J Pers Med. 2021 Dec 2;11(12):1279. doi: 10.3390/jpm11121279.

ABSTRACT

Early detection and prompt treatment of psychosis is of the utmost importance. The great variability in clinical onset, illness course, and response to pharmacological and psychosocial treatment is in great part gender-related. Our aim has been to review narratively the literature focusing on gender related differences in the psychoses, i.e., schizophrenia spectrum disorders. We searched the PubMed/Medline, Scopus, Embase, and ScienceDirect databases on 31 July 2021, focusing on recent research regarding sex differences in early psychosis. Although women, compared to men, tend to have better overall functioning at psychotic symptom onset, they often present with more mood symptoms, may undergo misdiagnosis and delay in treatment and are at a higher risk for antipsychotic drug-induced metabolic and endocrine-induced side effects. Furthermore, women with schizophrenia spectrum disorders have more than double the odds of having physical comorbidities than men. Tailored treatment plans delivered by healthcare services should consider gender differences in patients with a diagnosis of psychosis, with a particular attention to early phases of disease in the context of the staging model of psychosis onset.

PMID:34945748 | DOI:10.3390/jpm11121279

Indian J Ophthalmol. 2022 Jan;70(1):321-323. doi: 10.4103/ijo.IJO_2589_21.

ABSTRACT

Covishield is in wide use in India with about 80% efficacy. Serious side effects are still under study. A 30-year-old female presented to us 7 days post-vaccination with a 5-day history of sudden diminution of vision in both eyes. The clinical findings were suggestive of the Vogt-Koyanagi-Harada (VKH) syndrome. She was treated with high-dose oral steroids. At this juncture, the association was unclear. However, it was justified by an acute flare-up of uveitis on day 2 post the second dose of vaccination despite ongoing steroids. A direct correlation of Harada-like syndrome with the Covishield vaccine is observed here.

PMID:34937269 | DOI:10.4103/ijo.IJO_2589_21

Medicine (Baltimore). 2021 Dec 23;100(51):e28158. doi: 10.1097/MD.0000000000028158.

ABSTRACT

BACKGROUND: Leuprorelin is an analog of gonadotropin-releasing hormone that is used for the therapy of central precocious puberty (CPP). The aims of this prospective, open label, multicenter clinical trial were to establish its efficacy and safety during long-term use.

METHODS: Patients, who were all children, were treated with 1.88 to 3.75 mg leuprorelin subcutaneously once every 4 weeks for a total of 96 weeks between 2015 and 2018. The primary endpoint was the rate of occurrence of adverse events (AEs) and the secondary endpoint was no progression in the Tanner stage or regression by week 96 compared to baseline.

RESULTS: A total of 307 CPP patients, 305 (99.3%) females and 2 males (0.7%), completed the 96-weeks of treatment. Due to limited data for male patients, they are not discussed in the efficacy results. Treatment-emergent AEs (TEAEs) were reported for 252 (82.1%) patients, mostly (79.5%) being mild or moderate and only 33 (10.7%) of patients experienced TEAEs related to leuprorelin therapy. The most frequent (>2%) drug-related TEAEs were injection site induration (4.6%, 14/307) and vaginal bleeding (2.3%, 7/305). After treatment, 83.5% of patients had regression or no progression in the Tanner stage (95% confidence interval: 78.68%, 87.62%) and the majority had decreased gonadotropin-releasing hormone-stimulated peak luteinizing hormone and follicle-stimulating hormone concentrations, as well as reduced sex hormone concentrations and a reduction in the bone age/chronological age ratio compared to baseline.

CONCLUSIONS: The trial revealed that CPP was effectively treated in most patients who received leuprorelin for nearly 2 years. Any drug-related AEs were reported with low incidence (<5%) and were consistent with the known safety profile of leuprorelin.

TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (registration number: NCT02427958).

PMID:34941067 | DOI:10.1097/MD.0000000000028158

Influenza Other Respir Viruses. 2021 Dec 22. doi: 10.1111/irv.12947. Online ahead of print.

ABSTRACT

BACKGROUND: Zanamivir is a neuraminidase inhibitor effective against influenza A and B viruses. In 2009, GlaxoSmithKline (GSK) began clinical development of intravenous (IV) zanamivir and initiated a global Compassionate Use Program (CUP) in response to the evolving H1N1 global pandemic. The goal of the CUP was to provide zanamivir to critically ill patients with limited treatment options.

