Tolerability Satisfaction Research Articles

The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation

SummaryBackgroundGelclair is an oral lubricating gel used in the management of oral mucositis (OM). We evaluated its efficacy, tolerance and impact on oral cavity microbial colonization in patients with OM after allogeneic hematopoietic stem cells transplantation.Material/MethodGelclair was administered in a group of 22 patients with active OM. A control group of 15 patients used other rinsing solutions (chlorhexidine, benzydamine, salvia). Tests with oral cavity swabs for microbiology analysis were performed once a week.ResultsThe characteristics of OM in both groups were comparable, and rinsing solutions had satisfactory tolerability. There was no difference in the median improvement of oral intake and OM-related pain relief, which was assessed mostly as “slight effect”. In the Gelclair group, the effect duration was longer (median 3 [0–5] vs. 1 [0–3] hours, p=0.001). There was significant increase of Enterococcus faecalis and Candida sp. colonization of the oral cavity over the course of the hospitalization and significantly reduced incidence of such colonization in patients with OM in the Gelclair group: 1/22 (5%) vs. 6/15 (40%), p=0.01. In vitro tests showed inhibited growth of Enterococcus faecalis and Candida sp. colonies within the area of the Gelclair application.ConclusionsGelclair may be individually helpful in the management of OM and pain in patients after allogeneic stem cells transplantation. Its use did not lead to worsened oral bacterial and yeast colonization and probably even helped to protect mucosa from Enterococcus and Candida sp. Further studies based on larger cohorts are needed.

Efficacy, tolerability and pharmacokinetics of a modified release formulation of ADX10059, a negative allosteric modulator of metabotropic glutamate receptor 5: an esophageal pH‐impedance study in healthy subjects

Animal studies show metabotropic glutamate receptor 5 inhibition reduces transient lower esophageal sphincter relaxations and increases lower esophageal sphincter tone. A preliminary, single-day study, demonstrated oral ADX10059 reduced 24-h esophageal acid exposure and clinical symptoms in gastro-esophageal reflux disease (GERD) patients, but had suboptimal tolerability, ascribable to the compound's rapid absorption. This study evaluated ADX10059 modified-release (MR) formulation pharmacokinetics, tolerability, and pharmacodynamics. Randomized, double-blind placebo-controlled study. Three groups of eight healthy, male subjects received placebo (n = 2) or ADX10059 (n = 6) 50, 125 or 250 mg b.i.d. for 6 days. Esophageal pH-impedance was performed on day 1 and day 6 of treatment, for 1-h fasting and for 4 h post refluxogenic meal. Treatment effect was determined by Kruskall-Wallis test and placebo comparison by Wilcoxon rank sum. Following placebo, reflux episodes increased from day 1 to day 6. Significant treatment effect was seen for total esophageal acid exposure (P = 0.048) and postprandial number of weakly acidic reflux episodes (P = 0.041). Significant differences from placebo were seen for 125 mg b.i.d.; 250 mg b.i.d. was not more effective than 125 mg b.i.d. Twice daily ADX10059 MR gave satisfactory 24-h exposure and good tolerability. ADX10059 decreased reflux episodes in healthy subjects. The MR formulation is suitable for longer-term treatment to evaluate symptom control in GERD patients.

Autologous CD34+and CD133+stem cells transplantation in patients with end stage liver disease

To assess the utility of an autologous CD34(+) and CD133(+) stem cells infusion as a possible therapeutic modality in patients with end-stage liver diseases. One hundred and forty patients with end-stage liver diseases were randomized into two groups. Group 1, comprising 90 patients, received granulocyte colony stimulating factor for five days followed by autologous CD34(+) and CD133(+) stem cell infusion in the portal vein. Group 2, comprising 50 patients, received regular liver treatment only and served as a control group. Near normalization of liver enzymes and improvement in synthetic function were observed in 54.5% of the group 1 patients; 13.6% of the patients showed stable states in the infused group. None of the patients in the control group showed improvement. No adverse effects were noted. Our data showed that a CD34(+) and CD133(+) stem cells infusion can be used as supportive treatment for end-stage liver disease with satisfactory tolerability.

