scholarly journals Safety and Efficacy of Clomiphene Citrate in the Treatment of Secondary Hypogonadism. A Retrospective Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A761-A761
Author(s):  
Mariana Garcia-Touza

Abstract “Introduction: Clomiphene (Clomid) has an off-label indication to treat hypogonadism in select populations. “Based on clinical practice, this medication in certain types of hypogonadism is equally effective as testosterone in treating hypogonadism. It will lead to less side effects, lower treatment cost, and will decrease rates of infertility in the male veteran population.” Secondary hypogonadism can be most often caused by opioid use, obesity, sleep apnea, and diabetes.” “Aim of Study: To evaluate the safety and efficacy of Clomiphene Citrate in Treatment of Secondary Hypogonadism in comparison with testosterone. “Study Population: Data was obtained from the Veterans Administration Data Warehouse through the Veterans Administration Informatics and Computing Infrastructure. Data was extracted using SQL. There were 405,824 male patients with a diagnosis of hypogonadism (87.1%)and infertility (12.9%). nationally at the VA. Of these, 9566 patients have been treated with clomiphene citrate and 232,123 with various testosterone therapy. “ The two groups were then matched by propensity method to controls at a ratio of about 1:1 for Age, race, BMI and time for follow-up as potential confounding factors hat could have affected inclusion in the study controls. Patients without either Clomiphene or testosterone treatment were excluded. Statistical Analysis: SAS was used for propensity matching (PSM, greedy near) Categorical variables were evaluated as frequency counts with percentage within group, as well as ODDS ratio (OR) and differences were evaluated by a chi-square method. Comparisons of continuous variables were done were done by simple and paired t-test. Kaplan Meier plots and Cox Hazard ratio calculations were used to examine time dependent risk between treatments. Actual p-values are shown and p-values lower than 0.0001 are shown as such. All comparisons used a two-sided assumption. Measurements: Testosterone laboratory measures were recorded for start and end of trial. Survival was taken as the difference in days between start date and date of death. New diagnosis of Osteoporosis and Polycythemia was that which occurred after initiation of therapy. “Results: Clomid treatment normalized testosterone levels in 53.2% versus 46.8% in the testosterone group (OR 1.32 P<0.005). All-cause mortality was in the clomid group 0.16% and 1.62%in the testosterone group (OR 0.16 P<0.001). The incidence of new Osteoporosis for clomid was 3.9 % versus 5.9% for testosterone (OR 0.65 P<0.001)” Conclusion: This is a retrospective study comparing the efficacy and side effects of clomiphene versus testosterone for treatment of hypogonadism. The study showed that clomiphene is more effective than testosterone to treat secondary hypogonadism. We also found decreased overall mortality and incidence of polycythemia and osteoporosis.

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S42
Author(s):  
D. Wiercigroch ◽  
H. Sheikh ◽  
J. Hulme

Introduction: Substance use is prevalent in Canada yet treatment for alcohol use disorder (AUD) and opioid use disorder (OUD) is often inaccessible. Consequently, alcohol and opioid-related diagnoses such as intoxication, withdrawal, and overdose are a major reason for frequent emergency department (ED) visits. The Rapid Access to Addiction Medicine (RAAM) Clinic opened at the University Health Network (UHN) in January 2018 as part of a larger network of clinics in Toronto, and provides rapid, low barrier access to medical treatment for substance use disorder (SUD). Patients attended via self-referral, peer-referral, or referral by the ED, primary care, internal medicine or withdrawal management services. This study describes the demographic profile and short-term outcomes for patients attending a new RAAM clinic in its first 26 weeks of operation, including substance use and treatment retention for AUD and OUD. Methods: We reviewed the electronic medical record at the clinic over its first 26 weeks of operation. We assessed SUD diagnoses, referral source, prescribed medications, self-reported outcomes and retention rates. We calculated descriptive statistics using proportions for categorical variables and means with standard error for continuous variables. A student's t-test was used for all statistical analyses using Microsoft Excel. We reviewed the electronic medical record at the clinic over its first 26 weeks of operation. We assessed SUD diagnoses, referral source, prescribed medications, self-reported outcomes and retention rates. We calculated descriptive statistics using proportions for categorical variables and means with standard error for continuous variables. A student's t-test was used for all statistical analyses using Microsoft Excel. Results: The clinic saw 64 unique patients: 66% had an AUD, 39% had an OUD and 20% had a stimulant use disorder. 55% of patients were referred from outpatient care providers, 30% from the emergency department and 11% from withdrawal management services. 42% remained ongoing patients, 23% were discharged to other care and 34% were lost to follow-up. Gabapentin (38%), naltrexone (33%), and acamprosate (20%) were most frequently prescribed for AUD. Patients with AUD reported a significant decrease (p < 0.05) in alcohol consumption at their most recent visit compared to their initial visit. Most patients (78%) with OUD were prescribed buprenorphine, and most (89%) patients with OUD on buprenorphine had a negative urine screen at their most recent visit. Conclusion: A new RAAM outpatient clinic demonstrates the early success of a low-barrier addictions model in addressing unmet needs in substance use treatment. We see a reduction in both alcohol consumption and opioid use, and increased access to evidence-based pharmacotherapy for SUDs.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S527-S527
Author(s):  
V Ng ◽  
T G Lim ◽  
W C Ong ◽  
S Y A Wong ◽  
E Salazar ◽  
...  

