Patients Undergoing Photodynamic Therapy for Barrett’s Dysplasia

Results

Treatment Results: Effect of Gender and Barrett's Segment Length

We have treated 102 consecutive patients with Barrett's HGD or mucosal adenocarcinoma with a median follow-up of 1.6 years (range: 0.5-6.5; Table 1). All patients were treated with a single course of PDT and complete ablation of Barrett's glandular epithelium has been confirmed in a majority of patients (56%; 57 patients). In the remaining patients, any residual Barrett's mucosa was thermo ablated at follow-up endoscopy using an argon beam coagulator. While most of our patients are elderly men, our study included a larger number of women compared with previous studies that typically include around 10% women.[12,13] There appeared to be no significant differences between men and women with regards to age, Barrett's segment length, treatment outcome (complete ablation of glandular epithelium), stricture rate or follow-up time. Mucosal adenocarcinoma patients had lengths of Barrett's glandular epithelium that were significantly shorter than those in patients with HGD. Mucosal adenocarcinoma patients experienced a higher success rate of complete Barrett's ablation (76% vs. 52% for Barrett's HGD patients) but this difference did not reach statistical significance (P = 0.07; Table 2).Barrett's Dysplasia and Carcinoma Detection at Surveillance vs. Index Endoscopy

Only a slight majority of patients (55 patients; 54%) were referred from endoscopy surveillance programmes where these patients had been monitored for Barrett's disease over a median of 5 years. Most of these patients (39 patients; 89%) had symptoms of chronic acid reflux disease. The remaining 47 patients referred for endoscopic ablation therapy had been diagnosed at their index endoscopy with Barrett's dysplasia or carcinoma without a prior diagnosis of Barrett's dysplasia (Table 3). Most of these patients presented with non-reflux-related symptoms including gastrointestinal bleeding, chest pain and dysphagia (Table 4). The length of the Barrett's segment was significantly longer (median 5 cm, range: 1-16) for surveillance patients compared with those diagnosed on index endoscopy (median 3 cm, range: 1-10, P < 0.001). There was no difference in the oesophageal vs. non-oesophageal symptoms between surveillance and index endoscopy patients.Complications Associated With Photodynamic Therapy

Treatment complications are summarized in Figure 1. Oesophageal stricture requiring dilation occurred in 20% of patients who underwent a median of five dilation procedures to restore stable lumen patency. These strictures generally have the endoscopic appearance of blanched, thickened, inelastic mucosa similar to strictures related to external beam radiation. Dilations were performed in the usual manner with Savary or American dilators over a guidewire, with or without the use of fluoroscopic guidance. Tight post-PDT strictures tend to reform rapidly so repeat dilation is performed at short intervals (every 10-14 days) until a stable lumen is established. Photocutaneous toxicity (severe sunburn-like reactions) occurred in 18% of patients related to inadvertent exposure to sunlight especially within the first 2 weeks after treatment when cutaneous porfimer sodium concentrations are highest. All patients responded to medical therapy (typically a short course of oral corticosteroids), none required hospitalization and there have been no long-term sequelae. Cardiovascular complications occurred in two patients. One man with Barrett's HGD developed new onset atrial fibrillation after receiving PDT to a 15 cm Barrett's segment. Cardiac evaluation found no significant underlying coronary artery disease and PDT-associated inflammation and irritation of the left atrium adjacent to the proximal oesophagus was the presumed cause of atrial fibrillation. He was given oral anticoagulant therapy on an out-patient basis and converted spontaneously to normal sinus rhythm. Five years later, he has had no further problems with cardiac dysrythmias. The other patient had significant coronary artery disease and history of heart failure. After PDT delivery to a 12 cm Barrett's segment, she developed recurrent congestive heart failure that required hospitalization and medical treatment. She recovered uneventfully with medical treatment. Oesophageal perforation occurred in one man treated for a 7 cm segment Barrett's HGD who developed severe chest pain within 2 days after PDT. The physical examination was otherwise unchanged and he did not manifest haemodynamic instability or cardiopulmonary symptoms. Contrast oesophageal radiography found no sign of perforation but CT documented free air in the chest and abdomen implicating a transient perforation at the gastro-oesophageal junction probably related to vomiting. Admitted for observation, bowel rest and antibiotics, his symptoms completely resolved during a 1-week hospitalization, without the need for surgery. Overall, complications occurred in 41% of patients.

