Papers by Gaetano Procaccianti

Supplementary Material for: The Effect of Age on Characteristics and Mortality of Intracerebral Hemorrhage in the Oldest-Old
BACKGROUND Incidence of acute intracerebral hemorrhage (ICH) increases with age, but there is a l... more BACKGROUND Incidence of acute intracerebral hemorrhage (ICH) increases with age, but there is a lack of information about ICH characteristics in the oldest-old (age ≥85 years). In particular, there is a need for information about hematoma volume, which is included in most clinical scales for prediction of mortality in ICH patients. Many of these scales also assume that, independent of ICH characteristics, the oldest-old have a higher mortality than younger elderly patients (age 65-74 years). However, supporting evidence from cohort studies is limited. We investigated ICH characteristics of oldest-old subjects compared to young (<65 years), young-old (65-74 years) and old-old (75-84 years) subjects. We also investigated whether age is an independent mortality predictor in elderly (age ≥65 years) subjects with acute ICH. METHODS We retrospectively collected clinical and neuroimaging data of 383 subjects (age 34-104 years) with acute supratentorial primary ICH who were admitted to an Italian Stroke Unit (SU) between October 2007 and December 2014. Measured ICH characteristics included hematoma location, volume and intraventricular extension of hemorrhage on admission CT scan; admission Glasgow Coma Scale ≤8 and hematoma expansion (HE) measured on follow-up CT-scans obtained after 24 h. General linear models and logistic models were used to investigate the association of age with ICH characteristics. These models were adjusted for pre-admission characteristics, hematoma location and time from symptom onset to admission CT scan. Limited to elderly subjects, Cox models were used to investigate the association of age with in-SU and 1-year mortality: the model for in-SU mortality adjusted for pre-admission and ICH admission characteristics and the model for 1-year mortality additionally adjusted for functional status and disposition at SU discharge. RESULTS Independent of pre-admission characteristics, hematoma location and time from symptom onset to admission CT-scan, oldest-old subjects had the highest admission hematoma volume (p < 0.01). Age was unrelated to all other ICH characteristics including HE. In elderly patients, multivariable adjusted risk of in-SU and 1-year mortality did not vary across age categories. CONCLUSIONS Oldest-old subjects with acute supratentorial ICH have higher admission hematoma volume than young and young-old subjects but do not differ for other ICH characteristics. When taking into account confounding from ICH characteristics, risk of in-SU and 1-year mortality in elderly subjects with acute supratentorial ICH does not differ across age categories. Our findings question use of age as an independent criterion for stratification of mortality risk in elderly subjects with acute ICH.
I Fattori Indicativi DI Ricaduta Alla Sospensione Della Terapia Nei Pazienti Con Epilessie Parziali
Bollettino - Lega Italiana contro l'Epilessia, 1990

Clobazam in Therapy‐Resistant Patients with Partial Epilepsy: A Double‐Blind Placebo‐Controlled Crossover Study
Epilepsia, 1987
Summary: Clobazam was compared with placebo as an‐tiepileptic adjunct medication in 129 therapy‐r... more Summary: Clobazam was compared with placebo as an‐tiepileptic adjunct medication in 129 therapy‐resistant epileptic patients who were mainly suffering from complex partial seizures. The study was performed in five European countries according to a double‐blind crossover design lasting 7 months. Two treatment periods of 3 months (1 month adjustment and 2 months maintenance medication) were separated by one medication switch‐over month. The difference in seizure reduction between clobazam and placebo was significant (p < 0.05). Nineteen percent of patients receiving clobazam became seizure‐free during the maintenance dose period. In contrast, freedom from seizures was not observed in any placebo patient. Electroencephalogram (EEG) signs, mood ratings, and global impressions also indicated therapeutic effects of clobazam in epilepsy. The most frequent adverse reactions to clobazam were drowsiness and dizziness. However, the sedative effects of clobazam seemed to be less pronounced i...
Toxicological aspects of sodium valproate

