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Results for “adjunct therapy”

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PubMed2001

Pathogenetic aspects of sepsis and possible targets for adjunctive therapy.

The outcome of patients with sepsis arises from multiple factors affecting both the host and the invading microorganisms. Age, presence of underlying disease, source of infection and some specific etiological agents have been related to prognosis. Appropriateness of antimicrobial therapy, considering the in vitro susceptibility tests for the infecting bacteria, has been strongly associated with the outcome. Therefore even after the cascade of sepsis has been triggered, the control of bacteria growth is still fundamental for the outcome of the infection. This is a major distinction point from experimental studies in which whole killed bacteria and their products are used as model of sepsis. However, even within the setting of adequate antimicrobial use, patients still die of sepsis. Thus, strategies focusing on further therapy targets are an important area of interest for basic and clinical research. Although such adjunctive sepsis therapy has failed to achieve consistent better survival rates so far, nevertheless, it improved our understanding of the pathophysiological events seen in sepsis that the possibility that a new and effective treatment may arise has been warmly considered. In this paper we aim to review some aspects of the pathogenesis of sepsis, focusing on recent advances and on possible targets for adjunctive therapy. Published clinical trials and experimental data supporting such trials are commented on.

Animals↗

PubMed1986

Cold as an adjunctive therapy for headache.

We report the results of a study conducted recently at the Diamond Headache Clinic, Chicago, on the effectiveness of application of cold as an adjunctive therapy for acute headache. Ninety clinic outpatients were divided evenly into three groups according to headache type--migraine, cluster, and mixed. They used the standard headache medication for two attacks and the standard medication plus application of cold with a reusable, frozen gel pack for two attacks. There was no significant difference in patient response to the gel pack by headache type. Seventy-one percent of patients considered the pack effective; 52% reported an immediate decrease in pain, and 63% reported an overall decrease in pain. Seventy-one percent of patients intended to use the gel pack in the future. Use of such gel packs, which are available commercially, does not damage the skin. Our study indicates that cold application does provide some symptomatic relief of headache; it may also offer psychological alleviation of the pain.

Cluster Headache↗

PubMed2004

Adjunctive therapy for percutaneous revascularization in acute myocardial infarction.

Primary PCI is an effective reperfusion strategy for acute MI patients, which has evolved significantly in the last decade. While many adjunctive therapies have contributed to its success, substantial obstacles remain before optimal reperfusion can be achieved. Anti-platelet therapy with aspirin, clopidogrel and GP IIb/IIIa inhibitors reduces early ischemic complications, improves microvascular function and, potentially, affects the inflammatory response to ischemic injury. Current anti-thrombin therapy with UFH can be improved with LMWH, and, possibly with direct thrombin inhibitors. A number of important aspects of this strategy, though, need still to be elucidated. We need to optimize microvascular protection before and during PCI in order to capitalize on the myocardial sparing effects of reperfusion therapy. This will be probably achieved with a combination of pharmacological interventions and mechanical emboli protection devices. Improved and more targeted anti-inflammatory therapy should decrease the effects of neutrophil-related reperfusion injury, while a variety of metabolic interventions might preserve myocardial function during ischemia and after reperfusion.

Angioplasty, Balloon, Coronary↗

PubMed2003

Efficacy and safety of brimonidine, dorzolamide and latanoprost as adjunctive therapy in primary open angle glaucoma.

