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1.
MSMR ; 31(4): 9-14, 2024 Apr 20.
Article En | MEDLINE | ID: mdl-38722556

A largely preventable condition, exertional rhabdomyolysis persists as an occupational hazard of military training and operations, especially in high heat environments among individuals exerting themselves to their physical endurance limits. During the 5-year surveillance period of this study, unadjusted incidence rates of exertional rhabdomyolysis per 100,000 person-years among U.S. active component service members fluctuated, reaching a low of 38.0 cases in 2020 and peaking at 40.5 cases in 2023. The rate in 2020 constituted a decline of 3.8% from the rate in 2019 (39.5 cases). Beginning in 2020, incidence rates per 100,000 person-years gradually increased, by 1.8% in 2021 (38.7 cases), 5.3% in 2022 (40.0 cases), and 6.6% in 2023 (40.5 cases). Consistent with prior reports, subgroup-specific crude rates in 2023 were highest among men, those less than 20 years old, non-Hispanic Black service members, Marine Corps or Army members, and those in combat-specific and 'other' occupations. Recruits experienced the highest rates of exertional rhabdomyolysis during each year, with incidence rates 6 to 10 times greater than all other service members.


Military Personnel , Physical Exertion , Population Surveillance , Rhabdomyolysis , Humans , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Military Personnel/statistics & numerical data , United States/epidemiology , Male , Adult , Incidence , Female , Young Adult , Physical Exertion/physiology , Occupational Diseases/epidemiology
2.
Saudi Med J ; 45(5): 510-517, 2024 May.
Article En | MEDLINE | ID: mdl-38734436

OBJECTIVES: To evaluate the clinical and laboratory features, complications, and outcomes of patients with rhabdomyolysis in the Saudi population. METHODS: Retrospectives descriptive study of adult patients who presented to King Abdulaziz Medical City (KAMC) withrhabdomyolysis between January 2016 and December 2022. RESULTS: Most of the participants (84.5%) were male, with a median age of 41 years and a body mass index of 26.5 kg/m2. Medications, mainly statins (22.4%) and illicit drugs (15.5%), constituted the root causes of rhabdomyolysis in the cohort (44.8%). The most common presenting complaints were myalgia (63.8%) and fatigue (37.9%). More than one-third of the participants (32.8%) developed AKI, with 3 patients requiring temporary hemodialysis, and only 8.6% developed acute liver failure (ALF). Intensive care unit (ICU) admission was required for 10 patients (17.2%), and the overall mortality rate was 8.6%. Patients who developed complications (composite outcomes of AKI, ALF, multiorgan failure, or death) had significantly reduced kidney function and higher levels of blood urea nitrogen, anion gap, and uric acid upon admission than those who did not. CONCLUSION: This study offers a thorough understanding of clinical and laboratory features, causes, complications, and outcomes of rhabdomyolysis among Saudi patients. The insights gained enhance our understanding of rhabdomyolysis within this population, providing a foundation for future research and improvements in clinical management.


Acute Kidney Injury , Rhabdomyolysis , Tertiary Care Centers , Humans , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Rhabdomyolysis/complications , Rhabdomyolysis/therapy , Male , Female , Adult , Middle Aged , Saudi Arabia/epidemiology , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Acute Kidney Injury/therapy , Acute Kidney Injury/mortality , Retrospective Studies , Liver Failure, Acute/mortality , Liver Failure, Acute/epidemiology , Liver Failure, Acute/therapy , Liver Failure, Acute/etiology , Liver Failure, Acute/complications , Intensive Care Units , Renal Dialysis , Multiple Organ Failure/etiology , Multiple Organ Failure/epidemiology , Multiple Organ Failure/mortality , Fatigue/etiology , Young Adult
3.
In Vivo ; 38(3): 1285-1291, 2024.
Article En | MEDLINE | ID: mdl-38688634

BACKGROUND/AIM: Recent research has increasingly demonstrated an association between proton pump inhibitors (PPIs) and serious adverse events. This study aimed to evaluate the association between PPI and rhabdomyolysis (RM), examining its time-to-onset profiles using the Japanese Adverse Drug Event Report (JADER) database. PATIENTS AND METHODS: Data spanning from April 2004 to March 2022 were used. The association between PPIs and RM was evaluated using the reporting odds ratio (ROR), adjusted for sex and age. Subsequent analyses were conducted after excluding cases involving concomitant use of statins or fibrates. Furthermore, the onset time of RM and Weibull distribution parameters were calculated to evaluate the expression profile of RM, and the outcomes were examined. RESULTS: RM was associated with the use of esomeprazole, omeprazole, and rabeprazole, even in the absence of concomitant statin or fibrate use. The median time to RM onset varied among PPIs, ranging from 6.5 to 127 d. The Weibull distribution parameters indicated that the hazard types of nearly all orally administered PPIs were classified as early failure or close to random failure. Regarding outcomes, cases of death were reported for all PPIs except vonoprazan. CONCLUSION: The findings suggest the need for vigilant monitoring of RM during PPI administration, particularly in the early stages, considering the varying onset times.