Italian Journal of Medicine, Sep 19, 2013
The incidence of ischemic stroke rises exponentially with age, with a steep increase in the age i... more The incidence of ischemic stroke rises exponentially with age, with a steep increase in the age interval between 75 and 85 years. Thrombolytic therapy restores cerebral blood flow in patients with acute ischemic stroke of any etiology by using drugs that dissolve blood clots. Infusion for 1 h of alteplase at the dose of 0.9 mg/kg within 3 h of the start of the symptoms is associated to a 30% increase in the likelihood of gaining a favorable outcome with respect to placebo. There is strong evidence that selected patients with ischemic stroke may benefit from intravenous thrombolysis when treated within 3 h. The aim of the study was to evaluate available evidence for the efficacy and safety of thrombolytic therapy in patients with ischemic stroke aged 80 years and over. Compared to younger stroke patients treated with thrombolytic therapy, those aged 80 years and over have higher acute mortality due to symptomatic intracranial hemorrhage. However, functional outcome at six months is significantly better for over-80-year-olds than younger patients. There is a need for screening tools that take into account pre-stroke functional and cognitive status that are able to identify those over-80-year-old patients with ischemic stroke who can most benefit from thrombolytic treatment. Available evidence supports further recruitment of oldest-old patients into ongoing trials of thrombolysis.
Journal of the American Geriatrics Society, Apr 1, 2015
Hazard ratios (HRs), their corresponding 95% confidence intervals (95% CIs), and P-values are fro... more Hazard ratios (HRs), their corresponding 95% confidence intervals (95% CIs), and P-values are from an extended Cox proportional hazards regression model with time-varying coefficients. The model was adjusted for sex, prestroke use of antiaggregants, hypertension, diabetes mellitus, atrial fibrillation, dementia, prestroke modified Rankin Scale score, National Institutes of Health Stroke Scale score, anticoagulant-related etiology, admission pulse pressure, intraventricular extension, and neurosurgical procedures. Maximum length of stay in stroke unit was 68 days.
Movement Disorders, 1990
Eleven patients with cranial dystonia were investigated for diurnal variations in disability by m... more Eleven patients with cranial dystonia were investigated for diurnal variations in disability by means of video recordings. Disability increased significantly from morning to evening. The increase was not related to changes in vigilance levels assessed by dynamic electroencephalogram. Cranial movement disorders display diurnal fluctuations that are probably related to endogenous circadian rhythms.
Propranolol and acetylsalicylic acid in migraine prophylaxis
Acta Neurologica Scandinavica, Mar 1, 1983
The aim of this double-blind crossover study was to compare the prophylactic effect of acetylsali... more The aim of this double-blind crossover study was to compare the prophylactic effect of acetylsalicylic acid (ASA) with that of propranolol (PRP) in the treatment of migraine. Plasma concentrations of the two drugs were measured in order to investigate a possible relationship to the clinical effect. Compared to the pretreatment period, PRP and ASA reduced migraine index, frequency, duration, severity of attacks and headache days. Due to the limited number of patients, our results should be cautiously interpreted, however relevant the clinical improvement seemed. Improvement of migraine index was not related to different plasma levels of the two drugs.
Carbamazepine and Phenytoin
Archives of neurology, Aug 1, 1988
We compared the cognitive effects of carbamazepine and phenytoin with neuropsychological tests ex... more We compared the cognitive effects of carbamazepine and phenytoin with neuropsychological tests exploring intelligence, vigilance, attention, memory, and visuomotor performances in 25 epileptics (13 receiving carbamazepine and 12 receiving phenytoin) and 26 matched normal controls. Patients were seizure free for at least two years and taking prolonged monotherapy. We also evaluated the effects of drug withdrawal by retesting patients three months after reduction at half drug dose and three months and one year after complete withdrawal. Our findings suggest that phenytoin affects the cognitive functions more than carbamazepine does, although the negative effects of both drugs are reversible by complete therapy withdrawal.
Status epilepticus in acute ischemic stroke
Italian Journal of Neurological Sciences, Sep 1, 1995
Stroke is one of the most frequent causes of acute symptomatic status epilepticus. The aim of thi... more Stroke is one of the most frequent causes of acute symptomatic status epilepticus. The aim of this study was to investigate the electroclinical features of status epilepticus in acute ischemic stroke. Nine consecutively admitted patients with status epilepticus during ischemic stroke were examined: five of them had convulsive unilateral or generalized status epilepticus for from 24 hours to 9 days after a large hemispheric infarction, always associated with EEG epileptiform abnormalities; the remaining four had focal motor status epilepticus during the first 24 hours after a small cortical or subcortical infarction, and showed no clear EEG changes. Status epilepticus in acute ischemic stroke may have two distinct electroclinical patterns of different prognostic significance.
Phenobarbital and propranolol in essential tremor: A double-blind controlled clinical trial
Neurology, Mar 1, 1983
In a double-blind study with Latin square design, phenobarbital (about 1.3 mg per kilogram), prop... more In a double-blind study with Latin square design, phenobarbital (about 1.3 mg per kilogram), propranolol (about 1.7 mg per kilogram), and placebo were given orally for 1 month to 12 patients with essential tremor. By clinical evaluation, only propranolol appeared to be significantly more effective than placebo. As judged by tests of manual skill, none of the treatments significantly improved tremor. Patients&#39; subjective evaluation and tremor amplitude measurement (by accelerometer) showed a significantly better effect of both propranolol and phenobarbital than placebo. These data suggest that phenobarbital may be a valuable alternative to propranolol in essential tremor.
Predictors of outcome in severe acute stroke patients treated with intravenous thrombolysis
Studio Multicentrico Con Vigabatrin Nell'Epilessia Farmacoresistente
Bollettino - Lega Italiana contro l'Epilessia, 1990