SS01-04 - Clinical experience with agomelatine in depressed patients

Agomelatine, the first melatonergic antidepressant, has been widely recognized as a true innovation since its launch in Europe one year ago. Agomelatine has a unique pharmacological profile: an agonist at MT1/MT2 melatonergic receptors and antagonist at 5-HT2C receptors, it resynchronizes altered circadian rhythms in depression.Agomelatine has already become a first-line treatment option for patients with a first depressive episode, as well as those with recurrent depression. In daily practice, agomelatine can be used in all depressed patients, and is particularly indicated in patients complaining of sleep difficulties. Agomelatine ensures unimpaired daytime vigilance, cognition, gastrointestinal transit, and sexual functioning. Feedback to date from both inpatients and outpatients with major depression is positive: beyond the antidepressant effect, patients frequently report improvement in sleep-wake rhythms and daily functioning, as early as by the first week (mostly within the first 3 days), which differentiates agomelatine from other antidepressants. Most patients report improvement in mood and other symptoms after 2/3 weeks and satisfactory tolerability. The most frequently noted side effects are dizziness, headache, and nausea; liver function tests at initiation of treatment are not considered to be an issue. Because agomelatine, unlike conventional antidepressants, does not affect serotonin levels, in case of switch the initial antidepressant should be progressively downtitrated to avoid discontinuation symptoms, which risk masking the benefits of agomelatine.In summary, the early effects of agomelatine shown in controlled studies are also experienced by the majority of patients in daily practice and reflect its ability to resynchronize circadian rhythms.

Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I–II clinical trial

End-stage liver disease is a medical problem with high morbidity and mortality. We have investigated the feasibility, safety, and efficacy of using autologous mesenchymal stem cells (MSCs) as a treatment. Eight patients (four hepatitis B, one hepatitis C, one alcoholic, and two cryptogenic) with end-stage liver disease having Model for End-Stage Liver Disease score > or =10 were included. Autologous MSCs were taken from iliac crest. Approximately, 30-50 million MSCs were proliferated and injected into peripheral or the portal vein. Liver function and clinical features were evaluated at baseline and 1, 2, 4, 8, and 24 weeks after injection. Treatment was well tolerated by all patients. Liver function improved as verified by the Model for End-Stage Liver Disease score, which decreased from 17.9+/-5.6 to 10.7+/-6.3 (P<0.05) and prothrombin complex from international normalized ratio 1.9+/-0.4 to 1.4+/-0.5 (P<0.05). Serum creatinine decreased from 114+/-35 to 80+/-18 micromol/l (P<0.05). Serum albumin changed from 30+/-5 to 33+/-5 g/l and bilirubin from 46+/-29 to 41+/-31 micromol/l. No adverse effects were noted. Our data show that MSCs injection can be used for the treatment of end-stage liver disease with satisfactory tolerability. Furthermore, this treatment may improve clinical indices of liver function in end-stage liver disease.

Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥ 80, and CGI-S score ≥ 4. Patients were randomized to ziprasidone (80–160 mg/day, n = 73) or clozapine (250–600 mg/day, n = 74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (− 25.0 ± 22.0, 95% CI − 30.2 to − 19.8) and clozapine (− 24.5 ± 22.5, 95% CI − 29.7 to − 19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.

Adequacy of venlafaxine dose prescribing in major depression and hospital resources implications

Venlafaxine, a dual serotonin and noradrenaline re-uptake inhibitor, has been found to be effective at doses below 375 mg daily, but for patients with major depression higher doses can be required. In this retrospective naturalistic study, we investigated the effectiveness and resource implications of prescribing higher than standard doses of venlafaxine (tablet preparation). Ninety-six outpatients fulfilling DSM-IV criteria for major depressive disorder were assigned to two demographically matched cohorts: cohort A, receiving high doses (n = 38; doses > or =375 mg/day) and cohort B, receiving standard doses (n = 58; doses <375 mg/day). Data on hospital resources, drugs and medical profiles were extracted from patients' records. Information on cohort A was also obtained before their high-dose regime, while taking standard doses. A within-group analysis of cohort A showed that patients spent fewer days in hospital (P = 0.03) and had fewer outpatients visits (P < 0.01) when on high doses than when on standard doses. A between-group analysis found that cohort A, while on higher doses, had fewer outpatient visits compared with cohort B (P < 0.01). Patients in both groups had satisfactory drug tolerability and efficacy profiles. There were no differences between cohorts with regard to baseline characteristics, a part from the more intensive use of additional medications made by cohort A. Our preliminary investigation suggests that higher doses of venlafaxine may be cost-saving in relation to selected hospital resources. However, one cannot firmly conclude that the change in service use is due to the higher-dose regime, and we recommend further research to ascertain the cost-effectiveness of adequate dose prescribing in patients with poor symptom resolution at lower doses of venlafaxine.

