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Results for “adjunct therapy”

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PubMed1999

Comparison of dorzolamide and pilocarpine as adjunctive therapy in patients with open-angle glaucoma and ocular hypertension.

Many patients with glaucoma or ocular hypertension initially receive beta-blocker monotherapy to control intraocular pressure (IOP), but some of these patients will require an additional IOP-lowering agent within 1 year. This active-controlled, double-masked, randomized, multicenter, 12-week study compared the effectiveness and tolerability of dorzolamide hydrochloride ophthalmic solution 2% TID with those of pilocarpine hydrochloride 2% QID as adjunctive therapy to timolol maleate ophthalmic gel-forming solution (TG) 0.5% QD as measured by changes in IOP and occurrence of adverse events. One hundred ninety-four patients with open-angle glaucoma or ocular hypertension participated in this study. Their mean age was approximately 63 years. Slightly more than one half were white, and approximately one third were black. After a 3-week run-in period during which all patients received TG 0.5% QD, patients with an IOP of > or = 22 mm Hg at the morning trough measurement were randomly assigned to receive additional double-masked therapy with either dorzolamide or pilocarpine. The primary outcome measure was the mean change in IOP at the morning trough measurement from baseline to week 12. The secondary outcome measure was the mean change in IOP at the morning peak measurement from baseline to week 12. There was no significant difference in IOP-lowering effect between the 2 drugs at either morning trough or morning peak. The mean change in IOP at morning trough was -3.17 mm Hg (-12%) in patients receiving dorzolamide; it was -3.45 mm Hg (-13%) in patients receiving pilocarpine. The mean change in IOP at morning peak was -2.25 mm Hg (-10%) for patients who received dorzolamide and -2.51 mm Hg (-11%) for those who received pilocarpine. In the pilocarpine group, 62 (63%) patients experienced > or =1 adverse event compared with 35 (36%) patients in the dorzolamide group (P < 0.001). Twenty-one (21%) patients in the pilocarpine group discontinued treatment because of an adverse event compared with 2 (2%) patients in the dorzolamide group (P < 0.001). These results demonstrate that dorzolamide and pilocarpine were equally effective as adjunctive therapy in lowering IOP but that dorzolamide was better tolerated.

Adjuvants, Pharmaceutic↗

PubMed2006

Employment, medical absenteeism, and disability perception in Parkinson's disease: A pilot double-blind, randomized, placebo-controlled study of entacapone adjunctive therapy.

The objective of this study was to test the impact of entacapone (ENT) addition to levodopa with a decarboxylase inhibitor (LD) in full-time-employed patients with Parkinson's disease (PD), focusing on retirement rates, medical absenteeism, self-perception of disability, as well as motor assessments of parkinsonism, motor fluctuations, and dyskinesias. Thirty full-time-employed PD patients (disease onset before age 60 years) and on optimized monotherapy with LD exhibiting minor motor fluctuations or dyskinesias were entered into a 2-year randomized double-blind placebo-controlled study of ENT adjunctive therapy. The outcome measures were the number of full-time-employed patients at study end, cumulative days of medical absenteeism, patient-completed disability assessments, diary records, and the Unified Parkinson's Disease Rating Scale-based measures of motor fluctuations and dyskinesias. LD + ENT treatment was associated with a lower retirement rate (2 [17%] of 12 vs. 6 [50%] of 12; P = 0.12), lower absenteeism rate (21.5 vs. 43.5 days; P < 0.0001), improved self-perception of disability progression over 2 years (change score 1.0 vs. 4.5; P < 0.0001), and lower scores for both motor fluctuations and dyskinesia assessments compared to LD monotherapy. In this pilot study, LD with ENT adjunctive therapy positively influenced employment rate over 2 years; this effect was associated with reduced motor complications and patient perceptions of stabilized disability.

Absenteeism↗

PubMed1999

Gabapentin as adjunctive therapy for partial seizures.