Increased Dosage of Carbidopa in Parkinsonian Patients on Low Carbidopa-Levodopa Regimen
Clinical Neuropharmacology, Feb 1, 1989
The effect of a 2.5-fold increase in daily carbidopa intake on the bioavailability of levodopa wa... more The effect of a 2.5-fold increase in daily carbidopa intake on the bioavailability of levodopa was studied in six patients with Parkinson&amp;amp;#39;s disease on a low chronic regimen of carbidopa-levodopa (Sinemet) at the fixed ratio of 1:10. The extent of levodopa absorption, expressed as the area under the 11-h plasma levodopa concentration-time curve (AUC0-11 h), was not enhanced by the higher carbidopa dose. A significant increase in the AUC was found for the levodopa metabolite 3-O-methyldopa at the higher carbidopa intake. Clinical performances of individual patients were identical with both carbidopa-levodopa ratios. From these data, an adequate inhibition of peripheral decarboxylation and hence a good bioavailability of levodopa may be expected in patients taking low doses of carbidopa-levodopa, using currently available commercial preparations.

Neurology, Apr 1, 1985
The diurnal variation in total and free plasma phenytoin (PHT) concentration at steady state was ... more The diurnal variation in total and free plasma phenytoin (PHT) concentration at steady state was examined in eight epileptic patients receiving combination therapy with tid valproic acid (VPA) as sodium salt. Eight patients treated with PHT, but not with VPA, were studied for comparison purposes. In the absence of VPA coadministration, total and free PHT concentrations did not change significantly during the day and showed only minor intrapatient fluctuations (14 and 13%, respectively). In patients receiving VPA, the mean total PHT did not change significantly, whereas the free PHT increased during the day (p < 0.05). The fluctuations in total and free PHT in these patients were 16 and 17% on average. In the presence of VPA, the free PHT fraction was higher than in controls (13.9 f 2.3% versus 8.3 f 1.9%; p < 0.01) and fluctuated to a greater extent (29 versus 14% in controls; p < Om), mainly as a result of combined opposite swings in both total and free concentration. The diurnal changes in free PHT concentration and fraction correlated positively with the changes in plasma VPA. An inverse relationship between total PHT concentration and plasma VPA was found in some patients. These data demonstrate that the displacement interaction between PHT and VPA is subject to diurnal variation, probably as a result of the fluctuation in plasma VPA. The implications of these findings are discussed.