Adverse Drug Reaction Reporting Systems , Pharmacovigilance , Proton Pump Inhibitors , Rhabdomyolysis , Humans , Proton Pump Inhibitors/adverse effects , Proton Pump Inhibitors/administration & dosage , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , Male , Female , Middle Aged , Aged , Adult , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Databases, Factual , Aged, 80 and over , Young Adult , Adolescent , Esomeprazole/adverse effects , Esomeprazole/administration & dosage
4.
Eur J Clin Pharmacol ; 80(6): 911-918, 2024 Jun.
Article En | MEDLINE | ID: mdl-38441574

OBJECTIVE: To analyze the clinical characteristics, incidence, and distribution of drug-associated muscle adverse reactions (DAMAR) in real-world inpatients, to provide valuable references for clinical medication use. METHODS: We conducted an automatic retrospective monitoring of inpatients from May 1, 2022, to April 30, 2023, to collect information on adverse drug reactions (ADR) of patients and conducted subsequent analyses. RESULTS: Among 102,430 hospitalizations, 1106 cases of DAMARs were identified, yielding an incidence of 1.08%, including 125 cases of rhabdomyolysis at an incidence of 0.12%. Seventy-five percent of the patients experienced muscle adverse reactions within 5 days after taking medication, with a median elevated creatine kinase (CK) value of 420.4 IU/L. Risk factors of DAMAR include age ≥ 65, male sex, obesity, hypertension, hepatic and renal insufficiency, and anemia. No significant correlation was observed between the duration of surgery and CK elevation, while the surgical procedure itself had an impact. The 114 drugs associated were predominantly nervous system drugs, anti-infectives for systemic use, and cardiovascular system drugs, with levofloxacin, pregabalin, and parecoxib being the most frequently associated drugs. CONCLUSION: Healthcare professionals should be vigilant with patients exhibiting the identified risk factors. Monitoring creatine kinase and related indices when using myotoxic drugs is crucial to preventing serious adverse reactions, ultimately preserving patients' quality of life.


Creatine Kinase , Drug-Related Side Effects and Adverse Reactions , Inpatients , Rhabdomyolysis , Humans , Male , Female , Risk Factors , Middle Aged , Retrospective Studies , Aged , Incidence , Adult , Creatine Kinase/blood , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , Inpatients/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Adolescent , Aged, 80 and over , Young Adult , Hospitalization/statistics & numerical data , Child , Muscular Diseases/chemically induced , Muscular Diseases/epidemiology
5.
Indian J Med Res ; 159(1): 102-108, 2024 Jan 01.
Article En | MEDLINE | ID: mdl-38391136

BACKGROUND OBJECTIVES: Rhabdomyolysis in tropics has a unique aetiology and clinical profile. The objective of this study was to determine the aetiology and clinical outcomes of rhabdomyolysis and validate the McMahon risk prediction score in affected individuals from south India. METHODS: A retrospective study of affected individuals with rhabdomyolysis admitted to a tertiary care hospital in south India, between January 2015 and June 2020, was undertaken. In-patients who were ≥15 yr in age and had creatinine phosphokinase ≥5000 U/l were included in the study. Cardiac, stroke, chronic muscular diseases and chronic kidney disease on maintenance haemodialysis were excluded. The incidence of acute kidney injury (AKI) in this group was calculated. Other clinical outcomes determined were 28-day mortality, proportion of individuals who required renal replacement therapy (RRT), intensive care unit (ICU) admission, vasopressors, mechanical ventilation (MV), number of days on mechanical ventilator and length of stay in ICU and hospital. Validation of McMahon risk prediction score for the requirement of RRT and mortality was performed. RESULTS: Major aetiologies identified in the 75 study participants included were infections, trauma and seizures. Twenty eight-day mortality was 24 per cent (n=18). AKI incidence was 68 per cent, out of which 43.1 per cent had RRT. AKI in all survivors became dialysis independent. Vasopressors, MV and ICU requirement were 30.7, 32 and 77.3 per cent, respectively. Receiver operator characteristic curve for RRT and mortality risk prediction based on the McMahon Score showed a sensitivity of 71.4 per cent and specificity of 77.8 per cent for a cut-off ≥7.8. INTERPRETATION CONCLUSIONS: Rhabdomyolysis in tropics is associated with significant organ dysfunction and mortality. Although the incidence of AKI and RRT is high, the overall renal outcome is good among survivors. The wide confidence intervals for the area under curve for McMahon Score limit its predictability for RRT and mortality.