Abstract Background Immunomodulators (IMs) such as azathioprine are the cornerstone in the treatment of inflammatory bowel disease (IBD). However, they are associated with significant toxicity and requires close monitoring for side effects, which puts a stretch on our physician clinics. The pharmacist-run Immuno Clinic (IMC) was set up in 2016 to assist in the monitoring of stable patients and initial titration phase of IMs so that physicians are able to focus their time and energy on patients with more complex diseases. The objective of this study is to demonstrate that IMC is able to effectively and safely carry out its purpose for patient’s disease management, medication adherence and adverse events management, resulting in time and cost savings. Methods This is a retrospective study looking at IBD patients who attended IMC from Aug 2016 to July 2019. Patients’ demographics, disease control, medication adherence and adverse effects were obtained from the IMC database. Descriptive data were analyzed using frequency distribution for categorical variables. Continuous variables were expressed as median and interquartile range (IQR). Results A total of 73 patients were included. Thirty-six (49.3%) patients had CD, while 37 (50.7%) patients had UC. A total of 185 actions were executed over 173 IMC sessions, including dose adjustment (57), recommending additional medications (14), discontinuation or restarting IM (12), side effects detection (25), monitoring recommendations (10), non-adherence detection (39), referral to physician (23), and others (5). In 2 out of 173 visits (1.1%), severe disease flare requiring hospitalization was detected and referred back to the primary physician for inpatient admission. Thirty ADRs were detected (17.3 %) and managed promptly. There were 24 cases of non-adherence detected and counselled (13.9%). Out of 38 patients who were referred for titration of IM, 28 patients (73.7%) achieved the target dose of IM. Patient visits were largely independently managed by pharmacists (150 out of 173, 86.7%). Conclusion Implementation of pharmacist-led IMC is a safe and cost-effective alternative to conventional gastroenterology clinic for monitoring and titration of IMs, enabling physicians to focus on more complicated cases and thus improving access to the IBD ambulatory care service.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Qian Liu ◽  
Mingzhao Qin ◽  
Jian Zhou ◽  
Hui Zheng ◽  
Weiping Liu ◽  
...  

Abstract Background Palliative care education has been carried out in some hospitals and palliative care has gradually developed in mainland China. However, the clinical research is sparse and whether primary palliative care education influence treatment intensity of dying older adults is still unknown. This study aims to explore the changes to the intensity of end-of-life care in hospitalized older adults before and after the implementation of primary palliative care education. Methods A retrospective study was conducted. Two hundred three decedents were included from Beijing Tongren Hospital’s department of geriatrics between January 1, 2014 to December 31, 2019. Patients were split into two cohorts with regards to the start of palliative care education. Patient demographics and clinical characteristics as well as analgesia use, medical resources use and provision of life-sustaining treatments were compared. We used a chi-square test to compare categorical variables, a t test to compare continuous variables with normal distributions and a Mann–Whitney U test for continuous variables with skewed distributions. Results Of the total participants in the study, 157(77.3%) patients were male. The median age was 88 (interquartile range; Q1-Q3 83–93) and the majority of patients (N = 172, 84.7%) aged 80 years or older. The top 3 causes of death were malignant solid tumor (N = 74, 36.5%), infectious disease (N = 74, 36.5%), and cardiovascular disease (N = 23, 11.3%). Approximately two thirds died of non-cancer diseases. There was no significant difference in age, gender, cause of death and functional status between the two groups (p > 0.05). After primary palliative care education, pain controlling drugs were used more (p < 0.05), fewer patients received electric defibrillation, bag mask ventilation and vasopressors (p < 0.05). There was no change in the length of hospitalization, intensive care admissions, polypharmacy, use of broad-spectrum antibiotics, blood infusions, albumin infusions, nasogastric/nasoenteric tubes, parenteral nutrition, renal replacement and mechanical ventilation (p > 0.05). Conclusions Primary palliative care education may promotes pain controlling drug use and DNR implementation. More efforts should be put on education about symptom assessment, prognostication, advance care planning, code status discussion in order to reduce acute medical care resource use and apply life-sustaining treatment appropriately.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Lauren Y Lee ◽  
Aamir Twing ◽  
Kelley Wachsberg ◽  
Mayank M Kansal

