TY - JOUR
T1 - Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice
T2 - Results from the SCOLTA project long-term surveillance
AU - Madeddu, Giordano
AU - De Socio, Giuseppe V L
AU - Ricci, Elena
AU - Quirino, Tiziana
AU - Orofino, Giancarlo
AU - Carenzi, Laura
AU - Franzetti, Marco
AU - Parruti, Giustino
AU - Martinelli, Canio
AU - Vichi, Francesca
AU - Penco, Giovanni
AU - Dentone, Chiara
AU - Celesia, Benedetto Maurizio
AU - Maggi, Paolo
AU - Libertone, Raffaella
AU - Bagella, Paola
AU - Di Biagio, Antonio
AU - Bonfanti, Paolo
PY - 2015
Y1 - 2015
N2 - Muscle alterations ranging from asymptomatic creatine phosphokinase (CPK) increases to rhabdomyolysis and central nervous system (CNS) symptoms have been reported in patients receiving raltegravir. Muscle symptoms and CPK increases were investigated in a cohort of HIV-infected patients receiving raltegravir-based antiretroviral therapy, and possible associated predictors were evaluated. The SCOLTA Project is a prospective, observational, multicentre study created to assess the incidence of adverse events in patients receiving new antiretroviral drugs in clinical practice. In total, 496 HIV-infected patients were enrolled [333 (67.1%) male]. CDC stage was C in 196 patients (39.5%). Mean age at enrolment was 45.9 ± 9.3 years. Median follow-up was 21 months. Twenty-six patients (5.2%) reported muscle symptoms (16 muscle pain and 17 weakness; 7 had both). Of 342 patients with normal baseline CPK values, 72 (21.1%) had a CPK increase. Seven patients (1.4%) discontinued raltegravir because of muscular events (three for muscle pain/weakness and four CPK increases). No cases of rhabdomyolysis were observed. Patients with muscle symptoms were more frequently receiving in their regimen than those not receiving atazanavir (P = 0.04) and were more likely to also report CNS symptoms (P <0.0001). Significant predictors of muscle symptoms were CNS symptoms and use of atazanavir. Female sex was associated with a reduced risk of CPK increase. In conclusion, muscle symptoms and CPK elevations occurred frequently and caused most discontinuations due to adverse events. Their monitoring in patients receiving raltegravir should be considered, especially when co-administered with atazanavir or when CNS symptoms are also present.
AB - Muscle alterations ranging from asymptomatic creatine phosphokinase (CPK) increases to rhabdomyolysis and central nervous system (CNS) symptoms have been reported in patients receiving raltegravir. Muscle symptoms and CPK increases were investigated in a cohort of HIV-infected patients receiving raltegravir-based antiretroviral therapy, and possible associated predictors were evaluated. The SCOLTA Project is a prospective, observational, multicentre study created to assess the incidence of adverse events in patients receiving new antiretroviral drugs in clinical practice. In total, 496 HIV-infected patients were enrolled [333 (67.1%) male]. CDC stage was C in 196 patients (39.5%). Mean age at enrolment was 45.9 ± 9.3 years. Median follow-up was 21 months. Twenty-six patients (5.2%) reported muscle symptoms (16 muscle pain and 17 weakness; 7 had both). Of 342 patients with normal baseline CPK values, 72 (21.1%) had a CPK increase. Seven patients (1.4%) discontinued raltegravir because of muscular events (three for muscle pain/weakness and four CPK increases). No cases of rhabdomyolysis were observed. Patients with muscle symptoms were more frequently receiving in their regimen than those not receiving atazanavir (P = 0.04) and were more likely to also report CNS symptoms (P <0.0001). Significant predictors of muscle symptoms were CNS symptoms and use of atazanavir. Female sex was associated with a reduced risk of CPK increase. In conclusion, muscle symptoms and CPK elevations occurred frequently and caused most discontinuations due to adverse events. Their monitoring in patients receiving raltegravir should be considered, especially when co-administered with atazanavir or when CNS symptoms are also present.
KW - Creatine phosphokinase elevations
KW - Muscle symptoms
KW - Raltegravir
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UR - http://www.scopus.com/inward/citedby.url?scp=84923644234&partnerID=8YFLogxK
U2 - 10.1016/j.ijantimicag.2014.10.013
DO - 10.1016/j.ijantimicag.2014.10.013
M3 - Article
C2 - 25476452
AN - SCOPUS:84923644234
VL - 45
SP - 289
EP - 294
JO - International Journal of Antimicrobial Agents
JF - International Journal of Antimicrobial Agents
SN - 0924-8579
IS - 3
ER -