Low-Dose vs Conventional-Dose Trimethoprim-Sulfamethoxazole Treatment for Pneumocystis Pneumonia in Patients Not Infected With HIV

Abstract

BackgroundTrimethoprim-sulfamethoxazole (TMP-SMX) is an effective treatment for Pneumocystis jirovecii pneumonia (PCP) in immunocompromised patients with and without HIV infection; however, a high incidence of adverse events has been observed. Low-dose TMP-SMX is a potentially effective treatment with fewer adverse events; however, evidence is limited.Research QuestionWhat is the efficacy and safety of low-dose TMP-SMX for non-HIV PCP compared with conventional-dose TMP-SMX after adjusting for patient background characteristics?Study Design and MethodsIn this multicenter retrospective cohort study, we included patients diagnosed with non-HIV PCP and treated with TMP-SMX between June 2006 and March 2021 at three institutions. The patients were classified into low-dose (TMP < 12.5 mg/kg/d) and conventional-dose (TMP 12.5-20 mg/kg/d) groups. The primary end point was 30-day mortality, and the secondary end points were 180-day mortality, adverse events grade 3 or higher per the Common Terminology Criteria for Adverse Events v5.0, and initial treatment completion rates. Background characteristics were adjusted using the overlap weighting method with propensity scores.ResultsFifty-five patients in the low-dose group and 81 in the conventional-dose group were evaluated. In the overall cohort, the average age was 70.7 years, and the proportion of women was 55.1%. The average dose of TMP-SMX was 8.71 mg/kg/d in the low-dose group and 17.78 mg/kg/d in the conventional-dose group. There was no significant difference in 30-day mortality (6.7% vs 18.4%, respectively; P = .080) or 180-day mortality (14.6% vs 26.1%, respectively; P = .141) after adjusting for patient background characteristics. The incidence of adverse events, especially nausea and hyponatremia, was significantly lower in the low-dose group (29.8% vs 59.0%, respectively; P = .005). The initial treatment completion rates were 43.3% and 29.6% in the low-dose and conventional-dose groups (P = .158), respectively.InterpretationSurvival was similar between the low-dose and conventional-dose TMP-SMX groups, and low-dose TMP-SMX was associated with reduced adverse events in patients with non-HIV PCP. Trimethoprim-sulfamethoxazole (TMP-SMX) is an effective treatment for Pneumocystis jirovecii pneumonia (PCP) in immunocompromised patients with and without HIV infection; however, a high incidence of adverse events has been observed. Low-dose TMP-SMX is a potentially effective treatment with fewer adverse events; however, evidence is limited. What is the efficacy and safety of low-dose TMP-SMX for non-HIV PCP compared with conventional-dose TMP-SMX after adjusting for patient background characteristics? In this multicenter retrospective cohort study, we included patients diagnosed with non-HIV PCP and treated with TMP-SMX between June 2006 and March 2021 at three institutions. The patients were classified into low-dose (TMP < 12.5 mg/kg/d) and conventional-dose (TMP 12.5-20 mg/kg/d) groups. The primary end point was 30-day mortality, and the secondary end points were 180-day mortality, adverse events grade 3 or higher per the Common Terminology Criteria for Adverse Events v5.0, and initial treatment completion rates. Background characteristics were adjusted using the overlap weighting method with propensity scores. Fifty-five patients in the low-dose group and 81 in the conventional-dose group were evaluated. In the overall cohort, the average age was 70.7 years, and the proportion of women was 55.1%. The average dose of TMP-SMX was 8.71 mg/kg/d in the low-dose group and 17.78 mg/kg/d in the conventional-dose group. There was no significant difference in 30-day mortality (6.7% vs 18.4%, respectively; P = .080) or 180-day mortality (14.6% vs 26.1%, respectively; P = .141) after adjusting for patient background characteristics. The incidence of adverse events, especially nausea and hyponatremia, was significantly lower in the low-dose group (29.8% vs 59.0%, respectively; P = .005). The initial treatment completion rates were 43.3% and 29.6% in the low-dose and conventional-dose groups (P = .158), respectively. Survival was similar between the low-dose and conventional-dose TMP-SMX groups, and low-dose TMP-SMX was associated with reduced adverse events in patients with non-HIV PCP. Take-Home PointsStudy Question: What are the efficacy and safety of low-dose trimethoprim-sulfamethoxazole (TMP-SMX) for Pneumocystis jirovecii pneumonia in non-HIV-infected patients after adjusting for patient background characteristics?Results: In