A double-blind, randomised, controlled trial was carried out to evaluate the efficacy and safety of brimonidine, dorzolamide and latanoprost as an adjunctive therapy in patients with primary open angle glaucoma (POAG). A total of 200 males and 72 females with POAG uncontrolled with previous glaucoma therapy were randomly allocated to receive topical brimonidine 0.2% b.d. (n = 90), topical dorzolamide 2% b.d. (n=91) or topical latanoprost 0.005% o.d. (n = 91). One year post treatment, the mean percentage reduction in intraocular pressure (IOP) between the three groups was statistically significant (p < 0.0001). In an intergroup comparison of efficacy, there was a statistically significant difference between the brimonidine and dorzolamide groups (p = 0.018) and between the dorzolamide and latanoprost groups (p = 0.76) but the efficacy of brimonidine was not significantly higher than latanoprost in the brimonidine and latanoprost groups (p = 0.002). Patients experiencing mild to severe side-effects were statistically similar in the three groups. On an inter-drug comparison of side-effects, we found no statistically significant difference in the brimonidine and latanoprost groups (p = 0.25); and the brimonidine and dorzolamide groups (p = 0.067), while the number of side-effects with latanoprost was significantly higher in the dorzolamide and latanoprost groups (p<0.003). All three drugs caused a significant reduction in the mean IOP from pretreatment values. The brimonidine group had a higher number of patients experiencing severe side-effects necessitating alteration of therapy.

Administration, Topical↗

PubMed2006

Measurement of seizure freedom in adjunctive therapy studies in refractory partial epilepsy: the levetiracetam experience.

PURPOSE: To assess the advantages and disadvantages of six methodologies used in calculating seizure freedom rates in placebo-controlled, adjunctive therapy trials of new antiepileptic drugs (AEDs) in partial epilepsy, and two methodologies for long-term follow-up studies. METHODS: Data from levetiracetam trials were used to illustrate the impact of different methodologies on seizure freedom rates. Seizure-freedom data for several new AEDs were identified from the published medical literature using MEDLINE and from a recent comprehensive textbook. RESULTS: Most randomized, placebo-controlled add-on clinical trials of new AEDs contain little or no information about seizure freedom. Importantly, the methodology used can profoundly affect results when calculating seizure-free rates. Seizure freedom data should be reported as well as the methodology used. The minimum duration for assessing seizure freedom should be the entire stable dose period in short-term trials and at least six months for long-term follow-up studies. It is proposed that the seizure freedom rates be calculated and reported with at least two different methodologies, one that considers patients withdrawing from treatment without having had a seizure as successes, and one that considers the same patients as failures. For an effective and well-tolerated AED, seizure freedom rates will be consistent across the two methodologies. CONCLUSIONS: Seizure freedom is the ultimate goal of AED therapy and should be reported for all clinical trials. Methodological differences among the few clinical studies reporting seizure freedom rates make it difficult to compare results across trials. Improved reporting of methodologies and seizure-free rates is warranted.

Adult↗

PubMedDate not supplied

Cadaveric allograft as adjunct therapy for nonhealing ulcers.

The objective of this study was to describe the results of a retrospective survey of 27 patients who were treated with cadaveric skin allograft as an adjunct therapy for wound management. The evolution, benefits, indications, and future of cadaveric skin allografts are also discussed. Glycerin-preserved, frozen, cadaveric split-thickness skin allograft was sutured to excised wounds and held in place with a stent dressing. Retrospective data recovered from wound assessment forms and progress reports were used to evaluate the effectiveness of this treatment. The etiology, pre- and postexcisional volume, depth of debridement, time taken for granulation tissue to first appear, allograft life span, volume post allograft removal, healing time, time expired from allograft to skin grafting, and reported pain were documented and presented. A total of 34 ulcers in 27 patients of various etiologies were evaluated. Pre-excisional volume averaged 6448.2 mm3, while the volume post allograft debridement averaged 9159.0 mm3. The length of time the biologic dressing remained in place averaged 29.1 days. Granulation tissue became first apparent through the fenestrations in the graft at an average of 13.4 days. Pain was notably reduced in 53% of the patient's post debridement with application of allograft. Only 12% of the patients experienced an increase in pain and 35% related no change. Most (65%) of the patients healed via secondary intention. The rest (35%) underwent split-thickness skin grafting. The average healing time was 113.9 days. No infections occurred while the allograft was in place. Lower extremity wounds present many challenges that may lengthen the course of treatment. As healing time increases, so too does the risk of various complications such as infection, desiccation, and damage to underlying soft tissues. The benefits of allograft treatment are particularly noteworthy in areas where bone and/or tendon are exposed. In these cases it becomes especially difficult to promote granulation tissue growth. Cadaveric skin allografts aid in preventing desiccation, help to control infection, and can substantially reduce patient discomfort.

