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Selected AbstractsLong-term glycaemic control with metformin,sulphonylurea,pioglitazone triple therapy in PROactive (PROactive 17)DIABETIC MEDICINE, Issue 10 2009A. J. Scheen Abstract Aims, We assessed the long-term glycaemic effects and the safety profile of triple therapy with the addition of pioglitazone vs. placebo in patients with Type 2 diabetes treated with combined metformin,sulphonylurea therapy in the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive). Methods, In a post-hoc analysis, we identified patients treated with metformin plus sulphonylurea combination therapy and not receiving insulin at baseline (n = 1314). In those patients, we compared the effects of pioglitazone (force-titrated to 45 mg/day, n = 654) vs. placebo (n = 660) on glycated haemoglobin (HbA1c) reduction, concomitant changes in medications and initiation of permanent insulin use (defined as daily insulin use for a period of , 90 days or ongoing use at death/final visit). Results, Significantly greater reductions in HbA1c and greater proportions of patients with HbA1c at target were noted with pioglitazone vs, placebo, despite a decrease in the use of other oral glucose-lowering agents. There was an approximate twofold increase in progression to permanent insulin use in the placebo group vs. the pioglitazone group: 31.1 vs. 16.1%, respectively, when added to combination therapy. The overall safety of the metformin,sulphonylurea,pioglitazone triple therapy was good. Conclusions, Intensifying an existing dual oral therapy regimen to a triple oral regimen by adding pioglitazone to the classical metformin,sulphonylurea combination resulted in sustained improvements in glycaemic control and reduced progression to insulin therapy. The advantages and disadvantages of adding pioglitazone instead of adding basal insulin should be assessed further. [source] An audit of the value of patch testing and its effect on quality of lifeCONTACT DERMATITIS, Issue 5 2003P. N. Woo We have assessed the value of patch testing from the patient's perspective and examined the impact of patch testing on their quality of life (QoL). 140 patients were recruited over 5 months. 2 questionnaires were designed to investigate the patient's views on patch testing. The 1st questionnaire was completed at the final visit to the clinic and the 2nd was posted 6 weeks later. The Dermatology Life Quality Index (DLQI) questionnaire was completed on both occasions. There was a significant improvement of the DLQI score in all patch-tested subjects (P = 0·003). Patients with involvement of the trunk had worse QoL. At the 4-day visit, 77 patients (55%) expressed the opinion that patch testing had been helpful. 6 weeks later, 71 patients replied. 47 patients were diagnosed as having allergic contact dermatitis: 87% of them found that patch testing had been useful, 91% were able to avoid the allergen(s) and 57% reported improvement/clearing in their skin condition. 58% of the 24 patients with negative results also found that patch testing had been beneficial. Overall, patient perception was that they understood verbal information (92%) better than written information (76%). Patch testing is beneficial to patients, leading to improved QoL. Patient perception was that they understood verbal advice better than written information. [source] Earlier triple therapy with pioglitazone in patients with type 2 diabetesDIABETES OBESITY & METABOLISM, Issue 9 2009G. Charpentier Aims: This study assessed the efficacy of add-on pioglitazone vs. placebo in patients with type 2 diabetes uncontrolled by metformin and a sulphonylurea or a glinide. Methods: This multicentre, double-blind, parallel-group study randomized 299 patients with type 2 diabetes to receive 30 mg/day pioglitazone or placebo for 3 months. After this time, patients continued with pioglitazone, either 30 mg [if glycated haemoglobin A1c (HbA1c) ,6.5%] or titrated up to 45 mg (if HbA1c >6.5%), or placebo for a further 4 months. The primary efficacy end-point was improvement in HbA1c (per cent change). Secondary end-points included changes in fasting plasma glucose (FPG), insulin, C-peptide, proinsulin and lipids. The proinsulin/insulin ratio and homeostasis model assessment of insulin resistance (HOMA-IR) and homeostasis model assessment of ,-cell function (HOMA-B) were calculated. Results: Pioglitazone add-on therapy to failing metformin and sulphonylurea or glinide combination therapy showed statistically more significant glycaemic control