Background: Heart failure (HF) hospitalizations and readmissions are a major financial burden on patients, caregivers, and the healthcare system. The Jesse Brown Veterans Administration Medical Center (JBVAMC; Chicago, Illinois) has recently been scoring in the 90 th percentile in its HF risk-standardized readmission rate (RSRR) compared to other VA medical centers. Here, we present the factors influencing HF readmission at the JBVAMC. Methods: Veterans discharged from JBVAMC between 7/1/18 and 6/30/19 with a primary diagnosis of HF were identified per ICD-10 codes (I11.0, I13.X, and I50.X). For primary HF discharges between 7/1/18 and 12/31/18, retrospective chart review was performed to assess patient and hospitalization characteristics. Charts were excluded from review if the same veteran’s chart was reviewed for another admission within the preceding 30 days, or if a veteran was discharged against medical advice or to a skilled nursing facility. Continuous variables were analyzed using Student’s t-test and categorical variables with Pearson Chi-Square. Results: Between 7/1/18 and 6/30/19, there were 485 HF discharges resulting in 96 30-day readmissions. Of them, 51 (53%) were due to recurrent HF exacerbation, and 8 (8%) were due to hypotension, dehydration, or acute kidney injury. Only 32% of readmissions (8/25) during the first 7 days after discharge were due to recurrent HF, compared to 70% (19/27) during day 8-14 and 57% (13/23) during day 15-21. In characterizing the index hospitalizations between 7/1/18 and 12/31/18 (N=188), there were 42 (22%) admissions that resulted in readmissions (Table 1). Veterans in this cohort were 72 years old on average, 98% male, and 77% African-American. HF with reduced ejection fraction (HFrEF; EF≤40%) comprised 53% of non-readmitted and 57% of readmitted cohort. Readmitted patients had a higher prevalence of smoking (33% vs 16%, p=0.012) and less likely to have outpatient follow-up within 14 days of discharge (52% vs 29%, p=0.007). There was a low rate of sacubitril/valsartan utilization (N=6) and dietitian consultation (N=7). Conclusion: Over half of our HF readmissions are due to recurrent HF. An emphasis on timely outpatient follow-up after discharge, consideration for sacubitril/valsartan initiation, and dietary education may help reduce our HF readmissions.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 219-219
Author(s):  
Mehmet Faith Hepgur ◽  
Tanya B. Dorff ◽  
Lucy Brining ◽  
Jie Cai ◽  
Jacek K. Pinski ◽  
...  

219 Background: SipT prolongs overall survival of men with asymptomatic or minimally symptomatic mCRPC. Recently, it has been demonstrated that SipT immune parameters correlate with survival. We prospectively collected biological and inflammatory markers as part of an audit to identify possible predictors of immune response in patients (pts) receiving SipT. Methods: Circulating tumor cells (CTC), PSA, prostatic acid phosphatase (PAP), albumin (Alb), hemoglobin (Hb), serum alkaline phosphatase (SAP), LDH, C-reactive protein (CRP) and β2-microglobulin (β2m) were evaluated in reference lab before SipT. Product parameters CD54, CD54 upregulation (UPREG) and total nucleated cells (TNC) were measured by Dendreon. These datasets were analyzed using Spearman coefficients for continuous variables and the Kruskal-Wallis test for categorical variables. Results: 92 pts who received SipT were included. Median age was 69 (48-90). 43% had Gleason 8-9. 42% had ECOG Performance Status (PS) 0, 44% PS 1, and 13% PS 2. 26% had received prior chemotherapy and 18% had used opioids. 84% had bone mets, 42% had lymphadenopathy, 12% had visceral mets. Of clinical factors only PS was inversely correlated with UPREG (p=0.014) and TNC (p= 0.023). Biomarkers which significantly correlated with SipT immune parameters are shown in the Table. Age, location of mets, prior chemotherapy or opioid use did not impact the immune response to SipT Conclusions: Better product parameters correlated with good ECOG PS, lower PSA and SAP, and higher Hgb and Alb, suggesting that SipT induces a greater immune response in men with lower disease burden. The correlation of increased CD54 count with lower CRP, a surrogate for IL-6 activity, warrants investigation. [Table: see text]


