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- Patiromer in Patients with Kidney Disease and Hyperkalemia Receiving RAAS Inhibitors. [JOURNAL ARTICLE]
- N Engl J Med 2014 Nov 21.
Background Hyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system (RAAS) in high-risk patients. We assessed the safety and efficacy of patiromer, a nonabsorbed potassium binder, in a multicenter, prospective trial. Methods Patients with chronic kidney disease who were receiving RAAS inhibitors and who had serum potassium levels of 5.1 to less than 6.5 mmol per liter received patiromer (at an initial dose of 4.2 g or 8.4 g twice a day) for 4 weeks (initial treatment phase); the primary efficacy end point was the mean change in the serum potassium level from baseline to week 4. Eligible patients at the end of week 4 (those with a baseline potassium level of 5.5 to <6.5 mmol per liter in whom the level decreased to 3.8 to <5.1 mmol per liter) entered an 8-week randomized withdrawal phase in which they were randomly assigned to continue patiromer or switch to placebo; the primary efficacy end point was the between-group difference in the median change in the serum potassium level over the first 4 weeks of that phase. Results In the initial treatment phase, among 237 patients receiving patiromer who had at least one potassium measurement at a scheduled visit after day 3, the mean (±SE) change in the serum potassium level was -1.01±0.03 mmol per liter (P<0.001). At week 4, 76% (95% confidence interval, 70 to 81) of the patients had reached the target potassium level (3.8 to <5.1 mmol per liter). Subsequently, 107 patients were randomly assigned to patiromer (55 patients) or placebo (52 patients) for the randomized withdrawal phase. The median increase in the potassium level from baseline of that phase was greater with placebo than with patiromer (P<0.001); a recurrence of hyperkalemia (potassium level, ≥5.5 mmol per liter) occurred in 60% of the patients in the placebo group as compared with 15% in the patiromer group through week 8 (P<0.001). Mild-to-moderate constipation was the most common adverse event (in 11% of the patients); hypokalemia occurred in 3%. Conclusions In patients with chronic kidney disease who were receiving RAAS inhibitors and who had hyperkalemia, patiromer treatment was associated with a decrease in serum potassium levels and, as compared with placebo, a reduction in the recurrence of hyperkalemia. (Funded by Relypsa; OPAL-HK ClinicalTrials.gov number, NCT01810939 ).
- Prevalence and Effectiveness of Laxative Use Among Elderly Residents in a Regional Hospital Affiliated Nursing Home in Hsinchu County. [JOURNAL ARTICLE]
- Nurs Midwifery Stud 2014 Apr; 3(1):e13962.
Long-term care residents are susceptible to constipation and one-half to three quarter of older nursing home residents receive laxatives regularly.The purpose of this study was to evaluate the factors related to abnormal bowel function and explore the effectiveness of laxative treatment among the elderly residents of a nursing home.A total of 110 residents older than 65 years old was enrolled in this study. The following variables were gathered: age, gender, body mass index (BMI), length of stay, daily fluid intake, type of food, functional level, cognitive ability, physical therapy status, somatic and psychiatric diseases, number of medications, and medication use. The use and dosage of laxatives were recorded by means of Anatomical Therapeutic Chemical (ATC) classification system. Normal bowel function was defined as defecation frequency from three defecations per day to three defecations per week and stool consistency score of three to five on Bristol Stool Form Scale. A comparison between groups with normal and abnormal bowel function was drawn.Low BMI, increased fluid intake, liquid food intake, poor functional level, poor cognition, and a history of stroke were significantly associated with altered bowel function (P < 0.05). The most frequently used laxatives were glycerol, senna glycoside, and magnesium oxide. There were significant differences in laxative regimens between residents with normal and altered bowel function; those with altered bowel function tended to take more laxatives than those with normal bowel function.This study suggested that treatment of constipation in the nursing home was unsatisfactory. To improve treatment outcomes in those susceptible to altered bowel function, a coordinated approach with involvement of physicians, nursing staff, and other professionals including dieticians and pharmacists seems necessary.
- Patient Preferences for Change in Symptoms Associated with Opioid-Induced Constipation. [JOURNAL ARTICLE]
- Adv Ther 2014 Nov 21.