Bandages↗

PubMed2006

Inhaled insulin as adjunctive therapy in subjects with type 2 diabetes failing oral agents: a controlled proof-of-concept study.

AIM: This controlled proof-of-concept study investigated inhaled insulin (INH) as adjunctive therapy to existing oral antidiabetic agents in subjects with type 2 diabetes. METHODS: Twenty-four subjects with type 2 diabetes [19 men and 5 women, 56.1 +/- 6.6 years, body mass index 32.7 +/- 4.2 kg/m(2), glycosylated haemoglobin (HbA1c) 8.4 +/- 0.8% (mean +/- s.d.)] inadequately controlled by metformin and/or sulfonylureas were randomized to receive additional therapy with either INH administered preprandially using a metered-dose inhaler (MDI), or insulin glargine (GLA) injected subcutaneously at bedtime for 4 weeks. Both inhaled and injected insulin doses were titrated to predefined blood glucose (BG) targets. RESULTS: INH and GLA improved metabolic control to a similar extent. Mean daily BG decreased by 2.8 mmol/l in the INH group (p < 0.001) and by 2.4 mmol/l in the GLA group (p < 0.001). Accordingly, fasting BG (-2.7 vs. -3.6 mmol/l for INH vs. GLA), preprandial- and 2-h postprandial BG, HbA1c (-1.23 vs. -1.05%), body weight (-1.9 vs. -2.3 kg) and serum fructosamine were similarly and significantly reduced in both groups (p < 0.05). Triglycerides decreased significantly with INH (-1.15 micromol/l; p < 0.001) but not with GLA [-0.52 micromol/l; not significant (NS)]. Incidence rates of adverse events did not differ significantly, and there were no indications of respiratory tract irritation. CONCLUSIONS: In subjects with type 2 diabetes inadequately controlled by oral agents, preprandial administration of INH delivered by a MDI provided a comparable metabolic control to bedtime GLA and did not show any safety concerns during a 4-week treatment. These results warrant a more extensive investigation of preprandial treatment with INH in longer term studies.

Administration, Inhalation↗

PubMed1999

Corticosteroids as adjunctive therapy for severe Pneumocystis carinii pneumonia in non-human immunodeficiency virus-infected patients: retrospective study of 31 patients.

The aim of this retrospective study was to assess whether corticosteroid adjunctive therapy (CAT) could prevent death in immunocompromised patients with severe Pneumocystis carinii pneumonia (PCP) who do not have human immunodeficiency virus (HIV) infection, similarly to what has been demonstrated for HIV-infected patients. The charts of all non-HIV-infected patients who were admitted to two medical intensive care units between 1988 and 1996 because of severe PCP, defined by an arterial oxygen pressure (determined while the patient was breathing room air) of <70 mm Hg, and who were treated with trimethoprim-sulfamethoxazole were analyzed retrospectively. Thirty-one patients met the study criteria, of whom 23 received CAT (within 72 hours of antibiotic therapy) and eight did not receive CAT. The need for mechanical ventilation (10 [43%] of 23 vs. 4 [50%] of 8) and the mortality rate (9 [39%] of 23 vs. 4 [50%] of 8) were similar for the two groups. Although this small study does not have a statistical power high enough to rule out the possibility of a difference, the results suggest that CAT does not improve the survival of non-HIV-infected patients as has been described for HIV-infected patients with severe PCP.

Adolescent↗

PubMed2003

Tranexamic acid is beneficial as adjunctive therapy in treating major upper gastrointestinal bleeding in dialysis patients.