this multicenter retrospective cohort study, there was no significant difference in 30-day or 180-day mortality between the low-dose (TMP < 12.5 mg/kg/d) and conventional-dose (TMP 12.5-20 mg/kg/d) groups after adjusting for patient background characteristics. The incidence of adverse events, especially nausea and hyponatremia, was significantly lower in the low-dose group.Interpretation: Survival was similar between the low-dose and conventional-dose TMP-SMX groups, and low-dose TMP-SMX was associated with reduced adverse events in patients with non-HIV P jirovecii pneumonia. Study Question: What are the efficacy and safety of low-dose trimethoprim-sulfamethoxazole (TMP-SMX) for Pneumocystis jirovecii pneumonia in non-HIV-infected patients after adjusting for patient background characteristics? Results: In this multicenter retrospective cohort study, there was no significant difference in 30-day or 180-day mortality between the low-dose (TMP < 12.5 mg/kg/d) and conventional-dose (TMP 12.5-20 mg/kg/d) groups after adjusting for patient background characteristics. The incidence of adverse events, especially nausea and hyponatremia, was significantly lower in the low-dose group. Interpretation: Survival was similar between the low-dose and conventional-dose TMP-SMX groups, and low-dose TMP-SMX was associated with reduced adverse events in patients with non-HIV P jirovecii pneumonia. Pneumocystis jirovecii pneumonia (PCP) is a widely known opportunistic infection in immunocompromised patients.1Thomas Jr., C.F. Limper A.H. Pneumocystis pneumonia.N Engl J Med. 2004; 350: 2487-2498Crossref PubMed Scopus (878) Google Scholar,2Tasaka S. Tokuda H. Pneumocystis jirovecii pneumonia in non-HIV-infected patients in the era of novel immunosuppressive therapies.J Infect Chemother. 2012; 18: 793-806Abstract Full Text PDF PubMed Scopus (88) Google Scholar The occurrence of PCP in patients with AIDS has been problematic worldwide since the 1980s; however, the frequency of PCP in this population has decreased significantly because of early treatment for HIV in recent years.2Tasaka S. Tokuda H. Pneumocystis jirovecii pneumonia in non-HIV-infected patients in the era of novel immunosuppressive therapies.J Infect Chemother. 2012; 18: 793-806Abstract Full Text PDF PubMed Scopus (88) Google Scholar,3Morris A. Lundgren J.D. Masur H. et al.Current epidemiology of Pneumocystis pneumonia.Emerg Infect Dis. 2004; 10: 1713-1720Crossref PubMed Scopus (346) Google Scholar Nevertheless, the occurrence of PCP in non-HIV patients has increased because of the use of immunosuppressive drugs, anticancer drugs, and the increasing number of patients undergoing organ transplantations.2Tasaka S. Tokuda H. Pneumocystis jirovecii pneumonia in non-HIV-infected patients in the era of novel immunosuppressive therapies.J Infect Chemother. 2012; 18: 793-806Abstract Full Text PDF PubMed Scopus (88) Google Scholar,4Maini R. Henderson K.L. Sheridan E.A. et al.Increasing Pneumocystis pneumonia, England, UK, 2000-2010.Emerg Infect Dis. 2013; 19: 386-392Crossref PubMed Scopus (130) Google Scholar Furthermore, the mortality rate (30%-60%) of non-HIV PCP is higher than that (10%-20%) of HIV PCP because of a strong inflammatory response to a smaller number of organisms, unlike milder immune reactions in HIV PCP.1Thomas Jr., C.F. Limper A.H. Pneumocystis pneumonia.N Engl J Med. 2004; 350: 2487-2498Crossref PubMed Scopus (878) Google Scholar,2Tasaka S. Tokuda H. Pneumocystis jirovecii pneumonia in non-HIV-infected patients in the era of novel immunosuppressive therapies.J Infect Chemother. 2012; 18: 793-806Abstract Full Text PDF PubMed Scopus (88) Google Scholar Therefore, it is crucial to improve the therapeutic management of PCP in non-HIV immunocompromised patients to improve their prognoses. Prior reviews and guidelines indicate that the first-line therapy for patients with non-HIV PCP and HIV PCP is trimethoprim-sulfamethoxazole (TMP-SMX), and doses of 15 to 20 mg/kg/d trimethoprim and 75 to 100 mg/kg/d sulfamethoxazole are recommended.1Thomas Jr., C.F. Limper A.H. Pneumocystis pneumonia.N Engl J Med. 2004; 350: 2487-2498Crossref PubMed Scopus (878) Google Scholar,2Tasaka S. Tokuda H. Pneumocystis jirovecii pneumonia in non-HIV-infected patients in the era of novel immunosuppressive therapies.J Infect Chemother. 2012; 18: 793-806Abstract Full Text PDF PubMed Scopus (88) Google Scholar,5Maschmeyer G. Helweg-Larsen J. Pagano L. et al.ECIL guidelines for treatment of Pneumocystis jirovecii pneumonia in non-HIV-infected haematology patients.J Antimicrob Chemother. 