Noctiva was approved by the Food and Drug Administration (FDA) in March 2017 based on findings from two 12-week, randomized, double-blind, placebo-controlled trials (N=1045) in patients with nocturia due to nocturnal polyuria.
In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturations per 24 hours (primary endpoint), and the volume voided per micturation (secondary endpoint) compared to placebo or to individual active components.
A total of 14,453 (35%) cases and 86,403 (30%) controls were prescribed at least 1 anticholingeric drug with an Anticholinergic Cognitive Burden (ACB) score of 3; 1429 (3.5%) cases and 7909 (2.8%) controls were prescribed drugs with an ACB score of 2; most patients (89% of cases and 87% of controls) received a drug with an ACB score of 1 during the drug exposure period (DEP).
The manufacturers on the blister packs of these drugs show Acme Generics and Sun Pharma. The FDA also expressed concern that the seller may be distributing unapproved tadalafil, the generic version of Cialis
For the report, AKI was defined as the occurrence of at least 1 diagnostic code 584 (acute renal failure) or the occurrence of at least 1 procedure code of 39.95 (hemodialysis) or 54.98 (peritoneal dialysis).
The results showed no difference in the number of hospital-free days between either group but the balanced crystalloids group had a lower incidence of major adverse kidney events ≤30 days vs the saline group.
For this study, researchers aimed to determine the impact of statin use on the risk of nephrolithiasis and to assess whether higher lipid levels were associated with the risk of stone formation.
Fexapotide triflutate 2.5 mg was found to be safe and effective for long-term treatment of BPH.
The supplements are intended to reduce urinary urgency, accidents, and day/night frequency in patients with overactive bladder and urinary infections.
The risk of chronic kidney disease (CKD) may be increased in patients living with HIV receiving tenofovir (TDF) with a ritonavir-boosted protease inhibitor compared to those who receive TDF with a non-nucleosidic reverse transcriptase inhibitor (NNRTI)
Uric acid-lowering therapy might improve kidney outcomes, including kidney failure events, proteinuria, and the rate of change in eGFR, and seem to reduce the risk of cardiovascular events in adults with CKD.
Dietary interventions may be used for conservative uremia management and to delay or prevent dialysis therapy, say the authors of the review.
The researchers found in an eGFR trajectory analysis that 10.1% of participants were rapid decliners, with a mean decrease of 2.9 mL/min/1.73 m²/year.
Phase 2 trials have shown to be associated with reductions in urine protein levels following treatment with OMS721 in patients with lgA nephropathy.
The vaccine consists of the FimH bacterial adhesion protein as well as a new adjuvant designed to induce an immune response to prevent bacterial colonization of the urinary tract.
"We look forward to FDA's review of our application for a potential new treatment option for the millions of people living with OAB," said Bernhardt Zeiher, MD, president of Development at Astellas.
In addition, the companies are conducting other mechanistic studies that will evaluate the potential mechanisms by which empagliflozin may affect renal outcomes in patients with CKD.
Since oxidative stress is known to worsen DKD, study authors sought to review available data on the possible benefits of chronic antioxidant supplementation on DKD progression.
These undeclared ingredients may interact with nitrates contained in some prescription medications (eg, nitroglycerin), and may decrease blood pressure to dangerous levels.
The supplement contains pumpkin seed and soy germ extract, and Synetrim CQ, a botanical that further promotes bladder control by aiding metabolic health and managing weight.
The association between melanoma among PDE5i users was only statistically significant for male patients with low PDE5i exposure and with low-stage melanoma.
The researchers believe that based on their findings, e-cigarette smokers may be at increased risk for bladder cancer.
The 2017 AUA list contains evidence-based recommendations to guide conversations between physicians and patients about what care is appropriate.
A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018.
Nearly 7,000 Italian men participating in the Moli-sani epidemiological study aged ≥50 years were monitored for an average of 4.25 years.
Based on these studies, it would appear that dietary changes could prevent 1 in every 3,000 people treated for 1 year avoid ESKD, however the certainty in this effect was very low.
Results showed that 87.3% of the Veltassa plus food group and 82.5% of the Veltassa and no food group achieved and maintained potassium levels in the target range.
The USPSTF performed a systematic review of the existing evidence and concluded that the potential benefits and harms of prostate-specific antigen (PSA)-based screening are "closely balanced" in men aged 55-69 years.
These studies identified links to increased risks of thyroid, testicular and breast cancer, nonalcoholic fatty liver disease and even the early onset of puberty for boys, which can lead to diseases in adulthood.
The researchers hypothesized that some antimuscarinics with "high lipophilicity, neutral polarity, or low molecular size still cross the blood-brain barrier and further affect neurotransmission in the brain," which could possibly trigger the depressive symptoms.
Among elderly patients, oxybutynin was frequently prescribed and continued; incidence, 27.3%; prevalence, 33.2%.
The data showed adult males who used 5 alpha-reductase inhibitors did not exhibit a significantly increased risk of suicide, however the risk of self-harm did increase.