BACKGROUND: In a pilot, non-randomized trial we tested the efficacy of tranexamic acid (TXA), a potent fibrinolytic inhibitor, as adjunctive therapy in standard treatment of major upper gastrointestinal bleeding in dialysis patients. METHODS: Twenty consecutive patients (12 male, eight female; 63+/-8 years) with 36 episodes of major upper gastrointestinal bleeding were included in the study. In 16 episodes of bleeding TXA was used (in a dosage of 20 mg intravenously, followed for the next 4 weeks by 10 mg/kg/48 h orally), whereas in 20 other cases of bleeding, TXA was not used. The decision to use TXA was left to the attending physician's clinical judgement, resulting in all the more severe cases of bleeding being treated with TXA. RESULTS: Treatment including TXA was shown to be beneficial (relative to cases not treated with TXA) in terms of decreasing the rate of early re-bleeding (in the first week, 0 vs 6, P<0.05), the rate of early and late re-bleeding (in the first month, 1 vs 8, P<0.05), the rate of repeated endoscopic procedures (in the first month, 1 vs 8, P<0.05) and the number of blood transfusions needed (in the first month, 1.4+/-1.3 vs 2.6+/-1.5 units, P<0.05). CONCLUSIONS: The results of this pilot study suggest that TXA can be beneficial in the treatment of major upper gastrointestinal bleeding in dialysis patients. This remains to be definitely confirmed in a randomized study.

Aged↗

PubMed1999

A double-blind, randomized trial of topiramate as adjunctive therapy for partial-onset seizures in children. Topiramate YP Study Group.

OBJECTIVE: To evaluate the efficacy and safety of topiramate 6 mg/kg/day in children (age 2 to 16 years) as adjunctive therapy for uncontrolled partial-onset seizures with or without secondarily generalized seizures in a multicenter, randomized, double-blind, placebo-controlled trial. METHODS: Patients with at least six partial-onset seizures during the 8-week baseline phase were treated with either topiramate (n = 41) or placebo (n = 45) for 16 weeks. RESULTS: Topiramate-treated patients had a greater median percent reduction from baseline in average monthly partial-onset seizure rate than placebo-treated patients (33.1% versus 10.5%, p = 0.034), a greater proportion of treatment responders (i.e., patients with a > or = 50% seizure rate reduction; 16 of 41 [39%] versus 9 of 45 [20%], p = 0.080), and patients with a > or = 75% seizure rate reduction (7 of 41 [17%] versus 1 of 45 [2%], p = 0.019), and better parental global evaluations of improvement in seizure severity (p = 0.019). Emotional lability (12% versus 4%), fatigue (15% versus 7%), difficulty with concentration or attention (12% versus 2%), and forgetfulness/impaired memory (7% versus 0%) were more frequent among topiramate-treated than placebo-treated patients. Most treatment-emergent adverse events were mild or moderate in severity. No topiramate-treated patients discontinued the study due to adverse events. CONCLUSIONS: Topiramate was safe and effective in the treatment of partial-onset seizures in children.

Adolescent↗

PubMed1991

Adjunctive therapy of allergic bronchopulmonary aspergillosis with itraconazole.

Itraconazole is a new orally active antifungal triazole with impressive activity against Aspergillus spp. Six patients with allergic bronchopulmonary aspergillosis (ABPA), aged 14 to 49 years, were treated with oral itraconazole (200 mg twice daily) for a mean of 3.9 months (range, one to six months; three patients continue on therapy). Two patients received two courses. Three patients had underlying cystic fibrosis, and three had severe asthma; four of the six required continuous high-dose systemic prednisone (mean, 43 mg/day; confidence interval [CI], 23 to 63 mg/day) at the start of therapy. In those treated for two months or longer, the mean total serum IgE level fell from 2,462 U/ml (CI, 752 to 4,202 U/ml) to 502 U/ml (CI, 123 to 880 U/ml) during each course, and the mean daily steroid dosage was decreased to a mean of 24 mg/day (CI, 11 to 37 mg/day). All patients experienced improvement in pulmonary function during the trial, with mean FEV, increasing from 1.43 to 1.77L/sec and mean FVC from 2.3 to 2.9 L in those treated for two months or longer. The mean steady-state serum concentration of itraconazole was 5.1 micrograms/ml (range, 1.8 micrograms/ml to 7.3 micrograms/ml); the patient with the lowest concentrations had the least significant clinical response. Cultures of sputum from two of three patients became negative for A fumigatus during therapy. No adverse clinical effects occurred except loss of libido in one patient. We conclude that oral itraconazole may be an effective adjunctive therapy in ABPA, possibly by clearing the airway of Aspergillus, and that randomized trials of this agent are warranted to better define its usefulness in this disorder.