Acute Kidney Injury , Rhabdomyolysis , Humans , Retrospective Studies , Rhabdomyolysis/epidemiology , Rhabdomyolysis/therapy , Rhabdomyolysis/complications , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Acute Kidney Injury/etiology , Intensive Care Units , Risk Factors
6.
J Gastroenterol Hepatol ; 39(2): 289-296, 2024 Feb.
Article En | MEDLINE | ID: mdl-37961012

BACKGROUND AND AIM: The association between proton-pump inhibitors (PPIs) and rhabdomyolysis were unclear. The aim of this study was to explore and systematically analyze the potential link between five PPIs and the rhabdomyolysis events using the FDA Adverse Event Reporting System (FAERS) database. METHODS: Suspected rhabdomyolysis events associated with PPIs were identified by data mining with the reporting odds ratio (ROR), proportional reporting ratio (PRR), the information component (IC), and Empirical Bayes Geometric Mean (EBGM). Demographic information, drug administration, and outcomes of PPI-induced rhabdomyolysis events were also analyzed. RESULTS: There were 3311 reports associated with PPI-induced rhabdomyolysis that were identified. After removing duplicates, 1899 cases were determined to contain complete patient demographic data. The average age was 65 ± 18 year and 57% were male. Omeprazole and pantoprazole had the same largest percentage of reports. Lansoprazole had the highest ROR index of 12.67, followed by esomeprazole (11.18), omeprazole (10.27), rabeprazole (10.06), and pantoprazole (9.24). PRR, IC, and EBGM showed similar patterns. This suggested that lansoprazole exhibited the strongest correlation with rhabdomyolysis. In rhabdomyolysis events, PPIs were mainly "concomitant" (>60%), and only a few cases were "primary suspects" (<15%). Rabeprazole showed the lowest death rate while lansoprazole showed the highest. CONCLUSIONS: The study suggested that significant rhabdomyolysis signals were associated with PPIs. Further research should be performed in drug safety evaluation for a more comprehensive association.


Proton Pump Inhibitors , Rhabdomyolysis , Male , Humans , Middle Aged , Aged , Aged, 80 and over , Female , Proton Pump Inhibitors/adverse effects , Pantoprazole , Rabeprazole , Pharmacovigilance , Bayes Theorem , Omeprazole/adverse effects , Lansoprazole , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology
7.
Fundam Clin Pharmacol ; 38(2): 380-388, 2024 Apr.
Article En | MEDLINE | ID: mdl-37818695

BACKGROUND: Using statins in combination with other drugs was reported to increase the risk of myopathy. However, there was a sparse number of studies on the incidence of adverse events (AEs) associated with the concomitant use of statin and contraindicated drugs in the real world. OBJECTIVES: This study aimed to identify the risk of concomitant use of statins with contraindicated drugs by exploring signals related to statin-drug interactions. METHODS: We performed a disproportionality analysis for drugs and AEs by applying the case/non-case study using the KIDS-KAERS database (KIDS-KD), 2016-2020. A case was defined as an individual case safety reports (ICSRs) including "rhabdomyolysis/myopathy." A non-case was defined as an ICSR, including all other AEs. We applied Ω shrinkage measure model, chi-square statics model, additive model, multiplicative model, and combination risk ratio model to detect signals of myopathy due to statin with concomitant drugs including antiviral agents, immunosuppressants, and antifungals. RESULTS: Among 1 011 234 ICSRs, 2708 were cases, with 861 cases of statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting odds ratios were 3.27 (95% confidence interval [CI]: 3.11-3.43), 8.70 (95% CI: 8.04-9.40), and 1.83 (95% CI: 1.73-1.94), respectively. Several combinations of signals were detected through an additive model or multiplicative model. CONCLUSION: Signals of an increased risk of myopathy associated with the use of statins with concomitant drugs, including contraindicated drugs, were confirmed in a real-world setting.


Hydroxymethylglutaryl-CoA Reductase Inhibitors , Muscular Diseases , Rhabdomyolysis , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Muscular Diseases/chemically induced , Muscular Diseases/diagnosis , Muscular Diseases/epidemiology , Rhabdomyolysis/chemically induced , Rhabdomyolysis/diagnosis , Rhabdomyolysis/epidemiology , Drug Interactions
8.
Curr Atheroscler Rep ; 25(11): 879-888, 2023 11.
Article En | MEDLINE | ID: mdl-37831308

