Endoscopic and histological verification of upper GI tract side effects after long-term therapy with alendronate and strontium ranelate Endoskopowa i histopatologiczna weryfikacja objawów niepo¿¹danych ze strony górnego odcinka przewodu pokarmowego po leczeniu alendronianem oraz ranelinianem strontu (original) (raw)
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Indian Journal of Medical Sciences, 2011
BACKGROUND: Osteoporosis is defined as a reduction of bone density or the presence of a fragility fracture. One class of new antiosteoporotic drugs is the bisphosphonates. Oral bisphosphonates seems to induce serious gastrointestinal (GI) side effects in some patients. The aim of the study is to comparison the GI symptoms of Alendronate daily 10mg versus weekly 70mg administration in osteoporotic patients during 8 weeks. MATERIALS AND METHODS: This is a clinical trial study that was conducted in the
World Journal of Gastroenterology, 2006
AIM: To assess the efficacy and safety of a compound containing alginic acid plus antacid (Topaal ®) compared to equal-strength antacid (Nacid ®) in patients with endoscopy-negative reflux disease (ENRD). METHODS: A total of 121 patients with ENRD were randomized to receive Topaal ® (65 patients) or Nacid ® (56 patients) for 6 weeks, with a consultation every 3 weeks. The primary end-point assessment was the change in the severity of heartburn as evaluated using a visual analog scale (VAS) at 6 weeks. The secondary end-point assessments were the VAS at 3 weeks, the change of frequency of the reflux symptom, the change of quality of life and the adverse effects. RESULTS: Demographics of randomized subjects in each treatment group were comparable except that the Topaal ® group included more males. The baseline characteristics between the groups were similar. After 6 weeks of treatment, the reduction of VAS of heartburn was more prominent in the Topaal ® group (-6.29 cm vs-4.11 cm). At the 3 rd week, Topaal ® group showed greater reduction of VAS for heartburn (P = 0.0016), regurgitation (P = 0.0006), vomiting (P = 0.0373), and belching (P <0.0001). The patients of the Topaal ® group had lower frequency of heartburn (P = 0.0015) and pain (P = 0.0163) at the end of the 6-week treatment period. From the doctor's point of view, the Topaal ® group also showed significant reduction in the severity of heartburn (P = 0.0020), regurgitation (P = 0.0081), vomiting (P = 0.0182), and belching (P = 0.0018) at the end of the treatment. The improvement of the quality of life was more remarkable in the Topaal ® group at the end of the 6-week treatment period (P < 0.0001). For the adverse effect, there was no difference in both the groups. CONCLUSION: Topaal ® is more effective than Nacid ® for the treatment of symptoms presented by patients with ENRD.
Esophageal and gastric cancer incidence and mortality in alendronate users
Journal of Bone and Mineral Research, 2012
Recent studies have reached conflicting conclusions regarding the risk of esophageal cancer with oral bisphosphonates. Prior studies did not record the number of cancer deaths or endoscopy rates, which could be higher in bisphosphonate users and lead to more cancers being diagnosed at a stage when their esophageal or gastric location could be accurately distinguished. We conducted a register-based, open cohort study using national healthcare data for Denmark. Upper endoscopy frequency, cancer incidence and mortality was examined in 30,606 alendronate users (female, age 50þ) and 122,424 matched controls. Primary outcomes were esophageal cancer incidence and death because of esophageal cancer. The analysis showed that alendronate users were more likely to have undergone recent upper endoscopy (4.1 versus 1.7%, p < 0.001). Alendronate users had a lower risk of incident gastric cancer [odds ratio (OR) 0.61; 95% confidence interval (CI): 0.39-0.97) and no increased risk of esophageal cancer (OR 0.71; 95% CI: 0.43-1.19). Risk reductions were greater in users with 10þ prescriptions. The risk of dying of esophageal cancer was significantly reduced in alendronate users after 3 years OR 0.45 (95% CI: 0.22-0.92) but not after 9 years (OR 1.01; 95% CI: 0.52-1.95). An additional comparison with etidronate users revealed no statistically significant difference in outcomes. In conclusion, we found no excess in esophageal cancer deaths or incidence. The early decrease in esophageal cancer rates may relate to the greater use of endoscopy before starting alendronate. Longer term observations also indicated no excess risk of esophageal cancer death and a significantly decreased risk of gastric cancer death.