While opioids have become a standard treatment option for those experiencing moderate to severe chronic pain, side effects of constipation and related symptoms have interfered with their usage in as many as 40-50% of treated patients. Prior research has elucidated the range of these symptoms, but no study has determined which of these symptoms patients most desire improving or whether improving constipation itself by as little as one more bowel movement per week is deemed an important change.We conducted an online patient survey of 513 participants residing in one of six countries who reported having chronic pain, were taking opioids, and experiencing opioid-induced constipation (OIC) to address these questions.Respondents rank ordered their preferences and the following eight symptoms generated >80% endorsement as important to improve: improvement in having bowel movements without rectal pain, soft stools that are not loose or watery, regular bowel movements, a reduction in rectal straining, relief from feeling bloated, feeling less fear about having OIC when following their opioid medication regime, a desire to worry less overall about having a bowel movement, and with less 'stomach' area pain. When asked 'how important is it you to have 1 more bowel movement per week", over 90% endorsed it was 'somewhat', 'very', or 'extremely important' with nearly 70% (n = 354) endorsing the 'extremely' or 'very important' response options. In multivariate models, being in more overall pain or reporting fewer than 3 bowel movements per week were found to be independent predictors of the importance.These results highlight the notable range of OIC symptoms most desired by patients to improve and demonstrate that bowel movements of only one more per week were important to register a meaningful improvement. The latter is particularly helpful for those assessing the minimal clinically important difference in treating this condition.
- Anal fissure in children: a 10-yeay clinical experience with nifedipine gel and lidocaine. [JOURNAL ARTICLE]
- Minerva Pediatr 2014 Nov 20.
We aimed to evaluate efficacy and safety of the use of nifedipine gel with lidocaine in the treatment of acute anal fissures in children by reviewing of 106 children with acute anal fissure treated conservatively by nifedipine gel with lidocaine between the years 2003--2012. There were 48 males and 58 females. Their clinical presentation consisted of constipation, rectal bleeding, anal pain, perianal itching, abdominal pain, irritability and rectal prolapsed. Posterior, anterior, both anterior and posterior, multiple, both posterior and lateral locations were the main physical findings in 65,23,10,7,and 1 cases. Ninety nine patients completed the 4--week treatment course of nifedipine gel with lidocaine successfully (93.40%), with complete healing of the fissure. The recurrence rate observed was very low (6.60%). Topical 0.2% nifedipine with lidocaine appears an efficient mode of treatment for anal fissures in children, with a significant healing rate and no side effects.
- Bowel and bladder dysfunction following surgery within the presacral space: an overview of neuroanatomy, function, and dysfunction. [JOURNAL ARTICLE]
- Int Urogynecol J 2014 Nov 20.
The presacral space contains a dense and complex network of nerves that have significant effects on the innervation of the pelvic viscera and support structures. The proximity of this space to the bony promontory of the sacrum has lead to its involvement in an array of corrective surgical procedures for pelvic floor disorders including sacrocolpopexy and rectopexy. Other procedures involving the same space include presacral neurectomy which involves intentional transection of the contained neural plexus to relieve refractory pelvic pain and resection of retrorectal or presacral tumors. Potential complications of these procedures are postoperative constipation and voiding dysfunction.Our aim was to review the current published literature on outcomes following a variety of procedures involving the presacral space and review postoperative bowel and urinary function. We also include an overview of the functional and structural anatomy of the presacral space and its corresponding neural plexi.We conclude that quality data are lacking on the short-term and long-term rates for bowel and bladder dysfunction following surgical procedures involving the presacral space.
- Enterolithotomy for the treatment of large bowel obstruction secondary to gallstones. [JOURNAL ARTICLE]
- BMJ Case Rep 2014.
We describe the case of an 81-year-old woman with large bowel-obstruction caused by an impacted gallstone. An 81-year-old, Caucasian, fully independent woman without significant comorbidities presented with absolute constipation, faecal vomiting and abdominal pain. Abdominal radiography revealed dilated small bowel, and a subsequent contrast CT demonstrated a 2.5 cm gallstone in the sigmoid colon. This is believed to have entered the transverse colon via a cholecyst-colonic fistula, and then migrated to a section of sigmoid colon affected by diverticular disease, where it became impacted. Two sigmoidoscopic removals were attempted but were unsuccessful as the gallstone's size prevented removal with an endoscopic basket. A laparotomy was performed and the stone extracted via a sigmoid enterotomy. No covering stoma was formed, and following 48 h on intensive trauma unit and a short ward-based stay for rehabilitation, the patient was discharged home and is currently doing well.
- An Update on the Use of Botulinum Toxin Therapy in Parkinson's Disease. [JOURNAL ARTICLE]
- Curr Neurol Neurosci Rep 2015 Jan; 15(1):511.
Botulinum toxin (BoNT) has gained widespread use in a variety of neurological conditions. Parkinson's disease is a complex neurodegenerative disorder manifested by motor and non-motor symptoms that can cause significant disability. BoNT has been used to effectively treat a variety of symptoms related to Parkinson's disease. This review will examine the current therapeutic indications of BoNT use in the following disorders related to Parkinson's disease: cervical dystonia, blepharospasm and lid apraxia, focal hand dystonia, foot dystonia, laryngeal dystonia, oromandibular dystonia, camptocormia, hand and jaw tremor, sialorrhea, hyperhidrosis, dysphagia, constipation, and overactive bladder.
- Reporting Outcome Measures of Functional Constipation in Children from 0-4 Years of Age: A Systematic Review. [JOURNAL ARTICLE]
- J Pediatr Gastroenterol Nutr 2014 Nov 17.