PURPOSE OF REVIEW: Elevated plasma levels of low-density lipoprotein cholesterol (LDL-C) are a major risk factor for atherosclerotic cardiovascular disease (ASCVD), and lowering LDL-C reduces the risk of cardiovascular adverse events. Among natural approaches known for their lipid-lowering properties, red yeast rice (RYR) has a cholesterol-lowering effect due to the presence of bioactive components (monacolins) that act by inhibiting the activity of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. In August 2018, the European Food Safety Authority (EFSA) concluded in its assessment of the use of RYR (further amended in June 2022) that monacolins from RYR raise significant safety concerns when used as a food supplement at a dose of 10 mg/day. In particular, individual cases of serious adverse effects of monacolins from RYR have been reported at intakes as low as 3 mg/day. The EFSA Panel pointed out several uncertainties regarding the available data. RECENT FINDINGS: We conducted an in-depth and updated analysis of the serious adverse events, with a focus on rhabdomyolysis and acute hepatitis, associated with the consumption of RYR. An analysis of the Food and Drug Administration reporting systems revealed a very small number of cases of rhabdomyolysis or severe acute hepatitis associated with RYR use. In addition, only a few case reports of these serious adverse events associated with RYR use have been published. Based on data from adverse event reporting systems and available case reports, the occurrence of rhabdomyolysis or severe acute hepatitis that could be associated with the use of RYR appears to be extremely rare compared to the occurrence with statins, which is rare to common.


Biological Products , Hepatitis , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Rhabdomyolysis , Humans , Cholesterol, LDL , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Dietary Supplements/adverse effects , Cholesterol , Biological Products/adverse effects , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology
9.
Sci Rep ; 13(1): 17693, 2023 10 17.
Article En | MEDLINE | ID: mdl-37848606

Rhabdomyolysis is a potentially life-threatening condition induced by diverse mechanisms including drugs and toxins. We aimed to investigate the incidence of rhabdomyolysis occurrence in intoxicated patients with psychoactive substances. In this review, three databases (PubMed, Scopus, Web of Science) and search engine (Google Scholar) were searched by various keywords. After the screening of retrieved documents, related data of included studies were extracted and analyzed with weighted mean difference (WMD) in random effect model. The highest incidence of rhabdomyolysis was observed in intoxication with heroin (57.2 [95% CI 22.6-91.8]), amphetamines (30.5 [95% CI 22.6-38.5]), and cocaine (26.6 [95% CI 11.1-42.1]). The pooled effect size for blood urea nitrogen (WMD = 8.78, p = 0.002), creatinine (WMD = 0.44, p < 0.001), and creatinine phosphokinase (WMD = 2590.9, p < 0.001) was high in patients with rhabdomyolysis compared to patients without rhabdomyolysis. Our results showed a high incidence of rhabdomyolysis induced by psychoactive substance intoxication in ICU patients when compared to total wards. Also, the incidence of rhabdomyolysis occurrence was high in ICU patients with heroin and amphetamine intoxication. Therefore, clinicians should anticipate this complication, monitor for rhabdomyolysis, and institute appropriate treatment protocols early in the patient's clinical course.


Heroin , Rhabdomyolysis , Humans , Heroin/adverse effects , Incidence , Creatinine , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , Central Nervous System Agents
10.
Int J Clin Pract ; 2023: 6396576, 2023.
Article En | MEDLINE | ID: mdl-37808625

Background: Rhabdomyolysis (RM) refers to a clinical syndrome in which muscle cells are damaged by various causes and the clinical manifestations are mainly muscle pain, weakness, and dark urine. Acute kidney injury (AKI) is a serious complication of RM with complex mechanisms and high mortality. Therefore, understanding the pathogenesis and clinical manifestations, early diagnosis and treatment of RM are crucial to improve its prognosis. Method: Analysis of medical records of RM patients admitted to Tianjin Medical University General Hospital from October 2019 to October 2022. Statistical software SPSS 25.0 was used to analyze the data. The risk factors of RM-complicated AKI were analyzed by logistic regression. The receiver operating characteristic (ROC) curve was plotted, the area under the curve (AUC) was calculated, and the optimal cutoff value was determined by the Youden index. P < 0.05 indicates a statistically significant difference between the groups. Result: Among the 71 patients, the median age of the patients was 53.0 (30.0, 71.0) years and was 2.5 times higher in men than in women. Infection was the most common etiology. History of alcohol consumption, CK, and creatinine were independent influencing factors for AKI due to RM. Logistic regression analysis showed that CK combined with creatinine had a better predictive value than the single index. Conclusion: Our study revealed the clinical and laboratory characteristics of RM in the population attending the Tianjin Medical University General Hospital in the last three years, which is a reference for future multicenter, prospective studies.