METHODS: Zanamivir was administered to patients with suspected or confirmed influenza infection who were not suitable for other approved antiviral treatments. Reporting of serious adverse events (SAEs) was mandatory and recorded in the GSK safety database. A master summary tracking sheet captured requests and patient characteristics. A case report form was available for detailing medical conditions, dosing, treatment duration, and clinical outcomes.

RESULTS: In total, 4,033 requests were made for zanamivir treatment of hospitalized patients from 38 countries between 2009 and 2019; ≥95% patients received zanamivir via the IV route. Europe had the highest number of requests (n = 3,051) followed by North America (n = 713). At least 20 patients were aged ≤6 months, of whom 12 were born prematurely. The GSK safety database included 466 patients with ≥1 SAE, of whom 374 (80%) had a fatal outcome. Drug-related SAEs were reported in 41 (11%) patients, including hepatic failure (n = 6 [2%]) and acute kidney injury (n = 5 [1%)].

CONCLUSIONS: The CUP facilitated global access to zanamivir prior to product approval. No new safety concerns were identified in the CUP compared with IV zanamivir clinical studies.

PMID:34939702 | DOI:10.1111/irv.12947

BMJ Evid Based Med. 2021 Dec 21:bmjebm-2021-111759. doi: 10.1136/bmjebm-2021-111759. Online ahead of print.

NO ABSTRACT

PMID:34933931 | DOI:10.1136/bmjebm-2021-111759

J Oncol Pharm Pract. 2021 Dec 21:10781552211068139. doi: 10.1177/10781552211068139. Online ahead of print.

ABSTRACT

INTRODUCTION: Children with cancer may be one of the most vulnerable groups to drug-related adverse events because they possess characteristics of patients with cancer as well as pediatric patients. To evaluate the clinical and economic impact of pharmacists' intervention on the care of pediatric hematology and oncology patients in the inpatient and outpatient settings of a children's hospital.

METHODS: The pharmacist-intervention records from 2017 were retrospectively reviewed. Intervention rate, type of drug-related problems, acceptance rate, and frequently involved drugs in pharmacist interventions were analyzed. One physician and one pharmacist evaluated the clinical significance of each intervention. A cost-benefit analysis was conducted from hospital and patient perspective. The benefit from cost savings by reducing the number of prescribed drugs that are disposed was estimated as the benefit from hospital perspective. The benefit from cost avoidance based on the potential to avoid an adverse drug event (ADE) was estimated as the benefit from patient perspective. The cost of reviewing prescriptions was estimated based on the pharmacists' salary and the time involved.

RESULTS: In 2017, 2361 interventions were performed in 381 pediatric patients with cancer. The acceptance rate was 97.2%. More than half of the interventions were regarded as clinically "significant" (58.8%) and "very significant" (14.6%). The cost-benefit of US$28,705 was determined from hospital perspective, with a cost-benefit ratio of 1.45:1. The cost-benefit of US$35,611 was calculated from patient perspective, with a cost-benefit ratio of 1.55:1.

CONCLUSIONS: Pharmacists' intervention in the care of hematology and oncology pediatric patients was effective in preventing clinically significant ADEs and had a positive economic impact on the health-care budget from both hospital and patient perspective.

PMID:34931912 | DOI:10.1177/10781552211068139

BMC Gastroenterol. 2021 Dec 20;21(1):489. doi: 10.1186/s12876-021-02008-9.

ABSTRACT

BACKGROUND: Tenofovir disoproxil fumarate (TDF) is widely used and recommended as first-line treatment for patients infected with the hepatitis B virus (HBV). However, current data are limited regarding the efficacy and safety of switching to TDF for the treatment of chronic hepatitis B in hepatitis B e-antigen (HBeAg)-positive patients who are virologically suppressed with another nucleos(t)ide analogue. The primary objective of this study was to evaluate the hepatitis B surface antigen (HBsAg) reduction potential of switching from entecavir (ETV) to TDF at week 48 in HBeAg-positive chronic hepatitis B patients with undetectable serum HBV-DNA.

METHODS: In this multicenter, single-arm, open-label, phase 4 clinical study, 75 participants currently treated with ETV 0.5 mg once daily were switched to TDF 300 mg once daily for 96 weeks.