2017 ◽  
Vol 8 (5) ◽  
pp. 1
Author(s):  
Frederick R. Macapagal ◽  
Lisa Green ◽  
Emma McClellan ◽  
Carrie Bridges

The intraaortic balloon pump (IABP) is a treatment for end-stage heart failure patients not responsive to pharmacological therapy pre heart transplantation. An alternative approach--the percutaneously placed axillary-subclavian intraaortic balloon pump (PAxIABP) developed by cardiologists in our hospital enable patients to be mobilized while awaiting transplant versus the traditional bedrest in the femoral approach. Our objective is to determine if PAxIABP therapy enable pre-heart-transplant patients to safely mobilize. A retrospective study of pre-heart-transplant PAxIABP patients in the Coronary Intensive Care Unit (CICU) from 2007 to 2013 (n = 45; 35 men, 10 women) was conducted to determine mobility. Data are presented as mean (standard deviation) for continuous variables and number (percentage) for categorical variables. Patients were mobilized at 1.39 (± 1.41) days after PAxIABP insertion. The number of times mobilized per day was 1.79 ± 2). Transplant waiting time was 24.98 ± 25.03) days. Thirty-seven patients (82%) were transplanted. Two patients had a left ventricular assist device (LVAD) inserted and later transplanted. Six patients died before receiving a heart transplant, patients were 100% mobile. Complication rates: 4% bleeding; 7% ischemic complications; 2% IABP-related infection. Pre-heart-transplant patients receiving PAxIABP therapy can be safely mobilized. Nursing care protocols were developed to safely take care of this patient population. PAxIABP can be utilized for other procedures requiring long IABP therapy.


2018 ◽  
Vol 28 (12) ◽  
pp. 1421-1425
Author(s):  
Fabio Savorgnan ◽  
Nicholas B. Zaban ◽  
Justin J. Elhoff ◽  
Michael M. Ross ◽  
John P. Breinholt

AbstractBackgroundBalloon atrial septostomy is performed in infants with dextro-transposition of the great arteries to improve oxygenation before surgery. It is performed in the catheterisation laboratory with fluoroscopy or at the bedside using echocardiography. It is unclear whether procedural safety and efficacy is superior in one location versus the other, although the bedside procedure may improve resource utilisation and present an opportunity for reducing cost. This study compares safety and efficacy of atrial septostomy performed at the patient’s bedside versus the catheterisation laboratory.MethodsNeonates with dextro-transposition of the great arteries who underwent balloon atrial septostomy from October, 2000 to January, 2014 were included. Medical and procedural records, echocardiograms, and catheterisation data were reviewed. Comparisons between the two procedural locations included patient demographics, pre- and post-procedure oxygen saturations, and outcomes. Complications reviewed included bleeding, arrhythmia, cardiac trauma, stroke, and death. Coronary artery evaluations were recorded. T-tests were used for continuous variables, and Fisher’s exact tests were used for all categorical variables. Wilcoxon rank sum and analysis of covariance modelling were used for time variables and oxygen saturation, respectively.ResultsA total of 88 infants met the inclusion criteria. Among them, 53 underwent septostomy at the bedside and 35 underwent septostomy in the catheterisation laboratory. No safety or outcome benefit was identified between the two procedural locations.ConclusionSeptostomy performed at the bedside and in the catheterisation laboratory had similar outcomes and efficacy. Further, bedside septostomy has the advantage of no radiation exposure, and obviating risks with patient transfer from the ICU to the catheterisation laboratory.


2020 ◽  
Author(s):  
Qian Liu ◽  
Mingzhao Qin ◽  
Jian Zhou ◽  
Hui Zheng ◽  
Weiping Liu ◽  
...  