Acute Kidney Injury , Rhabdomyolysis , Female , Humans , Male , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Creatinine , Prognosis , Prospective Studies , Retrospective Studies , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Rhabdomyolysis/therapy , ROC Curve , Adult , Middle Aged , Aged
11.
Int J Infect Dis ; 136: 115-126, 2023 Nov.
Article En | MEDLINE | ID: mdl-37730012

OBJECTIVES: SARS-CoV-2 infection ("COVID-19") and the hypoxemia that has attended some cases may predispose to rhabdomyolysis. We sought to identify reported cases of COVID-19-associated rhabdomyolysis, examining concurrent risk factors (RFs) and mortality outcomes. METHODS: We searched PubMed for articles conveying individual-level information on COVID-19-associated rhabdomyolysis, published between January 2020 and July 2022, with an English-language abstract. Two independent parties performed the search, and then abstracted information on cases including rhabdomyolysis RFs and mortality. RESULTS: In total, 117 individual reported cases of COVID-19-associated rhabdomyolysis were identified from 89 articles. A total of 80 cases (68.4%) had at least one reported non-COVID-19 RF (i.e. not considering COVID-19 or hypoxemia). On average, 1.27 additional RFs were reported, including age ≥65, metabolic syndrome features, hypothyroidism, previous rhabdomyolysis, hemoglobinopathy, trauma/compression, pregnancy, exertion, inborn errors of metabolism, concurrent (co-)infection, capillary leak syndrome, and selected rhabdomyolysis-associated medications. Concurrent RFs are understated, as many articles omitted comorbidities/medications. Of 109 cases with ascertainable survival status, 31 (28%) died. CONCLUSIONS: COVID-19 and hypoxemia confer risk of rhabdomyolysis, but additional rhabdomyolysis RFs are commonly present. Mortality is substantial irrespective of the presence of such RFs. Clinicians should be aware of COVID-19-associated rhabdomyolysis, and caution may be warranted in administering agents that may amplify rhabdomyolysis risk.


COVID-19 , Rhabdomyolysis , Pregnancy , Female , Humans , COVID-19/complications , SARS-CoV-2 , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Hypoxia
12.
MSMR ; 30(4): 8-12, 2023 Apr 20.
Article En | MEDLINE | ID: mdl-37418508

Exertional rhabdomyolysis is a pathologic muscle breakdown associated with strenuous physical activity. A largely preventable condition, it persists as an occupational hazard of military training and operations, especially in high heat environments among individuals exerting themselves to endurance limits. During the 5-year surveillance period, unadjusted incidence rates of exertional rhabdomyolysis among U.S. service members declined by approximately 15%, from 43.1 cases per 100,000 person-years (p-yrs) in 2018 to 36.5 cases per 100,000 p-yrs in 2022. Consistent with prior reports, subgroup- specific rates in 2022 were highest among men, those younger than 20 years, non-Hispanic Black service members, Marine Corps or Army members, and those in combat-specific and "other" occupations. Recruit trainees had the highest rates of exertional rhabdomyolysis in 2021 and 2022, with incidence rates 10 times higher than all other service members. Prompt recognition of the symptoms of exertional rhabdomyolysis (muscular pain or swelling, limited range of motion, or the excretion of darkened urine after strenuous physical activity, especially in hot, humid weather) by health care providers is crucial to avoid the most severe consequences of this potentially life-threatening condition.


Heat Stress Disorders , Military Personnel , Rhabdomyolysis , Humans , Male , Heat Stress Disorders/epidemiology , Heat Stress Disorders/complications , Incidence , Physical Exertion/physiology , Population Surveillance , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , United States/epidemiology , Female , Young Adult , Adult
13.
Sci Rep ; 13(1): 12257, 2023 07 28.
Article En | MEDLINE | ID: mdl-37507539

Rhabdomyolysis is a syndrome potentially fatal and has been associated with selective serotonin reuptake inhibitors (SSRIs) treatment in a few case reports. Herein, we purpose to establish the correlation between SSRIs use and rhabdomyolysis using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. We conducted an analysis on reports that were submitted to the FAERS database during the period between January 1, 2004, and December 31, 2022. Four algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), were employed to quantify the signals of rhabdomyolysis associated with SSRIs. In total, 16,011,277 non-duplicated reports were obtained and analyzed. Among 33,574 reports related to rhabdomyolysis, SSRIs were classified as primary suspected drug in 889 cases. Disproportionality analysis identified a positive signal between rhabdomyolysis and SSRIs (ROR: 2.86, 95% CI 2.67-3.05; PRR: 2.84, χ2: 1037.16; IC0.25 = 1.39; EBGM0.5 = 2.64). Among six SSRIs, fluvoxamine had the strongest signal (ROR: 11.64, 95% CI 8.00-16.93; PRR: 11.38, χ2: 265.51; IC0.25 = 2.41; EBGM0.5 = 8.31), whereas no significant signal of rhabdomyolysis was detected for paroxetine (ROR: 1.83, 95% CI 1.55-2.15; PRR: 1.82, χ2: 53.82; IC0.25 = 0.73; EBGM0.5 = 1.59). After excluding cases co-administered with statins, the signal of rhabdomyolysis associated with SSRIs remains significant. Our analysis reveals that there are differences in safety signals among six SSRIs in respect to the risk of rhabdomyolysis, with fluvoxamine displaying the highest risk signal, while paroxetine did not show a significant signal. Given the potentially lethal nature of rhabdomyolysis, healthcare professionals should inform patients of the potential risk of rhabdomyolysis associated with SSRIs prior to initiating treatment.