Brain and behavior, Apr 5, 2016
Objectives: Plasma total homocysteine (tHcy) is a risk factor for ischemic stroke (IS) but its re... more Objectives: Plasma total homocysteine (tHcy) is a risk factor for ischemic stroke (IS) but its relationship with IS outcome is uncertain. Moreover, previous studies underrepresented older IS patients, although risk of both hyperhomocysteinemia and IS increases with age. We investigated whether, in elderly patients with acute IS, tHcy measured on admission to the Stroke Unit (SU) is an independent predictor of SU discharge outcomes. Materials and Methods: Data are for 644 consecutive patients aged 80.3 AE 8.7 years, admitted to an Italian SU with diagnosis of acute IS. Plasma tHcy was measured on SU admission. Investigated outcomes included mortality during SU stay and poor functional status (modified Rankin Scale score ≥3) at SU discharge for survivors. The association of plasma tHcy with the study outcomes was assessed using Odds Ratios (OR) and their corresponding 95% confidence intervals (95%CI) from logistic regression models adjusted for demographics, pre-stroke features, IS severity, and laboratory data on SU admission (serum C-reactive protein, serum albumin, and renal function). Results: Median plasma tHcy was 16.7 lmol/L (interquartile range, 13.0-23.3 lmol/L). Outcome incidence was 5.3% for mortality and 49.7% for poor functional status. Plasma tHcy was unrelated to mortality in both univariate and multivariable-adjusted analyses. Conversely, plasma tHcy was associated with poor functional status of survivors in univariate analyses (P = 0.014). Multivariable-adjusted analyses showed that, compared to normal homocysteinemia (tHcy <16 lmol/L), risk of being discharged with poor functional status significantly increased for moderate (tHcy ≥30 mol/L) but not mild (16.0-29.9 lmol/L) hyperhomocysteinemia. Conclusions: In elderly patients with acute IS, high admission plasma tHcy is unrelated to mortality during SU stay but is an independent predictor of poor functional status at SU discharge in survivors. The association, however, is limited to patients with moderate hyperhomocysteinemia.

Single-blind, placebo-controlled multicenter trial of vigabatrin in the treatment of epilepsy
Italian Journal of Neurological Sciences, Dec 1, 1992
A single-blind, placebo-controlled multicenter trial of vigabatrin was carried out in 101 epilept... more A single-blind, placebo-controlled multicenter trial of vigabatrin was carried out in 101 epileptic patients (mostly with partial seizures) refractory to conventional therapy. The study design included four consecutive periods: (i) an observation phase (run-in), (ii) a placebo period, (iii) fixed-dosage add-on vigabatrin (2 g/day) and (iv) dose titration (up to a maximum of 4 g/day) to optimize clinical response. Each period lasted 8 weeks, except for the titration phase, which could be extended to 16 weeks. 90 patients completed the trial. Eleven dropped out, one patient developing absence status and 4 cases showing an increased seizure frequency. In the patients completing the trial, the median number of seizures/month decreased from 16 (inter-quartile range 8-34) during placebo to 5 (2-10) during the last 8 weeks on vigabatrin (p &lt; 0.0001). Both partial and generalized tonic clonic (mostly secondary) seizures were significantly reduced. A greater than 50% reduction in seizure frequency (compared to placebo) was observed in 60 patients. Sedation and weight gain were the most frequently reported adverse events.
Familial Hypomelanosis of Ito
European Neurology, 1991
Two siblings presented the typical skin changes of hypomelanosis of Ito (HI) associated with ment... more Two siblings presented the typical skin changes of hypomelanosis of Ito (HI) associated with mental and cerebellar signs. Their mother showed only the skin changes of HI but no neurological disturbances. HI is a hereditary disorder, in which familiarity may go unnoticed because of the different expressions of neural and cutaneous features.
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Papers by Gaetano Procaccianti