than placebo addition. The between-group difference after 7 months of triple therapy was 1.18% in HbA1c and ,2.56 mmol/l for FPG (p < 0.001). Almost half (44.4%) of the patients in the pioglitazone group who had a baseline HbA1c level of <8.5% achieved the HbA1c target of < 7.0% by final visit compared with 4.9% in the placebo group. When the baseline HbA1c level was , 8.5%, 13% achieved the HbA1c target of < 7.0% in the pioglitazone group and none in the placebo group. HOMA-IR, insulin, proinsulin and C-peptide decreased and HOMA-B increased in the pioglitazone group relative to the placebo group. Conclusions: In patients who were not well controlled with dual combination therapy, the early addition of pioglitazone improved HbA1c, FPG and surrogate measures of ,-cell function. Patients were more likely to reach target HbA1c levels (< 7.0%) with pioglitazone treatment if their baseline HbA1c levels were < 8.5%, highlighting the importance of early triple therapy. [source] Behavioral Sleep Modification May Revert Transformed Migraine to Episodic MigraineHEADACHE, Issue 8 2007Anne H. Calhoun MD Background.,Sleep problems have been linked with headaches for more than a century, but whether the headaches are the cause or the result of the disrupted sleep is unknown. Objectives.,We previously reported that nonrestorative sleep and poor sleep habits are almost universal in a referral population of women with transformed migraine (TM). Since cognitive behavioral therapy is effective in improving sleep quality in individuals with poor sleep hygiene, we designed a randomized, placebo-controlled study to assess the impact of such treatment on TM. We hypothesized that behavioral sleep modification (BSM) would be associated with improvement in headache frequency and intensity and with reversion to episodic migraine. Methods.,Subjects were 43 women with TM referred to an academic headache center. After obtaining informed consent, patients were randomized to receive either behavioral sleep instructions or placebo behavioral instructions in addition to usual medical care. Subjects recorded headaches in standardized diaries. The first postintervention visit was scheduled at 6 weeks. At that visit, the blind was broken and all subjects received BSM instructions. A final visit was scheduled 6 weeks later. Results.,Compared to the placebo behavioral group, the BSM group reported statistically significant reduction in headache frequency [F (1, 33 = 12.42, P=.001)] and headache intensity [F(1, 33 = 14.39, P= .01)]. They were more likely to revert to episodic migraine ,2 (2, n = 43) = 7.06, P= .029. No member of the control group reverted to episodic migraine by the first postintervention visit. By the final visit, 48.5% of those who had received BSM instructions had reverted to episodic migraine. Conclusions.,In this pilot study of women with TM, we found that a targeted behavioral sleep invention was associated with improvement in headache frequency, headache index, and with reversion to episodic migraine. [source] Evaluation of fipronil spot-on in the treatment of flea allergic dermatitis in dogsJOURNAL OF SMALL ANIMAL PRACTICE, Issue 2 2003L. Medleau The purpose of this study was to evaluate the effectiveness of treatment with 10 per cent fipronil solution for controlling signs of flea allergic dermatitis in dogs under field conditions. Thirty-one client-owned dogs with flea allergic dermatitis were treated with three monthly applications of 10 per cent fipronil solution. Flea counts and pruritus were significantly reduced at all post-treatment visits. At the final visit, on day 90, flea counts were reduced by 98 per cent, and pruritus was reduced or eliminated in 84 per cent of the study dogs. Dermatological lesion scores for erythema, crusts, scales and papules were also significantly improved by the final visit. The overall assessment of efficacy on day 90 was,excellent'to,good'for 87 per cent of the study dogs. The results demonstrate that treatment with monthly topical applications of 10 per cent fipronil solution is effective in reducing the prevalence and severity of signs of flea allergic dermatitis in dogs. [source] Acetyl-l-carnitine in the treatment of painful antiretroviral toxic neuropathy in human immunodeficiency virus patients: an open label studyJOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, Issue 1 2006Maurizio Osio Abstract Antiretroviral toxic neuropathy causes morbidity in human immunodeficiency virus (HIV) patients under dideoxynucleoside therapy, benefits only partially