The safety, tolerability, and efficacy of gabapentin as adjunctive therapy were assessed in epileptic patients who had experienced up to four complex partial seizures per month while receiving phenytoin and/or carbamazepine. This was a multicenter, open-label prospective study, with the treatment period lasting 20 weeks. The gabapentin dosage was titrated to effective tolerated dose up to 2400 mg/day. Quality of life was evaluated with the QOLIE-10 questionnaire. A total of 141 patients were enrolled; 114 patients were evaluated for efficacy analysis. The mean maintenance dose of gabapentin was 1600 mg/day. Seventy-one percent of patients (81 patients) experienced a 50% or greater reduction in seizure frequency and 46% (52 patients) became seizure free. The most frequent adverse effects included drowsiness (16%), dizziness (9%), and asthenia (6%). Sixteen patients (11%) discontinued the study prematurely because of adverse events. A significant improvement was observed in five of the 10 questions of the QOLIE-10.

Acetates↗

PubMed1997

Intravenous lidocaine as adjunctive therapy in the treatment of decompression illness.

Two cases of severe decompression illness for which IV lidocaine was used as adjunctive therapy to recompression and hyperbaric oxygen therapy are described. The first patient demonstrated improvement only after lidocaine was added to her treatment; the second had essentially complete recovery after only a single treatment despite severe symptoms and a significant delay in presentation. These cases support the need for a controlled clinical trial of lidocaine as an adjunct to hyperbaric therapy in decompress on illness.

Adult↗

PubMed1995

Etretinate as an effective adjunctive therapy for recalcitrant palmar/plantar hyperkeratosis in patients with erythrodermic cutaneous T cell lymphoma undergoing photopheresis.

BACKGROUND: Patients with erythrodermic cutaneous T cell lymphoma (CTCL) frequently have debilitating hyperkeratosis of the palms and soles that is refractory to therapy. OBJECTIVE: To evaluate the efficacy of etretinate as an adjunctive therapy for recalcitrant palmar and plantar hyperkeratosis in erythrodermic CTCL patients undergoing photopheresis. METHODS: Five patients with erythrodermic CTCL and recalcitrant palmar and plantar hyperkeratosis were given etretinate (0.8 mg/kg per day) while undergoing photopheresis therapy. RESULTS: There was a rapid and marked improvement of the hyperkeratosis in all patients. CONCLUSION: Etretinate is a safe and effective adjunctive treatment for recalcitrant palmar and plantar hyperkeratosis in erythrodermic CTCL patients undergoing photopheresis.

Aged↗

PubMed1996

Early management of acute myocardial infarction: thrombolysis, angioplasty, and adjunctive therapies.

Early identification and treatment, including administration of intravenous thrombolytics, coronary angioplasty, and adjunctive therapies, has been shown to benefit patients who present with acute myocardial infarction. However, only a small percentage of these patients receive such therapies because of late presentation, associated risks, and controversies around certain myocardial infarct subsets. The logistics involved in carrying out these treatments have resulted in unnecessary prehospital and in-hospital delays. These issues make essential the availability of a streamlined protocol that should be updated at regular intervals to ensure that these time-dependent therapies are more routinely and rapidly utilized. This article discusses these topics in conceptual format and provides a ready-to-use protocol.

Angioplasty, Balloon, Coronary↗

PubMed2005

Intra-arterial thrombolysis for acute ischemic stroke: preliminary experience with platelet glycoprotein IIb/IIIa inhibitors as adjunctive therapy.

