Albendazole: a review of anthelmintic efficacy and safety in humans

Parasitology ◽  
2000 ◽  
Vol 121 (S1) ◽  
pp. S113-S132 ◽  
Author(s):  
J. HORTON

This comprehensive review briefly describes the history and pharmacology of albendazole as an anthelminthic drug and presents detailed summaries of the efficacy and safety of albendazole's use as an anthelminthic in humans. Cure rates and % egg reduction rates are presented from studies published through March 1998 both for the recommended single dose of 400mg for hookworm (separately for Necator americanus and Ancylostoma duodenale when possible), Ascaris lumbricoides, Trichuris trichiura, and Enterobius vermicularis and, in separate tables, for doses other than a single dose of 400mg. Overall cure rates are also presented separately for studies involving only children 2–15 years. Similar tables are also provided for the recommended dose of 400mg per day for 3 days in Strongyloides stercoralis, Taenia spp. and Hymenolepis nana infections and separately for other dose regimens. The remarkable safety record involving more than several hundred million patient exposures over a 20 year period is also documented, both with data on adverse experiences occurring in clinical trials and with those in the published literature and/or spontaneously reported to the company. The incidence of side effects reported in the published literature is very low, with only gastrointestinal side effects occurring with an overall frequency of just >1%. Albendazole's unique broad-spectrum activity is exemplified in the overall cure rates calculated from studies employing the recommended doses for hookworm (78% in 68 studies: 92% for A. duodenale in 23 studies and 75% for N. americanus in 30 studies), A. lumbricoides (95% in 64 studies), T. trichiura (48% in 57 studies), E. vermicularis (98% in 27 studies), S. stercoralis (62% in 19 studies), H. nana (68% in 11 studies), and Taenia spp. (85% in 7 studies). The facts that albendazole is safe and easy to administer, both in treatment of individuals and in treatment of whole communities where it has been given by paramedical and nonmedical personnel, have enabled its use to improve general community health, including the improved nutrition and development of children.

2005 ◽  
Vol 133 (2) ◽  
pp. 194-200 ◽  
Author(s):  
John J. Murray ◽  
Paz Emparanza ◽  
Eugenijus Lesinskas ◽  
Margaret Tawadrous ◽  
Jeanne D. Breen

Objective To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). Study Design and Setting An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients ≥18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). Results Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. Conclusions Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. Significance A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.


1995 ◽  
Vol 3 (6) ◽  
pp. 241-244 ◽  
Author(s):  
Marc F. Rosenn ◽  
George A. Macones ◽  
Neil S. Silverman

Objective:The purpose of this study was to compare erythromycin and azithromycin in the treatment of chlamydial cervicitis during pregnancy with regard to efficacy, side effects, and compliance.Methods:In a prospective manner, 48 pregnant patients with cervical chlamydial infections diagnosed by routine screening tests were randomly assigned to receive either erythromycin, 500 mg q.i.d. for 7 days (N = 24), or azithromycin, 1 g as a one-time dose (N = 24). All sexual partners were given prescriptions for doxycycline, 100 mg b.i.d. for 7 days. The treatment efficacy was assessed by follow-up chlamydia testing 3 weeks after the therapy was completed. The side effects, intolerance to therapy, and overall compliance were evaluated by means of a standardized posttreatment questionnaire.Results:There was no significant difference in cure rates noted between the erythromycin group and the azithromycin group (77% vs. 91%, respectively;P= 0.24). Gastrointestinal side effects were reported more frequently among patients treated with erythromycin compared with patients treated with azithromycin (45% vs. 17%, respectively;P= 0.004). The patients who received erythromycin reported intolerance to therapy secondary to side effects more frequently than patients who received azithromycin (23% vs. 4%, respectively;P= 0.07). Furthermore, the patients in the azithromycin group were more likely to complete their course of therapy as prescribed than the patients in the erythromycin group (100% vs. 61%, respectively;P= 0.002).Conclusions:Azithromycin is efficacious and well tolerated for the treatment of chlamydial cervicitis in pregnancy. Erythromycin, though efficacious, is poorly tolerated, as demonstrated by the number of patients reporting significant side effects during the course of therapy. Since the cost of azithromycin is comparable to that of generic erythromycin, the present study supports the use of azithromycin as an alternative to erythromycin for the treatment of chlamydial cervicitis in pregnancy.


2020 ◽  
Vol 7 (1) ◽  
pp. e000484 ◽  
Author(s):  
Damian Bruce-Hickman ◽  
Shanaz Matthew Sajeed ◽  
Yin Huei Pang ◽  
Choon Sheong Seow ◽  
Weihao Chen ◽  
...  

