Biomedical subjects

Luciano Caprino

Publications and source records attributed to Luciano Caprino.

3 recordsLinked to original sources

PubMed2006

Developing a paradigm of drug innovation: an evaluation algorithm.

Assessment of drug innovation is a burning issue because it involves so many different perspectives, mainly those of patients, decision- and policy-makers, regulatory authorities and pharmaceutical companies. Moreover, the innovative value of a new medicine is usually an intrinsic property of the compound, but it also depends on the specific context in which the medicine is introduced and the availability of other medicines for treating the same clinical condition. Thus, a model designed to assess drug innovation should be able to capture the intrinsic properties of a compound (which usually emerge during R&D) and/or modification of its innovative value with time. Here we describe the innovation assessment algorithm (IAA), a simulation model for assessing drug innovation. IAA provides a score of drug innovation by assessing information generated during both the pre-marketing and the post-marketing authorization phase.

Algorithms↗

PubMed2005

[Herbal supplements in sports: use and abuse].

The use of natural supplements, included herbal supplements, by athletes has become an habit which often lacks any valid scientific rationale. It appears evident that this habit may entail health risks (including more or less serious adverse effects), consequent either: 1) to the pharmacodynamic effects of the drugs at high doses; or 2) to the occurrence of accumulation especially when their administration is not justified by a reduced synthesis or an increased demand; or 3) to the occurrence of intolerance; or, finally, 4) to the presence of unlabelled ingredients. The abuse of this kind of products always entails risks to the consumer, not only to the elite athlete, that can incur an adverse analytical finding on the occasion of anti-doping tests, but also to the amateur sportsman, for the possible occurrence of adverse drug reactions (ADR).

Adaptation, Physiological↗

PubMed2004

Effectiveness of interferon beta treatment in relapsing-remitting multiple sclerosis: an Italian cohort study.

RATIONALE, AIMS AND OBJECTIVES: Randomized clinical trials (RCTs) have provided evidence for the efficacy of interferon beta (IFNbeta) in the treatment of relapsing-remitting multiple sclerosis (RRMS). The aim of this study was to evaluate the effectiveness of IFNbeta treatment in clinical practice. METHODS: This was a national, multicentre, observational study of patients with confirmed RRMS. Demographic, clinical and therapeutic data were retrospectively collected for each patient enrolled in the study. RESULTS: The study cohort consisted of 427 patients exposed to and 245 never exposed to IFNbeta treatment during the study period (for a total 2297 patient-years of follow-up). Among the exposed patients, 215 were initially untreated and then began IFNbeta later in the follow-up period; 137 of these patients were exposed to IFNbeta for more than 2 years. In these patients, IFNbeta treatment reduced the mean relapse rate by 24.2%[95% confidence interval (CI): 5.8-42.5%]. For 640 of the 672 patients enrolled in the study, it was possible to calculate the area under the disability/time curve compared to that present at baseline. A total of 117 (18.3%) patients displayed disability progression. Adjustment of the disability progression rates for potential confounders and/or for propensity scores by Poisson regression model resulted in relative risks for patients exposed to IFNbeta treatment compared to those never exposed to IFNbeta of 0.87 (95% CI: 0.56-1.34) after an exposure of < or = 2 years, and of 0.35 (95% CI: 0.21-0.60) after an exposure of >2 years. CONCLUSIONS: These findings suggest that the evidence from RCTs on the treatment of RRMS with IFNbeta has been effectively translated into routine clinical practice.

Adult↗