OBJECTIVE: To evaluate the safety profile of platelet glycoprotein IIb/IIIa inhibitors administered as adjunctive therapy to patients with large-vessel occlusion and acute ischemic stroke refractory to pharmacological thrombolysis with recombinant tissue plasminogen activator (rtPA) and mechanical disruption, balloon angioplasty, or both. METHODS: Twenty-one patients (mean age, 62 yr; range, 29-88 yr) met the following criteria: 1) large-vessel occlusion and acute ischemic stroke syndrome at presentation, 2) failure to recanalize after administration of rtPA (intra-arterial and/or intravenous) with or without mechanical thrombolysis, and 3) subsequent treatment with IIb/IIIa inhibitors (intra-arterial or intravenous). RESULTS: Eleven patients had ischemia in the dominant hemisphere, 8 in the vertebrobasilar system, and 2 in the nondominant hemisphere. Twelve patients received intravenous rtPA without significant improvement; 9 patients were not candidates for intravenous rtPA. All patients received intra-arterial rtPA. The IIb/IIIa inhibitors were administered intravenously in 3 patients, intra-arterially in 16, and both intravenously and intra-arterially in 2. Balloon angioplasty was performed in 18 patients. Complete or partial recanalization was achieved in 17 of the 21 patients. After thrombolysis, 15 improved clinically. Three patients (14%) sustained an asymptomatic intracerebral hemorrhage after thrombolytic therapy. No patient was clinically worse after intervention. At last follow-up (mean, 8.5 mo), 13 patients were functionally independent (modified Rankin score, 0-3) and 8 were disabled or dead. CONCLUSION: IIb/IIIa inhibitors are an alternative for achieving recanalization. The risk of hemorrhage may be low. As part of an escalating protocol that includes pharmacological and mechanical thrombolysis, IIb/IIIa inhibitors may improve clinical outcomes.

Abciximab↗

PubMed2006

Associated inflammatory response in pneumonia: role of adjunctive therapy with glucocorticoids.

PURPOSE OF REVIEW: This article reviews the potential use of glucocorticoids as adjunctive therapy in the management of patients with severe bacterial pneumonia or pulmonary infections of other etiologies. RECENT FINDINGS: The importance of an adequate assessment of the inflammatory process and the appearance of inflammatory markers that correlate with the severity of pneumonia is underlined. A recent randomized clinical trial indicates that adjunctive treatment of severe community-acquired pneumonia with glucocorticoids reduces complications and improves survival. The role of glucocorticoids in other lung infections is also reviewed. The design of new compounds with similar anti-inflammatory properties to classical glucocorticoids but with significantly fewer side effects constitutes a specific challenge for the near future. SUMMARY: Although adjunctive treatment with glucocorticoids in severe pneumonia is probably indicated, further randomized clinical trials are urgently needed to confirm the preliminary positive results. In this regard, a proper evaluation of the inflammatory response is likely to be essential for the accurate selection of the target population.

Drug Therapy, Combination↗

PubMed1996

Enhancing Thrombolysis with Adjunctive Therapy.

The striking clinical benefits that can be derived from thrombolytic therapy in acute myocardial infarction emphasize the need for further improvement of our reperfusion strategies. New approaches in that direction include the development of more efficient thrombolytic drugs as well as an adjunctive therapy to control the ongoing thrombogenic stimulation. Aspirin is already useful in this regard as well as heparin with recombinant tissue-type plasminogen activator. The field of antithrombotic therapy is rapidly expanding with the development of patent drugs targeted at inhibiting specific steps of platelet activation and of the coagulation cascade. This new therapy provides opportunities to better understand the pathophysiological processes involved in acute ischemic syndromes and to modulate them. This article reviews the adjunctive antithrombotic therapy currently available or under clinical investigation with the potential of enhancing the benefits of thrombolysis.

Journal Article↗

PubMed2005

Intraocular pressure lowering effect of brinzolamide 1.0% as adjunctive therapy to latanoprost 0.005% in patients with open angle glaucoma or ocular hypertension: an uncontrolled, open-label study.

