The TANDEM investigation: efficacy and tolerability of levodopa-carbidopa intestinal gel in (LCIG) advanced Parkinson's disease patients

Angelo Antonini, Giovanni Abbruzzese, Alfredo Berardelli, Nicola Modugno, Italo Stroppa, Filippo Tamma, Mariachiara Sensi, Francesca Mancini, Giovanni Cossu, Alessandro Stefani, Nicola Tambasco, Alessandro Tessitore, Giovanni Fabbrini, Francesco E Pontieri, Paolo Solla, Anna Rita Bentivoglio, Cristoforo Comi, Brigida Minafra, Giulio Riboldazzi, Donato MelchiondaTommaso Martino, Leonardo Lopiano

Research output: Contribution to journalArticle

Abstract

The TANDEM investigation was carried out in 17 Italian Movement Disorder centers on behalf of a joint initiative of neurologist members of the Italian Academy for Parkinson's disease and Movement Disorders (LIMPE-DISMOV Academy) and gastroenterologist members of the Italian Society of Digestive Endoscopy (SIED) to evaluate the efficacy and tolerability of levodopa-carbidopa intestinal gel (LCIG) in patients with advanced Parkinson's disease (PD) in routine medical care. Motor scores in "ON" and OFF" state (UPDRS-III), complications of therapy (UPDRS-IV), activities of daily living, sleep disorders and quality of life were evaluated at baseline and at two follow-up assessments (FUV1 and FUV2) within the initial 12-month LCIG treatment. In 159 patients (55% males) with a mean age of 69.1 ± 6.6 years and a diagnosis of PD since 13.6 ± 5.5 years, the UPDRS-III total score (in "OFF") decreased from baseline (45.8 ± 13.2) to FUV1 (41.0 ± 17.4; p < 0.001) and FUV2 (40.5 ± 15.5; p < 0.001), the UPDRS-IV total score decreased from baseline (8.8 ± 2.9) to FUV1 (5.1 ± 3.4; p < 0.001) and FUV2 (5.5 ± 3.2; p < 0.001). The percentage of patients exhibiting freezing, dystonia, gait/walking disturbances, falls, pain and sleep disorders was significantly reduced. Twenty-eight device complications were reported and 11 (6.9%) patients prematurely terminated the study. LCIG after 12-month treatment led to sustained improvement of time spent in "OFF", complications of therapy, PD-associated symptoms and sleep disorders. LCIG tolerability was consistent with the established safety profile of LCIG.

Original languageEnglish
Pages (from-to)881-891
Number of pages11
JournalJ. Neural Transm.
Volume127
Issue number6
DOIs
Publication statusPublished - Mar 24 2020

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    Antonini, A., Abbruzzese, G., Berardelli, A., Modugno, N., Stroppa, I., Tamma, F., Sensi, M., Mancini, F., Cossu, G., Stefani, A., Tambasco, N., Tessitore, A., Fabbrini, G., Pontieri, F. E., Solla, P., Bentivoglio, A. R., Comi, C., Minafra, B., Riboldazzi, G., ... Lopiano, L. (2020). The TANDEM investigation: efficacy and tolerability of levodopa-carbidopa intestinal gel in (LCIG) advanced Parkinson's disease patients. J. Neural Transm., 127(6), 881-891. https://doi.org/10.1007/s00702-020-02175-1