PMID- 37895897
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231030
IS  - 1424-8247 (Print)
IS  - 1424-8247 (Electronic)
IS  - 1424-8247 (Linking)
VI  - 16
IP  - 10
DP  - 2023 Oct 8
TI  - Evaluating Sex Differences in Efficacy, Safety and Pharmacokinetics in Patients 
      Treated with Cannabis by a Metered-Dose Inhaler.
LID - 10.3390/ph16101426 [doi]
LID - 1426
AB  - BACKGROUND: Clinical studies on medical cannabis (MC) treatment have shown 
      sex-related differences, including higher susceptibility to adverse events among 
      women and greater analgesia among men. Here, we used the Syqe metered-dose 
      inhaler (MDI) and a single chemovar to analyze sex differences. METHODS: A total 
      of 1249 Israeli chronic pain patients were assessed for pain intensity, sleep and 
      adverse events (AEs) over 240 days. RESULTS: Following the first two weeks, no 
      significant sex differences were found in the effectiveness or safety of MC 
      treatment (p > 0.05). Inhaled Delta(9)-THC doses did not vary significantly between 
      sexes (p > 0.05) except in the first month of treatment. Pain reduction and sleep 
      improvement were similar for both sexes (p > 0.05). The overall rate of AEs was 
      equal and relatively low at 10% (n = 65, 10% of women and n = 60, 10% of men; 
      chi(2) (1) = 0.05, p = 0.820). A secondary analysis of pharmacokinetic data showed 
      no significant differences between sexes in Delta(9)-THC and its metabolite 
      pharmacokinetics, cardiovascular measures, or AE severity (p > 0.05). 
      CONCLUSIONS: Uniform MC treatment via the Syqe MDI showed no sex differences in 
      short-term effectiveness, safety and pharmacokinetics, nor in long-term effects, 
      under "real-life" conditions. These findings provide insights into MC treatment 
      which may inform clinical practice and policy-making in the field.
FAU - Aviram, Joshua
AU  - Aviram J
AUID- ORCID: 0000-0003-2075-5446
AD  - Syqe Medical Ltd., Tel Aviv 6816914, Israel.
FAU - Glezerman, Marek
AU  - Glezerman M
AUID- ORCID: 0000-0002-9175-2253
AD  - Faculty of Medicine and Head, Gender- and Sex Conscious Medicine, Tel Aviv 
      University, Tel Aviv 69978, Israel.
FAU - Hayam, Eytan
AU  - Hayam E
AD  - Syqe Medical Ltd., Tel Aviv 6816914, Israel.
FAU - Belobrov, Rostislav
AU  - Belobrov R
AD  - Syqe Medical Ltd., Tel Aviv 6816914, Israel.
FAU - Procaccia, Shiri
AU  - Procaccia S
AD  - Faculty of Biology, Technion-Israel Institute of Technology, Haifa 3200003, 
      Israel.
FAU - Meiri, David
AU  - Meiri D
AD  - Faculty of Biology, Technion-Israel Institute of Technology, Haifa 3200003, 
      Israel.
FAU - Eisenberg, Elon
AU  - Eisenberg E
AD  - Rappaport Faculty of Medicine-Technion, Israel Institute of Technology, Haifa 
      3525433, Israel.
LA  - eng
GR  - NA/Syqe Medical LTD/
PT  - Journal Article
DEP - 20231008
PL  - Switzerland
TA  - Pharmaceuticals (Basel)
JT  - Pharmaceuticals (Basel, Switzerland)
JID - 101238453
PMC - PMC10610259
OTO - NOTNLM
OT  - Syqe inhaler
OT  - adverse effects
OT  - chronic pain
OT  - medical cannabis
OT  - medicinal cannabis
OT  - pharmacokinetics
OT  - phytocannabinoids
OT  - sex
COIS- Authors Joshua Aviram, Rostislav Belobrov and Eytan Hayam were employed by the 
      company Syqe Medical Ltd. The remaining authors declare that the research was 
      conducted in the absence of any commercial or financial relationships that could 
      be construed as a potential conflict of interest.
EDAT- 2023/10/28 11:48
MHDA- 2023/10/28 11:49
PMCR- 2023/10/08
CRDT- 2023/10/28 01:24
PHST- 2023/09/19 00:00 [received]
PHST- 2023/10/03 00:00 [revised]
PHST- 2023/10/06 00:00 [accepted]
PHST- 2023/10/28 11:49 [medline]
PHST- 2023/10/28 11:48 [pubmed]
PHST- 2023/10/28 01:24 [entrez]
PHST- 2023/10/08 00:00 [pmc-release]
AID - ph16101426 [pii]
AID - pharmaceuticals-16-01426 [pii]
AID - 10.3390/ph16101426 [doi]
PST - epublish
SO  - Pharmaceuticals (Basel). 2023 Oct 8;16(10):1426. doi: 10.3390/ph16101426.