Anomalías hematológicas asociadas al síndrome de Down: síndrome mieloproliferativo transitorio neonatal y leucemia mieloblástica congénita / Hematological abnormalities associated with Down syndrome: transient myeloproliferative disorder and congenital acute myeloblastic leukemia

La asociación entre síndrome de Down y anomalías hematológicas es bien conocida. En el periodo neonatal son frecuentes las alteraciones inespecíficas (neutrofilia, trombocitopenia y policitemia), pero la entidad más importante clínicamente es el síndrome mieloproliferativo transitorio (SMPT), casi exclusivo de recién nacidos con fenotipo Down. Se presentan dos casos de recién nacidos con este fenotipo con hiperleucocitosis, en uno de ellos asociada además a colestasis y lisis tumoral (AU)

It is known that Down syndrome is frequently associated with hematological abnormalities. In newborn infants, it is not unusual to find nonspecific features (neutrophilia, thrombocytopenia, polycythemia),but the entity of the greatest clinical importance is transient myeloproliferative disorder (TMD), which is observed almost exclusively in neonates with Down syndrome. Two newborns with Down syndrome are presented. They were studied forhyperleukocytosis, in one case, associated with cholestasis and tumor lysis síndrome (AU)

Utilidad del PET-18FDG en la localización del tumor primario en un paciente con metástasis cerebrales / Utility of PET-18FDG in primary tumor site in a patient with cerebral metastases

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Aniceto Fernández-Armayor / Aniceto Fernández-Armayor

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[Spanish contribution to the clinical development of eletriptan: an analysis of controlled studies]. / Contribución española al desarrollo clínico de eletriptán: un análisis de los estudios controlados.

INTRODUCTION: Eletriptan is a recently marketed second-generation triptan with a potent agonist activity on 5-HT1B/ 1D receptors. Our aim has been to analyze the specific results from the Spanish participation in phase IIIa and IIIb clinical trials vs placebo and compare them with the results obtained in the global clinical development of eletriptan. PATIENTS AND METHODS: Analysis of the results obtained in 40 centers in Spain (358 patients) vs global sample 4,677 patients) for the first migraine attack in 6 controlled clinical trials with eletriptan 40 mg, eletriptan 80 mg and placebo. This ad hoc analysis was carried out for those treatment groups with more than 50 patients, which reduced the final number of patients from Spain to 250. RESULTS: The proportion of patients with relief at 2 hours (main endpoint) in the Spanish sample was 22 %, 59 % and 67 % for placebo, eletriptan 40 mg and eletriptan 80 mg, respectively. These values were significantly higher (p < 0.05) than those of placebo and similar to those from the total sample. The proportion of pain free patients at 2 hours in the Spanish sample was 10 %, 36 % and 41 % for placebo, eletriptan 40 mg and eletriptan 80 mg, respectively. These values were significantly better than those for placebo (p < 0.05) and about 15 %-20 % higher than those from the total sample. Recurrence rate in the Spanish sample was 50 %, 16 % and 25 % for placebo, eletriptan 40 and eletriptan 80 mg, respectively, and did not differ from that of the total sample. Sustained relief for the two eletriptan doses was 46 % for both eletriptan 40 and eletriptan 80, this being significant (p < 0.05) over placebo (11 %) for the Spanish sample and similar to that of the global sample. The results for other efficacy parameters, such as need of rescue medication, functional response at 2 hours, complete response for pain-freeness and acceptability followed a similar pattern. Eletriptan was, in general, well-tolerated. Adverse events were slight-moderate in intensity, transient and were not different, either in profile or proportion, from those from the global sample. CONCLUSIONS: These results confirm eletriptan 40 mg and 80 mg as an excellent option for the symptomatic treatment of migraine in our setting.

Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.

Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.

Efficacy and safety of metamizol vs. acetylsalicylic acid in patients with moderate episodic tension-type headache: a randomized, double-blind, placebo- and active-controlled, multicentre study.

We assessed the efficacy and safety of oral single doses of 0.5 and 1 g metamizol vs. 1 g acetylsalicylic acid (ASA) in 417 patients with moderate episodic tension-type headache included in a randomized, double-blind, placebo- and active-controlled, parallel, multicentre trial. Eligibility criteria included 18-65 years of age, history of at least two episodes of tension-type headache per month in the 3 months prior to enrollment, and successful previous pain relief with a non-opioid analgesic. Treatment arms were metamizol 0.5 g (n = 102), metamizol 1 g (n = 108), ASA 1 g (n = 102) and placebo (n = 105). The analgesic efficacy of 0.5 and 1 g metamizol vs. placebo was highly statistically significant (alpha: 0.025; one-sided) for sum of pain intensity differences, maximum pain intensity difference, number of patients with at least 50% pain reduction, time to 50% pain reduction, maximum pain relief and total pain relief. A trend towards an earlier onset of a more profound pain relief of 0.5 and 1 g metamizol over 1 g ASA was noticed. All medications including placebo were almost equally safe and well tolerated.