Abstract Background In recent years, palliative care has gradually developed in mainland China. Since 2018, primary palliative care education has been carried out in the department of geriatrics at Beijing Tongren Hospital. This study aimed to explore the changes to the intensity of end-of-life care in hospitalized older adults before and after the implementation of primary palliative care education. Methods A retrospective study was conducted. 203 decedents were included from Beijing Tongren Hospital’s department of geriatrics between January 1, 2014 to December 31, 2019. Patients were split into two cohorts with regards to the start of palliative care education. Patient demographics and clinical characteristics as well as analgesia use, other medical resources use and provision of life-sustaining treatments were compared between the two groups. We used a chi-square test to compare categorical variables, a t test to compare continuous variables with normal distributions and a Mann–Whitney U test for continuous variables with skewed distributions. Results Of the total participants in the study, 157(77.3%) patients were male. The median age was 88 (interquartile range; Q1-Q3 83–93) and the majority of patients (N = 172, 84.7%) aged 80 years or older. The top 3 causes of death were malignant solid tumor (N = 74, 36.5%), infectious disease (N = 74, 36.5%), and cardiovascular disease (N = 23, 11.3%). Approximately two thirds died of non-cancer diseases. There was no significant difference in age, gender, cause of death and functional status between the two groups (p > 0.05). After primary palliative care education, pain controlling drugs were used more (p < 0.05), fewer patients received electric defibrillation, bag mask ventilation and vasopressors ( p༜0.05). There was no change in the length of hospitalization, intensive care admissions, polypharmacy, use of broad-spectrum antibiotics, blood infusions, albumin infusions, nasogastric/nasoenteric tubes, parenteral nutrition, renal replacement and mechanical ventilation (p > 0.05). Conclusions Primary palliative care education promotes symptom control and DNR implementation. In the future, more efforts should be put on education about symptom assessment, prognostication, advance care planning, code status discussion with particular focus on patients with end stage non-cancer diseases.


Author(s):  
Afaf S. Abd El Kader ◽  
Ayman S. Dawood ◽  
Ahmed T. Morsy ◽  
Hesham A. Salem

Background: Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder among women in the reproductive period. It is one of the leading causes of infertility. The manifestations of PCOS include irregular or no menstrual periods, excess body weight and facial hair, acne, heavy periods and pelvic pain. The aim of this study is to determine the efficacy of stair step protocol compared to traditional protocol in ovulation induction of polycystic ovarian syndrome (PCOS) patients in terms of increasing rate of ovulation and pregnancy. Methods: This study is non-blinded, multicenter, randomized controlled study and was carried out on infertile women attending the Fertility Clinic of Tanta University Hospital and Hurghada General Hospital. Two Hundred infertile patients with PCOS criteria and no other causes of infertility were enrolled according to inclusion and exclusion criteria. Results: Student t test was used for the continuous variables (FSH, LH, Prolactin, AMH, TSH, Free testosterone). Student t test was used for the continuous variables (Endometrial thickness, Time to ovulate (d)). Chi-square analysis was used for the categorical variables (Ovulation rate, Pregnancy rate). Chi-square analysis was used for the categorical variables (Ovulation rate per cycle). There was no significant difference between two groups as regards mild and severe side effects. Conclusions: This study concluded that stair step regimen improves the ovulation rate and pregnancy rate without any detrimental side effects compared to traditional regimen. It helps to know the sensitivity and resistance of an individual to clomiphene citrate much earlier and helps to plan ahead with alternative treatment for desired outcome. The advantage of shorter treatment period with similar side effects makes the stair step protocol suitable for use in routine clinical practice.


2020 ◽  
pp. 150-153
Author(s):  
Yasar Karatas ◽  
Fatih Keskin ◽  
Mehmet Fatih Erdi ◽  
Bulent Kaya ◽  
Ibrahim Kosemen ◽  
...  

Background: Spinal instrumentation surgery causes significant pain in patients. As a result, patients are exposed to excessive opioid use and the associated side effects, as well as prolonged hospital stay, resulting in economic burden. Local anaesthetics can help both reduce postoperative pain and minimize the side effects associated with systemically administered opioid analgesics. Objective: The aim of this retrospective study was to investigate the effect of erector spinae plane block on analgesia in spinal instrumentation surgery and to reduce the side effects of excessive opioid use. Materials and Methods: We reported a retrospective study. Thirty patients, who underwent spinal instrumentation surgery from 2017 to 2018, were chosen from the hospital records. We performed spinal instrumentation and decompression by laminectomy to all patients under general anaesthesia. While 15 of these patients underwent erector spinae plane block, these patients received patient-controlled analgesia postoperative period. The other 15 patients received only patient-controlled analgesia postoperative period. We analyzed patients' data for differences in preoperative and postoperative visual analogue scores, nausea vomiting scores, constipation life quality scale, patient-controlled analgesia shot count and mean opioid consumption of patients. Results: The data of 30 patients undergoing lumbar spinal instrumentation surgery were retrospectively analyzed. There was no significant difference in the age, preoperative VAS, preoperative ODI and sex between the two groups (p?0,05). In addition, there were statistically significant differences in postoperative VAS, postoperative ODI, Nausea Vomiting Score, Constipation Life Quality Score (CLQS), petidin consumption and PCA shot count (p <0.05). In all variables with significant differences, the values ??in the block group were lower than the non-block group. Conclusion: ESPB provides effective analgesia and reduces side effects due to excessive opioid usage.


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