2007
Giriş: İnsanların üçte biri karnın üst bölgesinde tekrarlayan ağrılardan yakınırlar ve bu hastaların çoğunda altta yatan olası patoloji iritabl bağırsak sendromu’dur (İBS). Gereç ve Yöntem: Acil servise üst abdomen ağrısı nedeniyle başvuran tüm hastalar ardışık olarak çalışmaya alındı. İB S, olası hayatı tehdit edebilecek karın ağrısı nedeni ile başvuran hastalar hariç Rome II kriterlerine göre koyuldu. Üst abdomen ağrısı diğer nedenleride saptandıktan sonra, sonuçlar İBS olan ve olmayan hastalar arasında karşılaştırıldı. Bulgular: Çalışmaya İBS tanısı koyulan 120 hasta ile konulmayan 138 hasta alındı. İBS tanısı konulan hastaların %61.6’sı (n=74), ‹BS tanısı koyulmayan hastaların ise %42’si (n=58) kadındı (p<0.001). Kronik gastrit ‹BS grubunun %72.5’inde (n=87), saptanmayan hastalarınsa %36.2’sinde (n=50) mevcuttu (p<0.001). Benzer olarak hem hemoroid prevalansı (%33.3, n=40 vs %15.2, n=21; p<0.001) hem de ürolithiyazis prevalansı (%17.5, n=21 vs %11.5, n=16; p<0.005) ‹...
Ischemic colitis during treatment with alosetron
Gastroenterology, 2001
Irritable bowel syndrome (IBS) is one of the most common entities observed by both primary care physicians and gastroenterologists. Alosetron is a potent and selective serotonin antagonist that recently became the first Food and Drug Administration–approved agent for diarrhea-predominant IBS. However, since approval, significant side effects have been noted with the use of alosetron including severe constipation, fecal impaction, and ischemic colitis. We describe a case of ischemic colitis in a male patient with IBS who was briefly treated with alosetron. Clinical, endoscopic, and pathologic features of the focal colitis strongly suggested ischemia. Symptoms correlated temporally with alosetron use, and symptoms abated with discontinuation of the drug. Endoscopic and pathologic resolution of the colitis were documented.GASTROENTEROLOGY 2001;120:557-560
Gastrointestinal side-effects of alendronate (ALN) are believed to be associated with oesophageal lodging of tablets and perhaps reflux of gastric contents with alendronate under strongly acidic pH conditions. This leads to unfavourable posture restrictions when dosing. This clinical study evaluated gastric emptying and gastric pH after administration of Fosamax ® tablets and a novel effervescent ALN formulation with a high buffering capacity. This novel formulation, EX101, was developed to potentially improve gastric tolerance. Gastric pH was monitored by nasogastric probes. Gastric emptying was determined simultaneously by scintigraphic imaging of 99m Tc-DTPA labelled formulations. Both formulations tested rapidly cleared the oesophagus and there were no statistically significant or physiologically relevant differences in gastric emptying times. Mean pH at time to 50% gastric emptying of the radiolabel was significantly higher in EX101-treated subjects compared to those treated with Fosamax ®. At time to 90% gastric emptying of the radiolabel, mean pH values were comparable. Mucosal exposure to ALN at pH less than 3 is irritating to gastro-oesophageal tissue. Ingestion of Fosamax ® resulted in ALN being present in the stomach at a pH below 3 within minutes. EX101 minimised the possibility of exposing the oesophagus (in case of reflux) to acidified ALN.