PURPOSE: A prospective study was conducted to evaluate the intraocular pressure (IOP) lowering effect of brinzolamide 1.0% ophthalmic suspension as an adjunctive therapy with latanoprost 0.005% ophthalmic solution in patients with open angle glaucoma or ocular hypertension. PATIENTS AND METHODS: Fourteen patients with open angle glaucoma (OAG) or ocular hypertension (OH) who had been using latanoprost 0.005% for more than 6 months were initiated on adjunctive brinzolamide therapy. The IOP values at 1 month, 2 months, and 3 months were compared with those measured immediately before adding brinzolamide to the regimen (baseline). The incidence of adverse events such as conjunctival hyperemia and corneal epithelial defect were also examined. RESULTS: The baseline IOP was 21.1 +/- 4.8 mmHg (mean +/- standard deviation). After 1 month, 2 months, and 3 months of therapy IOP was 16.9 +/- 4.5 mmHg, 16.6 +/- 4.0 mmHg, and 15.9 +/- 3.1 mmHg, respectively, showing significant reductions in IOP at all the measuring time-points during the study compared with the baseline value (p < 0.01). Conjunctival hyperemia developed in one patient after 1 month and in another after 2 months; however, both were mild, and therapy was continued. Corneal epithelium defect was observed in 3 patients. One of them had mild defect before brinzolamide was added to the regimen. Increase of eye discharge was seen in one patient. No serious side effects were otherwise observed. CONCLUSION: The addition of brinzolamide to a latanoprost 0.005% regimen may further lower intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Aged↗

PubMed1986

[Hyperbaric oxygenation--a sensible adjunctive therapy in malignant external otitis].

This study shows the effect of hyperbaric oxygenation as an adjunctive therapy in malignant external otitis on the basis of three cases: one stage I, one stage II, two stages III (according to Ganz). Due to the successes achieved, and basing on a comparative study of the literature, we can conclude, even without a control group, that hyperbaric oxygenation exercises a positive influence on the reduction of Pseudomonas aeruginosa in the external auditory canal, and on the symptoms of pain and regeneration of cerebral nerves injured with a broad-spectrum allergy to antibiotics, even the exclusive application of the hyperbaric oxygenation proved successful.

Aged↗

PubMed1997

Lamotrigine adjunctive therapy in childhood epileptic encephalopathy (the Lennox Gastaut syndrome).

PURPOSE: We assessed efficacy and safety of adjunctive lamotrigine (LTG) therapy in patients with the Lennox-Gastaut syndrome (LGS). METHODS: The study was a single-center, retrospective chart review of open-label adjunctive LTG therapy in patients with LGS. Initial LTG dose and titration was dependent on concomitant antiepileptic drugs (AEDs). Efficacy was based on the change in seizure frequency between the initiation of LTG therapy and December 1, 1995 (or LTG discontinuation). Seizure diaries were used to count patient seizures. A secondary evaluation of efficacy was a parental or guardian assessment of the patient's global status. The evaluation of safety involved chart review for treatment-emergent adverse events (AE). RESULTS: Data from 16 LGS patients were analyzed. Fifty-three percent (8 of 15) had a > 50% reduction in seizure frequency with LTG adjunctive therapy. Tonic, atonic, generalized tonic-clonic (GTCS), and atypical absence seizure frequency but not myoclonic seizure frequency decreased significantly during LTG therapy. Fifty-three percent of the patient's parents (8 of 15) reported that their child's quality of life (QOL) was much or very much improved during the study. The major treatment-emergent AE were infection (50%, 8 of 16) and sleep disturbance (19%, 3 of 16). A rash was noted in 13% (2 of 16) of the patients and resulted in LTG discontinuation in 1. No clinically significant changes were noted in neurologic examination or laboratory tests during the study. CONCLUSIONS: Our results indicate that LTG adjunctive therapy is effective and well tolerated in patients with LGS.

Adolescent↗

PubMed1999

Ursodeoxycholic acid as adjunctive therapy for problematic type 1 autoimmune hepatitis: a randomized placebo-controlled treatment trial.