Experience of Indinavir/Ritonavir 400/100 mg Twice-Daily Highly Active Antiretroviral Therapy-Containing Regimen in HIV-1-Infected Patients in Bamako, Mali

The combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) is the first-line antiretroviral treatment of choice in developing countries. NNRTIs are not effective against HIV-2 or on HIV-1 group O and present a low genetic barrier resulting in failure rates of 16% to 38% in different African studies. In these situations access to protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimens is essential. In Mali unboosted indinavir (IDV) was the only PI available to treat adults. This regimen necessitates 3 daily intakes and dietary restrictions leading to poor adherence and therefore to a risk of resistance. Twice-daily low-dose ritonavir-boosted IDV (IDV/r) regimens (400/ 100 mg) had shown satisfactory efficacy pharmacokinetics adherence and tolerability in HIV-infected patients but no study had been conducted in Africa mainly because of ritonavir (RTV) storage conditions. (excerpt)

Risperidone in the Management of Disruptive Behavior Disorders

Disruptive behavior disorders (DBDs) represent a spectrum of disorders, including conduct disorder and oppositional-defiant disorder. The atypical antipsychotic risperidone may be useful for the management of patients with DBDs. Clinical data on risperidone have demonstrated efficacy and satisfactory tolerability in improving angry, aggressive, self-injurious, and disruptive symptoms and behavior in children with pervasive developmental disorders and mood disorders. This paper reviews the results of recent studies that have evaluated the efficacy and safety of risperidone in the treatment of pediatric patients with DBDs. Because concerns have been raised regarding the safety of atypical antipsychotic treatment in pediatric patients, this paper further evaluates safety risks by presenting newly completed analyses of movement disorders, prolactin concentrations, body weight, and cognitive function data from short- and long-term studies in this patient population. A comprehensive review of all of the findings suggests that risperidone is an effective and well-tolerated treatment option for children and adolescents with DBDs. As with all antipsychotics, practitioners should monitor young patients' growth, weight, sexual maturation, and metabolic parameters.

Topiramate in migraine prophylaxis: data from a pooled analysis and open-label extension study

Topiramate is approved for the preventive treatment of migraine in several countries based on the results of three large randomised, double-blind studies that showed that this compound was significantly more effective than placebo in migraine prophylaxis. We review the results of two studies: one which pooled data from the three controlled double-blind trials using 100 mg/day of topiramate, and an open-label extension of two of these trials in which patients received different topiramate doses for an eight-month maintenance period. The overall results confirm that topiramate is effective in reducing migraine frequency, and has a satisfactory tolerability profile.

The role of quetiapine in the treatment of bipolar disorder

Through a review of randomised, controlled trials, this article evaluates the efficacy and tolerability of quetiapine in the acute and maintenance phases of bipolar disorder. In trials involving mania patients, quetiapine was found to be effective as adjunctive therapy in combination with lithium or valproate, significantly superior to placebo, and equal to lithium or haloperidol as monotherapy. With regard to the prevention of relapses in bipolar disorder, quetiapine seems to differ from other atypical antipsychotics in its characteristics as a mood stabiliser, which are associated with a promising efficacy in the treatment of bipolar depressive episodes. However, further larger controlled long-term prospective studies are needed to confirm the efficacy of quetiapine for the prevention of relapses in bipolar disorder. Quetiapine seems to have a satisfactory safety and tolerability profile, with a low prevalence of extrapyramidal symptom-related adverse events, treatment-emergent depression and weight gain. Sedation is the main side effect of treatment with quetiapine.

