-remitting multiple sclerosis during a stable phase.

The autonomic cardiovascular system was studied by means of autonomic tests and heart rate variability related to body movements during sleep, in 20 patients with relapsing-remitting multiple sclerosis in a stable phase and in 9 normal subjects. Responses to autonomic tests in multiple sclerosis and control subjects were similar. Heart rate variability, instead, showed a lower degree of adaptability in patients with multiple sclerosis than in controls during sleep, because of sympathetic system dysfunction. No significant correlation between magnetic resonance lesions and cardiovascular sleep indexes was found.

Adult↗
PubMed1993

A prospective study of cerebral ischemia in the young. Analysis of pathogenic determinants. The National Research Council Study Group.

BACKGROUND AND PURPOSE: The etiology of stroke in the young is different from that in older patients and remains unknown in almost one third of the cases. To gain further insight into both pathogenic and etiologic determinants, we prospectively studied a large number of consecutive young adults with focal cerebral ischemia. METHODS: Three hundred thirty-three patients aged 15-44 years with transient ischemic attack or ischemic stroke within the 8 weeks before hospital admission were recruited and investigated by using a standardized protocol of clinical evaluation, blood tests, electrocardiography, echocardiography, chest roentgenography, and brain computed tomography. Presumed etiology was diagnosed by prospectively applied criteria. RESULTS: Women predominated (61%) among patients under 35 years of age, mainly due to the frequency of cerebral ischemia related to oral contraceptive use, while men outnumbered women (60%) among patients over that age because of a higher prevalence of atherothrombotic disease. Potential cerebral embolism of cardiac origin was the presumed cause of stroke in 23.7%, but conventional sources of emboli were found only in 7.5% of cases. There was a low prevalence of atrial fibrillation among young patients with cerebral ischemia. Mitral valve prolapse was found in 8.4%, as expected, predominantly (71.4%) among the younger patients. The prevalence of stroke over transient ischemic attack was proportional to the likelihood of cardiac embolism. Acute alcohol intoxication was considered a precipitating factor in only three patients. The percentages of cerebral ischemia attributed to arterial dissection (0.3%), oral contraceptive use in women (8.1%), migraine (1.2%), and other associated medical diseases (1.5%) were lower than reported in recent clinical series. CONCLUSIONS: Two different groups of pathogenic determinants predominate in younger women and in older men, supporting public health measures aimed at strict medical control of the recognized cerebrovascular risk factors.

Adolescent↗
PubMed1992

Does hyperglycaemia play a role on the outcome of acute ischaemic stroke patients?

A consecutive series of 327 patients (188 males, 139 females; mean age 68.4, SEM 1.33) were hospitalized within 12 h of the onset of their first-ever hemispheric infarct. Three groups of patients were identified: diabetics (n = 70), non-diabetic hyperglycaemics (n = 93) and normoglycaemics (n = 164). Case-fatality ratios at 30 days after stroke were 38.6%, 22.6% and 9.2% (P less than 0.001) respectively, whereas the causes of death and functional outcome of survivors were not significantly different between the groups. Mean admission serum glucose levels (SGLs) of decreased, impaired/unchanged and improved patients within each one of the three groups, were also not significantly different as opposed to their mean Canadian Neurological Scale (CNS) scores at entry (P less than 0.01). Among patients with less severe initial neurological deficit (i.e., CNS score greater than or equal to 7.0), 82.6% of non-diabetic hyperglycaemic subjects fared well, in comparison with 56.5% of diabetic and 70.1% of normoglycaemic individuals. The size of the infarcted areas at the second CT correlated with mean CNS scores (P less than 0.01) but not with mean SGLs on admission. The site of the ischaemic areas did not correlate with mean SGLs at entry. Therefore the influence of initial SGLs on the clinical course of the present series of patients is questionable or, alternatively, varied probably according to the pattern of residual cerebral blood flow after arterial occlusion.

Aged↗
PubMed1992

Reversed laterality of cerebral functions in a non-right-hander: neuropsychological and spect findings in a case of 'atypical' dominance.