Rhabdomyolysis , Selective Serotonin Reuptake Inhibitors , United States/epidemiology , Humans , Selective Serotonin Reuptake Inhibitors/adverse effects , Bayes Theorem , Pharmacovigilance , Fluvoxamine , Paroxetine , Adverse Drug Reaction Reporting Systems , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , United States Food and Drug Administration
14.
Br J Clin Pharmacol ; 89(8): 2636-2638, 2023 08.
Article En | MEDLINE | ID: mdl-37186323

Rhabdomyolysis is a serious adverse drug reaction of statins. There are few studies comparing the risk of rhabdomyolysis between the different statins. Using the WHO pharmacovigilance database, VigiBase®, we compared the risk of rhabdomyolysis reporting of seven statins (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin, with cerivastatin excluded). All reports of rhabdomyolysis in VigiBase® in adults with statins until 31 December 2022 were included. Results are expressed as reporting odds ratio (ROR, 95% CI). Among 10 657 reports with rhabdomyolysis with statins, simvastatin was the highest risk statin in comparison with others: ROR = 2.20 (2.11-2.29). The risk was higher in men, older than 74 years and in cases of drug interactions.


Hydroxymethylglutaryl-CoA Reductase Inhibitors , Rhabdomyolysis , Male , Adult , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Pharmacovigilance , Simvastatin/adverse effects , Atorvastatin , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology
15.
Br J Clin Pharmacol ; 89(8): 2430-2445, 2023 08.
Article En | MEDLINE | ID: mdl-36912450

AIMS: Recent case reports have suggested that sodium-glucose co-transporter 2 (SGLT2) inhibitors may interact with statins to increase their risk of myotoxicity. We assessed the risk of myotoxicity reporting associated with concomitant use of SGLT2 inhibitors and statins. METHODS: We queried the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 2013 to 2021 for reports including SGLT2 inhibitors, statins or both. We estimated several measures of disproportionate reporting of myopathy and rhabdomyolysis associated with concomitant use of SGLT2 inhibitors and statins: reporting odds ratio (ROR) with 95% confidence interval (CI), Ω shrinkage measure (safety signal if >0) and an extension of the proportional reporting ratio (PRR) (two-criteria set, safety signal if both criteria are met), using the full FAERS dataset as the reference set. In sensitivity analyses, we focussed on specific SGLT2 inhibitor-statin pairs with higher interaction potential (canagliflozin-rosuvastatin, empagliflozin-rosuvastatin) and accounted for stimulated reporting. RESULTS: There were 456 myopathy and 77 rhabdomyolysis reports involving both an SGLT2 inhibitor and a statin. Concomitant use of SGLT2 inhibitors and statins was not associated with an increased risk of myopathy (ROR 0.79, 95% CI 0.70 to 0.89) or rhabdomyolysis (ROR 0.58, 95% CI 0.41 to 0.83) reporting. For both outcomes, the Ω shrinkage measure was negative and only one criterion of the PRR extension was met. SGLT2 inhibitor-statin pairs with higher interaction potential yielded potential signals for rhabdomyolysis; these signals disappeared after accounting for stimulated reporting. CONCLUSION: There was no increased risk of myotoxicity reporting associated with concomitant use of SGLT2 inhibitors and statins or for specific drug pairs.


Hydroxymethylglutaryl-CoA Reductase Inhibitors , Muscular Diseases , Rhabdomyolysis , Sodium-Glucose Transporter 2 Inhibitors , Symporters , Humans , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Myotoxicity , Rosuvastatin Calcium , Adverse Drug Reaction Reporting Systems , Muscular Diseases/chemically induced , Muscular Diseases/epidemiology , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , Glucose , Sodium
16.
Ann Pharmacother ; 57(11): 1255-1263, 2023 11.
Article En | MEDLINE | ID: mdl-36847276