Evaluation of efficacy and safety of fixed dose lovastatin and niacinER combination in Asian Indian dyslipidemic patients: a multicentric study

Asian Indian dyslipidemia is characterized by: borderline high low-density lipoprotein (LDL) cholesterol and apolipoprotein (apo) B; high triglycerides, low high-density lipoprotein (HDL) cholesterol and apoA1; and high lipoprotein(a) (lp[a]). We performed a controlled multicentric trial in India to evaluate the efficacy and safety of a fixed dose combination of lovastatin and niacin extended release (niacin(ER)) formulation in patients with moderate to severe dyslipidemia. Consecutive subjects that satisfied the selection criteria, agreed to an informed consent, and with no baseline presence of liver/renal disease or heart failure were enrolled in the study. After a 4-week run-in period there were 142 patients with LDL levels > or = 130 mg/dL. Eleven patients were excluded because of uncontrolled hyperglycemia and 131 patients were recruited. After baseline evaluation of clinical and biochemical parameters all subjects were administered lovastatin (20 mg) and niacin(ER) (500 mg) combination once daily. Dose escalation was done on basis of lipid parameters at 8 weeks and in 11 patients increased to lovastatin (20 mg) and niacin(ER) (1000 mg). An intention-to-treat analysis was performed and data was analyzed using nonparametric Wilcoxon signed rank test. Thirteen patients (10%) were lost to follow-up and 4 (3%) withdrew because of dermatological adverse effects: flushing, pruritus, and rash. The mean values of various lipid parameters (mg/dL) at baseline, and at weeks 4, 12, and 24 respectively were: total cholesterol 233.9 +/- 27, 206.3 +/- 27, 189.8 +/- 31, and 174.9 +/- 27 mg/dL; LDL cholesterol 153.4 +/- 22, 127.3 +/- 21, 109.2 +/- 27, and 95.1 +/- 23 mg/dL; triglycerides 171.1 +/- 72, 159.5 +/- 75, 149.2 +/- 45, and 135.2 +/- 40 mg/dL; HDL cholesterol 45.6 +/- 7, 48.9 +/- 7, 51.6 +/- 9, and 53.9 +/- 10 mg/dL; lp(a) 48.5 +/- 26, 40.1 +/- 21, 35.4 +/- 21, and 26.9 +/- 19 mg/dL; and apoA1/apoB ratio 0.96 +/- 0.7, 1.04 +/- 0.4, 1.17 +/- 0.5, and 1.45 +/- 0.5 (p < 0.01). The percentage of decline in various lipids at 4, 12, and 24 weeks was: total cholesterol 11.8%, 18.8%, and 25.2%; LDL cholesterol 17.0%, 28.8%, and 38.0%; triglyceride 6.8%, 12.8%, and 21.0%; lp(a) 17.5%, 26.9%, and 44.5% respectively (p < 0.01). HDL cholesterol and apoA1/apoB increased by 7.2%, 13.1%, and 18.2%; and 7.9%, 21.9%, and 51.6% respectively (p < 0.01). Target LDL levels (< 100 mg/dL in subjects with manifest coronary heart disease or diabetes; < 130 mg/dL in subjects with > 2 risk factors) were achieved in 92 (80.7%) patients. No significant changes were observed in systolic or diastolic blood pressure, blood creatinine, transaminases, or creatine kinase. A fixed dose combination of lovastatin and niacin(ER) significantly improved cholesterol lipoprotein lipids as well as lp(a) and apoA1/apoB levels in Asian Indian dyslipidemic patients. Satisfactory safety and tolerability profile in this population was also demonstrated.

ASSESSMENT OF RILMENIDINE EFFICIENCY IN PATIENTS WITH ARTERIAL HYPERTENSION WITH DETERIORATION OF DAILY PROFILE OF BLOOD PRESSURE