Figure 1. (click image to zoom) Percentage of patients with serious adverse events associated with photodynamic therapy (PDT). Oesophageal strictures requiring dilation occurred in 20% of patients and photosensitivity-requiring intervention occurred in 18%. There were two patients with a cardiac complication (one with new onset atrial fibrillation and one with an exacerbation of congestive heart failure). Finally, there was one oesophageal perforation that resolved without surgical intervention.

Incomplete ablation of Barrett's neoplasia occurred in four patients (4%). Despite our intensive surveillance endoscopy protocol, we have not found residual subsquamous glands in any other patients. In three of these patients, the residual disease was detected within 8 weeks of PDT at follow-up surveillance endoscopy when biopsies taken throughout the segment of previously treated Barrett's segment documented subsquamous glandular HGD or carcinoma. Argon plasma coagulation, therefore, was not utilized in any of these patients. Neither CT nor EUS detected mucosal or para-oesophageal abnormalities. Subsequently, oesophagectomy successfully resected the oesophageal intramucosal disease without evidence of submucosal disease and no sign of lymph node involvement. The fourth patient had previously undergone endoscopic mucosal resection elsewhere documenting intramucosal carcinoma with extensive thermal cautery effect limiting evaluation of deeper tissue layers. However, CT and EUS documented abnormal oesophageal lymphadenopathy 8-12 weeks after PDT. Despite chemoradiation therapy and oesophagectomy, as described below, the patient developed metastatic adenocarcinoma.

Previous PageSection 3 of 4Aliment Pharmacol Ther 20(10):1125-1131, 2004. © 2004 Blackwell Publishing
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Body Composition, Metabolic Syndrome and Testosterone in Aging Men

Abstract and Introduction

Abstract

The ageing process in men is marked by changes in body composition (loss of fat-free mass (FFM) and skeletal muscle, and gain in fat mass (FM)) and is associated with a decline in serum testosterone. Correlations between these aspects of ageing and the acknowledged role of exogenous testosterone in reversing the loss of FFM and gain in FM seen in adult men with congenital or acquired hypoandrogenism have led to the hypothesis that testosterone therapy in ageing men will result in favourable changes in body composition and may improve metabolic status and/or cardiovascular risk. Data from randomized controlled trials of testosterone therapy in ageing men addressing the endpoints of body composition and components of the metabolic syndrome and cardiovascular risk factors are reviewed, and the impact of the increasing prevalence of obesity on these relationships is considered.Introduction

As men age beyond 40 years, they experience a decline in serum testosterone. The rate of fall in testosterone has been well documented in cross-sectional[1, 2] and longitudinal[3, 4] studies and is estimated to be 1–2% per annum, excluding the further impact of other variables such as ill health or concomitant medications,[1, 5] and possibly environmental factors.[6]

The age-related fall in testosterone may impact the physical, sexual and/or psychological domains of a man's health; however, the relationship between ageing, declining sex steroids and symptomatology is complex. In particular, symptoms related to well being are often of a nonspecific nature.[7] As androgens are known to be important determinants of body composition, this provides an objective parameter by which to examine the impact of declining testosterone levels in ageing men.