All current home use fertility devices measure sperm concentration only but not motility
Patients with C3G experience progressive deterioration in renal function, ultimately leading to renal failure requiring dialysis and kidney transplant, if left untreated.
Acetohydroxamic acid, which has proven a successful antibiotic treatment of urea-splitting Proteus infections after surgical removal of struvite stones, was in shortage since July 2014.
Among those who developed PED, the condition continued for months or years, despite patients stopping treatment.
The Food and Drug Administration (FDA) announced a shortage in the supply of Nulojix (belatacept; Bristol-Myers Squibb) due to an increase in demand for the drug exacerbated by a delay in transition to a more efficient manufacturing process.
The approval was based on two 12-week, randomized, double-blind, placebo-controlled trials that included 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria.
A voluntary recall of the erectile dysfunction treatment, Edex (alprostadil for injection) was announced due to a defect in the crimp caps used in the manufacturing of the product lot.
The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%.
The trial demonstrated a statistically significant difference in serum phosphorus levels for the tenapanor group over the placebo group.
Significant differences are seen for immunochemical, bromcresol green (BCG), and bromcresol purple (BCP) methods of albumin measurement, according to a study published online in Clinical Chemistry.
The FDA has accepted for review the New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF; MonoSol Rx) for the treatment of erectile dysfunction (ED).
For patients with chronic kidney disease (CKD), skin sodium content is associated with left ventricular mass, according to a study published online February 2 in the Journal of the American Society of Nephrology.
3M announced the launch of Cavilon Advanced Skin Protectant for the prevention of moderate to severe incontinence-associated dermatitis (IAD).
There is no statistically significant correlation between typical vitamin D intake and incident kidney stones, according to a study published in the February issue of The Journal of Urology.
For patients with chronic kidney disease (CKD), a diet that stresses healthy food vs. individual ingredients may help reduce the risk of early death, a study published in the Clinical Journal of the American Society of Nephrology has found.
The Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-4 in favor of the benefit risk profile of the New Drug Application (NDA) for SER120 (desmopressin nasal spray; Allergan and Serenity). In addition, the Committee voted 17-1 regarding the evidence in favor of at least one of the doses being effective.
Innovus Pharma announced the launch of Sensum+, an over-the-counter (OTC) cream to increase penile sensitivity.
AGEs improve RFL prediction in American-Indians with type 2 diabetes
Atrial fibrillation is associated with a wider range of conditions than previously believed, according to a review and meta-analysis published online in The BMJ.
The Food and Drug Administration (FDA) is warning consumers not to buy or use Kopi Jantan Traditional Natural Herbs Coffee.
Nymox announced positive data from the Phase 3 study of fexapotide for the treatment of benign prostatic hyperplasia (BPH) and localized prostate cancer.
OnabotulinumtoxinA treatment is safe and effective for long-term treatment of overactive bladder syndrome, according to a study published in the September issue of The Journal of Urology.
The American Urologic Association has issued a new guideline for the surgical management of patients with kidney and/or ureteral stones, containing over 50 statements on best practices.
For women undergoing urogynecologic surgery, addition of polyethylene glycol 3350 (PEG3350) to docusate sodium does not reduce the time to first bowel movement, according to a study published in Obstetrics & Gynecology.
Women with vaginal mesh with complications have a significantly increased proinflammatory response, according to a study published in the American Journal of Obstetrics & Gynecology.
In adults with septic shock, early vasopressin use vs. norepinephrine did not improve the number of kidney failure-free days, a study in JAMA concluded.
A significant reduction in all-cause mortality risk was seen in men with type 2 diabetes who were taking phosphodiesterase type-5 inhibitors (PDE5is).
Older adults with chronic kidney disease (CKD) have a considerable burden of functional impairment, according to research published online in the Journal of the American Geriatrics Society.
Analytica announced that the Food and Drug Administration (FDA) has approved PeriCoach at-home pelvic floor trainer device and smartphone app as an over-the-counter (OTC) treatment for mild, moderate, and stress urinary incontinence (UI) and urge incontinence.
Researchers conducted a literature review to assess current evidence of drug class combinations and their association with the development of acute kidney injury (AKI).
The small apparent increase in risk of melanoma in men prescribed phosphodiesterase type 5 (PDE5) inhibitors may be explained by greater sun exposure, according to new research published online in PLOS Medicine.
The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).
Selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) do not appear to significantly impact nocturnal urinary frequency, researchers from Albany Medical College, Albany, NY, reported.
For males with mild hypogonadism, only scores in sexual desire showed significant improvement
AM-Pharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to recAP (recombinant human Alkaline Phosphatase) for the treatment of acute kidney injury (AKI).
Consuming multiple cups of coffee a day is likely to be safe for the kidneys in the general population, and is associated with an increase in estimated glomerular filtration rate (eGFR), according to findings of a study from the Netherlands.
In a commentary published in EMBO reports, study authors present data showing that herbals containing Aristolochia species can cause aristolochic acid nephropathy (AAN).