Aim. To estimate an efficiency and tolerability of rilmenidine in hypertensive patients with different types of blood pressure (BP) daily profile – dipper and non-dipper. Methods. 23 patients with essential hypertension (EH), I-II stages, were included into the study. They were treated with rilmeneidine 1 mg daily during one month. Ambulatory BP monitoring (ABPM) and office BP measurements were made before and after the treatment. Based on ABPM results all patients were divided into two groups: with adequate decrease of BP at nighttime (dipper, D), and with insufficient decrease of BP at night￾time (non-dipper, ND). Results. One month rilmenidine monotherapy resulted in BP normalization in 52% of patients. Decrease in 24-hour BP, daytime and nighttime BP, burden with BP and BP variability during daytime was observed in both groups. A distinction in rilmenidine influence on BP daily index was revealed: initially normal BP daily index didn’t change in D group, while initially decreased BP daily index increased in ND group. Rilmenidine reduced the speed of morning BP rise in patients of ND group. Conclusion. Results of the study testify efficiency and satisfactory tolerability of monotherapy with rilmenidine 1 mg daily in patients with EH of I-II stages. For patients with insufficient decrease in BP during nighttime rilmenidine provides normalization of BP daily profile intensifying BP night decrease and reducing the speed of morning BP rise.

Effectiveness and tolerability of enalapril plus nitrendipine on a fixed dose in hypertensive patients over 65 years

P-217 Key Words: Enalapril + Nitrendipine, Hypertension, Elderly

The KARTAN study: A postmarketing assessment of Irbesartan in patients with hypertension

Background: An important purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in the clinical setting. Another goal is to confirm the effectiveness of these drugs in patients who are candidates for antihypertensive therapy and who may have been excluded from Phase III studies. Irbesartan is a long-acting angiotensin II-receptor blocker specific for the angiotensin 1-receptor subtype that, in clinical trials in patients with hypertension, reduces blood pressure. Objectives: The KARTAN (this word was derived from the first and last syllables of Karvea® [trademark of Bristol-Myers Squibb Group, Madrid, Spain] and irbesar tan) study was designed to confirm and extend the findings from previous clinical trials using data from a large number of patients with hypertension treated with irbesartan in routine clinical practice. The primary goal was to assess the types and incidences of adverse drug reactions (ADRs) occurring at a low frequency (<0.05%) with irbesartan. The secondary objectives were to study the effect of irbesartan as an antihypertensive agent, to assess the types and incidences of the most frequent ADRs (≥0.05%) occurring in routine clinical practice, and to detect possible interactions between irbesartan and other drugs frequently used in the primary care setting. Methods: This 6-month, observational, open-label, uncontrolled, national, longitudinal, prospective study was conducted by 852 primary care physicians across Spain. Men and women aged ≥18 years with mild to moderate hypertension who, in their physicians' opinion, should have been treated with irbesartan were included. Each patient was followed up for 6 months, attending visits at baseline (ie, the start of treatment) and 1, 3, and 6 months after the start of treatment. A sample size of 3219 patients was calculated for the detection of ≥1 low-incidence (<0.05%) ADR. After the baseline visit, therapy typically was begun with irbesartan 150 mg/d. The initial dose was titrated up, at 300-mg increments based on the patient's response, at each visit as needed to achieve the treatment goals (systolic blood pressure, <140 mm Hg; diastolic blood pressure, <90 mm Hg). Information regarding ADRs was collected on case-report forms designed for each visit and analyzed by the scientific committee of the study. All recruited patients were included in the tolerability analysis. Results: A total of 4887 patients were enrolled (2165 men, 2 772 women ; mean [SD] age, 61.1 [11.0] years [range, 19–94 years]; 23.3% of patients were aged >70 years); 4612 were assessable for efficacy. One hundred eight patients (2.2%) experienced ADRs over the 6-month treatment period; 3 of these patients (0.1%) experienced >1 ADR. Of the total number of clinical manifestations of ADRs, 24 occurred at an incidence <0.05%. Irbesartan produced reductions in blood pressure that were statistically significant from the first visit (all P < 0.001), and 39.9% of the patients achieved the treatment goal at the end of the follow-up period. Conclusion: In this postmarketing surveillance study of patients with hypertension treated in routine clinical practice, irbesartan showed a satisfactory tolerability profile that was consistent with that seen in randomized, controlled trials.