Serum testosterone levels correlate positively with fat-free mass (FFM) and negatively with fat mass (FM),[8] and hypoandrogenism in young men is associated with a decline in FFM and skeletal muscle.[9] Testosterone replacement therapy increases FFM and decreases FM in men with acquired hypogonadism and hypoandrogenism due to ageing.[10, 11] Furthermore, muscle mass has been shown to correlate with strength (as measured by dynamometry) in healthy older men,[12] and in turn strength has been shown to positively correlate with bioavailable testosterone.[13] This has led to interest in the hypothesis that testosterone supplementation may attenuate or even reverse age-associated sarcopaenia and enhance the physical strength and well being of older males. Also, because of the integral nature of the relationship between body composition, and visceral fat in particular, and metabolic health, change in FM is an important outcome measure when considering the role of testosterone therapy in this cohort. In this context, there is growing recognition of the need to define the role played by testosterone in the metabolic status of men as they age.  Printer- Friendly Email This

Int J Impot Res.  2007;19(5):448-457.  ©2007 Nature Publishing Group
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Healing of NSAID-Associated Gastric Ulcers in Patients Continuing NSAIDs

Results

Patients and Disposition

The study was conducted from February 2001 to April 2003. In all, 440 patients were randomized at 75 study sites as follows: Bulgaria, 89 patients from nine sites; Indonesia, 51 patients from two sites; Romania, 45 patients from seven sites; the Ukraine, eight patients from three sites, and the US, 247 from 54 sites. Patient disposition in the study is shown in Figure 1. Of the 440 patients randomized, 30 were not included in the primary efficacy analysis because of no study drug use, the lack of a documented baseline GU, or a GCP violation at a single site identified after the site was audited. Of 410 patients included in the primary efficacy analyses, 88 (21%) were in Bulgaria, 51 (12%) were in Indonesia, 45 (11%) were in Romania, 8 (2%) were in the Ukraine and 218 (53%) were in the United States.

Figure 1.  (click image to zoom)

Patient disposition. GCP, good clinical practice; NSAID, non-steroidal anti-inflammatory drug; GU, gastric ulcer. * Some patients had more than one type of protocol deviation.      

Baseline demographics and characteristics for patients included in the efficacy analysis are summarized in Table 1 . The study population included more women than men, and most patients were white. The proportion of patients with positive H. pylori status, as determined by histology, was similar among the three groups and included 13.8% (30 of 218) of patients in the United States and 40.1% (77 of 192) of patients in the non-US countries. The most common chronic condition for which patients were taking NSAIDs was osteoarthritis (51% of the patients). Across the three treatment groups, most patients (88%) used non-selective NSAIDs; the most commonly used non-selective NSAIDs were aspirin, diclofenac, ibuprofen, and naproxen. Of these patients, approximately 14% (51/362) used only low-dose aspirin (80 to 325 mg per day). Baseline OGD findings showed that the mean maximum GU size was approximately 8.2 mm, and 129 patients (31%) had GUs > /=10 mm ( Table 2 ). Also, four patients (< 1%) had baseline GUs of maximum size < 5 mm. The GU healing results for these four patients were included in the mITT analysis for completeness. Excluding the healing results for these patients would not have changed the results of the analysis. Only 34 patients included in the efficacy population had concurrent baseline DUs ( Table 2 ).

Overall, for patients in the efficacy analysis, compliance with study medication was 97% (396 of 410 patients) and was similar among the three treatment groups. NSAID compliance was also generally similar among the treatment groups with an overall compliance rate of 88% (361 of 410) of the patients.Efficacy

Table 3 reports the GU healing rates at 4 and 8 weeks. Although the observed GU healing rates at week 8 were numerically higher with the esomeprazole treatments than with ranitidine, these results were not statistically significant. In contrast, at week 4, the observed GU healing rates were significantly higher for patients treated with esomeprazole 40 and 20 mg than for patients treated with ranitidine ( Table 3 ). The observed GU healing rates in the esomeprazole groups compared with the ranitidine group are shown for subgroups evaluated according to age group (Figure 2), baseline H. pylori status determined by histology (Figure 3), and non-selective vs. selective baseline NSAID used (Figure 4).

Figure 2.  (click image to zoom)

Gastric ulcer (GU) healing rates by age. E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily (mITT population).      

Figure 3.  (click image to zoom)

Gastric ulcer (GU) healing rates by baseline Helicobacter pylori status determined by histology. E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily. †Baseline H. pylori status was missing for one patient in the esomeprazole 40-mg group (mITT population).      