2016; 71: 2405-2413Crossref PubMed Scopus (120) Google Scholar, 6Limper A.H. Knox K.S. Sarosi G.A. et al.An Official American Thoracic Society Statement: treatment of fungal infections in adult pulmonary and critical care patients.Am J Respir Crit Care Med. 2011; 183: 96-128Crossref PubMed Scopus (459) Google Scholar, 7Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. Recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America.https://www.idsociety.org/contentassets/7ab3d1e72a9d4868be6d6c2c2553818e/adult_oi.pdfDate accessed: October Scholar, Pneumocystis a with a prevention and PubMed Scopus Google Scholar The efficacy of TMP-SMX a therapy is however, it is associated with a high incidence of adverse events, and and it to et to use of in the treatment of patients with Pneumocystis jirovecii a retrospective Antimicrob Chemother. 2012; PubMed Scopus Google Scholar, et doses of are an for adverse reactions in patients with pneumonia and 2016; PubMed Scopus Google Scholar, et trimethoprim-sulfamethoxazole treatment for pneumonia in immunocompromised a retrospective cohort PubMed Scopus Google Scholar In of TMP-SMX were in the in with and the of adverse events from that in the population of patients with PCP without G. et the treatment of Pneumocystis jirovecii Infect Dis. PubMed Scopus Google Scholar non-HIV PCP is in and a proportion of and is associated with organ and et trimethoprim-sulfamethoxazole treatment for pneumonia in immunocompromised a retrospective cohort PubMed Scopus Google Scholar, G. et the treatment of Pneumocystis jirovecii Infect Dis. PubMed Scopus Google Scholar, et and safety of lower dose therapy for Pneumocystis jirovecii pneumonia in patients with a retrospective multicenter Infect Chemother. Full Text Full Text PDF PubMed Scopus Google Scholar, A. et retrospective of the efficacy and of low-dose trimethoprim-sulfamethoxazole for the treatment of pneumonia in patients without HIV Chemother. PubMed Scopus Google Scholar Therefore, low-dose therapy (TMP < mg/kg/d) and therapy with TMP-SMX been therapeutic and the of the incidence of adverse compared with that in et trimethoprim-sulfamethoxazole treatment for pneumonia in immunocompromised a retrospective cohort PubMed Scopus Google et and safety of lower dose therapy for Pneumocystis jirovecii pneumonia in patients with a retrospective multicenter Infect Chemother. Full Text Full Text PDF PubMed Scopus Google Scholar, A. et retrospective of the efficacy and of low-dose trimethoprim-sulfamethoxazole for the treatment of pneumonia in patients without HIV Chemother. PubMed Scopus Google Scholar, of Pneumocystis pneumonia with and to low-dose from an cohort 2016; PubMed Scopus Google Scholar, G. A. Low-dose TMP-SMX in the treatment of Pneumocystis jirovecii a and Infect Dis. PubMed Google Scholar, H. A. S. et with reduced dose trimethoprim-sulfamethoxazole is effective in to Pneumocystis jirovecii pneumonia in patients with Infect Dis. PubMed Scopus Google Scholar the evidence is because there are a number of retrospective et trimethoprim-sulfamethoxazole treatment for pneumonia in immunocompromised a retrospective cohort PubMed Scopus Google et and safety of lower dose therapy for Pneumocystis jirovecii pneumonia in patients with a retrospective multicenter Infect Chemother. Full Text Full Text PDF PubMed Scopus Google Scholar, A. et retrospective of the efficacy and of low-dose trimethoprim-sulfamethoxazole for the treatment of pneumonia in patients without HIV Chemother. PubMed Scopus Google Scholar, of Pneumocystis pneumonia with and to low-dose from an cohort 2016; PubMed Scopus Google Scholar, G. A. Low-dose TMP-SMX in the treatment of Pneumocystis jirovecii a and Infect Dis. PubMed Google Scholar and the patient background between the low-dose and conventional-dose groups was adjusted to mortality rates and H. A. S. et with reduced dose trimethoprim-sulfamethoxazole is effective in to Pneumocystis jirovecii pneumonia in patients with Infect Dis. PubMed Scopus Google Scholar In a study, et H. A. S. et with reduced dose trimethoprim-sulfamethoxazole is effective in to Pneumocystis jirovecii pneumonia in patients with Infect Dis. PubMed Scopus Google Scholar no in between and in low-dose and conventional-dose TMP-SMX groups using an adjusted for patients with PCP from this 30-day mortality or adverse reactions after adjusting for and it was to patients with their Therefore, we to the efficacy and safety of low-dose TMP-SMX compared with conventional-dose TMP-SMX in patients with non-HIV PCP with 30-day mortality the primary end point after adjusting for patient background in a multicenter cohort was a multicenter retrospective cohort diagnosed patients with non-HIV PCP treated with non-HIV patients diagnosed with PCP between 2006 and March 2021 at and to and for the of Pneumocystis in to and a of non-HIV et trimethoprim-sulfamethoxazole treatment for pneumonia in immunocompromised a retrospective cohort PubMed Scopus Google R. Pneumocystis pneumonia associated with in Engl J Med. PubMed Scopus Google S. Masur H. et jirovecii for the fungal in without Infect Dis. 