In Vitro Activity of Thiamphenicol Against Multiresistant Streptococcus pneumoniae, Haemophilus influenzae and Staphylococcus aureus in Italy

Thiamphenicol is a derivative of chloramphenicol characterized by a spectrum comparable to that of the parent compound against multiresistant pathogens but showing satisfactory tolerability. The In Vitro activity of thiamphenicol and of 11 comparative drugs against 397 recently isolated antibiotic-resistant and/or invasive pneumococci and 52 multiply-resistant MRSA including 2 VISA strains was determined. Bactericidal activity against Haemophilus influenzae and the post-antibiotic effect on Streptococcus pneumoniae, H. influenzae, Staphylococcus aureus and Escherichia coli were also assessed. Against invasive pneumococci, thiamphenicol and chloramphenicol were the most potent non-β-lactam molecules together with vancomycin and rifampin. Against high-level penicillin-resistant strains phenicol activities were superior to those of cefotaxime, ceftriaxone and imipenem. Against MRSA thiamphenicol and chloramphenicol were second only to the glycopetides and also inhibited the VISA strains. Thiamphenicol showed a significant PAE (0.33 to 2.9h) on all pathogens studied and a powerful bactericidal effect against β-lactamase-positive and -negative H. influenzae. These results indicate a good In Vitro activity of thiamphenicol against difficult-to-treat multiply resistant pathogens.

Slow-release lanreotide treatment in endocrine gastrointestinal tumors

Objectives: Lanreotide is a somatostatin analogue whose activity persists for 10–14 days. In this study, we treated a group of patients with gastrointestinal endocrine tumors with lanreotide to assess its therapeutic efficacy and tolerability. Methods: Eighteen patients, 12 male and six female, mean age 58 yr (range, 25–80 yr) were studied. Ten had carcinoid tumors, five had nonfunctioning endocrine tumors, two had glucagonomas, and the remaining one had a gastrinoma. All patients had somatostatin receptors, demonstrated by octreoscan scintigraphy. Lanreotide was administered intramuscularly at a dose of 30 mg every 10 days, for a mean of 12 months (range, 5–18 months). Fifteen of the 18 patients had been previously treated with octreotide. Results: In patients with carcinoid tumors, lanreotide markedly reduced daily bowel movements and flushing episodes. A reduction was also observed in urinary serotonin and urinary 5-hydroxyindoleacetic acid, although it was not statistically significant. A marked reduction in symptoms, and in plasma glucagon and serum gastrin levels, was also observed in patients with glucagonoma and gastrinoma. In the five patients with nonfunctioning endocrine tumors, as in all the other 13 patients, no significant effects were noted in the size of the tumor. The administration of lanreotide did not cause side effects, apart from transient abdominal pain and pain at the injection site in two patients. Only in the patient with gastrinoma was lanreotide suspended, because of the appearance of attacks of marked hypoglycemia. In the 15 patients previously treated with octreotide, no differences in the effects were noted with lanreotide. Conclusions: Lanreotide has a satisfactory therapeutic efficacy and tolerability in the treatment of gastrointestinal endocrine tumors; its effects are similar to those of octreotide. However, unlike octreotide, it can be administered once every 10–14 days, instead of 2 or 3 times daily and for this reason, it is preferable in clinical practice.

Aceclofenac versus naproxen in the treatment of ankylosing spondylitis: A double-blind, controlled study

The efficacy and tolerability of aceclofenac and naproxen sodium in the treatment of ankylosing spondylitis (AS) were evaluated and compared in this double-blind, multicenter, controlled study. Of the 130 patients who entered the study, 126 patients met the inclusion criteria. Efficacy was evaluated at baseline, 15 days, and 1, 2, and 3 months using a visual analog scale for spontaneous pain, a zero to three-point scale for pain on movement and pain at rest, and measurements of chest expansion, hand-to-floor distance, Schober's test, and normal daily activities. No significant between-group differences were seen for any of the variables at baseline, except hand-to-floor distance. Both drugs provided effective analgesia and a corresponding improvement in functional activity. Overall efficacy assessment made by the physician and patients was not statistically significant between the two treatment groups. The overall incidence of adverse effects was higher in the naproxen group than the aceclofenac group, 22 versus 15 patients, respectively. All adverse effects resolved. However, the overall assessment of tolerability given by the physician and patients was significantly ( P < 0.05) higher for the aceclofenac group than for the naproxen group. The anti-inflammatory drug aceclofenac was shown to have satisfactory efficacy and tolerability when used in the treatment of AS.