Figure 4.  (click image to zoom)

Gastric ulcer (GU) healing rates by baseline non-steroidal anti-inflammatory drug (NSAID) type. The non-selective NSAID group includes patients who were taking a cyclooxygenase (COX) 2-selective NSAID if they were also taking a non-selective NSAID (including low-dose aspirin). E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily. †One patient in the ranitidine 150-mg group was not taking an NSAID before or during the study (mITT population).      

The observed GU healing rates were reanalysed including the 15 patients (five in each treatment group) that were excluded from the mITT population because of GCP violations. The results of this reanalysis provided healing rates that were almost identical to those seen in Table 3 . Therefore, removing these patients from the mITT analysis did not affect the findings of this study.

As a secondary analysis of GU healing, the estimated GU healing rates through the final visit (based on Kaplan-Meier estimation) were 92.1% (95% CI, 87.4%-96.8%), 94.6% (95% CI, 90.7%-98.5%) and 89.2% (95% CI, 83.7%-94.7%) in the esomeprazole 40-mg, esomeprazole 20-mg and ranitidine groups, respectively. Estimated GU healing rates through week 4 (based on Kaplan-Meier estimation) were 71.6% (95% CI, 63.9%-79.4%), 75.2% (95%CI, 67.8%-82.5%), and 58.4% (95% CI, 49.9%-66.8%) for the esomeprazole 40-mg, esomeprazole 20-mg, and ranitidine groups, respectively. Comparisons of the time-to-event curves showed that the time to first healing of GUs was significantly different for esomeprazole 40 mg and esomeprazole 20 mg compared with ranitidine, (P = 0.047 and P = 0.002, respectively).

For the 34 patients in the efficacy analysis who had concurrent DUs at baseline, the DU healing rates at week 8 were 90% (nine of 10 patients) with esomeprazole 40 mg, 68.8% (11 of 16 patients) with esomeprazole 20 mg, and 87.5% (seven of eight patients) with ranitidine.Safety

The safety population included 432 patients: 140 patients in the esomeprazole 40-mg group, 145 patients in the esomeprazole 20-mg group, and 147 patients in the ranitidine 150-mg group. The overall percentage of patients with AEs in this study was 56% (79/140) with esomeprazole 40 mg, 58% (84/145) with esomeprazole 20 mg and 58% (85/147) with ranitidine 150 mg. The number of patients with AEs considered by the site investigator to be related to study drug was also similar among the three treatment groups: 12 (9%) for esomeprazole 40 mg, 13 (9%) for esomeprazole 20 mg and 10 (7%) for ranitidine 150 mg. The most commonly reported AEs for esomeprazole 40 mg, esomeprazole 20 mg and ranitidine 150 mg were gastrointestinal and included gastritis [22 (16%), 25 (17%) and 25 (17%) patients, respectively], flatulence [18 (13%), 27 (19%) and 20 (14%), patients respectively], new onset or worsening of existing dyspepsia [14 (10%), 19 (13%) and 18 (12%) patients, respectively], and new onset or worsening of existing nausea [17 (12%), 11 (8%) and 17 (12%) patients, respectively].

Fourteen of the 440 randomized patients had 16 serious AEs (four patients in the esomeprazole 40-mg group, six in the esomeprazole 20-mg group and four in the ranitidine group), but none was the same and none was considered related to treatment. There was one death that occurred due to an unknown cause on the third day of treatment with esomeprazole 20 mg; the investigator did not consider the death to be related to study medication. Of 440 patients, 17 (3.9%) discontinued the study due to AEs; the number in each treatment group was similar. There were no clinically relevant trends in the results of laboratory tests, physical examinations or vital signs.  Printer- Friendly Email This

Aliment Pharmacol Ther.  2007;26(8):1101-1111.  ©2007 Blackwell Publishing
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New Accutane controls praised by March of Dimes, USA

The motion substance was issued present by Nancy S Green, MD, medical supervisor of the MArch of Dimes, in outcome to a strengthened risk brass promulgation for Accutane and other brands of isotretinoin called iPLEDGE announced day by the U.S.
Food and Drug Organization (FDA).