RESULTS: At week 48, 3/74 participants (4%) achieved 0.25 log10 reduction of HBsAg levels from baseline (the primary endpoint). Mean HBsAg reduction was -0.14 log10 IU/mL and 12% (9/74) achieved 0.25 log10 reduction by 96 weeks. No participants achieved HBsAg seroclearance. HBsAg reduction at weeks 48 and 96 was numerically greater in participants with higher alanine aminotransferase levels (≥ 60 U/L). Seventeen participants (25%) achieved HBeAg seroclearance up to week 96. No participants experienced viral breakthrough. All drug-related adverse events (18 participants [24%]) were mild in intensity, including an increase in urine beta-2-microglobulin (15 participants [20%]).

CONCLUSIONS: In conclusion, HBsAg reduction was limited after switching from ETV to TDF in this study population. Further investigation is warranted to better understand the clinical impact of switching from ETV to TDF. ClinicalTrials.gov: NCT03258710 registered August 21, 2017. https://clinicaltrials.gov/ct2/show/NCT03258710?term=NCT03258710&draw=2&rank=1.

PMID:34930140 | DOI:10.1186/s12876-021-02008-9

Int J Infect Dis. 2021 Dec 17:S1201-9712(21)01235-2. doi: 10.1016/j.ijid.2021.12.335. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the application value of metagenomic next-generation sequencing (mNGS) in children with hematological diseases presenting with Febrile Neutropenic (FN).

METHODS: We retrospectively analyzed the clinical data of 49 hematological children with FN, and compared the results of mNGS with those of traditional pathogen detection (TPD) and the prognoses of mNGS positive group and negative group.

RESULTS: A total of 77 pathogenic strains were identified, of which 70 strains were detected by mNGS, 19 strains by TPD , and Aspergillus and G- bacterias were the predominant strains in FN children who developed bloodstream infections. 42 cases were in the mNGS-positive group, of which 17 were simple infections, 25 were mixed infections, and 7 were in the negative group; the TPD-positive group contained 19 cases, all of which were simple infections. The detection rate of total and mixed pathogens was higher than that of TPD, and the difference was statistically significant (P<0.05). mNGS positive group was detected earlier than the negative group, and with lower mortality and drug-related adverse events (DRAE) , and the difference was statistically significant (P<0.05).

CONCLUSION: For FN children with hematological diseases, early mNGS can effectively improve the efficacy of pathogen detection, and precise treatment after clarifying the pathogens can reduce mortality and avoid antibiotic abuse.

PMID:34929357 | DOI:10.1016/j.ijid.2021.12.335

J Pineal Res. 2021 Dec 19:e12782. doi: 10.1111/jpi.12782. Online ahead of print.

ABSTRACT

IMPORTANCE: Melatonin is commonly used for sleep and jetlag at low doses. However, there is less documentation on the safety of higher doses which are being increasingly used for a wide variety of conditions, including more recently COVID-19 prevention and treatment.

OBJECTIVE: To investigate the safety of higher doses of melatonin in adults.

DATA SOURCES: Medline, Scopus, Embase and PsycINFO databases from inception until December 2019 with convenience searches until October 2020.

STUDY SELECTION: Randomised controlled trials investigating high-dose melatonin (≥10mg) in human adults over 30 years of age.

DATA EXTRACTION AND SYNTHESIS: 2 investigators independently abstracted articles using PRISMA guidelines. Risk of bias was assessed by a committee of 3 investigators. 79 studies were identified with a total of 3861 participants. Studies included a large range of medical conditions. The meta-analysis was pooled data using a random effects model.

MAIN OUTCOMES AND MEASURES: The number of adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs.

RESULTS: 29 studies (37%) made no mention of the presence or absence of AEs. Overall, only 4 studies met the pre-specified low risk of bias criteria for meta-analysis. In that small subset melatonin did not cause a detectable increase in SAEs (Rate Ratio=0.88 [0.52, 1.50], p=0.64) or withdrawals due to AEs (0.93 [0.24, 3.56], p=0.92), but did appear to increase the risk of AEs such as drowsiness, headache, and dizziness (1.40, [1.15, 1.69], p<0.001).

CONCLUSIONS AND RELEVANCE: Overall, there has been limited AE reporting from large-dose melatonin studies. Based on this limited evidence, melatonin appears to have a good safety profile. Better safety reporting in future long-term trials is needed to confirm this as our confidence limits were very wide due to the paucity of suitable data.

PMID:34923676 | DOI:10.1111/jpi.12782

Curr Med Sci. 2021 Dec 18. doi: 10.1007/s11596-021-2492-1. Online ahead of print.

ABSTRACT

OBJECTIVE: Drug-induced sleep endoscopy (DISE) allows for the evaluation of dynamic airway collapse in patients with obstructive sleep apnea. However, a standardized sedation regimen for DISE is not yet available. This study aimed to investigate the safety profiles and efficacies of dexmedetomidine combined with butorphanol for DISE.