A 54-year-old non-right-handed man with positive familial sinistrality showed a pure right hemisphere syndrome following a left hemisphere stroke. Severe right side hemineglect, transcortical motor dysprosodia, spatial dysgraphia and visuo-constructive impairments were observed. At no time were the expected left hemisphere abnormalities such as aphasia, alexia, right-left disorientation or finger agnosia noted. A left fronto-temporal subcortical lesion was documented on CT scan. A Tc-99m HM-PAO SPECT study revealed no cerebral blood flow changes in the right hemisphere while in the left hemisphere a fronto-temporo-parietal cerebral blood flow reduction was evident. This case of a complete reversed laterality of cognitive functions argues for a distinction to be made between 'anomalous' cerebral dominance and 'atypical' cerebral dominance.

Brain↗
PubMed1991

Update on calcium antagonists in cerebrovascular diseases.

Clinical management of patients affected by subarachnoid hemorrhage has been modified by the use of nimodipine. Although no differences in overall neurologic outcome and rates of symptomatic spasm have been observed between nimodipine and control patients, severity of permanent neurologic deficits consequent to cerebral vasospasm is reduced in the former. On the other hand, clinical trials with nimodipine in ischemic stroke did not substantiate the expected neurologic benefits. A meta-analysis of the two phase IV studies published thus far shows that of 350 patients examined, mortality rate was 11.5% and 19% in subjects given nimodipine and placebo, respectively (n.s.). Cerebral death accounted for 30% of cases in both groups, whereas a lower percentage of cardiac and pulmonary fatal events were observed among nimodipine-treated subjects. Moreover, neurologic outcome of survivors was not significantly different. These results may be associated with the notion that the voltage-operated channel blockade exerted by calcium antagonists is only a part of the complex events leading to the enhancement of calcium ion intracellular concentration as a "common final pathway." However, difficulties encountered in planning clinical trials in acute ischemic stroke also might explain the lack of conclusive results. The feasibility of randomization of an adequate sample of patients and of very early therapeutic intervention after stroke onset are discussed.

Brain Ischemia↗
PubMed1991

Effect of stress on cardiovascular regulation in neurological diseases with dysautonomia.

Ten patients with Multiple Sclerosis (MS) and ten with Myotonic Dystrophy (MD) underwent an evaluation of cardiovascular reflexes by classic tests, tilt table test and mental stressors. Sympathetic and parasympathetic changes were detected by classical tests in MS patients. Mental stressors appeared able to reveal blood pressure control impairment in MD patients. Lower differential blood pressure was observed during mental stressors administration in MS with brainstem lesions at MRI.

Adult↗
PubMed1991

Controlled clinical trials in stroke.

Reasons for the unsatisfactory number and reliability of most trials on the pharmacological treatment of acute cerebral ischemia are reviewed, focusing mainly on the clinical aspects of the issue. The opportunity of early intervention, supported by current pathophysiological hypotheses, is recognized. Past and recent Italian trials on ischemic stroke patients evaluated and treated within the first 6 h from onset are reported, also mentioning the results of a study including early cerebral angiography and SPECT (Single Photon Emission Computed Tomography). Early fibrinolytics associated to brain protecting agents are regarded as the future choice in clinical trials of acute cerebral ischemia.

Cerebrovascular Disorders↗
PubMed1984

A placebo-controlled study of the antidepressant activity of moclobemide, a new MAO-A inhibitor.

Preliminary open trials performed by the authors and others with Moclobemide, a new MAO-A inhibitor, indicated that the drug has a satisfactory antidepressant activity. In the present double-blind study Moclobemide has been compared to placebo in a group of 34 unipolar psychotic or neurotic depressed patients. The mean daily dose of Moclobemide was 297 mg and treatment lasted from two to four weeks. Drug effectiveness was measured by improvements in the Hamilton Rating Scale for Depression (HRSD), Clinical Global Impression (CGI) and 100 mm Visual Analogue Scale (VAS). The results have shown that the active drug was markedly superior to placebo. The mean total score of HRSD was reduced from 41.7 to 16.5 in 18 pts. treated with Moclobemide and from 36.3 to 29.1 in 16 pts. who received placebo. Self-assessment with VAS showed a mean reduction from 82.7 mm to 42.2 mm and from 84.3 to 70.6 mm respectively. Moderate to marked improvement was observed by the CGI in 15 cases treated with Moclobemide and mild to moderate in 5 cases who received placebo. The treatment was well tolerated.

Adult↗