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Biomedical subjects

Y Hekster

Publications and source records attributed to Y Hekster.

9 recordsLinked to original sources
PubMed2006

Movement disorders induced by gastrointestinal drugs: two paediatric cases.

A number of frequently prescribed gastrointestinal drugs can cause movement disorders in children, as well as in adults. In our centre for paediatric neurology, we saw a 3-year-old girl with abnormal movements mostly of the legs with an inner restlessness (akathisia) while using cisapride. Another patient, a 17-year-old male, developed a hemiballism (a fierce movement of one arm and shoulder with a hurling appearance) while using ranitidine for gastric distress. In both children, the movement disorder disappeared after discontinuing the drug. The pathophysiological mechanisms of these drug-induced movement disorders might be related to the central function of histamine in the developing brain. These cases illustrate the importance of being alert for possible drug-induced events early in the process of diagnosing abnormal movement disorders.

Adolescent↗
PubMed2005

Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.

Didanosine enteric-coated should be taken on an empty stomach, but the once-daily combination of indinavir/ritonavir can be taken with food. Because these drugs are frequently included in 1 regimen, the food effects on the pharmacokinetics were evaluated. This was a randomized, 4-way crossover study of single doses of didanosine enteric-coated 400 mg and indinavir/ritonavir 1200/400 mg in 8 healthy subjects. The following regimens were given: didanosine enteric-coated 2 hours after breakfast (reference regimen A), indinavir/ritonavir with breakfast (reference regimen B), didanosine enteric-coated + indinavir/ritonavir 2 hours after breakfast (test regimen C), and didanosine enteric-coated + indinavir/ritonavir with breakfast (test regimen D). Breakfast was 550 kcal, 28% fat. Blood samples were drawn before and up to 24 hours after ingestion. Statistical comparisons of test regimens C and D with reference regimens A and B were made using the equivalence approach for indinavir and didanosine area under the curve and C(max) (0.80-1.25). Eight subjects (5 men, 3 women) were enrolled and completed the study. Indinavir area under the curves were bioequivalent in test regimens C and D compared to reference regimen B. A 14% increased C(max) was observed in test regimen C. Didanosine area under the curve in test regimen D was 4% lower and suggestive of bioequivalence compared to reference regimen A. However, test regimen C didanosine area under the curve was 23% lower and bioinequivalent compared to reference regimen A. Didanosine C(max) decreased 42% and 46% in test regimens C and D, respectively, in comparison to reference regimen A. In this study, dosing didanosine enteric-coated 400 mg once daily + indinavir/ritonavir 1200/400 mg once daily with breakfast indicated no decrease in the amount of absorption for either didanosine and indinavir and that this regimen could be administered with food.

Administration, Oral↗
PubMed1997

Scenario analysis of the future of clinical pharmacy.

The role of clinical pharmacy in the health care system is changing rapidly. This change is almost universal among different countries and is related to developments in medical technology, health economics, informatics, socio-economic status, and professional relations. Transitions to new systems of clinical pharmacy are difficult to anticipate. Even with well defined targets, it remains uncertain what the future of clinical pharmacy will bring us. The construction of plausible scenarios may help us better in preparing for the 'new world' ahead. At the annual congresses of ESCP in Prague 1995 (24th) and Lisbon 1996 (25th), a number of scenario analysis workshops with respect to the future of clinical pharmacy were organized. This paper gives a report of the results of these scenario sessions and reflects on the implications for future policy making. After we identified the driving forces behind the future of clinical pharmacy, various sets of assumptions were made and from them scenarios were constructed which are plausible: they 'could' happen. This analysis provided a logical framework in which we ultimately depicted three alternating stories of the future of clinical pharmacy, named 'CLERK', 'CONTROLLER' and 'CARE MANAGER'. These scenarios are intended to help clinical pharmacists to break free of familiar mental maps and to stimulate creative thinking on the future.

Education, Pharmacy↗
PubMed1997

Outcome measures for the assessment of new antiepileptic drugs.

For the approval of any new medicinal product quality, safety and efficacy are essential requirements. This manuscript focuses on the clinical development programme. For the investigation of antiepileptic drugs some international guidelines are of special importance. They are based on the knowledge of many experts and can be seen as a consensus on minimal requirements; deviations must be thoroughly justified. In phases II and III, usually randomised, double-blind add-on studies versus placebo in patients with therapy-resistant seizures are used to get an impression of the efficacy and certain safety issues. A clear dose-response relationship may be a good indication for efficacy. However, assessment of safety of the new product in add-on studies is difficult. Therefore comparative phase III monotherapy studies versus established antiepileptic drugs are essential to confirm the results obtained in add-on studies and are needed for a proper judgement of the efficacy/safety balance. The percentage of reduction of seizure frequency has played a dominating role as efficacy criterium. Nowadays preference is being given to the percentage responders. Which parameter is the most relevant for the given group of patients and what change is considered clinically relevant must be thoroughly argued. The definition of responder should focus on major benefit for the patients involved.

Anticonvulsants↗