from medical therapy, and often leads to drug discontinuation. Proposed pathogeneses include a disorder of mitochondrial oxidative metabolism, eventually related to a reduction of mitochondrial DNA content, and interference with nerve growth factor activity. Carnitine is a substrate of energy production reactions in mitochondria and is involved in many anabolic reactions. Acetyl carnitine treatment promotes peripheral nerve regeneration and has neuroprotective properties and a direct analgesic role related to glutamatergic and cholinergic modulation. The aim of this study was to evaluate acetyl-l-carnitine in the treatment of painful antiretroviral toxic neuropathy in HIV patients. Twenty subjects affected by painful antiretroviral toxic neuropathy were treated with oral acetyl-l-carnitine at a dose of 2,000 mg/day for a 4-week period. Efficacy was evaluated by means of the modified Short Form McGill Pain Questionnaire with each item rated on an 11-point intensity scale at weekly intervals and by electromyography at baseline and final visit. Mean pain intensity score was significantly reduced during the study, changing from 7.35 ± 1.98 (mean ± SD) at baseline to 5.80 ± 2.63 at week 4 (p = 0.0001). Electrophysiological parameters did not significantly change between baseline and week 4. In this study, acetyl-l-carnitine was effective and well tolerated in symptomatic treatment of painful neuropathy associated with antiretroviral toxicity. On the contrary, no effect was noted on neurophysiological parameters. [source] High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: A prospective randomized trial,ARTHRITIS & RHEUMATISM, Issue 5 2010Michelle Petri Objective Monthly intravenous (IV) cyclophosphamide for 6 months has been the standard induction regimen for lupus nephritis, followed by a maintenance regimen of quarterly infusions for 2 years. We undertook this study to compare the efficacy and safety of the standard regimen versus a high-dose IV cyclophosphamide regimen. Methods We performed a prospective randomized trial comparing monthly IV cyclophosphamide at 750 mg/m2 body surface area for 6 months followed by quarterly IV cyclophosphamide for 2 years (traditional treatment) against high-dose IV cyclophosphamide (50 mg/kg daily for 4 days) (high-dose treatment). Entry criteria included renal lupus, neurologic lupus, or other organ system involvement with moderate-to-severe activity. Results Fifty-one patients were randomized; 3 withdrew before treatment and 1 committed suicide after 2 months of high-dose treatment. Twenty-two had renal lupus, 14 had neurologic lupus, and 11 had other organ involvement. The outcome measure was the Responder Index for Lupus Erythematosus (complete response, partial response, no change, or worsening). At 6 months (the end of induction), 11 of 21 patients (52%) in the high-dose treatment group had a complete response compared with 9 of 26 patients (35%) in the traditional treatment group (P = 0.13). At the final visit (30 months), 10 of 21 patients (48%) in the high-dose treatment group had a complete response compared with 13 of 20 patients (65%) who continued with traditional treatment (P = 0.13). Six patients crossed over from traditional treatment to high-dose treatment because of lack of response, and 3 of those patients became complete responders. Conclusion There was not strong evidence that monthly IV cyclophosphamide and high-dose IV cyclophosphamide differed in complete or in any (complete or partial) response to induction or maintenance therapy. However, nonresponders to monthly IV cyclophosphamide can sometimes be rescued with high-dose IV cyclophosphamide. [source] Comparison of a 3-day with a 1-day regimen of an extended-release formulation of ciprofloxacin as antimicrobial prophylaxis for patients undergoing transrectal needle biopsy of the prostateBJU INTERNATIONAL, Issue 1 2007Anthony J. Schaeffer OBJECTIVE To compare the clinical and bacteriological efficacy and the clinical safety of a 1-day with a 3-day regimen of an extended-release formulation of ciprofloxacin (ciprofloxacin XR) given as antimicrobial prophylaxis to men undergoing transrectal needle biopsy of the prostate (TRNBP). PATIENTS AND METHODS This was a multicentre, prospective, international, double-blind study in patients who required TRNBP. Patients were randomized to receive oral ciprofloxacin XR 1000 mg as either a 1-day or a 3-day regimen. Single doses were given at 24 h before, 2,3 h before, and 24 h after TRNBP. Patients in the 1-day regimen had placebo