BACKGROUND: It is unclear whether use of a proton pump inhibitors (PPIs) increases the risk of rhabdomyolysis. OBJECTIVE: To clarify whether use of PPIs increases the risk of rhabdomyolysis. METHODS: This cross-sectional study analyzed data entered into the Medical Data Vision (MDV) database in Japan and into the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). The MDV data were analyzed to evaluate the association between use of PPIs and rhabdomyolysis. Then, the FAERS data were analyzed to evaluate whether the risk of rhabdomyolysis was increased further when a statin or fibrate was used concomitantly with a PPI. In both analyses, histamine-2 receptor antagonist was set as a comparator because it is used to treat gastric disease. In the MDV analysis, Fisher's exact test and multiple logistic regression analysis were performed. In the FAERS analysis, a disproportionality analysis using Fisher's exact test and multiple logistic regression analysis were performed. RESULTS: Multiple logistic regression analysis of both databases showed a significant association between use of PPIs and an increased risk of rhabdomyolysis (odds ratio [OR] = 1.74-1.95, P ≤ 0.01). However, use of a histamine-2 receptor antagonist was not significantly associated with increased risk of rhabdomyolysis. In the sub-analysis of the FAERS data, use of a PPI did not increase the risk of rhabdomyolysis in patients receiving a statin. CONCLUSION AND RELEVANCE: The data in 2 separate databases consistently suggest that PPIs may increase the risk of rhabdomyolysis. The evidence for this association should be assessed in further drug safety studies.


Hydroxymethylglutaryl-CoA Reductase Inhibitors , Rhabdomyolysis , Humans , Proton Pump Inhibitors/adverse effects , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Cross-Sectional Studies , Histamine , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology , Rhabdomyolysis/drug therapy , Histamine H2 Antagonists/adverse effects
17.
Obes Surg ; 33(4): 990-1003, 2023 04.
Article En | MEDLINE | ID: mdl-36805462

PURPOSE: This study aimed to evaluate the prevalence of rhabdomyolysis (RML) following bariatric surgery and potential associated factors. MATERIALS AND METHODS: We systematically searched PubMed, Embase, and CENTRAL for relevant trials from database inception through August 2022. Articles were eligible for inclusion if they reported the prevalence of RML after bariatric surgery and provided at least one of the following outcome indicators: preoperative mean BMI/mean operative time for the included population. RESULTS: Sixteen studies with a total of 1540 patients were analyzed. The mean preoperative age distribution of the included patients was centered between 32.9 and 47.0 years, and the mean preoperative BMI ranged from 42.3 to 60.0 kg/m2. The operative time varied between 126.7 and 403.3 min. The overall pooled crude prevalence of post-bariatric surgery RML was 19.4%. Subgroup analyses showed the pooled prevalence of RML was 8.1% for operative duration > 120 and ≤ 180 min, 32.8% for > 180 and ≤ 240 min, and 47.4% for > 240 min. Meta-regression revealed that operation time was an independent risk factor for developing RML. Besides, BMI > 50 kg/m2 and open Roux-en-Y gastric bypass (RYGB) indicated a higher risk of RML. CONCLUSION: Post-bariatric surgery RML prevalence occurred more frequently with the extension of the operation time. For bariatric subjects with surgery time > 180 min, open RYGB, or BMI > 50 kg/m2, CKP could be routinely measured early to verify the presence of RML and to actively prevent its fatal complications.


Bariatric Surgery , Gastric Bypass , Obesity, Morbid , Rhabdomyolysis , Adult , Humans , Middle Aged , Bariatric Surgery/adverse effects , Gastric Bypass/adverse effects , Obesity, Morbid/surgery , Prevalence , Retrospective Studies , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Risk Factors , Treatment Outcome
18.
Rev Environ Health ; 38(4): 613-620, 2023 Dec 15.
Article En | MEDLINE | ID: mdl-35852130

OBJECTIVES: To analyze case reports with individual patient data belonging to the Armed Forces submitted to specific physical or military combat training that was affected by rhabdomyolysis and identify factors that influenced the diagnosis and clinical evolution of the syndrome. CONTENT: We conducted a systematic review following the PRISMA guidelines and registered on PROSPERO (CRD42021242465). We searched MedLine (via PubMed), Scopus, Cochrane, Lilacs, SciELO, CINAHL, Web of Science, SPORTDiscus, ScienceDirect, and PEDro databases for studies that reported cases of military personnel affected by rhabdomyolysis. SUMMARY AND OUTLOOK: Thirteen studies met the inclusion criteria. Forty-nine individual cases of rhabdomyolysis were analyzed. From them, it was possible to identify several associated factors, which were responsible for developing rhabdomyolysis in military personnel. Thirty military personnel (60%) practiced physical training and 20 (40%) practiced specific military combat training. The creatine kinase (CK) peak ranged from 1,040 to 410,755 U/L, with an average of 44.991 U/L, and 14 (28%) of the cases reported alteration of renal function and four militaries (8%) evolved to death condition. Physical activities performed strenuously and without proper planning conditions such as room temperature, the period without adequate water intake, the amount of equipment used during the activity contributed to the development of rhabdomyolysis in the cases of military personnel analyzed in the present study. Therefore, it is recommended that future studies investigate the relationship between the prevalence of rhabdomyolysis cases and the severity of its consequence when associated with progressive methods of training, hydration control, acclimatization to austere environments, monitoring for the existence of hereditary diseases, and control of the use of supplementary nutritional substances.