Tocilizumab, a monoclonal antibody against interleukin-6, has been used to treat cytokine release syndrome (CRS) in a subset of patients with severe COVID-19 disease. Acute ulcerative bowel disease has been only rarely documented in patients treated for rheumatological conditions. The gastrointestinal side effects seen when used in the context of COVID-19 are unknown. We present a case of COVID-19 CRS in which acute terminal ileum and perforated caecal ulceration evolved after tocilizumab exposure. We raise awareness of a possible causal relationship between even a single dose of tocilizumab and gut ulceration in patients with COVID-19. Any such drug enteropathy relationship requires watchful monitoring during upcoming trials of tocilizumab in patients with COVID-19.


1994 ◽  
Vol 12 (12) ◽  
pp. 2756-2765 ◽  
Author(s):  
E Eisenberg ◽  
C S Berkey ◽  
D B Carr ◽  
F Mosteller ◽  
T C Chalmers

PURPOSE To assess the efficacy and safety of nonsteroidal antiinflammatory drugs (NSAIDs) in the treatment of cancer pain by meta-analyses of the published randomized control trials (RCTs). PATIENTS AND METHODS Twenty-five studies met inclusion criteria for analysis. Of these, 13 tested a single-dose effect, nine multiple-dose effects, and three both single- and multiple-dose effects of 16 different NSAIDs in a total of 1,545 patients. Baseline pain intensity (when provided) of moderate or higher was indicated in 81% of patients. RESULTS Single-dose NSAID studies found greater analgesic efficacy than placebo, with rough equivalence to 5 to 10 mg of intramuscular morphine. Pain scores differed insignificantly for aspirin versus three other NSAIDs. Analgesic responses to low- and high-dose NSAIDs suggested a dose-response relationship, but this was not statistically significant. Recommended and supramaximal single doses of three NSAIDs produced comparable changes in pain scores, which indicates a ceiling analgesic effect. Common side effects included upper gastrointestinal symptoms, dizziness, and drowsiness. The incidence of side effects showed a trend to increase with dose, without a ceiling effect, and to increase with multiple doses. Single or multiple doses of weak opioids (WO) alone or in combination (WO/C) with nonopioid analgesics did not produce greater analgesia than NSAIDs alone. Single doses of WO/C analgesics produced more side effects than NSAIDs alone, although both side effect incidence and patient dropout rates were equal when multiple doses were administered. CONCLUSION These findings question whether the traditional World Health Organization (WHO) second analgesic step (addition of a weak opioid when pain is inadequately treated by a nonopioid analgesic alone) is warranted. A lack of comparable studies precluded testing the hypothesis that NSAIDs are particularly effective for malignant bone pain.


2004 ◽  
Vol 5 (4) ◽  
pp. 243-250
Author(s):  
Lorenzo Pradelli ◽  
Mario Eandi

Tramadol is one of the preferred weak opioid agonists in the management of chronic pain, due to a good efficacy and safety profile, to a particularly low interference with cardiovascular and respiratory functions and a low dependence and abuse potential. The successful use of tramadol, nevertheless, is often limited by low patient compliance, a consequence of gastrointestinal side effects (mainly nausea and vomiting) and frequent dosing regimens, among other reasons. In this paper, clinical studies conducted on slow-release formulations of tramadol and other strategies for compliance improvement in various pain conditions are reviewed. From the examined literature, it appears that the strategy with the best compliance is the use of slow release (SR) formulations, which simplify dosing regimens and tend to have a somewhat better tolerability, and a slow dose escalation, which improves tolerability. The advantages of SR formulations have to be weighed against the superior acquisition cost and the slower onset of analgesia. A frame for the evaluation of the clinical and economical advantages and disadvantages of SR versus immediate release formulations of tramadol is also proposed.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Carlo Massimetti ◽  
David Micarelli ◽  
Sandro Feriozzi

