Re-eradication of Helicobacter pylori infection following initial treatment failure: treatment options in clinical practice.
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Anti-Bacterial Agents↗
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Toward a definition and method of assessment of treatment failure and treatment effectiveness: the case of leflunomide versus methotrexate.
OBJECTIVE: Time to treatment discontinuation (TTD) is an accepted method of assessing treatment effectiveness in the community, but is susceptible to channeling bias and secular and cohort effects. In addition, TTD does not consider the addition of new disease modifying antirheumatic drugs (DMARD) to insufficiently effective therapies. We expand the definition of treatment failure to include discontinuation or addition of a second DMARD (1) to examine leflunomide (LEF) versus methotrexate (MTX) effectiveness in clinical practice; (2) to obtain an estimate of overall clinical effectiveness; and (3) to identify factors associated with treatment successes and failure. In addition, (4) we test the feasibility of performing a clinical trial using a longitudinal data bank. METHODS: Using the National Data Bank for Rheumatic Diseases longitudinal data bank, 1431 patients with rheumatoid arthritis (RA) who began taking LEF or MTX as part of their routine medical care were followed from 1998 through 2001. None of the 1431 patients had received either treatment previously. Patients were assessed at 6 month intervals for periods up to 36 months by mailed questionnaires concerning DMARD therapy and demographic and RA severity factors. Kaplan-Meier survivor functions and Cox regression analyses were used to assess treatment failure, defined as time to discontinuation or to the addition of a second DMARD. RESULTS: For 756 patients taking LEF, the failure rate was 55.5 per 100 patient-years, and the median time to failure was 15 (95% CI 13, 17) months. For 675 patients taking MTX the failure rate was 57.3 per 100 patient-years, and the median failure time was 14 (95% CI 12, 18) months. These differences were not statistically significant. The overall rate of discontinuation was 68.7% of the failure rate. Discontinuation was predicted by adverse effects [hazard ratio 1.76 (95% CI 1.51, 2.04)] and by clinical status prior to starting DMARD, and these results were not affected by specific DMARD treatment. Discontinuation was more common with LEF, and addition of a second DMARD was more common with MTX. More than 77% of treatment failures, defined by use of additional therapy, resulted in starting anti-tumor necrosis factor treatment rather than a conventional DMARD. CONCLUSION: In an observational clinical trial using a contemporary longitudinal data bank, with time to treatment failure as the outcome, LEF and MTX had equal effectiveness as measured by time to treatment failure. Treatment failure rates were substantially greater than noted historically. Given the availability of many efficacious additional treatment options, this increase in failure rate appears to reflect a greater propensity to discontinue and/or add therapy.
Adult↗
Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures.
When treatment failures occur during the course of a clinical trial, the treatment regimen following failure may be changed. This change in therapy complicates comparisons among the original treatment arms. As in some clinical trials with dropouts, intent-to-treat analysis can yield a large bias. We examine the use of multiple imputation to replace observations after treatment failure has occurred. As a sensitivity analysis, this approach is compared to existing methods for handling treatment failures - removing treatment failure subjects, removing data after the onset of treatment failure, and imputation the last observation prior to treatment failure for all subsequent observations - in addition to an analysis of all collected data based on randomized treatment assignment. A data set from the Asthma Clinical Research Network is used to demonstrate the methods.
Algorithms↗
Endovenous laser ablation of the great saphenous vein with a 980-nm diode laser in continuous mode: early treatment failures and successful repeat treatments.
