PMID- 37820508
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20240102
IS  - 1532-866X (Electronic)
IS  - 0049-0172 (Linking)
VI  - 63
DP  - 2023 Dec
TI  - Co prescription of anti-acid therapy reduces the bioavailability of mycophenolate 
      mofetil in systemic sclerosis patients: A crossover trial.
PG  - 152270
LID - S0049-0172(23)00112-9 [pii]
LID - 10.1016/j.semarthrit.2023.152270 [doi]
AB  - OBJECTIVE: Mycophenolate mofetil (MMF) is an effective treatment option for 
      interstitial lung disease (ILD) in systemic sclerosis (SSc). Many patients 
      require co-administration of proton pump inhibitors (PPI) or H2 receptor blockers 
      (HRB) because of various gastrointestinal (GI) manifestations in SSc. 
      Co-treatment with PPI or HRB have shown to reduce serum drug levels in 
      post-transplant patients. We wanted to see if there is a similar phenomenon for 
      Mycophenolate in SSc. METHODS: Twenty SSc patients, who were on a stable dose of 
      MMF (1.5-3 g) underwent a sequential cross over study with MMF alone in the first 
      month, followed by co-treatment with Ranitidine and then Esomeprazole in the 
      second and third month respectively. Estimation of 12-hour area under curve (AUC) 
      of Mycophenolic Acid (MPA) levels and total GI score were calculated at the end 
      of each month and compared between the treatment arms. [Trial registration: 
      CTRI/2020/06/025,939] RESULTS: Co-administration of esomeprazole was associated 
      with 32.7% (mean difference = 22.28 mug h ml(-1)) reduction in mean AUC MPA, 
      whereas ranitidine caused a reduction of 21.97% (mean difference = 14.93 mug h 
      ml(-1)) in MPA AUC when compared to MMF without anti-acid therapies. The addition 
      of ranitidine or esomeprazole resulted in significant reduction in the total GI 
      score. CONCLUSION: Co-administration of PPI or HRB can significantly reduce the 
      bioavailability of MMF in patients with SSc. To avoid therapeutic failure of MMF 
      drug level monitoring is essential when these agents are co-prescribed with MMF.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Alex, Glaxon
AU  - Alex G
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India.
FAU - Shanoj, K C
AU  - Shanoj KC
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India.
FAU - Varghese, Delcey Rachel
AU  - Varghese DR
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India.
FAU - Sageer Babu, A S
AU  - Sageer Babu AS
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India.
FAU - Reji, Reshma
AU  - Reji R
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India.
FAU - Shenoy, Padmanabha D
AU  - Shenoy PD
AD  - Centre for Arthritis and Rheumatism Excellence (CARE), Kochi, India. Electronic 
      address: drdpshenoy@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20230928
PL  - United States
TA  - Semin Arthritis Rheum
JT  - Seminars in arthritis and rheumatism
JID - 1306053
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - N3PA6559FT (Esomeprazole)
RN  - 884KT10YB7 (Ranitidine)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (Gastrointestinal Agents)
SB  - IM
MH  - Humans
MH  - *Mycophenolic Acid/therapeutic use
MH  - Cross-Over Studies
MH  - Esomeprazole/therapeutic use
MH  - Ranitidine
MH  - Biological Availability
MH  - Immunosuppressive Agents/therapeutic use
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Gastrointestinal Agents
MH  - *Scleroderma, Systemic/complications/drug therapy
OTO - NOTNLM
OT  - Anti-acid therapy
OT  - Bioavailability
OT  - Co prescription
OT  - Interactions
OT  - MPA-AUC
OT  - Mycophenolate mofetil
OT  - Systemic sclerosis
OT  - gastrointestinal effects
COIS- Declaration of Competing Interest Nil.
EDAT- 2023/10/12 00:43
MHDA- 2023/12/17 09:43
CRDT- 2023/10/11 18:07
PHST- 2023/06/01 00:00 [received]
PHST- 2023/08/13 00:00 [revised]
PHST- 2023/08/27 00:00 [accepted]
PHST- 2023/12/17 09:43 [medline]
PHST- 2023/10/12 00:43 [pubmed]
PHST- 2023/10/11 18:07 [entrez]
AID - S0049-0172(23)00112-9 [pii]
AID - 10.1016/j.semarthrit.2023.152270 [doi]
PST - ppublish
SO  - Semin Arthritis Rheum. 2023 Dec;63:152270. doi: 10.1016/j.semarthrit.2023.152270. 
      Epub 2023 Sep 28.