Abstract Background and Aims Currently the therapeutic strategies most frequently used in the treatment of secondary hyperparathyroidism (SHPT) are represented by vitamin D receptors activators (VDRAs) and cinacalcet. However, both drugs have side effects that limit their use. Recently, in the treatment of SHPT has been introduced the etelcalcetide, a second generation calcimimetic given intravenously (i.v.). This new route of administration could improve adherence to therapy and reduce gastrointestinal side effects. The aim of the study was to evaluate the efficacy and safety of the etelcalcetide in hemodialysis (HD) patients with SHPT inadequately controlled with traditional therapy (cinacalcet and/or VDRAs), or who had side effects with cinacalcet, or that were not adherent to cinacalcet therapy. Method For this purpose we have selected 28 HD patients with inadequate control of SHPT (PTH > 500 pg / ml; range 502-2148 pg/ml). Serum albumin-corrected calcium (sCa), phosphate (P), calcium–phosphate product (Ca x P), and PTH were assessed monthly. Baseline 19 patients were taking stable doses of active vitamin D analogs and all patients were taking phosphate binders. Etelcalcetide was administered three times a week after each hemodialysis session. The starting dose was 2.5 or 5.0 mg and then adjusted between 2.5 and 10.0 mg according to sCa and PTH levels. Treatment was temporarily withheld for sCa <7.5 mg/dl, or symptomatic hypocalcemia and was subsequently resumed at a lower dose. The primary endpoint was a PTH reduction > 30% compared to baseline levels. Results At present 12 months have passed since the beginning of etelcalcetide therapy. In most patients PTH levels were reduced immediately after the start of therapy. After 12 months we observed a reduction > 30% in 82% of patients, meanly -54% with a range between – 22% and – 81%. On average PTH levels decreased from 1167±444 to 558±310 pg/ml (P<.001). Serum calcium significantly reduced already after one month of therapy settling on stable levels from the third month onward, sCa decreased from 9.7±0.4 to 9.2±0.5 mg/dl (P<.01). However, the percentage of patients treated with calcium salts rose from 21% at baseline to 44% at F-U, mean dose at F-U 1.8 ± 0.9 g/d, while the percent of patients treated with VDRAs increased from 68% to 91%. Serum phosphate decreased from 6.4±1.4 to 4.6±1.3 mg/dl (P<.001), Ca x P decreased from 60±13 to 42±12 mg2/dl2 (P<.001). The median average dose of etelcalcetide at F-U was 6.2 ± 1.7 mg/HD, with a range of 2.5-10.0 mg/HD. Throughout the study, the only side effect was asymptomatic hypocalcemia that required the use of calcium salts. There were no gastrointestinal adverse effects. Conclusion Our results confirm that in hemodialysis etelcalcetide therapy is effective and safe in the control of SHPT refractory to conventional therapy over a 1-year treatment period.


Author(s):  
S.K. Aggarwal ◽  
J. San Antonio

Cisplatin (cis-dichlorodiammineplatinum(II)) a potent antitumor agent is now available for the treatment of testicular and ovarian cancers. It is however, not free from its serious side effects including nephrotoxicity, gastro intestinal toxicity, myelosuppression, and ototoxicity. Here we now report that the drug produces peculiar bloating of the stomach in rats and induces acute ulceration.Wistar-derived rats weighing 200-250 g were administered cisplatin(9 mg/kg) ip as a single dose in 0.15 M NaCl. After 3 days the animals were sacrificed by decapitation. The stomachs were removed, the contents analyzed for pepsin and acidity. The inner surface was examined with a dissecting microscope after a moderate stretching for ulcers. Affected areas were fixed and processed for routine electron microscopy and enzyme cytochemistry.The drug treated animals kept on food and water consistently showed bloating and lesions (Fig. 1) with a frequency of 6-70 ulcers in the rumen section of the stomachs.


1979 ◽  
Author(s):  
F Albert ◽  
U Schmidt

The effect of sulfinpyrazone (200 mg three times a day) and acetylsalicylic acid (500 mg three times a day) on the incidence of thrombosis of arteriovenous shunts was investigated in a controlled clinical trial. In 36 patients with chronic renal failure scheduled to begin haemodialysis the same operating team constructed a subcutaneous fistula in the distal forearm. During the first six weeks after the operation the antithrombotic efficacy proved to be good for both substances. No differences of thrombotic events between the two treatment groups were statistically significant. But in contrast to acetylsalicylic acid sulfinpyrazone made no significant inhibition of platelet - aggregation; sulfinpyrazone probably will prevent the clot formation by prolonging the shortened platelet survival in uraemic patients. In a high rate of patients given acetylsalicylic acid (10 out of 17) there were local bleeding and gastrointestinal side effects. In consequence we should prefer sulfinpyrazone, because in the sulfinpyrazone group side effects were minimal and in none patient withdrawal from the study was necessitated.


2016 ◽  
pp. 23-30
Author(s):  
Van Huy Tran ◽  
Thi Ngoc Diep Bui

Background: The recurrent variceal bleeding is still very high with a very poor prognosis. The combination of a non-selective beta-blocker and endoscopic variceal ligation (EVL) is still a standard therapy for the prevention, but many patients showed no response to propranolol. Carvedilol is a new, non-selective beta-blocker having intrinsic alpha-blocker activity, but the data about the efficacy and safety of carvedilol is still very limited. This study is aimed at assessing the efficacy and safety of carvedilol combined with EVL in the prevention of recurrent variceal bleeding. Patients and methods: 33 patients having variceal bleeding were enrolled. All patients received carvedilol and were performed the EVL until variceal eradication. All the patients were followed after 9 months. Results: rate of variceal eradication of oesophageal varices was 87.88%; the recurrence rate of variceal bleeding was 12.12% after 9 months. The side effects of carvedilol were rare and not severe, including vertiges, headache, and orthostatic hypertension. Conclusion: Carvedilol combined with EVL appeared as a relatively safe and effective in the prevention of recurrent variceal bleeding in patients of cirrhosis. Key words: carvedilol, variceal bleeding, EVL


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