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CDK2(Cyclin-dependent kinase 2)	1

1: The aim was to investigate whether precision-cut rat tissue slices could be used to predict metabolic drug clearance in vivo. To obtain a complete picture, slices not only from liver, but also from lung, kidney, small intestine and colon were included. 2: The metabolic clearances of 7-ethoxycoumarin, 7-hydroxycoumarin, testosterone, methyltestosterone and warfarin were determined by measuring the disappearance of these compounds during incubation with slices prepared from liver, lung, kidney, small intestine and colon. 3: The total in vitro metabolic clearance was determined by adding the individual in vitro organ clearances from the slices. Prediction based on the in vitro clearance was within an order of magnitude to the corresponding in vivo values. Interestingly, the relative contribution of extrahepatic metabolic clearance of the studied compounds to total clearance was remarkably high, ranging from 35 to 72% of the total metabolic clearance. 4: It is concluded that the model of multi-organ precision-cut slices is a useful in vitro tool for prediction of in vivo metabolic clearance. In addition, it provides information about the relative contribution of the liver, lung, kidney, small intestine and colon to the total metabolic clearance.

01 Mar 2003·PharmacoEconomics Italian Research Articles

Cost-analysis of a 6-week cycle of therapy with celecoxib vs conventional NSAIDs in ostheoarthritis in Italy

Author: D. Roggeri ; S. Chiroli ; G. Annoni ; Carlo Lucioni

To estimate the cost in the Italian National Health Service (INHS) perspective of a 6-week treatment course with celecoxib vs NSAIDs in ostheoarthritis patients. A decision-tree analysis with a 6-week time-frame. Costs included the acquisition cost of celecoxib 200 mg/day and of a basket of the first ten prescribed NSAIDs in Italy during the year 2000. Probabilities of side effects were derived from clinical trials comparing celecoxib vs NSAIDs and adjusted for 6-week exposure. Costs to treat the adverse events and probability of hospitalization were derived from a previous study conducted in Italy among GPs. Sensitivity and treshold analyses were conducted to test the robustness of the model. In the 6-week period, celecoxib resulted the less expensive strategy vs NSAIDs (€ 72,35 vs 78,63). Probability of serious events with NSAIDs was most critical for the results and the cost-effectiveness of the new therapy was correlated to the risk of serious events with NSAIDs. According to our study results, celecoxib represents a cost-effective first-line strategy alternative to NSAIDs for the symptomatic therapy of ostheoarthritis in Italy.

01 Jan 2003·Clinical Drug InvestigationQ4 · MEDICINE

Utilisation Pattern of Nonspecific Nonsteroidal Anti-Inflammatory Drugs and COX-2 Inhibitors in a Local Health Service Unit in Northeast Italy

Q4 · MEDICINE

Article

Author: G Didoni ; C Lucioni ; A Chinellato ; S Mazzi ; S Chiroli

BACKGROUND AND OBJECTIVENonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed widely in Italy. They include nonspecific NSAIDs (NS-NSAIDs) and the newly marketed cyclo-oxygenase (COX)-2 specific inhibitors (COXIBs) celecoxib and rofecoxib. The objective of this study was to describe the prescribing patterns for NS-NSAIDs and COXIBs in a local Italian area, analysing an administrative database.PATIENTS AND METHODSWe extracted from the database information on subjects who had received at least one reimbursed prescription of an NSAID during the period between 1 January 2001 and 31 December 2001, including age, sex, patient identification code, Anatomical Therapeutic Chemical (ATC) classification system code, strength, formulation, number of packs prescribed, prescription date, and prescription of gastroprotective agents (GPAs) on the same day as the prescription of the NSAID. On the basis of the type of NSAID received, we divided the patients into five cohorts: oral NS-NSAIDs only during the observed year, injectable NS-NSAIDs only, celecoxib only, rofecoxib only, and a combination. For descriptive purposes, we defined three age groups: <40 years, 40-64 years, and >64 years. The duration of exposure to NSAID therapy was calculated using the most commonly prescribed dose for the different drugs. Subjects receiving >/=30 doses per year were defined as "regular users". Analyses included mean age, mean duration of exposure, percentage of regular users, and percentage of GPAs co-prescribed in the different cohorts.RESULTSNSAIDs were prescribed to 62 059 subjects from a resident population of 365 321 inhabitants; 43.8% received oral NS-NSAIDs only, 22.6% injectable NS-NSAIDs only, 7.2% celecoxib only, 5.2% rofecoxib only, and 22% different regimens of different types of NSAIDs. The mean duration of treatment increased with age in all cohorts; the mean age was 56 years in the NS-NSAID cohort, 61 years in the celecoxib cohort, and 62 years in the rofecoxib cohort (p = 0.01, COXIBs vs NS-NSAIDs). The mean duration of therapy was 11.4 days/year for injectable NS-NSAIDs, 43.8 days/year for rofecoxib, 50.5 days/year for oral NS-NSAIDs, and 53.7 days/year for celecoxib. Fifty-four percent of subjects in the oral NS-NSAID cohort were regular users versus 64% in the rofecoxib and 70% in the celecoxib groups (p = 0.001, COXIBs vs NS-NSAIDs). Co-prescription with GPAs was 9.5% for NS-NSAIDs, 8.4% for rofecoxib, and 7.7% for celecoxib.CONCLUSIONSAnalysis of an administrative database in Italy showed a trend suggesting that COXIBs are prescribed to an older population and for a longer period of time than NS-NSAIDs, and that their use is less frequently associated with GPAs.

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Pipeline Snapshot as of 24 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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