PURPOSE: To investigate the efficacy of lower-energy endovenous laser treatment for great saphenous vein (GSV) incompetence and treatment parameters associated with early treatment failure. MATERIALS AND METHODS: Sixty consecutive endovenous laser treatments (32 left, 28 right; 57 initial treatments, three repeat treatments) in 48 patients (13 men, 35 women; mean age, 55.2 +/- 12.9 years), with bilateral treatments in nine patients, were studied. Preprocedural clinical signs, etiology, anatomy, and physiologic classifications demonstrated class 2 limbs in 11.7% of cases, class 3 limbs in 25.0%, class 4 limbs in 48.3%, and class 5 limbs in 15.0%. All initial and repeat treatments were performed with lower-energy with use of a 980-nm diode endovenous laser at 11 W in continuous mode. Patients wore class II compression stockings for 2 weeks and were followed up at 1, 3, and 6 months with clinical and duplex ultrasound examinations. Treatment failures were diagnosed at 3 months on the basis of GSV patency or lack of clinical improvement. Diameter and length of GSV treated, treatment energy parameters, and clinical outcomes were prospectively measured and compared between successful and failed treatments. RESULTS: The initial treatment success rate was 94.7% (54 of 57). The mean maximum diameter of successfully treated GSVs was 1.12 +/- 0.52 cm, and the mean maximum diameter of GSVs in which treatment failure occurred was 2.05 +/- 0.23 cm (P = .008). Mean total energy applied for successful treatments was 1,131.3 +/- 248.1 J, and mean total energy applied for failed treatments was 1,439.6 +/- 425.0 J (P = 0.053). Mean unit energy applied for successful treatments was 32.7 +/- 7.5 J/cm, and that for failed treatments was 32.8 +/- 4.9 J/cm (P = .986). All patients in whom treatment failed were successfully treated again with a mean total energy of 1,393.0 +/- 81.0 J and a mean unit energy of 29.4 +/- 4.9 J/cm. There were no significant differences in mean total energy or unit energy applied among successful, failed, and repeat treatments (P > .05). Mean follow-up duration was 6.8 months. CONCLUSIONS: Endovenous laser treatment with lower energy appears to be safe and effective. Larger GSV diameter is associated with early treatment failures.
Female↗
Chloroquine-resistant Plasmodium falciparum malaria in Ilorin, Nigeria: prevalence and risk factors for treatment failure.
Presumptive treatment of fever with Chloroquine (CQ) remains the major strategy for malaria control in Nigeria. Efficacy surveillance of CQ must therefore be continuous for this strategy to remain valid. In this study we determined the efficacy of CQ in 120 patients aged 6m to 34yr who presented with acute uncomplicated Plasmodium falciparum malaria. Clinical success was 86.6%. Parasitological cure was 56.7%. Mean fever and parasite clearance times were 2.5 +/- 1.2D and 4.2 +/- 1.6D, respectively. Recrudescence rate was 24.45%. Twenty-four patients (20%) showed R11 response while 6 patients (5%) showed R111 response. Risk of treatment failure was significantly higher among children (< or = 15 yr) [P = 0.02, RR = 2.35 ] and among patients whose level of parasitaemia on day 2 was higher than day zero value. [P = 0.04; RR = 6.54]. Although malnutrition was not associated with higher risk of parasitological failure (P = 0.52), the proportion of children with R11/R111 response compared to R1 response was significantly higher among malnourished children compared to children with satisfactory nutritional status (OR 2.92; p = 0.001). The findings suggests the need for extra vigilance of CQ-Resistant P. falciparum (CRPF) malaria in children in general, and malnourished children in particular if potentially serious complications are to be averted.
Adolescent↗
Re-occurrence of HIV-1 drug mutations after treatment re-initiation following interruption in patients with multiple treatment failure.
Antiretroviral treatment interruption in 20 extensively pre-treated HIV-1 patients with treatment failure led to genotype viral reversion of at least one class of drug-mutation resistance in half of the patients. The only predictive factor of reversion was found to be the duration of interruption. The outgrowth of residual wild-type virus seems not to be a true genetic reversion because drug mutations are detected rapidly at salvage therapy re-initiation.
Antiretroviral Therapy, Highly Active↗
Penicillin tolerance and treatment failure in group A streptococcal pharyngotonsillitis.