METHODS: Sixty patients with obstructive sleep apnea scheduled to undergo DISE were randomly divided into Group D and Group DB. All recipients were initially given intravenous butorphanol (1 mg) (Group DB) or saline (Group D). Subsequently, both groups were sedated using a loading dose of 1.0 µg/kg/h of dexmedetomidine. Hemodynamic and respiratory parameters, the time to attain sufficient sedation, wakeup time, and adverse events during DISE were recorded.

RESULTS: Compared with Group D, the time until sufficient sedation and wakeup time in Group DB were significantly reduced. A higher performer satisfaction level was achieved in Group DB. Patients in Group DB showed a higher incidence of bradycardia compared with Group D. However, the bradycardia resolved spontaneously in both groups without any treatment. There was no instance of cough, hypotension, arrhythmia, nausea or vomiting in either group.

CONCLUSION: Compared to dexmedetomidine alone, a small dose of butorphanol infusion (1 mg) as an adjunct treatment to dexmedetomidine during DISE can reduce the dosage of dexmedetomidine, shorten the time until sufficient sedation and enhance the performer satisfaction level. This synergistic combination could be a promising sedation regimen for DISE in terms of procedural convenience and patient safety.

PMID:34921663 | DOI:10.1007/s11596-021-2492-1

Int J Mycobacteriol. 2021 Oct-Dec;10(4):463-468. doi: 10.4103/ijmy.ijmy_160_21.

ABSTRACT

BACKGROUND: An adverse drug event (ADE) is an injury resulting from medical intervention associated with a drug. This study assesses the incidence of ADEs among participants on second-line drugs for tuberculosis (TB) in Cameroon.

METHODS: This was a longitudinal observational study including 65 participants and carried out from January 2017 to December 2017. Markers of ADEs were obtained from creatinine, transaminase audiogram, and clinical data. Multivariate analysis was used to determine the association between predictors and ADEs.

RESULTS: Forty-eight (73.8%) of the 65 participants developed 72 ADEs. Fifty-four (75%), 11 (15.3%), and 7 (9.7%) of the 72 ADEs were classified as Grades 1, 2, and 3, respectively. Gastrointestinal disorders were most common (35 [46.6%]) followed by auditory injuries (16 [22.2%]), hepatotoxicity (11 [15.3%]), neurological disorders (6 [8.3%]), and kidney disorders (4 [5.6%]). The follow-up duration of this study was 11,250-person day (PDY). The incidence rate for ADEs was 4.3/1000 PDY and that for gastrointestinal disorders, auditory injuries, hepatotoxicity, neurological disorders, and kidney disorders was 3.1, 1.4, 1.0, 0.5, and 0.2 (/1000PDY), respectively. Kanamycin (65 [90.3%]), isoniazid (4 [5.6%]), and ethambutol (3 [4.2%]) were incriminated with ADEs. Most (29 [60.4%]) of the ADEs occurred during the first 2 months of drug initiation. There was an association between poor treatment outcome and ADEs (P = 0.04, odds ratio = 1.20, 95% confidence of interval = 0.21-6.80].

CONCLUSIONS: The incidence of ADEs is associated with several factors and most of them occurred during the intensive phase of treatment. Kanamycin was the most associated drug linked to ADEs requiring its replacement with a less toxic one.

PMID:34916468 | DOI:10.4103/ijmy.ijmy_160_21

Tumori. 2021 Dec 17:3008916211063939. doi: 10.1177/03008916211063939. Online ahead of print.

ABSTRACT

People at high risk of morbidity and mortality from coronavirus disease 2019 (COVID-19), including patients dealing with malignancies and patients on immunosuppressive anticancer therapies, need to be followed carefully as the pandemic continues. Challenges in continuing cancer management and patient monitoring are of concern given the importance of timing in cancer therapy. Alternative treatment decisions and priorities are also important considerations. The efficacy and safety of various cancer treatments in patients with COVID-19 are other important considerations. In this systematic review, we summarize the potential risks and benefits of cancer treatments applied to patients with COVID-19 and malignant tumors. Using the PubMed and Scopus databases, we reviewed studies involving cancer therapy and COVID-19 to address the recent discoveries and related challenges of cancer therapy in patients with COVID-19 and cancer.

PMID:34918602 | DOI:10.1177/03008916211063939

Cureus. 2021 Nov 13;13(11):e19553. doi: 10.7759/cureus.19553. eCollection 2021 Nov.