To evaluate the efficacy of ursodeoxycholic acid as adjunctive therapy in type 1 autoimmune hepatitis, 37 patients who had experienced treatment failure, repeated relapse, or incomplete response were randomized to ursodeoxycholic acid (13-15 mg/kg daily) or placebo for 6 months in addition to their usual corticosteroid schedule. Serum aspartate transaminase (70% vs. 31%, P =.04) and alkaline phosphatase (47% vs. 7%, P =.02) levels improved more commonly in the 21 patients randomized to ursodeoxycholic acid. Mean serum levels, however, were similar before and after the treatment period. The frequency of dose reduction or corticosteroid withdrawal was comparable in both groups (29% versus 31%, P >.9), and clinical improvement (48% vs. 44%, P >.9) or its absence (52% vs. 56%, P >.9) occurred as commonly in patients receiving ursodeoxycholic acid or placebo. The modified histological activity score (3.5 +/- 0.8 vs. 3. 5 +/- 0.9) and the modified fibrosis score (2.4 +/- 0.4 vs. 2.4 +/- 0.4) were similar before and after treatment with ursodeoxycholic acid and no different than after placebo therapy. We conclude that ursodeoxycholic acid can improve certain laboratory tests in problematic patients with type 1 autoimmune hepatitis when administered adjunctively for 6 months. Short-term therapy, however, does not facilitate reduction in the dose of corticosteroids or its withdrawal, affect clinical outcome, or reduce histological activity.

Adult↗

PubMed1994

Intravenous torsemide as adjunctive therapy in patients with acute pulmonary edema.

The safety and efficacy of intravenous (i.v.) torsemide as adjunctive therapy for acute cardiogenic pulmonary edema was evaluated. Thirteen patients were treated with i.v. torsemide and six patients, with i.v. furosemide, as a positive control. Doses of torsemide, 20 mg or 40 mg, and furosemide, 40 mg or 80 mg, were administered initially. The dose was titrated as necessary over the next 24 hours. In patients who received i.v. torsemide, median fractional sodium excretion significantly increased from 2.88% (0.04-10.1%) at baseline to 6.76% (0.71-11.6%) at peak (P = 0.0342). Hourly urine volume increased from 134 mL (25-400 mL) to 375 mL (145-790 mL) (P = 0.0034). Torsemide administration resulted in a significant improvement in both pulmonary rales and orthopnea. None of the patients experienced serious adverse events or required withdrawal from the study. These results suggest that i.v. torsemide is an effective and well-tolerated diuretic in patients with acute cardiogenic pulmonary edema.

Acute Disease↗

PubMed2003

Subconjunctival mitomycin C as adjunctive therapy before pterygium excision.

PURPOSE: To evaluate the safety and efficacy of subconjunctival mitomycin C as adjunctive therapy before pterygium surgery. DESIGN: Prospective noncomparative case series. PARTICIPANTS: Thirty-six eyes of 36 patients. INTERVENTION: Thirty-six eyes of 36 patients prospectively received 0.1 ml of 0.15 mg/ml mitomycin C subconjunctivally injected into the head of the pterygium 1 month before bare sclera surgical excision. MAIN OUTCOME MEASURE: Recurrence of pterygia. RESULTS: The pterygia resolved in 34 (94%) of 36 eyes, with a recurrence rate of 6% over a mean follow-up of 24.4 months. No wound-healing complication developed in any patient. CONCLUSIONS: Subconjunctival mitomycin C is an effective treatment before pterygium excision. Subconjunctival injection allows exact titration of mitomycin C delivery to the activated fibroblasts and minimizes epithelial toxicity.

Adult↗

PubMed2003

Lamotrigine as adjunctive therapy in patients with refractory epilepsy and mental retardation.

