Relative validity of a food frequency questionnaire for adolescents from a capital in the Northeastern region of Brazil

The present study was conducted to evaluate the validity of the Food Frequency Questionnaire (FFQ) used in the RPS Birth Cohort Consortium (Ribeirão Preto, Pelotas, and São Luís) to assess dietary intake of adolescents from São Luís, Maranhão. The research was developed with 152 adolescents aged 18 and 19 years. For the validation of the FFQ, the average of three 24-hour recalls (24HRs) was used as the reference method. The mean and standard deviation of energy and nutrient intake extracted from the surveys were estimated. The paired Student's t-test was used to verify the differences between the instruments. Pearson correlation coefficient, intraclass correlation coefficient (ICC), weighted Kappa, and the Bland-Altman plot were calculated in order to measure the agreement. The study adopted a level of significance <5%. Compared with the three 24HRs, the FFQ overestimated the consumption of most nutrients. Energy-adjusted and de-attenuated concordance Pearson correlation coefficients ranged from 0.06 to 0.43, and correlations were significant for iron, calcium, riboflavin, sodium, saturated fat, niacin, and vitamin C. The energy-adjusted and de-attenuated ICCs ranged from 0.01 to 0.31, and the weighted Kappa ranged from 0.01 to 0.46. The analyses of agreement were significant for vitamin C, fiber, calcium, riboflavin, niacin, sodium, lipids, and iron. In conclusion, the FFQ presented acceptable relative validity for lipids, saturated fatty acids, fiber, calcium, iron, riboflavin, niacin, vitamin C, and sodium. This instrument will be useful in studies about food consumption of adolescents in São Luís, Maranhão.

Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT study.

AIM: The Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy (PRESENT) study was done to assess the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in patients with type 2 diabetes mellitus in routine clinical practice. MATERIALS AND METHODS: This was a prospective, multicentric, multinational, observational study in type 2 diabetes patients. The patients were transferred to BIAsp 30 with or without oral antidiabetic drugs (OADs). We present the results of 6 months of treatment in the Indian cohort (n = 3559) with type 2 diabetes mellitus who were inadequately controlled on current treatment. RESULTS: At three and six months, significant reductions from baseline were observed in the mean glycated haemoglobin (HbA1c) (-1.32% and -1.94%), fasting plasma glucose (-56.16 mg/dl and -75.24 mg/dl) and post-prandial plasma glucose (-88.74 mg/dl and -119.16 mg/dl) (p < 0.001). A significantly greater proportion of patients achieved target HbAlc of less than 7% at six months (31.1%), compared with baseline (3.1%), of which 70.4% did not report hypoglycaemia. The rate of total hypoglycaemia was reduced from 3.1 events per patient-year at baseline to 1.5 events per patient-year at end of the study. Episodes were mostly minor and diurnal. Except for two serious adverse drug reactions (ADRs) reported by one patient at 3 months, there were no reports of ADRs during the treatment period. More than 95% of patients and doctors were "very satisfied" or "satisfied" with BIAsp 30 treatment, compared to previous treatment. CONCLUSIONS: The use of BIAsp 30 monotherapy or in combination with OADs in clinical practice was effective and safe in poorly controlled Indian type 2 diabetes patients. Both patients and doctors showed a high degree of treatment satisfaction.

Clinical relevance of reduced bioavailability of rifampicin.

Bioavailability (BA) of rifampicin (RMP) is a critical factor in successful treatment of tuberculosis. The BA of RMP can be reduced by pharmaceutical factors, patient factors and drug interactions. Failure of treatment and development of drug resistance are potential consequences of reduction in BA and it is necessary to understand and control the factors influencing BA of RMP.

Influence of caffeine on pharmacokinetic profile of sodium valproate and carbamazepine in normal human volunteers.

The present study evaluates effect of pharmacokinetic interaction between caffeine (300 mg) in three divided doses with sodium valproate (400 mg) and carbamazepine (200 mg) given as single doses, in normal human volunteers, using a open cross over design. Both the serum concentration of sodium valproate and pharmacokinetic parameters remained unaltered, as against significant reduction in plasma concentration and area under the concentration curve of carbamazepine following the coadministration of caffeine. Also, the plasma t 1/2 (of carbamazepine was prolonged by two folds and bioavailability reduced by about 32% in presence of caffeine. The results are of clinical significance as xanthine consumption may have to be restricted in patients on carbamazepine therapy and this aspect may need further investigation.

Aminophylline alters pharmacokinetics of carbamazepine but not that of sodium valproate--a single dose pharmacokinetic study in human volunteers.

Pharmacokinetic interaction of aminophylline with single dose sodium valproate (400 mg) and carbamazepine (200 mg) was evaluated in normal healthy volunteers using a cross over design. Neither the serum concentrations nor the pharmacokinetic parameters of sodium valproate (SV) were altered by the coadministration of aminophylline (AMP). In contrast AMP significantly decreased the plasma concentrations of carbamazepine (CBZ). The Cmax of CBZ was significantly lowered from 1.73 +/- 0.18 to 0.94 +/- 0.08 microgram/ml and the AUC o-t was significantly decreased from 76.19 +/- 6.20 to 52.66 +/- 1.84 micrograms/h/ml (P < 0.05). The pharmacokinetic parameters of CBZ that were altered in the presence of AMP were: the Tmax and t1/2 which was prolonged about threefold from 5.60 +/- 1.60 to 16.80 +/- 7.94 h and 44.88 +/- 4.50 to 125.07 +/- 29.09 h, respectively. The Vd was marginally increased from 2.19 +/- 0.13 to 3.85 +/- 0.57 L/kg and the Cl was decreased from 34.07 +/- 3.78 to 25.26 +/- 5.15 mL/min. None of these alterations are statistically significant. Bioavailability of CBZ was reduced by 29% in the presence of AMP, while that of SV was increased by about 8%. Results are of clinical significance because simultaneous administration of CBZ and AMP may reduce the efficacy of CBZ in epileptic patients.

Estudo multicêntrico aberto, näo comparativo, com etomidato em procedimentos cirúrgicos de curta duraçäo / Open multicenter study, non-comparative, with etomidate in short-term surgical procedures

Realizou-se um estudo multicêntrico em 155 pacientes de ambos os sexos, ASA 1, 2, e 3, submetidos a anestesia venosa com etomidato (0,3 mg.k-1) para procedimentos cirúrgicos de curta duraçäo. Foram administrados, como medicaçäo pré-anestésica, 10 minutos antes da induçäo, 100 micron-grama de fentanil por via venosa. Ao final do procedimento anestésico, verificou-se aumento das pressöes sistólica e diastólica, enquanto que a freqüência cardíaca manteve-se estável. A freqüência respiratória apresentou aumento, porém sem significado clínico. Em 113 pacientes (72,9%) houve necessidade de se administrar doses complementares da droga. O tempo médio de perda da consciência foi de 48 + ou - 22s do início da injeçäo. O tempo de recuperaçäo da consciência foi de 8,26 + ou - 5,16 min. A média do tempo para possível alta hospitalar foi de 61,7 + ou - 30,5 min. Com relaçäo aos efeitos secundários observou-se que em 15 (9,7%) pacientes houve dor no local da injeçäo, em 79 (51%) surgiram mioclonias, na maioria das vezes de grau leve, e em 36 (23,2%) pacientes ocorreu ereçäo pilosa. Concluíram ser o etomidato uma droga adequada para uso venoso em procedimentos de curta duraçäo