Failure of treatment of group A streptococcal pharyngitis and tonsillitis is well documented. One of the possible explanations for treatment failure is penicillin tolerance in group A streptococci. Reports on the prevalence of penicillin tolerance among group A streptococci (0-100%) and the presumed relationship with therapeutic failure vary considerably. Therefore, it appears worthwhile to review pharyngotonsillitis studies, devoting special attention to the variables of MIC-MBC laboratory determinations such as inoculum preparation, composition and volume of test medium, and the criteria used to define penicillin tolerance. Alternative methods (gradient-replica plate method, beta-lactamase disk test, time-kill assay, and cell-lysis assay) are discussed. It is concluded that technical factors and the definitions used influenced the reported rates of penicillin tolerance. The epidemiological data suggest that tolerance is not limited to a single streptococcal serotype. Furthermore, there is not sufficient data to support a correlation between in vitro penicillin tolerance of group A streptococci and treatment failure, either in clinical cases or in animal studies. On the other hand, evidence to exclude penicillin tolerance as a cause of treatment failure is also not available. Therefore, at present penicillin tolerance cannot be ruled out as a cause of penicillin treatment failures.
Drug Tolerance↗
A review of heart failure treatment.
Heart failure is a common and costly medical condition. Ischemic heart disease and hypertension account for most cases of heart failure in developed countries. Estimates of the one-year mortality rates for patients with New York Heart Association (NYHA) Class II, III, and IV are 10%, 20%, and 40%, respectively. Angiotensin-converting enzyme (ACE) inhibitors reduce mortality of heart failure patients by approximately 25% (odds ratio 0.77, 95% CI 0.67 0.88). Larger doses of ACE inhibitors are more effective in preventing hospitalization than are lower doses. Angiotensin II receptor blockers (ARBs) are an alternative for patients who cannot tolerate ACE inhibitors because of their side effects (e.g., cough). Evidence for benefits of using combination of ACE inhibitors and ARBs is encouraging, but requires further study. For patients who cannot tolerate either ACE inhibitors or ARBs, vasodilator therapy with hydralazine and nitrates will probably provide benefit. (Diuretic therapy, while a mainstay of heart failure treatment, is primarily used for symptom relief.) There is also evidence that spironolactone reduces mortality (relative risk reduction 30%, 95% CI 18 40%) for patients with NYHA class III and IV heart failure. When administering spironolactone to heart failure patients, monitoring for hyperkalemia is essential. After two centuries of use, randomized controlled trials have finally demonstrated that digoxin is effective in preventing hospitalizations (relative risk reduction 28%, 95% CI 21 34%). There is now overwhelming evidence that beta-blockers are safe for heart failure patients but that they reduce the risk of death for these patients by approximately 30%. In addition to these medical interventions, heart failure patients may also benefit from a number of non-pharmacological interventions.
Adrenergic beta-Antagonists↗
Treatment failure in filariasis mass treatment programmes.
The data from the first 3 years of the Samoan pilot filariasis control programme were reanalysed using incidence instead of prevalence statistics. With these statistics, failures of diethylcarbamazine treatment can be roughly divided into three groups: primary treatment failures, manifested by persistent microfilaraemia; secondary treatment failures, manifested by microfilaraemia recurring within the prepatent period after apparently successful treatment; and new infections. When cases of persistent and recurrent microfilaraemia are excluded by appropriate statistical manipulations, the incidence of new infections is seen to be many times higher in persons who originally showed microfilaraemia. This suggests that susceptibility or exposure, or both, are not homogeneously distributed in the population, and indicates that proposed mathematical models of filarial epidemiology must be further refined. It also indicates that filariasis control programmes should devote more attention to studies and control methods aimed at this high-risk subgroup of the population.
Adolescent↗
Malaria treatment failures after artemisinin-based therapy in three expatriates: could improved manufacturer information help to decrease the risk of treatment failure?
