Comparing the risk of deep vein thrombosis of two combined oral contraceptives: Norethindrone/ethinyl estradiol and drospirenone/ethinyl estradiol.

Background: Deep vein thrombosis (DVT) has been reported as an adverse event for patients receiving combined oral contraceptives. Norethindrone/ethinyl estradiol (NET/EE) and drospirenone/ethinyl estradiol (DRSP/EE) are two commonly prescribed combined hormonal oral contraceptive agents used in the United States, differing in their progestin component. Objective: The purpose of this study was to determine the association between the progestin component of a combined oral contraceptive and the risk of DVT in patients taking oral contraceptives for birth control using data derived from the FDA Adverse Event Reporting System (FAERS). Methods: The risk of DVT was compared between patients that had taken NET/EE with those that had taken the DRSP/EE COC formulation for birth control. In addition, age was assessed as a possible confounder and the outcome severity for those diagnosed with DVT were compared between the two groups. Finally, association rule mining was utilized to identify possible drug-drug interactions that result in elevated DVT risk. Results: DVT was the fourth most commonly adverse event reported for patients taking DRSP/EE accounting for 8558 cases and the seventeenth most commonly reported adverse event for NET/EE accounting for 298 cases. Age was found to be a significant confounder for users of DRSP/EE with regards to DVT risk across all age groups assessed: 2040 (ROR = 3.69, 95% CI 3.37-4.04) However, there was only a statistically significant elevated risk in patients over 40 years of age taking NET/EE (ROR = 1.98, 95% CI 1.36-2.88). Patients that had taken DRSP/EE and the corticosteroid prednisone simultaneously had an approximately 3-fold increase in DVT risk (ROR = 2.77, 95% CI 2.43-3.15) relative to individuals that had only taken DRSP/EE. Conclusion: Based on this analysis, there is a higher risk of developing DVT when taking DRSP/EE than when taking NET/EE as hormonal contraception. In addition, a possibly significant drug-drug interaction between different COC formulations and prednisone were identified. This interaction may result in elevated DVT risk due to a synergistic impairment of fibrinolysis and a decrease in plasmin production.

The association between warfarin usage and international normalized ratio increase: systematic analysis of FDA Adverse Event Reporting System (FAERS).

Introduction: Elevated international normalized ratio (INR) has been commonly reported as an adverse drug event (ADE) for patients taking warfarin for anticoagulant therapy. Aim: The purpose of this study was to determine the association between increased INR and the usage of warfarin by using the pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS). Methods: The ADEs in patients who took warfarin (N = 77,010) were analyzed using FAERS data. Association rule mining was applied to identify warfarin-related ADEs that were most associated with elevated INR (n = 15,091) as well as possible drug-drug interactions (DDIs) associated with increased INR. Lift values were used to identify ADEs that were most commonly reported alongside elevated INR based on the correlation between both item sets. In addition, this study sought to determine if the increased INR risk was influenced by sex, age, temporal distribution, and geographic distribution and were reported as reporting odds ratios (RORs). Results: The top 5 ADEs most associated with increased INR in patients taking warfarin were decreased hemoglobin (lift = 2.31), drug interactions (lift = 1.88), hematuria (lift = 1.58), asthenia (lift = 1.44), and fall (lift = 1.32). INR risk increased as age increased, with individuals older than 80 having a 63% greater likelihood of elevated INR compared to those younger than 50. Males were 9% more likely to report increased INR as an ADE compared to females. Individuals taking warfarin concomitantly with at least one other drug were 43% more likely to report increased INR. The top 5 most frequently identified DDIs in patients taking warfarin and presenting with elevated INR were acetaminophen (lift = 1.81), ramipril (lift = 1.71), furosemide (lift = 1.64), bisoprolol (lift = 1.58), and simvastatin (lift = 1.58). Conclusion: The risk of elevated INR increased as patient age increased, particularly among those older than 80. Elevated INR frequently co-presented with decreased hemoglobin, drug interactions, hematuria, asthenia, and fall in patients taking warfarin. This effect may be less pronounced in women due to the procoagulatory effects of estrogen signaling. Multiple possible DDIs were identified, including acetaminophen, ramipril, and furosemide.

Dysphagia Risk in Patients Prescribed Rivastigmine: A Systematic Analysis of FDA Adverse Event Reporting System.

BACKGROUND: Dysphagia has been reported as an adverse event for patients receiving rivastigmine for Alzheimer's disease (AD) treatment. OBJECTIVE: The purpose of this study was to determine the association between dysphagia and the usage of rivastigmine by using the pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS). METHODS: The risk of dysphagia in patients who took rivastigmine was compared with those of patients who took other medications. In addition, this study sought to determine if the dysphagia risk was influenced by sex, age, dosage, and medication routes of administration. RESULTS: When compared to patients prescribed donepezil, galantamine, or memantine, individuals prescribed rivastigmine were almost twice as likely to report dysphagia as an adverse event. The dysphagia risk in individuals prescribed rivastigmine is comparable to individuals prescribed penicillamine but significantly higher than clozapine, drugs of which have been previously shown to be associated with elevated dysphagia likelihood. Individuals older than 80 were 122% more likely to report having dysphagia after being prescribed rivastigmine than patients that were 50-70 years of age. Oral administration of rivastigmine was associated with approximately 2 times greater likelihood of reporting dysphagia relative to users of the transdermal patch. In addition, dysphagia showed higher association with pneumonia than other commonly reported adverse events. CONCLUSION: Patients prescribed rivastigmine were at greater risk of reporting dysphagia as an adverse event than patients prescribed many other medicines. This increase in dysphagia occurrence may be attributed to the dual inhibition of both acetylcholinesterase and butyrylcholinesterase.