ABSTRACT

Angioedema is one of the dreaded side effects of angiotensin-converting enzyme (ACE) inhibitors. It has been well established in the literature and the timing of onset is variable from months to years after initiation of therapy. Patients remain at risk of recurrence of angioedema even after discontinuation of the drug if they developed it once while on the drug. While only recurrences of ACE inhibitor-induced angioedema are described in the literature, our patient did not develop angioedema while being on the drug and had the first occurrence of angioedema one month after the medication was discontinued. We argue that since our patient did report an ACE inhibitor-related dry cough, this case emphasizes the strength of the relation between the two common side effects of the ACE inhibitors. This favors that among the risk factors that predispose individuals to develop angioedema, ACE inhibitor-associated cough is a major one. Although the mechanism of ACE inhibitor-related cough is poorly understood, bradykinin seems to be the common culprit mediator for these two side effects. Hence, clinicians need to be aware of this potential threat and be cautioned when they witness an ACE inhibitor-related cough.

PMID:34917435 | PMC:PMC8669203 | DOI:10.7759/cureus.19553

Int J Immunopathol Pharmacol. 2021 Jan-Dec;35:20587384211065628. doi: 10.1177/20587384211065628.

ABSTRACT

OBJECTIVES: Vaccination rollout against COVID-19 has started in developed countries in early December 2020. Mass immunization for poor or low-income countries is quite challenging before 2023. Being a lower-middle-income country, Bangladesh has begun a nationwide COVID-19 vaccination drive in early February 2021. Here, we aimed to assess the opinions, experiences, and adverse events of the COVID-19 vaccination in Bangladesh.

METHODS: We conducted this online cross-sectional study from 10 February 2021, to 10 March 2021, in Bangladesh. A self-reported semi-structured survey questionnaire was used using Google forms. We recorded demographics, disease history, medication records, opinions and experiences of vaccination, and associated adverse events symptoms.

RESULTS: We observed leading comorbid diseases were hypertension (25.9%), diabetes (21.1%), heart diseases (9.3%), and asthma (8.7%). The most frequently reported adverse events were injection site pain (34.3%), fever (32.6%), headache (20.2%), fatigue (16.6%), and cold feeling (15.4%). The chances of having adverse events were significantly higher in males than females (p = 0.039). However, 36.4% of respondents reported no adverse events. Adverse events usually appeared after 12 h and went way within 48 h of vaccination. Besides, 85.5% were happy with the overall vaccination management, while 88.0% of the respondents recommended the COVID-19 vaccine for others for early immunization.

CONCLUSION: According to the present findings, reported adverse events after the doses of Covishield in Bangladesh were non-serious and temporary. In Bangladesh, the early vaccination against COVID-19 was possible due to its prudent vaccine deal, previous mass vaccination experience, and vaccine diplomacy.

PMID:34911394 | PMC:PMC8689597 | DOI:10.1177/20587384211065628

Zhonghua Nan Ke Xue. 2021 Aug;27(8):733-737.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of Lingze Tablets in the treatment of BPH with kidney deficiency, blood stasis and dampness resistance.

METHODS: Totally 235 eligible BPH patients, aged 50－80 years and meeting the inclusion criteria, were enrolled and treated with Lingze Tablets orally, 4 tablets per time, tid. Before and after an 8-week course of medication, IPSS, quality of life (QOL) and TCM syndromes scores were obtained from the patients.

RESULTS: Of the total number of patients, 211 completed the whole course of treatment. Compared with the baseline, the IPSS was dramatically reduced after 4 and 8 weeks of medication (18.28 ± 5.29 vs 12.82 ± 4.66 and 9.23 ± 4.21, P < 0.01), and so were the QOL scores (6.44 ± 1.99 vs 4.95 ± 1.64 and 3.16 ± 1.53, P < 0.01) and TCM syndromes scores (17.49 ± 5.30 vs 12.45 ± 3.74 and 9.17 ± 3.24, P < 0.01). The incidence rates of adverse events and drug-related adverse reactions were 15.2% and 1.9%, respectively, and no organ function impairment was observed.

CONCLUSIONS: Lingze Tablets are definitely effective and safe for the treatment of BPH with kidney deficiency, blood stasis and dampness resistance.

PMID:34914247

Cureus. 2021 Nov 11;13(11):e19488. doi: 10.7759/cureus.19488. eCollection 2021 Nov.