BACKGROUND: Artemisinin-containing therapies are highly effective against Plasmodium falciparum malaria. Insufficient numbers of tablets and inadequate package inserts result in sub-optimal dosing and possible treatment failure. This study reports the case of three, non-immune, expatriate workers with P. falciparum acquired in Africa, who failed to respond to artemisinin-based therapy. Sub-therapeutic dosing in accordance with the manufacturers' recommendations was the probable cause. METHOD: Manufacturers information and drug content included in twenty-five artemisinin-containing specialities were reviewed. RESULTS: A substantial number of manufacturers do not follow current WHO recommendations regarding treatment duration and doses. CONCLUSION: This study shows that drug packaging and their inserts should be improved.
Adult↗
[Treatment failures of surgical and combined (surgery and radiotherapy) treatment in carcinoma of the larynx and hypopharynx--20 years experience of ENT Department, District Hospital in Kielce].
The 280 cases (29.8%) of treatment failures after surgical and combined (surgery + rtg-therapy) treatment in 940 cases of carcinoma of larynx and hypopharynx has been taken into analysis. The recurrence within regional lymph nodes (11.9%), followed by local recurrences (11.5%) has dominated in this group. The distant metastases had been registered only in 2.6% of the whole treated group and the second primary tumours (included to the analysis of treatment failures) has been registered in 3.8%. The failures distribution has not been related to the sex and age of the patients, but significant dependence of failures rate to the general condition of the patient, the local and nodal advancement of the disease, and histological grade of tumour has been found. The highest rate of treatment failures was in hypopharynx localisation of primary tumour and the lowest in glottic region of the larynx. The results obtained in salvage treatment after failure of primary treatment has been unfavourable. In general, only 22.1% of patient with primary treatment failure has achieved 3-years survival, and 13.6% 5-years survival rate. In should be pointed out, that salvage treatment has been applied only to 40.8% of this group. The remaining patients received only symptomatic and palliative treatment.
Adult↗
Relapse in childhood acute lymphoblastic leukemia after elective cessation of initial treatment: failure of subsequent treatment with cyclophosphamide, cytosine arabinoside, vincristine and prednisone (COAP).
Although the majority of children with acute lymphoblastic leukemia (ALL) can electively stop treatment after 2 1/2-5 years of continuous disease-free remission, 20-25% of those patients relapse after discontinuation of therapy. We treated 15 patients whose disease recurred after stopping treatment. Fourteen of them attained complete remission, but the median duration of disease-free survival was only 11 months. In this population, the site of initial relapse, bone marrow or testicle, did not influence subsequent outcome. Patients who relapsed within six months of stopping initial therapy had shorter second remissions than those who relapsed after six months. We conclude that the combination chemotherapy utilized in this study was inadequate for the control of relapsed ALL. Future programs will have to use different drug combinations or bone marrow transplantation.
Antineoplastic Agents↗
Adolescent inpatient treatment "failures": subtypes and treatment implications.
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Adolescent↗
Regrowth resistance in leukemia and lymphoma: the need for a new system to classify treatment failure and for new approaches to treatment.
Treatment failure in drug sensitive malignancies is a complex phenomenon resulting from both drug resistance and from the rapid regrowth of malignant cells ('regrowth resistance'). Attempts to overcome regrowth resistance during the treatment of the aggressive lymphomas by increasing the frequency of cytotoxic therapy appears to have failed. An alternative approach of significant potential would be to administer biologically active agents to directly slow the regrowth of neoplastic cells between courses of full dose cytotoxic therapy. To facilitate this approach a new system for classifying treatment failure in the leukemias and lymphomas is needed so that the extent of regrowth resistance and the effects of treatment on regrowth resistance can be directly assessed. Accordingly, a new classification system is proposed.
Antineoplastic Combined Chemotherapy Protocols↗
Treatment failure and methadone dose in a public methadone maintenance treatment programme in Geneva.
The aim of this study was to identify predictors of treatment failure in a methadone maintenance treatment programme in Geneva. All patients (n = 149) starting treatment between May 1993 and May 1995 were followed until end of treatment or 31st July 1996. The proportion of depressed patients decreased significantly over time, as did the proportion of those injecting illegal drugs. The overall treatment failure was 21%. The probability of treatment failure was higher for women than for men (RR 2.2, P = 0.03) and decreased in successive cohorts. There was no correlation between the methadone dose at 2 months and treatment outcome, probably because doses were individualised and the associated level of psycho-social services high.