Comparative efficacy and safety of calcium carbasalate plus metoclopramide versus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks.

This randomized, double-blind, double-dummy, multicenter, parallel-group study aimed at comparing the efficacy and safety of calcium carbasalate (equivalent to 900 mg aspirin) plus metoclopramide 10 mg (CM) with ergotamine tartrate 1 mg plus caffeine 100 mg (EC) administered in the treatment of 2 acute migraine attacks. A total of 296 patients fulfilling the International Headache Society diagnostic criteria for migraine were enrolled. In total, one or two migraine attacks were treated in 268 and 235 patients, respectively. The primary endpoint for the first treated attack was headache relief, with intensity decreasing from moderate or severe to mild or absent 2 h after drug intake. Usual secondary efficacy endpoints were assessed. A superiority of CM over EC was observed for both treated attacks for the main endpoint: success in 54 versus 36%, p = 0.003 for the first attack and 60 versus 44%, p = 0.02 for the second attack. CM was also significantly superior to EC during the first attack for complete headache relief (20 vs. 8%, p = 0.006), nausea (42 vs. 63%, p = 0. 007) and willingness to take the drug again (90 vs. 80%, p = 0.043). The global efficacy evaluation, rated by the investigators, was significantly more favorable to CM for both attacks (p = 0.001 for the first attack and p = 0.02 for the second). The patients' evaluation was significant for the first attack (p = 0.002). The global incidence of adverse events was 45% higher with EC, though not significant (32 vs. 22%, p = 0.075). They were most often unspecific and mild to moderate in intensity. Gastrointestinal side effects were significantly less frequent with CM than EC (7 vs. 21%, p = 0.001). Thus, CM is more effective and has a better gastrointestinal safety than EC in the acute treatment of migraine attacks.

Early combination of bromocriptine and levodopa in Parkinson's disease: a prospective randomized study of two parallel groups over a total follow-up period of 44 months including an initial 8-month double-blind stage.

To determine if the combination of levodopa (LD) plus bromocriptine (Br) in the early stages of Parkinson's disease (PD) permits reduction of LD dosage and consequently results in fewer motor fluctuations and dyskinesias, a double-blind, multicenter prospective study in 50 PD patients who had responded favorably to LD while under treatment with that drug for < or = 6 months was undertaken. Patients were randomized into two parallel groups (LD alone and LD plus Br). During the first placebo-controlled stage of the study lasting 8 months, association of a fixed dose of Br (15 mg/day) in the LD regimen did not allow a significant reduction in the daily LD dose. Still, in patients on combined LD plus Br, there was a tendency toward smaller daily requirements of LD as compared with those on LD alone, and the difference in LD dose between the two groups was significantly different (515.4 +/- 240 vs. 725.6 +/- 230 mg/day; p < 0.01) after 44 months of continuous treatment in the 40 patients still enrolled in the open-label stage. At that point in time, the mean dose of Br had been increased by 9.2 mg in the combined treatment group, and the mean dose of LD was 40.7% lower than in the group receiving LD alone. On subsequent evaluations, the number of patients with dyskinesias or describing wearing-off fluctuations severe enough to require changes in treatment was lower than in the group under combined therapy, the differences being significant after 20 and 44 months, respectively (36.8 vs. 9.5 and 47.3 vs. 14.2%). Our results support early combined LD-Br therapy in PD, but no conclusions can be drawn as to whether this dopamine agonist exerts a preventive effect on the late side effects of LD or has another mechanism of action.

[Cognitive functions in agenesis of the corpus callosum]. / Estudio de las funciones superiores en la agenesia del cuerpo calloso.

Four patients with agenesis of the corpus callosum diagnosed through neuroradiologic tests has been studied, from the upper cerebral functions point of view. Three had consulted because of seizure, and the other because of cerebellar hemorrhage. Multiple fields of the cognitive functions were examined and the presence of an interhemispheric disconnection syndrome was investigated. All tests were absolutely normal in the four patients. We discuss clinical and radiologic aspects as well as other associated malformations.