Rockwell Medical announced that the Food and Drug Administration (FDA) has approved Triferic (ferric pyrophosphate citrate) powder packet for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (CKD).
Administration of the human papillomavirus (HPV) vaccine led to sustained immune response in girls and young women with chronic kidney disease (CKD) and in those on dialysis but led to an inadequate response in those with a kidney transplant.
No significant difference was seen in the incidence of acute kidney injury (AKI) development or other outcomes between patients who received vancomycin + piperacillin-tazobactam vs. vancomcyin + cefepime.
Statin use did not reduce the risk for kidney failure events in adults not receiving dialysis but may modestly reduce proteinuria and rate of estimated GFR (eGFR) decline, a study published in American Journal of Kidney Disease has reported.
A newly proposed bill by a Kentucky legislator requires men to get signed consent from their spouses and visit a doctor twice prior to receiving drugs for erectile dysfunction (ED).
Teva announced a voluntary recall of one lot of Paricalcitol 1mcg capsules, the generic version of AbbVie's Zemplar.
An app produced by the Interstitial Cystitis Network (ICN) may bring some relief to patients with urinary disorders looking to avoid foods that may provoke the pain and discomfort of their condition.
Researchers found a link between increased risk of kidney damage and two common antibiotics, vancomycin and piperacillin-tazobactam.
National Video Supply announced a voluntary recall of all lots of RHINO 7 3000 Platinum Capsules after an analysis by the Food and Drug Administration (FDA) found these products contain two undeclared ingredients.
The decision to discontinue the product is business-related and not due to product safety or efficacy.
llergan announced results from an extension study of two Phase 3 trials on the long-term safety and efficacy of Botox (onabotulinumtoxinA) in female patients with overactive bladder (OAB) with symptoms of urge urinary incontinence.
Although greater consumption of dietary calcium may lower the risk of kidney stone recurrence, research presented at the American Society of Nephrology's (ASN) Kidney Week 2015 in San Diego, suggests that calcium supplementation could actually increase this risk.
The first population-based study on high grade prostate cancer and long-term exposure to testosterone therapy reported no increased risk with exposure to this treatment, nor a dose-dependent relationship between prostate cancer risk and testosterone therapy.
Research presented at the 2015 Annual Meeting of The North American Menopause Society (NAMS) supports previous findings that use of local estrogens for genitourinary symptoms of menopause (vaginal dryness, painful intercourse, and urinary tract infections) are underutilized, but the study also reports that method of local treatment can impact treatment duration and adherence to therapeutic guidelines.
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for phosphodiesterase 5 (PDE-5) inhibitors regarding a new contraindication with guanylate cyclase stimulators, such as riociguat.
Too much sodium and potassium intake may accelerate the progression of kidney disease, a recently published study has shown.
The One Minute Miracle, Inc. announced a voluntary recall of all lots of Miracle Diet 30 and Miracle Rock 48 capsules.
The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.
A review in the journal Endocrine Reviews and Metabolic Disorders reports that greater education and awareness of the potential risks associated with two treatments for benign prostate hyperplasia (BPH) is needed among both patients and clinicians, along with additional research exploring these reported adverse effects.
The Food and Drug Administration (FDA) has approved changes to the Myrbetriq (mirabegron; Astellas Pharma) label to include a new contraindication and a new update to the Warnings and Precautions section.
Blue Square Market, Inc. announced voluntary recalls of Kaboom Action Strips and LiDa DaiDaiHua due to the presence of undeclared active ingredients.
Tamsulosin was found to improve passage of larger, but not smaller, kidney stones compared to placebo, according to a study in the Annals of Emergency Medicine.
Phosphates artificially added to foods like dairy and cereal products have been associated with sharp increases in blood phosphorous levels that could be harmful to the kidneys, particularly for patients with existing reduced kidney function.
Patiromer oral suspension, an investigational drug, was found to reduce elevated potassium levels in patients with chronic diabetic kidney disease in a study published in JAMA.
Testosterone replacement therapy did not improve sexual function males with ejaculatory disorders and low testosterone levels, data from a new study showed.
The PeriCoach System is now available to strength and tone pelvic muscles in women with urinary incontinence following its approval in March 2015.
Patients taking medications for erectile dysfunction may have an increased risk of melanoma, but these drugs are not a cause of melanoma, researchers concluded.
A women's low resting heart rate variability may be associated with sexual dysfunction, a study published in Applied Psychophysiology and Biofeedback has shown.
Men treated for benign prostatic hyperplasia (BPH) with the type II 5 alpha-reductase inhibitor finasteride could be significantly more likely to experience erectile dysfunction (ED) compared to those taking the alpha-1A blocker tamsulosin.
The American Urological Association (AUA) has issued a new list of recommendations as part of the Choosing Wisely campaign.
Vitamin D supplementation could help children with mild-to-moderate chronic kidney disease (CKD) in reducing the risk of renal failure progression, according to a study published in the Journal of the American Society of Nephrology (JASN).