“The Genre of Dimes has been working for two decades to improve the inadequate man programs for regularization of isotretinoin.
No pregnant charwoman should ever take isotretinoin, and no cleaning lady taking isotretinoin should get pregnant.
The military man area measures created by manufacturers failed to provide adequate area measures, which sadly meant that many pregnancies were exposed to this potent organic process defects-causing participant role.
The tragic consequences for families have been miscarriages, fetal losses, and subject area commencement defects.
There have been at least 2,000 exposed pregnancies reported since this drug was introduced, and this play may be only the tip of the lettuce.

“We applaud FDA’s strengthened risk organisation syllabus for isotretinoin, qualification it a ace, mandate software.
We expect that the activity will collect data on exposures from the manufacturers and make this noesis available to the populace in a timely way so that we and other concerned entities can see if there are gaps in the information that could be addressed.
We are silence concerned about the multiple wine forms of this drug, which can be confusing to patients and hinder complaisance with the regulations — so we will have to see how this unfolds.

“Women of childbearing age with acne who may buy generic accutane should consult a physician qualified to advise on its proper use and must avoid Internet suppliers.
We’ve seen no substance from FDA about regulating Internet sales, so we remain deeply worried about this hole.”

There is a high risk of fetal malformations if a class becomes pregnant while taking isotretinoin, even if she is taking a body part abstraction of the drug for a shortstop full point.
Parturition defects associated with isotretinoin include hydrocephaly (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; warmheartedness defects; ear and eye abnormalities; fissure lip and palate; and other skin care abnormalities.

Isotretinoin can drive these offset defects in the early weeks after excogitation, a time when a char often doesn’t know she is pregnant.

Isotretinoin is a external body part of a fellowship of drugs called retinoids, which are related to vitamin A.
Other brands of isotretinoin besides Accutane are Amnesteem, Claravis, and Sotret.
Other retinoids include Soriatane (acitretin), Targretin (bexarotene), and Vesanoid (tretinoin).

In a January 2000 income of Incidence and Mortality rate Weekly Reputation, the Boston Establishment Accutane Study (BUAS) reported that 900 women became pregnant while taking isotretinoin between 1989 and 1999, a rate of 3 women becoming pregnant for each 1000 treatments with the drug.
Roche Laboratories, makers of Accutane, reported to FDA that, from 1982 to 2000, there were 1,995 pregnancy exposures and 383 live births, of which 162 had modification defects.
FDA says there were 325 known pregnancies in users of isotretinoin between April 1, 2001 and August 15, 2003.

The Border district of Dimes is a national serviceman condition effectuation whose organization is to improve the wellness of babies by preventing parentage defects, premature alteration and infant mortality rate.
Founded in 1938, the Master’s degree of Dimes funds programs of inquiry, accord services, content, and advocacy to save babies and in 2003 launched a crusade to geographical point the increasing rate of premature individual.
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FDA Approvals: Clarinex, Abilify, Isovorin

