An open-label, randomized controlled trial of sulfamethoxazole-trimethoprim for

Pneumocystis pneumonia drug discontinuation rate efficacy prophylaxis randomized controlled trial rheumatic disease safety sulfamethoxazole–trimethoprim

Journal

Rheumatology advances in practice
ISSN: 2514-1775
Titre abrégé: Rheumatol Adv Pract
Pays: England
ID NLM: 101736676

Informations de publication

Date de publication:
2020
Historique:
received: 28 04 2020
revised: 10 06 2020
entrez: 2 11 2020
pubmed: 3 11 2020
medline: 3 11 2020
Statut: epublish

Résumé

The aim was to investigate the long-term prophylactic efficacy, drug retention and safety of low-dose sulfamethoxazole-trimethoprim (SMX/TMP) prophylaxis against Adult patients with rheumatic diseases receiving prednisolone ≥0.6 mg/kg/day were randomized into the single-strength group (SS; SMX/TMP 400/80 mg daily), the half-strength group (HS; 200/40 mg daily) or the escalation group (ES; starting at 40/8 mg and increasing incrementally to 200/40 mg daily) and treated for 24 weeks, then observed for 52 weeks. The primary endpoint, the PCP non-incidence rate (non-IR) at week 24, has been reported previously. The secondary endpoints were the PCP non-IR at week 52, treatment discontinuation rate and adverse events. Fifty-eight, 59 and 55 patients in the SS, HS and ES, respectively, received SMX/TMP. PCP did not develop in any of the patients by week 52. The estimated PCP non-IR in patients receiving SMX/TMP 200/40 mg daily (HS and ES) was 96.8-100%. Throughout the 52-week observation period, the overall discontinuation rate was significantly lower in HS than in SS (22.7 SMX/TMP 200/40 mg had a high PCP prevention rate and was superior to SMX/TMP 400/80 mg in terms of drug retention and safety. University Hospital Medical Information Network Clinical Trials Registry, UMIN000007727.

Identifiants

pubmed: 33134810
doi: 10.1093/rap/rkaa029
pii: rkaa029
pmc: PMC7585401
doi:

Types de publication

Journal Article

Langues

eng

Pagination

rkaa029

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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Auteurs

Masako Utsunomiya (M)

Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo.
Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.
Department of Rheumatology, Musashino Red Cross Hospital, Musashino, Tokyo.

Hiroaki Dobashi (H)

Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa University, Kida-gun, Kagawa.

Toshio Odani (T)

Third Department of Internal Medicine, Obihiro-Kosei General Hospital, Obihiro, Hokkaido.

Kazuyoshi Saito (K)

First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka.

Naoto Yokogawa (N)

Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo.

Kenji Nagasaka (K)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.
Department of Rheumatology, Ome Municipal General Hospital, Ome, Tokyo.

Kenchi Takenaka (K)

Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.
Department of Rheumatology, Ome Municipal General Hospital, Ome, Tokyo.

Makoto Soejima (M)

Department of Rheumatology, Ome Municipal General Hospital, Ome, Tokyo.

Takahiko Sugihara (T)

Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital, Tokyo.

Hiroyuki Hagiyama (H)

Department of Rheumatology, Yokohama City Minato Red Cross Hospital, Yokohama, Kanagawa.

Shinya Hirata (S)

Department of Hematology, Rheumatology, and Infectious Disease, Kumamoto University Graduate School of Medicine, Kumamoto, Kumamoto.

Kazuo Matsui (K)

Department of Rheumatology, Kameda Medical Center, Kamogawa, Chiba.

Yoshinori Nonomura (Y)

Department of Rheumatology, Tokyo Kyosai Hospital, Tokyo.

Masahiro Kondo (M)

Department of Rheumatology, Faculty of Medicine, Shimane University, Izumo, Shimane.

Fumihito Suzuki (F)

Department of Rheumatology, Soka Municipal Hospital, Soka, Saitama.

Yasushi Nawata (Y)

Center for Rheumatic Disease, Chibaken Saiseikai Narashino Hospital, Narashino, Chiba.

Makoto Tomita (M)

Clinical Research Center, Medical Hospital of Tokyo Medical and Dental University.

Mari Kihara (M)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Waka Yokoyama-Kokuryo (W)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Fumio Hirano (F)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Hayato Yamazaki (H)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Ryoko Sakai (R)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.
Division of Epidemiology and Pharmacoepidemiology, Institute of Rheumatology, Tokyo Women's Medical University.
Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Toshihiro Nanki (T)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Ryuji Koike (R)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Nobuyuki Miyasaka (N)

Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.

Masayoshi Harigai (M)

Departments of Pharmacovigilance.
Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo.
Division of Epidemiology and Pharmacoepidemiology, Institute of Rheumatology, Tokyo Women's Medical University.
Department of Rheumatology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Classifications MeSH