This study evaluated the effects of lamotrigine as adjunctive therapy for refractory epilepsy in patients with mental retardation. Patients with epilepsy and mental retardation having uncontrolled seizures despite treatment with other antiepileptic drugs were eligible (n=67). The open-label study comprised a Baseline Phase, an Escalation Phase during which lamotrigine was titrated to a target dose, an 8-week Maintenance Phase during which doses of lamotrigine and concomitant antiepileptic drugs were maintained, and a 12-week Optimization Phase during which doses of lamotrigine and other antiepileptic drugs could be adjusted. Almost half (44%) of patients experienced a 50% reduction in seizure frequency during the Maintenance Phase after addition of lamotrigine; 15% of patients became seizure-free. A similar pattern of results was reported for the Optimization Phase. Investigator-rated clinical status was improved relative to baseline in 66 and 74% of patients at the end of the Maintenance and Optimization Phases, respectively. Most patients experienced improvements in seizure frequency, duration, and intensity during the Maintenance Phase (62 to 72%) and the Optimization Phase (65 to 74%). Many patients were rated as having improved social functioning during the Maintenance Phase (42%) and the Optimization Phase (46%). The Aberrant Behavior Checklist score for lethargy and the mean Habilitative Improvement Scale score were improved at the ends of the Maintenance and Optimization Phases relative to baseline (P< or =0.04). One limitation of this study is its open-label design, which limits the ability definitively to attribute the clinical improvements to lamotrigine. Adjunctive lamotrigine in patients with refractory epilepsy and mental retardation appears to decrease seizure frequency and improve behavior while permitting a reduction in dose of concomitant antiepileptic drugs.

Adolescent↗

PubMed2006

Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials.

INTRODUCTION: We conducted a post-hoc analysis on the effect of recombinant factor VIIa (rFVIIa) on coagulopathic patients from two randomized, placebo-controlled, double-blind trials of rFVIIa as an adjunctive therapy for bleeding in patients with severe trauma. METHODS: Blunt and penetrating trauma patients were randomly assigned to rFVIIa (200 + 100 + 100 microg/kg) at 0, 1, and 3 hours after transfusion of 8 units of red blood cells (RBCs) or to placebo. Subjects were monitored for 48 hours post-dosing and followed for 30 days. Coagulopathy was retrospectively defined as transfusion of fresh frozen plasma (FFP) (>1 unit of FFP per 4 units of RBCs), FFP in addition to whole blood, and transfusion of platelets and/or cryoprecipitate. RESULTS: Sixty rFVIIa-treated and 76 placebo subjects were retrospectively identified as being coagulopathic. No significant differences were noted in baseline characteristics. The rFVIIa-treated coagulopathic subgroup consumed significantly less blood product: RBC transfusion decreased by 2.6 units for the whole study population (P = 0.02) and by 3.5 units among patients surviving more than 48 hours (P < 0.001). Transfusion of FFP (1,400 versus 660 ml, P < 0.01), platelet (300 versus 100 ml, P = 0.01), and massive transfusions (29% versus 6%, P < 0.01) also dropped significantly. rFVIIa reduced multi-organ failure and/or acute respiratory distress syndrome in the coagulopathic patients (3% versus 20%, P = 0.004), whereas thromboembolic events were equally present in both groups (3% versus 4%, P = 1.00). CONCLUSION: Coagulopathic trauma patients appear to derive particular benefit from early adjunctive rFVIIa therapy.

Adult↗

PubMed1997

Can Extended-Release Isosorbide Mononitrate be Used as Adjunctive Therapy for Systolic Hypertension? An Open Study Employing Pulse-Wave Analysis to Determine Effects of Antihypertensive Therapy.

Augmentation of the systolic ejection pressure wave by an exaggerated reflectance wave, demonstrable by applanation tonometry of the radial artery, is an important contribution to systolic hypertension of the elderly. Therefore, a study of extended-release isosorbide mononitrate, which may reduce the augmentation, was performed in a group of patients aged 49 to 80 years with systolic hypertension. This agent was added, in a dose of 30 to 120 mg once daily, to existing antihypertensive medications and the response of the arterial pulse wave pattern was observed after 7 to 34 weeks of continuing treatment. There were decreases in brachial systolic blood pressure, indirectly measured aortic systolic blood pressure, and pulse wave augmentation. These findings indicate the need for controlled studies of nitrate therapy as an adjunct to treatment with conventional antihypertensive drugs in systolic hypertension of the elderly. The studies should include analysis of pulse waveform to complement conventional sphygmomanometry.

Journal Article↗