The American Journal of Gastroenterology, 2001
Alosetron (Lotronex) is a new therapeutic agent for irritable bowel syndrome (IBS) in women with diarrhea-predominant IBS. This multicenter randomized, double-blind, placebo-controlled study assessed the safety and tolerability of alosetron during long-term (< or = 12 months) treatment. A total of 859 subjects (637 female and 222 male) with IBS were enrolled from 130 sites in the United States and were randomized 3:1 to receive 1 mg alosetron or placebo b.i.d. for 48 wk; of the subjects, 649 (76%) were randomized to the alosetron group and 212 (24%) to the placebo group. Of the original group, 850 subjects received at least one dose of alosetron (n = 640) or placebo (n = 210). In all, 59% of the subjects completed the study. Safety data were similar in treatment groups and within age, sex, racial origin, and hormone use. Adverse events were reported by 83% (530/640) and 76% (159/210) of subjects in the alosetron and placebo groups, respectively, (p < 0.05) and were similar with the exception of constipation; 32% of subjects receiving alosetron reported constipation, compared to 5% in the placebo group (p < 0.001). Most reports (72%) of constipation were of mild or moderate severity, and 66% of subjects with constipation had single episode of 8 days median duration. Constipation occurred a median of 13 days after initiating treatment and resolved spontaneously, with laxative, or after a brief interruption of therapy. Of the subjects, 4% (11/210) in the alosetron and 5% (28/ 640) in the placebo group experienced serious adverse events. Two deaths occurred in subjects with pre-existing cardiovascular risk factors; neither death was attributed to the study drug. Alosetron 1 mg b.i.d. for 12 months was well tolerated. Constipation is the most frequent adverse event, with a higher incidence of transient constipation in alosetron-treated patients, typically occurring in the first month of treatment.
Evaluation of Protective Effect of Methyl Sulfonyl Methane on Colon Ulcer Induced by Alendronate
Journal of Pharmacy and Nutrition Sciences
Background: Bisphosphonates represent a new class of drugs that have shown very promising therapeutic efficacy in the treatment of a number of diseases associated with abnormally accelerated bone resorption including osteoporosis, Paget's disease, and hypercalcemia of malignancy. As an increasing number of these drugs become available for clinical use in the treatment of the millions of individuals with these skeletal diseases, evidence is becoming available that their chronic usage may be associated with a number of gastrointestinal side effects, such as diarrhea, abdominal pain and inflammation, and erosions and ulceration of the upper gastrointestinal tract. Methyl sulfonyl methane (MSM) which is used for osteoarthritis was used to prevent bisphosphonates ulceration. Our objective was to study the preventive effect of MSM against colon ulcer induced by Alendronate (ALN) in rats. The experiments had been done on 8 white wistar rats for each group. The gastric ulcer has been induced by administration of Alendronate (20mg/kg/day) by gavage for 4 days. MSM (400mg/kg/day) has been given for the protective group for 4 days before administration of Alendronate. The ulcers in rats' colon were examined histologically and microscopically. The results showed that administration of MSM before Alendronate inducing ulcer led to a reduction in ulceration and showed significant difference comparing with morbidity group. Conclusion: MSM (400 mg/kg/day) has protective effect of colon ulcer induced by alendronate.
Gastrik mukozadaki diffüz makroskopik değişiklikler gastrit olarak yorumlanır. Makroskopik değerlendirmeler ile Helikobakter pilori (Hp) kaynaklı ve diğer nedenli gastritlerin ayırımını endoskopik olarak yapmak konusunda yeterli bilgi olmayıp bu konuda belirli bir konsensus sağlanamamıştır. Hp enfeksiyonu tüm dünyada görülmekle birlikte aynı ülkedeki farklı populasyon gruplarında farklı oranlara sahiptir (1). Dünya nüfusunun yaklaşık olarak %60'ının bu bakteri ile enfekte olduğu düşünülmektedir. Bu mikroorganiz-mayı taşıyanların %100'e yakınında gastrit gelişirken, ömür boyu peptik ülser olma riski ise %15-20'dir (2). Hp veya diğer nedenli gastritlerin tanısında sadece endoskopik inceleme ile biyopsiye gerek kalmadan bir hastada gastritin varlığını ve nedenini belirlemek daha pratik ve ekonomik bir yöntem olacaktır. Ülkemizde bu amaçla yapılan her endoskopik işlemde kesin tanı sağlanması amacıyla biyopsi işleminin yapılamadığı dikkate alındığında, endoskopik olarak yapılan tanımlamanın ne