Military Personnel , Rhabdomyolysis , Humans , Rhabdomyolysis/epidemiology , Rhabdomyolysis/etiology , Rhabdomyolysis/diagnosis , Exercise/physiology , Risk Factors , Creatine Kinase , Biomarkers
19.
Injury ; 54(1): 189-197, 2023 Jan.
Article En | MEDLINE | ID: mdl-36437166

BACKGROUND: The incidence of acute kidney injury (AKI) is high in critically ill patients with rhabdomyolysis. Limited evidence was proved of the association between serum phosphate levels at intensive care unit (ICU) admission and the subsequent risk of AKI. Our study aims to assess if serum phosphate levels at admission were independently associated with AKI risk in these patients. METHODS: This study extracted and analyzed data from Medical Information Mart for Intensive Care-Ⅲ (MIMIC-Ⅲ, version1.4). Rhabdomyolysis was defined as a peak creatine kinase (CK) level higher than 1000 U/L. Serum phosphate was measured within the first day into the ICU and was categorized to 4 groups (<2.6, 2.6-3.4, 3.5-4.5, >4.5mg/dl). AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) guidelines. Adjusted smoothing spline plots and multivariable logistic regressions were carried out to explode the association between serum phosphate and risk of AKI. Subgroup analyse was applied to verify the consistency of the association. RESULTS: Three hundred and twenty-one patients (68% male) diagnosed as rhabdomyolysis were eligible for this analysis. AKI occurred in 204 (64%) patients of total. Incidence of AKI with admission serum phosphate groups<2.6, 2.6-3.4, 3.5-4.5 and>4.5mg/dl were 53%, 57%, 68% and 76%, respectively. Smoothing spline curve showed that there was a positive curve between the elevated phosphate values and increasing risk of AKI, and there was no threshold saturation effect. In multivariable logistic regression, OR was 1.2 (95%CI 1.0-1.5, P=0.035, P trend=0.041) after adjusting confounders. Subgroup analyses proved the consistency of the relationship in these patients, possibly, except in the strata of potassium. CONCLUSION: In rhabdomyolysis patients admitted to ICU, serum phosphate levels at admission were independently associated with an increased risk of AKI. As phosphate levels rise, the risk of AKI increased.


Acute Kidney Injury , Rhabdomyolysis , Humans , Male , Female , Retrospective Studies , Critical Illness , Intensive Care Units , Acute Kidney Injury/etiology , Phosphates , Rhabdomyolysis/complications , Rhabdomyolysis/epidemiology , Risk Factors
20.
Br J Clin Pharmacol ; 89(3): 956-966, 2023 03.
Article En | MEDLINE | ID: mdl-36585759

AIMS: Several reports have suggested an association between febuxostat and muscle injury. The purpose of this study was to determine whether febuxostat increases the risk of muscle injury. This study included an analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and a systematic review/meta-analysis of randomized controlled trials. METHODS: First, evaluation of the FAERS data included a disproportionality analysis that compared patients with and without rhabdomyolysis according to whether they were receiving febuxostat or allopurinol. Second, a systematic review/meta-analysis was performed to assess the risk of rhabdomyolysis and muscle injury in patients who used febuxostat or allopurinol. RESULTS: Analysis of the FAERS data revealed disproportionality for increasing rhabdomyolysis in patients who received febuxostat (reporting odds ratio 4.49, 95% confidence interval [CI] 3.72-5.38, P < .01) and allopurinol (reporting odds ratio 2.49, 95% CI 2.25-2.75, P < .01). Nineteen studies were eligible for inclusion in the systematic review/meta-analysis. Rhabdomyolysis was reported in only 1 study. The risk of any type of muscle damage was not significantly increased with febuxostat compared with placebo (risk ratio 0.92, 95% CI 0.73-1.17, P = .52, I2  = 0%; 8 studies including 2597 participants, high-certainty evidence) or allopurinol (risk ratio 1.03, 95% CI 0.94-1.11, P = .56, I2  = 0%; 9 studies including 17 644 participants, moderate-certainty evidence). CONCLUSION: Febuxostat does not seem to affect the risk of muscle injury. However, the findings of this meta-analysis indicate a need for further high-quality observational studies with long-term follow-up.


Gout , Muscular Diseases , Rhabdomyolysis , Humans , Allopurinol/adverse effects , Febuxostat/adverse effects , Gout/drug therapy , Gout Suppressants/adverse effects , Muscles , Muscular Diseases/chemically induced , Randomized Controlled Trials as Topic , Rhabdomyolysis/chemically induced , Rhabdomyolysis/epidemiology
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