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PubMed Scopus Google Scholar, of Pneumocystis pneumonia with and to low-dose from an cohort 2016; PubMed Scopus Google Scholar, G. A. Low-dose TMP-SMX in the treatment of Pneumocystis jirovecii a and Infect Dis. PubMed Google Scholar, H. A. S. et with reduced dose trimethoprim-sulfamethoxazole is effective in to Pneumocystis jirovecii pneumonia in patients with Infect Dis. PubMed Scopus Google Scholar a of mg/kg/d has been the point of adverse reactions in the the to patients with adverse et and safety of lower dose therapy for Pneumocystis jirovecii pneumonia in patients with a retrospective multicenter Infect Chemother. Full Text Full Text PDF PubMed Scopus Google Scholar Therefore, we a dose of 12.5 the dose of to 15 the point for low-dose The primary end point was 30-day mortality from the of The secondary end points were mortality at from the of incidence of adverse and completion rate of initial guidelines a treatment of to for non-HIV G. Helweg-Larsen J. 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The using is in 3 and In the adjusted cohort, the 30-day mortality and adverse events were significantly lower in the low-dose group. with an Nevertheless, this was for the low-dose and it the of the from primary that there was no difference in mortality between the low-dose and conventional-dose groups. multicenter retrospective the treatment of low-dose vs conventional-dose TMP-SMX in patients with non-HIV PCP after adjusting for patient and characteristics. There were no significant in the 30-day and 180-day rates between the low-dose and conventional-dose groups. the rate of adverse events of grade 3 or higher was significantly lower in the low-dose group than in the conventional-dose group. The of was after the this is the and multicenter to the mortality rate and safety of low-dose TMP-SMX for non-HIV PCP after adjusting for patient characteristics. evidence the of low-dose TMP-SMX treatment for the management of non-HIV PCP. the dose of trimethoprim and sulfamethoxazole at 15 to 20 and 75 to 100 G. Helweg-Larsen J. Pagano L. et al.ECIL guidelines for treatment of Pneumocystis jirovecii pneumonia in non-HIV-infected haematology patients.J Antimicrob Chemother. 2016; 71: 2405-2413Crossref PubMed Scopus (120) Google Scholar, 6Limper A.H. Knox K.S. Sarosi G.A. et al.An Official American Thoracic Society Statement: treatment of fungal infections in adult pulmonary and critical care patients.Am J Respir Crit Care Med. 2011; 183: 96-128Crossref PubMed Scopus (459) Google Scholar, 7Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. Recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America.https://www.idsociety.org/contentassets/7ab3d1e72a9d4868be6d6c2c2553818e/adult_oi.pdfDate accessed: October Scholar because of adverse events and of the dose and because the dose for non-HIV PCP is in the and S. of trimethoprim and sulfamethoxazole in the prevention and treatment of Pneumocystis Chemother. PubMed Scopus Google Scholar, S. of Pneumocystis with J. Google Scholar, Trimethoprim-sulfamethoxazole for the treatment of Pneumocystis Med. Scopus Google Scholar the efficacy of low-dose or treatment with In et G. A. Low-dose TMP-SMX in the treatment of Pneumocystis jirovecii a and Infect Dis. 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PubMed Scopus Google Scholar compared low-dose (TMP mg/kg/d) and conventional-dose TMP-SMX (TMP mg/kg/d) in patients with the in the difference in between and a primary end There were no significant in the primary end point between the groups, or after for in an adjusted H. A. S. et with reduced dose trimethoprim-sulfamethoxazole is effective in to Pneumocystis jirovecii pneumonia in patients with Infect Dis. PubMed Scopus Google Scholar The population for this was to patients with and three and at were for In the mortality and safety of low-dose TMP-SMX (TMP < 12.5 mg/kg/d) in patients with non-HIV PCP with a of and adjusted for patient background that mortality in patients with non-HIV of and G. Helweg-Larsen J. Pagano L. et al.ECIL guidelines for treatment of Pneumocystis jirovecii pneumonia in non-HIV-infected haematology patients.J Antimicrob Chemother. 2016; 71: 2405-2413Crossref PubMed Scopus (120) Google L. 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