Biomedical subjects

T Rentmeester

Publications and source records attributed to T Rentmeester.

5 recordsLinked to original sources

PubMed1998

Pharmacokinetics and cognitive effects of carbamazepine formulations with different dissolution rates.

OBJECTIVE: In this study our aim was to assess pharmacokinetic effects and adverse cognitive effects of switches between generic and branded formulations of carbamazepine (CBZ). METHOD: Twelve patients were included in a randomized open-label, observer-blind, cross-over design with a double-baseline period, comparing three different formulations of carbamazepine in monotherapy--the innovatory branded form Tegretol and two generic forms, CBZ Pharmachemie and CBZ Pharbita. Cognitive assessment was carried out at baseline and 3 days after a cross-over. RESULTS: Area under the curve and a number of pharmacokinetic properties (serum concentration day curves, change in serum concentration (delta scores), peak/trough concentrations and peak time) did not differ among the three CBZ formulations. Therefore, the basic assumption for this study, i.e. to test pharmacokinetic-related differences in cognitive profile, was not met. In line with these findings, none of the cognitive variables showed statistically significant differences with respect to the cognitive profile during the day. CONCLUSION: Switches between the investigated generic CBZ formulations and the branded product did not result in any difference in cognitive profiles. These results are not necessarily valid, though, for other generic forms of CBZ, for other types of antiepileptic drugs or for CBZ treatment in higher doses or in polytherapy.

Adult↗

PubMed1991

Efficacy and safety evaluation of loreclezole as add-on treatment in therapy-resistant epilepsy patients.

Thirteen drug-resistant epilepsy patients received loreclezole as add-on therapy. The trial lasted 6 months. Loreclezole was dosed to reach a target plasma concentration between 1 and 3 mg/l. The seizure frequency in the total group decreased by 23%. A reduction of 50% or more was observed in four patients. These effects are most likely related to loreclezole, as doses and plasma levels of the associated anti-epileptic drugs remained unchanged during the study. Loreclezole was tolerated well and no changes in haematological or biochemical parameters were observed.

Adult↗

PubMed1984

Vasodepressor carotid sinus syncope.

There have been few reports of vasodepressor carotid sinus syncope, as opposed to the cardioinhibitory type, and no definitive treatment has been described. A 58 year old man developed episodes of syncope after surgery and radiotherapy for a laryngeal tumour. The episodes were characterised by hypotension, sharp pain in the right neck, dizziness, and bradycardia. A temporary pacemaker failed to prevent the symptoms, but ephedrine and fludrocortisone produced substantial improvement. Of the four types of treatment used in carotid sinus syncope, irradiation was ruled out because the patient had had irradiation before developing syncope, surgery was inappropriate because of the laryngeal tumour, and pacing failed. Combined drug treatment with a vasoconstrictor and plasma volume expander produced an improvement in symptoms but did not eliminate them.

Carcinoma, Squamous Cell↗

PubMedDate not supplied

A double-blind, placebo-controlled evaluation of the efficacy and safety of loreclezole as add-on therapy in patients with uncontrolled partial seizures.

Sixty-two patients with uncontrolled partial seizures participated in a 12-week, double-blind, placebo-controlled add-on-trial. Thirty-two patients received loreclezole and 30 a placebo as add-on therapy. Loreclezole was targeted at a plasma level of 1-2 mg/l. In spite of an antiepileptic therapy, usually with 2 or 3 antiepileptic drugs, these patients had at least 4 seizures a month during the baseline period. At the end of the treatment phase with loreclezole and placebo, individual responses varied widely. The median change in the daily seizure frequency was not significantly different in the 2 groups. However, when individual responses are considered, 6 patients in the verum group (19%) experienced a seizure reduction of 50% or more, compared with no patients in the placebo group. During the trial, only mild adverse events were reported in both the loreclezole and the placebo group, nor were any clinically relevant abnormalities seen in the haematological and biochemical analysis. The efficacy and safety of higher loreclezole plasma concentrations were studied in a long-term follow-up trial, the results of which are presented in the following article.

Adult↗

PubMedDate not supplied

Long-term evaluation of the efficacy and safety of loreclezole as add-on therapy in patients with uncontrolled partial seizures: a 1-year open follow-up.

The effect and safety of loreclezole were evaluated during a long-term follow-up trial targeting higher plasma concentrations than those of the preceding controlled trial. The result is better than in the double-blind trial, in which loreclezole doses were administered to reach plasma concentrations of 1-2 mg/l and 6/32 patients (19%) of the verum group experienced a seizure reduction of 50% or more. None of the 30 placebo-treated patients experienced a similar decrease. At the end of the double-blind trial, 56 patients (29 from the original loreclezole and 27 from the original placebo group) elected to participate in the open follow-up trial. After 12 months' add-on treatment with loreclezole, mean plasma concentrations of 5.53 and 5.97 mg/l for the original placebo and loreclezole group were measured and the median decreases in seizure frequency were -44% and -40. At these concentrations, 22/56 patients (39%) showed a seizure reduction of at least 50%.

Adult↗