Adolescent↗

PubMed2003

Nonconvulsive status epilepticus due to a de novo contralateral focus during tiagabine adjunctive therapy.

We describe a 30-year-old woman with an infantile-onset epilepsy due to a left temporal gliotic area who developed a nonconvulsive status epilepticus (NCSE) during tiagabine (TGB) adjunctive therapy. The ictal EEG recording showed a de novo right temporal focus not previously evident. After the i.v. administration of 4 mg lorazepam, the NCSE episode rapidly resolved and her usual left temporal EEG abnormalities reappeared. To our knowledge this is the first case of paradoxical seizure exacerbation associated with TGB therapy in which the clinical and EEG features are congruous with a new contralateral focus.

Adult↗

PubMed1975

Primary and adjunctive therapy in carcinoma of the adrenal cortex.

The absence of a clinically useful staging system for carcinoma of the adrenal cortex has permitted undue pessimism to develop and prevented effective evaluation of postoperative adjunctive therapy. The records of 15 patients undergoing operation for carcinoma of the adrenal gland were studied, and a staging system is proposed. The correlation between the proposed clinical stages and a patient's survival time was highly significant. An aggressive surgical approach toward both the primary tumor and the isolated metastatic lesion appears warranted. In those patients with functioning tumors, determination of urinary steroid levels provides early evidence of recurrence.

Adolescent↗

PubMed1998

A multicenter study comparing dorzolamide and pilocarpine as adjunctive therapy to timolol: patient preference and impact on daily life.

BACKGROUND: A multicenter, 4-week, two-period crossover study, comparing 2% dorzolamide three times daily to 2% pilocarpine four times daily as adjunctive therapy to 0.5% timolol twice daily, was conducted on 81 patients with elevated intraocular pressure (IOP). The treatments were evaluated for patient preference, tolerability, impact on daily life, IOP control, and visual-field changes. METHODS: The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to assess patient preference, as well as the perception of side effects and activity limitations resulting from the study medications. IOP measurements and visual-field examinations were obtained at baseline and at the end of each crossover period. RESULTS: Of the 77 patients who participated in both periods, 63 (82%) preferred dorzolamide. Patients who expressed a preference preferred dorzolamide over pilocarpine by a ratio of more than 10:1. Patients reported less interference with their daily life because of side effects and activity limitations while receiving dorzolamide than while receiving pilocarpine. Dorzolamide and pilocarpine were comparably effective in lowering IOP (16% to 17%). Also, significantly more patients reported adverse experiences and discontinued therapy as a result of adverse experiences while receiving pilocarpine than while receiving dorzolamide. CONCLUSION: The results of this multicenter study support those of two previous single-center studies; these results show that dorzolamide was greatly preferred over pilocarpine and had better tolerability and less adverse impact on patients' daily lives than pilocarpine.

Adrenergic beta-Antagonists↗

PubMed1999

Adjunctive therapy in epilepsy: a cost-effectiveness comparison of two AEDs.

The objective of this study was to compare the relative cost-effectiveness of two AEDs by a prospective clinical audit. Patients starting on the adjunctive therapies lamotrigine and topiramate were recruited from the out-patient epilepsy clinics at Queen Square. Three interview were scheduled: baseline; three months follow-up and six months from baseline. Of the 81 patients recruited, a total of 73 patients completed all three interviews. An intention to treat analysis was performed on the data. Seizure severity and frequency were assessed using the National Hospital Seizure Severity Scale. Side-effects, adverse events and reasons for stopping medication were also recorded. At the third interview, a total of 47/73 (64%) were still on the prescribed adjunctive drug. Outcome was assessed by two methods: the > 50% seizure reduction cited in the literature and a more stringent assessment of patient 'satisfaction' which we defined operationally on clinical criteria. Using this definition, a total of 10/73 (14%) patients were 'satisfied'. The relative costs of starting patients on each of the two AEDs were calculated, both drug costs and the costs of adverse events (the latter were defined as events requiring urgent medical attention). The costs of the two drugs were compared. A number of methodological issues relating to cost comparison are discussed. Outcome and pharmaco-economic studies need to assess more than reduction in number of seizures. They should take into account variables important for quality of life including side-effects and adverse events.

