Current medical research and opinion
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Randomized Controlled Trial Comparative Study
Reversal of an unfavorable effect of hydrochlorothiazide compared to angiotensin converting enzyme inhibitor on serum uric acid and oxypurine levels by estrogen-progestin therapy in hypertensive postmenopausal women.
Background: The aim was to assess the effect of estrogen-progestin therapy (EPT) on serum levels of uric acid (SUA) and its precursors xanthine (X) and hypoxanthine (HX), and on uric acid (UA) renal excretion in hypertensive postmenopausal women treated with an angiotensin-converting enzyme inhibitor (ACEI) or thiazide diuretic (HCTZ) (ClinicalTrials.gov identifier: NCT03921736, registered 19 April 2019). Methods: Postmenopausal women with untreated essential hypertension were recruited to the study. The control group consisted of 40 postmenopausal women with normal blood pressure. ⋯ However, in the HCTZ and EPT + group, SUA decreased significantly when compared to baseline. None of these unfavorable effects was observed in the ACEI group regardless of EPT. Conclusions: 1) EPT prevents the development of hyperuricemia during antihypertensive treatment with thiazide diuretics. 2) Arterial hypertension and menopause cause impairment of UA excretion and increase the levels of SUA and its precursors X and HX. 3) EPT reduces the risk of hyperuricemia in postmenopausal women.
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Multicenter Study Observational Study
Non-interventional observational study broadens positive benefit-risk assessment of an immunomodulating herbal remedy in the common cold.
Background: The unique extract of a mixture of Baptisiae tinctoriae radix, Echinaceae pallidae/purpureae radix and Thujae occidentalis herba alleviates the typical symptoms of the common cold and shortens the duration of the disease. Purpose: The risk-benefit ratio of a concentrated formulation of this herbal extract was investigated under everyday conditions. Study design: Pharmacy-based, non-interventional, multicenter, open, uncontrolled study registered at DRKS00011068. ⋯ The tolerability was assessed as "good or very good" by 98% of the patients. Conclusion: The benefit-risk assessment of this herbal extract clearly remains positive. This non-interventional study accords with and shows transferability of the results of previous placebo-controlled studies with this extract in a real-life setting.
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Randomized Controlled Trial
Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer.
Objective: To analyze patient-reported swallowing difficulties, healthcare resource utilization and associated costs during the PROCLAIM study. Methods: Patients with stage III non-squamous non-small cell lung cancer received pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy. Patient - reported swallowing function was measured using diaries. ⋯ When adjusting for treatment duration, other monthly medical costs were favorable to PemCis. Patients on pemetrexed remained longer on therapy, suggesting better tolerability. ClinicalTrials.gov identifier: NCT00686959.
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Background and purpose: Several recent randomized controlled trials (RCTs) in non-metastatic castration resistant prostate cancer (nmCRPC) have demonstrated a significant improvement in metastasis-free survival (MFS); however, an improvement in overall survival (OS) is not reported yet. Since the surrogacy of MFS to OS has not been formally investigated in nmCRPC in Japan, this study evaluated the correlation between MFS and OS among a nmCRPC population in Japan. Methods: This is a retrospective longitudinal observational cohort study in patients with nmCRPC using the Japanese Medical Data Vision (MDV) database covering over 20 million patients. ⋯ There was a statistically significant correlation between MFS and OS (Pearson's correlation coefficient = 0.62; 95% CI: 0.58-0.65; p < .0001, Spearman's correlation coefficient = 0.62; 95% CI: 0.58-0.65; p < .0001 and Kendall's τ statistic = 0.53; 95% CI: 0.49-0.56; p < .0001). Conclusions: The results of this study indicate a significant correlation between MFS and OS. It may justify the usefulness of MFS as surrogate for OS in nmCRPC.
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Observational Study
Gamma-hydroxybutyrate: is it a feasible alternative to midazolam in long-term mechanically ventilated children?
Aim: Benzodiazepines like midazolam are commonly used for long-term sedation of critically ill children requiring mechanical ventilation. Tolerance to midazolam may occur in these patients resulting in a ceiling effect with insufficient or missing sedative response to increases of midazolam infusion or bolus application. The aim of this study was to evaluate the feasibility of a drug rotation protocol replacing continuous infusion of midazolam with gamma-hydroxybutyrate (GHB) to counteract midazolam tolerance. ⋯ In these children, dosing of midazolam could not be reduced following drug rotation. We could not identify factors which predict success or failure of drug rotation from midazolam to GHB. Conclusions: The data from our single-center study suggest that drug rotation from midazolam to GHB may be worth trying in children with midazolam tolerance during long-term sedation, but physicians should be aware of possible treatment failure.