ABSTRACT

Lisinopril as a cause for acute drug-induced pancreatitis is an emerging phenomenon that due to its generally low-risk profile often goes unnoticed. The true incidence of drug-induced pancreatitis is unknown, probably because of its nonrecognition among differential diagnosis. Only a handful of lisinopril-induced pancreatitis has been discussed in the literature, and little epidemiological evidence exists to establish true causality. Additionally, many of these reports have been met with skepticism claiming that it is difficult to isolate a true cause since many of these patients had comorbidities or were concomitantly taking other medications that may have contributed to the pancreatitis. Here, we report a case in which a generally otherwise healthy patient presented with acute drug-induced pancreatitis caused by an angiotensin-converting enzyme (ACE) inhibitor taken eight weeks prior to the onset of symptoms. The drug was immediately stopped, and the patient recovered well, with no complications.

PMID:34912629 | PMC:PMC8664365 | DOI:10.7759/cureus.19488

J Med Virol. 2021 Dec 15. doi: 10.1002/jmv.27525. Online ahead of print.

ABSTRACT

Methylprednisolone (MP) is usually used to reduce the inflammation reaction and tissue damage, which may have a benefit assistant treatment effect on coronavirus disease 2019 (COVID-19). However, We present the case of a child who manifest significant bradycardia with the use of just low dose MP on the premise of the long-term use of arbidol. Arbidol can affect the activity of CYP3A4 which is also a key metabolic enzyme of MP by competitive inhibition, which is easy to aggravate the side effects of the MP. Therefore, more attention should be paid with bradycardia occurrence in the patient with COVID-19 when MP is considered in COVID-19. This article is protected by copyright. All rights reserved.

PMID:34911144 | DOI:10.1002/jmv.27525

Dermatol Surg. 2022 Jan 1;48(1):152-153. doi: 10.1097/DSS.0000000000003302.

NO ABSTRACT

PMID:34904583 | PMC:PMC8667799 | DOI:10.1097/DSS.0000000000003302

JMIR Form Res. 2021 Dec 13. doi: 10.2196/32126. Online ahead of print.

ABSTRACT

BACKGROUND: Asynchronous health care encounters are becoming an increasingly mainstream form of telehealth. While synchronous phone or video visits have become more widely accepted, US policymakers and other key health care stakeholders have been hesitant to fully embrace asynchronous diagnosis and treatment. This is particularly true in the context of direct-to-consumer (DTC) platforms, where encounters are patient-initiated and there is no pre-established relationship with a provider. This hesitation is compounded by limited research comparing outcomes between asynchronous and synchronous care, especially in the DTC context.

OBJECTIVE: The purpose of this study is to explore whether asynchronous care leads to different patient outcomes in the form of medication-related adverse events when compared to synchronous virtual care.

METHODS: Using 10,000 randomly sampled patient records from a prominent U.S.-based DTC platform, we analyzed rates of patient-reported side effects from commonly prescribed medications and compared these rates across modalities of treatment.

RESULTS: Asynchronous care resulted in lower but nonsignificant differences in the rates of reported drug-related side effects compared to synchronous treatment.

CONCLUSIONS: In some circumstances, asynchronous care can offer the same level of safety in prescribing when compared to synchronous care. More research is needed to evaluate the safety of asynchronous care across a wider set of conditions and measures.

PMID:34905499 | DOI:10.2196/32126

Fertil Steril. 2021 Dec 8:S0015-0282(21)02214-7. doi: 10.1016/j.fertnstert.2021.11.013. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of 40-mg relugolix (REL) compared with those of leuprorelin (LEU) in women with endometriosis-associated pain.

DESIGN: Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.

SETTING: Hospitals and clinics.

PATIENT(S): Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.

INTERVENTION(S): In the REL group, 40 mg of REL was orally administered once a day for 24 weeks. In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.

MAIN OUTCOME MEASURE(S): The primary endpoint was the change in the maximum visual analog scale score for pelvic pain from baseline until 28 days before the end of treatment.

RESULT(S): Changes in the maximum visual analog scale score were -52.6 ± 1.3 for REL and -57.5 ± 1.4 for LEU. Ovarian endometrioma decreased by 12.26 ± 17.52 cm3 for REL and 14.10 ± 18.81 cm3 for LEU. Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage. Discontinuations from treatment emergent adverse events were 2.9% for REL and 4.3% for LEU.

CONCLUSION(S): Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.

CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT03931915.

PMID:34895700 | DOI:10.1016/j.fertnstert.2021.11.013