Different patterns of dynamic variations on electrical conductances of acupoints between Qi Vacuity and Qi non-Vacuity after glucose ingestion.

OBJECTIVES: In Traditional Chinese Medicine (TCM), Qi maintains the physiologic function and indicates physiologic energy. Glucose provides energy to humans, thereby playing a role analogous to "nutritive Qi." This study aims to identify the correlations among blood glucose, Qi Vacuity (QV), and the electrical conductances of acupoints. METHODS: Twenty (20) subjects who had ingested a glucose solution after a 10-hour overnight fast were divided into two groups based on QV score. Then their acupoint conductances were measured sequentially using a Ryodoraku instrument during the following 120 minutes. Data were analyzed using generalized estimating equations as a time-series model. RESULTS: Eight (8) subjects were categorized into a Qi Vacuous group for QV score >6, and the other 12 subjects were categorized into a Qi non-Vacuous group for QV score ≤6. During the first 30 minutes, the acupoint conductances decreased on the left Pericardium, left Heart, right Liver, Kidney, and Gallbladder meridians in the Qi Vacuous group, and increased on the right Pericardium meridian and decreased on the right Gallbladder meridian in the Qi non-Vacuous group. From 30 to 60 and 60 to 90 minutes, the acupoint conductances decreased on the Gallbladder, Heart, left Pericardium, left Kidney, right Liver, and right Stomach meridians in the Qi Vacuous group, and increased on the Pericardium, Heart, left Small Intestine, and left Lung meridians in the Qi non-Vacuous group. During the last 30 minutes, more of the acupoint conductances were increased in the Qi non-Vacuous group, whereas only the acupoint conductance on the liver meridian was increased and that on the left gallbladder meridian was decreased in the Qi Vacuous group. CONCLUSIONS: The findings suggest that the energy distribution and transformation in meridian vessels present different patterns in QV and non-QV groups after glucose consumption.

Effect of long-term music therapy intervention on autonomic function in anthracycline-treated breast cancer patients.

Anthracyclines are potent antineoplastic agents associated with cardiotoxicity, which may lead to congestive heart failure, causing impairment of autonomic cardiovascular function as assessed by heart rate variability (HRV). This decreases survival rates. This study aimed to determine whether music therapy intervention improves autonomic function in anthracycline-treated breast cancer patients, and if so, whether such improvements persist after cessation of the intervention. Participants were 12 women with breast cancer who had undergone mastectomy or breast-conserving treatment and adjuvant chemotherapy; they attended 8 weekly music therapy sessions, each lasting 2 hours. Electrocardiogram traces (5 minutes) for HRV analysis were recorded 4 times: prior to the first music session, T1; after the fourth music session, T2; after the eighth music session, T3; and 4 weeks after the completion of music therapy, T4. HRV parameters were subjected to a nonparametric Friedman test on the differences between T1 and T2, T3, and T4. The standard deviation of normal intervals and the total power of HRV parameters, related to global autonomic function, were significantly higher at T3 than at T1. The root-mean-square differences of successive normal R-R intervals and high-frequency (HF) HRV parameters, related to parasympathetic activity, were significantly increased, but no change was seen in the LF/HF ratio of HRV parameters (which is related to sympathetic activity) during the music therapy. Global autonomic function and parasympathetic activity had not changed significantly at T4 relative to T1. The authors provide preliminary evidence of the benefits of music therapy for anthracycline-treated breast cancer survivors.

Effects of music therapy on subjective sensations and heart rate variability in treated cancer survivors: a pilot study.

OBJECTIVE: Data on the effects of music therapy on subjective sensations and the physiological parameters of heart rate variability (HRV) in treated cancer survivors are scarce. The aim of this study was to determine whether or not music therapy affects the sensations of fatigue, comfort, and relaxation in cancer survivors, and affects the activities of the sympathetic and parasympathetic nervous systems as indicated by HRV parameters. METHODS: Twenty-three patients aged 30-67 years and with cancer that had been treated at least 6 months previously received music therapy for about 2h, which included singing, listening to music, learning the recorder, and performing music. Subjective sensations and electrocardiogram were recorded before and after the music therapy. The low-frequency and high-frequency components of HRV were assessed by the frequency analysis of sequential R wave to R wave intervals of electrocardiogram obtained from 5-min recordings. Subjective sensations were quantitatively assessed using a visual analog mood scale. RESULTS: Two hours of music therapy significantly increased relaxation sensations and significantly decreased fatigue sensation in treated cancer survivors. Moreover, the HRV parameters showed that parasympathetic nervous system activity increased and sympathetic nervous system activity decreased. CONCLUSION: This study provides preliminary evidence that music therapy may be clinically useful for promoting relaxation sensation and increasing parasympathetic nervous system activity in treated cancer survivors.