Please cite this article in press as: Madeddu G, et al. Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillance. Int J Antimicrob Agents (2014), http://dx.doi.org/10.1016/j.ijantimicag.2014.10.013 ARTICLE IN PRESS G Model ANTAGE-4453; No. of Pages 6 International Journal of Antimicrobial Agents xxx (2014) xxx–xxx Contents lists available at ScienceDirect International Journal of Antimicrobial Agents j o ur nal ho me pag e: http://www.elsevier.com/locate/ijantimicag Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillance Giordano Madeddu a,∗ , Giuseppe V.L. De Socio b , Elena Ricci c , Tiziana Quirino d , Giancarlo Orofino e , Laura Carenzi f , Marco Franzetti f , Giustino Parruti g , Canio Martinelli h , Francesca Vichi i , Giovanni Penco j , Chiara Dentone k , Benedetto Maurizio Celesia l , Paolo Maggi m , Raffaella Libertone n , Paola Bagella a , Antonio Di Biagio o , Paolo Bonfanti p , on behalf of the C.I.S.A.I. Group, Italy a Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Sassari, Viale San Pietro 8, 07100 Sassari, Italy b Unit of Infectious Diseases, Santa Maria Hospital, Perugia, Italy c epi2004, Milano, Italy d Unit of Infectious Diseases, Busto Arsizio Hospital, Busto Arsizio, Italy e Department of Infectious Diseases, Amedeo di Savoia Hospital, Turin, Italy f Department of Infectious Diseases, L. Sacco Hospital, Milan, Italy g Department of Infectious Diseases, Pescara Hospital, Pescara, Italy h Unit of Infectious Diseases, Careggi Hospital, Firenze, Italy i Unit of Infectious Diseases, Santa Maria Annunziata Hospital, Firenze, Italy j Unit of Infectious Diseases, Galliera Hospital, Genoa, Italy k Unit of Infectious Diseases, San Remo Hospital, San Remo, Italy l Unit of Infectious Diseases, ARNAS Garibaldi Hospital, Catania, Italy m Infectious Disease Clinic, University of Bari, Bari, Italy n III Department of Infectious Diseases, L. Spallanzani Hospital, Rome, Italy o Infectious Diseases, IRCCS San Martino Hospital, University of Genoa, Genoa, Italy p Unit of Infectious Diseases, A. Manzoni Hospital, Lecco, Italy a r t i c l e i n f o Article history: Received 22 July 2014 Accepted 5 October 2014 Keywords: Raltegravir Muscle symptoms Creatine phosphokinase elevations a b s t r a c t Muscle alterations ranging from asymptomatic creatine phosphokinase (CPK) increases to rhabdomyol- ysis 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 mus- cle 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 mus- cle 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 mus- cle 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. © 2014 Published by Elsevier B.V. ∗ Corresponding author. Tel.: +39 079 206 1036; fax: +39 079 217 620. E-mail address: giordano.madeddu@uniss.it (G. Madeddu). http://dx.doi.org/10.1016/j.ijantimicag.2014.10.013 0924-8579/© 2014 Published by Elsevier B.V.