Adult↗

PubMedDate not supplied

Adjunctive therapy for intractable epilepsy with ethotoin.

In a retrospective study, records of 46 patients (24 women and 22 men aged 17-51 years; mean 29.2 years), who had been treated with ethotoin (EHN) as adjunctive therapy for control of intractable seizures were reviewed. Overall, approximately 51% of this highly selected patient population had a reduction greater than 50% in overall seizure frequency 1 month after initiation of treatment. This was reduced to approximately 25% for the last 3 months of follow-up (mean follow-up period 10.6 months). Tonic seizure frequency was reduced most dramatically, by greater than 50%, in 60% of patients at 1 month and in 35% of patients for the last 3 months of follow-up. This study suggests that prospective controlled trials of EHN, especially for tonic seizures, are needed.

Adolescent↗

PubMed1991

Adjunctive therapy with intravenous human immunoglobulin G improves survival of patients with acute renal failure.

The objective of this prospective, randomized, double-blind, placebo-controlled clinical trial was to evaluate the efficacy of adjunctive therapy with iv human immunoglobulin G in reducing the morbidity and mortality associated with acute renal failure. Forty patients greater than or equal to 18 yr of age who were identified within 48 h of the onset of acute renal failure and who met the enrollment criteria were enrolled in the study. Thirty-five patients were considered evaluable. Patients were grouped according to the admitting service (medical or surgical/trauma) and were randomized to receive either immunoglobulin G (400 mg/kg body wt) or placebo (normal saline; 8 mL/kg body wt) at study entry and then weekly thereafter for a maximum of 4 doses. The groups were well balanced with respect to demographics, clinical presentation, and severity of illness (APACHE II scores). A significant reduction in mortality at 42 days after study entry was observed. Two of 17 (12%) patients in the immunoglobulin G-treated group compared with 8 of 18 (44%) patients in the placebo-treated group died (P = 0.025). No differences were observed in the frequency of major complications that occurred in association with acute renal failure. However, in patients who manifested infection, greater survival was observed in the immunoglobulin G treatment group. The results suggest that immunoglobulin G administered at the onset of acute renal failure reduced mortality possibly by decreasing the severity of infectious complications associated with the occurrence of of acute renal failure.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Kidney Injury↗

PubMed2003

Intravenous immunoglobulin adjunctive therapy in sepsis, with special emphasis on severe invasive group A streptococcal infections.

Immunotherapy targeted against microbial toxins and host mediators has been studied in many preclinical investigations and clinical trials of sepsis during the past 20 y. Intravenous immunoglobulin, including both monoclonal and polyclonal antibodies, represents one such immunotherapeutic strategy. Mononclonal antibodies directed against endotoxin or tumour necrosis factor-alpha have been tested extensively in clinical trials, but have so far failed to reveal a significant effect on mortality rates. Several studies have assessed the efficacy of polyclonal intravenous immunoglobulin (IVIG) in sepsis, with varying results. Although there are no conclusive data available to date to support the use of IVIG therapy in all sepsis cases, there are strong indications that certain defined septic subgroups, such as streptococcal toxic shock syndrome caused by group A streptococcus, will benefit from its use. This review briefly summarizes the clinical trials on IVIG therapy in sepsis, and describes in more detail the mechanistic actions of IVIG and the clinical data that support the use of IVIG as adjunctive therapy in severe invasive group A streptococcal infections.

Humans↗