Adult↗
Treatment failure in tuberculosis.
Treatment of latent tuberculosis (TB) infection with 3 months of rifampicin/isoniazid is a major part of preventive TB programmes. The effectiveness of treatment of latent TB infection can only be assessed by rates of subsequent breakdown and there are few outcome data for this combination of rifampicin/isoniazid. Therefore, the aim of the present study was to estimate the failure rate following treatment for the latent TB infection. A questionnaire survey was carried out in all parents of children aged <16 yrs who completed treatment for latent TB infection at Leicester Royal Infirmary (Leicester, UK) over the period 1997-2003. Cases of treatment failure were identified by reviewing all re-referrals to the clinic, identifying children developing TB while on treatment and by postal questionnaire to all patients discharged. Of the 400 eligible children, 344 (86%) replied. Three children who had latent TB infection subsequently developed TB disease over the time period. Of those three patients, one developed chest radiograph signs at the end of treatment and two presented with symptoms within 2 yrs of completing treatment. Overall, the mean treatment failure rate was 0.87% (95% confidence interval 0.3-2.5) or 2.2 cases per 1,000 patient-yrs. In conclusion, rates of tuberculosis breakdown after treatment for latent tuberculosis infection with 3 months rifampicin/isoniazid are acceptably low.
Adolescent↗
Retreatment of Helicobacter pylori infection after initial treatment failure.
OBJECTIVES: Helicobacter pylori treatment regimens fail to cure the infection in at least 10-20% of patients undergoing initial treatment. Retreatment strategies for patients who have failed initial treatment for H. pylori infection remain poorly described. METHODS: The literature describing the frequency of H. pylori treatment failure and factors leading to failure is reviewed. The role of antibiotic resistance is discussed and clinical studies assessing success rates according to antibiotic resistance are described. Clinical trials evaluating the treatment success rates for a second episode of treatment are discussed. RESULTS: The literature describing retreatment of failed H. pylori infection remains limited. The existing data support the use of bismuth-based quadruple therapy or ranitidine bismuth citrate (RBC)-based triple therapy as the preferred agents after initial treatment failure. CONCLUSION: Further studies are needed to better define the optimal second treatment regimen after failed H. pylori treatment.
Anti-Ulcer Agents↗
Determinants of pharmacologic treatment failure in panic disorder.
BACKGROUND: We systematically assessed reasons for failure of pharmacologic treatment for panic disorder in patients referred to a specialty anxiety and mood disorders clinic and examined possible determinants of treatment-resistant panic disorder. METHOD: Interview data were obtained from 106 patients with DSM-III-R panic disorder seen in consultation. Data for each of 252 past medication trials included dose, duration of treatment, side effects, outcome, and reason for discontinuation. T tests and chi-square analyses were used to compare demographic and clinical characteristics of patients failing versus responding to adequate trials and those with and without intolerable medication side effects. RESULTS: Of 252 medication trials, 190 used effective antipanic medications, and only 59 (23%) were adequate in dose and duration. The most common reason for treatment failure was intolerable side effects, occurring in 51 (27%) of 190 trials using effective antipanic medications. Patients discontinuing treatment due to adverse effects had higher Hamilton Rating Scale for Anxiety scores and were less likely to have a history of substance abuse. Discontinuation due to side effects was significantly more common with tricyclic antidepressants than with benzodiazepines. True treatment resistance was reported in 14 (24%) of 59 adequate medication trials. Treatment-resistant patients were younger and had a higher lifetime rate of major depression. CONCLUSION: Although use of ineffective medications or inadequate trials were important factors, the most common reason for treatment failure was side effects, especially with tricyclic antidepressants. True treatment resistance was less common, since few medication trials were adequate in dose and duration, and may be associated with comorbidity.
Adolescent↗