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New SARS-CoV-2 Omicron variant with spike protein mutation Y451H, Kilifi, Kenya, March–May 2023
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Mwanga, Mike J., Lambisia, Arnold W., Morobe, John Mwita, Murunga, Nickson, Moraa, Edidah, Ndwiga, Leonard, Cheruiyot, Robinson, Musyoki, Jennifer, Mutunga, Martin, Guzmán-Rincón, Laura M., Sande, Charles, Mwangangi, Joseph, Bejon, Philip, Ochola-Oyier, Lynette Isabella, Nokes, D. James, Agoti, Charles N., Nyiro, Joyce and Githinji, George (2023) New SARS-CoV-2 Omicron variant with spike protein mutation Y451H, Kilifi, Kenya, March–May 2023. Emerging Infectious Diseases , 29 (11). pp. 2376-2379. doi:10.3201/eid2911.230894 ISSN 1080-6059.
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Official URL: http://doi.org/10.3201/eid2911.230894
Abstract
Objective
Assessment of the efficacy and safety/tolerability of the aromatase inhibitor leflutrozole to normalise testosterone in Obesity-associated Hypogonadotropic Hypogonadism (OHH).
Design
Placebo-controlled, double-blind, RCT, in 70 sites in Europe/USA.
Methods
Patient inclusion criteria: men with BMI of 30-50 kg/m2, morning total testosterone (TT) < 10.41 nmol/L, and two androgen deficiency symptoms (at least one of sexual dysfunction). Patients randomised to weekly leflutrozole (0.1/0.3/1.0 mg) or placebo for 24 weeks. Primary endpoint: normalisation of TT levels in ≥75% of patients after 24 weeks. Secondary endpoints (included): time to TT normalisation and change in LH/FSH. Safety was assessed through adverse events and laboratory monitoring.
Results and Conclusions
Of 2103 screened, 271 were randomised, 81 discontinued. Demographic characteristics were similar across groups. Mean BMI was 38.1 kg/m2 and TT 7.97 nmol/L. The primary endpoint was achieved in all leflutrozole-treated groups by 24 weeks with a dose-tiered response; mean TT 15.89; 17.78; 20.35 nmol/L, for leflutrozole 0.1 mg, 0.3 mg, and 1.0 mg groups respectively, vs 8.04 nmol/L for placebo. LH/FSH significantly increased in leflutrozole vs placebo groups. No improvements in body composition or sexual dysfunction were observed. Semen volume/total motile sperm count improved with leflutrozole vs placebo. Treatment-emergent adverse events, more common in leflutrozole-treated groups included, raised haematocrit, hypertension, increased PSA, and headache. Some reduction in lumbar bone density was observed with leflutrozole (mean −1.24%, −1.30%, −2.09%) and 0.66% for 0.1 mg, 0.3 mg, 1.0 mg, and placebo, respectively, without change at the hip. This RCT of leflutrozole in OHH demonstrated normalisation of TT in obese men. FSH/LH and semen parameter changes support that leflutrozole may preserve/improve testicular function.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Science > Life Sciences (2010- ) | ||||||||
Journal or Publication Title: | Emerging Infectious Diseases | ||||||||
Publisher: | US Department of Health and Human Services | ||||||||
ISSN: | 1080-6059 | ||||||||
Official Date: | November 2023 | ||||||||
Dates: |
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Volume: | 29 | ||||||||
Number: | 11 | ||||||||
Page Range: | pp. 2376-2379 | ||||||||
DOI: | 10.3201/eid2911.230894 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access |
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