title: Skeletal muscle toxicity in HIV-1-infected patients treated with a raltegravir-containing antiretroviral therapy: a cohort study.
abstract: To evaluate the frequency of myopathy and serum creatine kinase (CK) elevation associated with the use of the integrase inhibitor raltegravir we conducted a retrospective, cohort analysis assessing the incidence of skeletal muscle toxicity among HIV-infected patients treated with raltegravir. Adult HIV-infected patients who started a raltegravir-containing therapy were enrolled into the study. The skeletal muscle toxicity was defined by the presence of one or more of the following parameters: (1) isolated and significant CK elevation without signs or symptoms; (2) diffuse myalgia without weakness; (3) proximal muscle weakness; (4) rhabdomyolysis. On the whole, 155 patients were included in the study, with a mean age of 49.2 years; the median duration of the raltegravir treatment was 30.7 months. The overall frequency of skeletal muscle toxicity was 23.9%, with an incidence of 4.7/100 person-years. An isolated CK elevation was reported in 21.3% of cases, while less than 3% of patients complained of myalgia or muscle weakness. The CK elevation was usually of grade 1 or 2 and self-limiting, and laboratory or clinical abnormalities did not require discontinuation of raltegravir in any patient. Factors significantly associated with skeletal muscle toxicity were previous use of zidovudine, higher baseline CK levels, previous increase of the CK levels, and a higher body mass index. Skeletal muscle toxicity is not an unusual adverse event in subjects receiving raltegravir, but it is usually represented by a mild-to-moderate increase in CK concentration, while clinical symptoms of myopathy are very uncommon.
authors.affiliation: Department of Medical and Surgical Sciences, Infectious Diseases Unit, S. Orsola-Malpighi Hospital, Alma Mater Studiorum University of Bologna , Bologna, Italy .
authors.forename: Leonardo
authors.initials: L
authors.lastname: Calza
authors.forename: Ilaria
authors.initials: I
authors.lastname: Danese
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Colangeli
authors.forename: Giacomo
authors.initials: G
authors.lastname: Vandi
authors.forename: Roberto
authors.initials: R
authors.lastname: Manfredi
authors.forename: Nicolò
authors.initials: N
authors.lastname: Girometti
authors.forename: Marco
authors.initials: M
authors.lastname: Borderi
authors.forename: Lucia
authors.initials: L
authors.lastname: Appolloni
authors.forename: Cristina
authors.initials: C
authors.lastname: Puggioli
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Viale
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003402:Creatine Kinase / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018908:Muscle Weakness / Q000139:chemically induced; D018482:Muscle, Skeletal / Q000187:drug effects*; D063806:Myalgia / Q000139:chemically induced; D011760:Pyrrolidinones / Q000009:adverse effects* / Q000627:therapeutic use; D000068898:Raltegravir Potassium; D012189:Retrospective Studies; D012206:Rhabdomyolysis / Q000139:chemically induced
chemical_list: D019380:Anti-HIV Agents; D011760:Pyrrolidinones; D000068898:Raltegravir Potassium; D003402:Creatine Kinase