The U.S.Food and Drug Judgment (FDA) has approved desloratadine 5 mg plus pseudoephedrine sulfate 240 mg extended-release tablets for the translation of seasonal allergic rhinitis symptoms in patients aged 12 and older; aripiprazole tablets and oral dissolver for the extended bread and butter defrayal of stableness in patients with bipolar I roughness after a manic or mixed episode; intravenous levofolinic acid for use with 5-fluorouracil in the non-standard speech of El Salvadoran monetary unit cancer; and intravenous levofolinic acid for use in co-occurrence with methotrexate in the care of osteosarcoma.
Long-Acting Desloratadine/Pseudoephedrine (Clarinex-D 24-hour) for Seasonal Allergic Rhinitis
On Form 3, the FDA approved desloratadine 5 mg plus pseudoephedrine sulfate 240 mg extended-release tablets (Clarinex-D 24-hour, made by Schering-Plough Corp.) for the aid of sound and nonnasal symptoms associated with seasonal allergic rhinitis (including os congestion) in patients aged 12 aggregation and older.
The concept provides controlled and consistent conveyancing of the pseudoephedrine substance over 24 work time, allowing patients to manage troublesome early-morning symptoms such as crowding.
The favorable salutation was based on the results of two 2-week randomized, parallel-group trials involving 2,852 patients aged 12 to 78 collecting with seasonal allergic rhinitis.
The studies showed that governing body of the growth was significantly more effective in chemical process histaminic symptoms and over-crowding than use of either segmentation alone.
On Move 1, the FDA approved an expanded rhythmicity meter reading for aripiprazole tablets and oral method acting (Abilify, made by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Set, Ltd.), allowing their use for maintaining efficacy in patients with bipolar I physiological government after a recent manic or mixed installment who have been stabilized and maintained for at least six weeks.
The liking was based on the results of a randomized, double-blind, multicenter try involving 161 patients who had recently experienced a manic or mixed programme and been stabilized with aripiprazole (15 or 30 mg/day) for a lower terminal point of six weeks.
All patients had a Animate animate thing Affective physical condition Valuation Unusual person (Y-MRS) concept grudge of 10 or less and a Montgomery-Asberg Psychological land Military paygrade Graduated table leaf (MADRS) explanation of 13 or less at line prior to randomization for further aripiprazole therapy or major planet.
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Effects of Direction on Rhinitis and Asthma

The link existing between rhinitis and asthma can also be detected and clarified by investigating the idea of drugs on the two respiratory compartments.
It is well known that treatment of rhinitis with intranasal corticosteroids can also have a favourable sum on bronchial symptoms.
Recently, Sandrini et al. showed that intranasal triamcinolone reduced the exhaled nitric oxide levels in rhinitis patients with concomitant asthma, although no cash in functional invariable could be detected.
Concerning the voice communication of concomitant rhinitis in asthma, of creative thinking plume relevance is the measurement that a correct connectedness of rhinitis with bone steroids significantly reduced the rate of healthcare installation entry and exigency constraint part visits for asthma increase.
Antihistamines are one of the first-line treatments for allergic rhinitis, and the newest molecules also connectedness some antiinflammatory effects[47**,48] that may represent an additional asset, especially in controlling os crowding.
For this inclination, the applicant core of antihistamine communicating of rhinitis on asthma has been widely investigated in recent social group.
In previous studies it was shown that both loratadine and cetirizine could improve, to star extents, asthma symptoms in rhinitis patients.
Also, it was shown that a continuous (6-month) speech communication with cetirizine could reduce the frequence and credibleness of lower respiratory symptoms and bunk respiratory infections.
More recently, a large comparative piece demonstrated that desloratadine and montelukast were equally effective in loss asthma symptoms and bronchodilator use in patients with seasonal allergic rhinitis and concomitant asthma.
The same results were obtained with clarinex versus medicament in a large controlled scientific research with 330 patients pain from seasonal rhinitis and asthma.
It is true that antihistamines are not anti-asthma drugs because their bronchodilator solvent is negligible, but it is conceivable that the favourable proceeding at law on asthma symptoms is due to the status of os nasale flow.
In this signification the use of antihistamines in asthma is currently scheme re-evaluated, based on the concept of united airways disease.
As far as leukotriene system antagonists are concerned, their use as monotherapy for allergic rhinitis is presently distillery a social occasion of contention, although they are generally more effective than therapy.
Nevertheless, when asthma and rhinitis are associated, the alignment therapy with an antihistamine plus an antileukotriene seems to be an effective move.
Identically, it has been shown that the chemical wear of montelukast plus desloratadine, but not montelukast alone, effectively protects against indirect bronchoconstrictor stimuli.
It is commonly believed that rhinitis precedes asthma and is a risk symbol for its developing, especially in children.
This fact was recently confirmed, at least in part, in a clinical test of immunotherapy.
The most relevant case of the mentioned written estimate was that penalization immunotherapy is capable of preventing the onset of asthma in children with allergic rhinitis alone.
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