Functional constipation (FC) often begins in the first year of life. Although standard definitions and criteria have been formulated to describe FC, these are rarely used in research and clinical practice.To systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of infants with FC.PubMed, EMBASE and Cochrane databases were searched. Studies were included if (1) it was a (systematic review of) therapeutic RCT; (2) children ≤4 years old; (3) they had FC; (4) a clear definition of constipation was provided; (5) were written in English. Quality was assessed using the Delphi list.1115 articles were found; only 5 studies fulfilled the inclusion criteria. Four different definitions were used, of which only 2 used the internationally accepted Rome-III criteria. Defecation frequency was used as primary outcome in all included trials and stool consistency in 3 trials. Two trials involving infants investigated new infant formulas, whereas the third RCT evaluated the efficacy of a probiotic strain. The 2 trials including infants up to 4 years of age compared polyethylene glycol without electrolytes (PEG4000) with lactulose and milk of magnesia. All trials used non-validated parental diaries.Different definitions and outcome measures for FC in infants are used in RCTs. Disappointingly; there is a lack of well-designed therapeutic trials in infants with constipation. In order to make comparison between future trials possible, standard definitions, core outcomes and validated instruments are needed.
- The changing clinical profile of celiac disease: a 15-year experience (1998-2012) in an Italian referral center. [Journal Article]
- BMC Gastroenterol 2014; 14(1):194.
Celiac disease is a multiform, challenging condition characterized by extremely variable features. Our goal was to define clinical, serological and histopathological findings in a large cohort of celiacs diagnosed in a single referral center.From January 1998 to December 2012, 770 patients (599 females, median age 36 years, range 18-78 years) were diagnosed as celiacs at St.Orsola-Malpighi Hospital (Bologna, Italy). The clinical phenotypes were classified as: 1) classical (malabsorption syndrome); 2) non-classical (extraintestinal and/or gastrointestinal symptoms other than diarrhea); 3) subclinical. Serology, duodenal histology, comorbidities, response to gluten-free diet and complications were evaluated.Disease onset was symptomatic in 610 patients (79%), while 160 celiacs showed a subclinical phenotype. In the symptomatic group the non-classical prevailed over the classical phenotype (66% vs 34%). Diarrhea was found in 27%, while other gastrointestinal manifestations were bloating (20%), aphthous stomatitis (18%), alternating bowel habit (15%), constipation (13%) and gastroesophageal reflux disease (12%). Extraintestinal manifestations included osteopenia/osteoporosis (52%), anemia (34%), cryptogenic hypertransaminasemia (29%) and recurrent miscarriages (12%). Positivity for IgA tissue transglutaminase antibodies was detected in 97%. Villous atrophy was found in 87%, while 13% had minor lesions consistent with potential celiac disease. A large proportion of patients showed autoimmune disorders, i.e. autoimmune thyroiditis (26.3%), dermatitis herpetiformis (4%) and diabetes mellitus type 1 (3%). Complicated celiac disease was very rare.Our study demonstrates that the clinical profile of celiac disease changed over time with an increasing rate of non-classical and subclinical phenotypes.
- Safety and Tolerability of Gabapentin for Aneurysmal Subarachnoid Hemorrhage (SAH) Headache and Meningismus. [JOURNAL ARTICLE]
- Neurocrit Care 2014 Nov 18.
Headache after aneurysmal subarachnoid hemorrhage (SAH) is very common and is often described as the "worst headache imaginable." SAH-associated headache can persist for days to weeks and is traditionally treated with narcotics. However, narcotics can have significant adverse effects. We hypothesize that gabapentin (GBP), a non-narcotic neuropathic pain medication, would be safe and tolerable and would reduce narcotic requirements after SAH.We retrospectively reviewed the clinical, radiographic, and laboratory data of SAH patients at the neuroscience intensive care unit at Mayo Clinic in Jacksonville, Florida, from January 2011 through February 2013. Headache intensity was quantified by a visual analog scale score. Total opioid use per day was tabulated using an intravenous morphine equivalents scale. Cerebrospinal fluid was also reviewed when available.There were 53 SAH patients who were treated with GBP along with other analgesics for headache. Among these SAH patients, 34 (64 %) were women, with a mean age of 54 years (SD 12.3). Severe headache was observed in all SAH patients. GBP dosing was rapidly escalated within days of SAH up to a median of 1,200 mg/day, with a range of 300 mg three times a day to 900 mg three times a day. Approximately 6 % of patients treated with GBP had nausea (95 % CI 1-16 %), and only one patient (1.8 %) had to discontinue GBP.GBP appears to be relatively safe and tolerable in SAH patients with headache and may be a useful narcotic-sparing agent to prevent narcotics-associated complications, such as gastrointestinal immobility, ileus, and constipation.