instead of the first and third doses of ciprofloxacin. RESULTS Of 497 patients enrolled, 247 were randomized to 1-day ciprofloxacin XR and 250 to the 3-day regimen. In the population valid for microbiological efficacy, the final assessment identified bacteriological success (primary efficacy endpoint) in more patients who had the 3-day regimen (98%) than in those who received the 1-day regimen (94.8%, 95% confidence interval, CI, ,,6.1%, 0.8%), although the difference was not statistically significant. In this population, the clinical response at the final visit was 98.5% and 96.7% for patients receiving the 3-day and the 1-day regimens, respectively (95% CI ,,5.2%, 0.8%). However, in the clinical efficacy population the clinical success rate was significantly greater for the 3-day (99.0%) than for the 1-day regimen (95.8%; 95% CI ,,6.4%, ,,0.3%). In a multivariate analysis, patients with diabetes mellitus and patients with a history of prostatitis had higher microbiological and clinical failure rates, respectively, than those without such conditions. For these patients, all failures occurred among those treated with the 1-day regimen. CONCLUSION As defined by bacteriological success in the population assessed for microbiological efficacy, prophylaxis with one dose of ciprofloxacin XR was statistically no worse than a 3-day regimen. However, in all efficacy analyses, bacteriological and clinical success rates were consistently lower for the 1-day than for the 3-day treatment. Thus, for selected patients undergoing TRNBP, there might be a role for 3-day preventive therapy with ciprofloxacin XR. [source] Oxcarbazepine treatment in male epilepsy patients improves pre-existing sexual dysfunctionACTA NEUROLOGICA SCANDINAVICA, Issue 2 2009G. Luef Objective,,, To collect data on sexual dysfunction in a larger population of male patients with epilepsy treated with oxcarbazepine in a naturalistic setting. Patients and methods,,, Six hundred seventy-three adult male patients with partial epilepsy in whom monotherapy with oxcarbazepine was indicated were evaluated at baseline and after approximately 12 weeks of treatment with regard to the number of seizures and occurrence of any adverse drug reactions. All patients were questioned regarding their sexual function. Results,,, Out of 228 patients with pre-existing sexual function impairment at baseline, an improvement was observed in 181 (79.4%) patients, 23 (10.1%) patients experienced no impairment at the final visit. The improvements were more marked in those patients, who were pretreated with enzyme-inducing antiepileptic drugs. No worsening of the sexual dysfunction was observed. Conclusions,,, Oxcarbazepine was found to have beneficial effects on sexual dysfunction and to be effective and well tolerated in male patients with partial epilepsy. [source] Topiramate in painful diabetic polyneuropathy: findings from three double-blind placebo-controlled trialsACTA NEUROLOGICA SCANDINAVICA, Issue 4 2004The Topiramate Diabetic Neuropathic Pain Study Group Objectives , To evaluate the efficacy and tolerability of topiramate in patients with painful diabetic polyneuropathy. Materials and methods , Patients with moderate to extreme pain (0,4 Categorical Pain Scale score , 2) were randomized to placebo or topiramate (100, 200, or 400 mg/day) in three similar double-blind trials. The primary efficacy analysis was pain reduction from final visit to baseline in the 100-mm Visual Analog Scale (VAS) for the intent-to-treat populations. Results , After 18,22 weeks of double-blind treatment, pain reductions were numerically greater with topiramate in two studies but differences between topiramate and placebo in VAS scores or in the secondary efficacy endpoints did not reach statistical significance in any of the three studies. Across all studies, 24% of topiramate-treated patients and 8% of placebo-treated patients discontinued due to adverse events; groups did not differ in the occurrence of serious adverse events. Conclusion , These studies did not find topiramate to be significantly more effective than placebo in reducing pain scores in patients with painful diabetic polyneuropathy. Several design features may have precluded the studies from having sufficient sensitivity to differentiate effective and ineffective treatments. The study design and results are instructive for other investigators designing future clinical studies in neuropathic pain. [source] 2327: Preservative free tafluprost 0.0015% in the treatment of patients with ocular hypertension and glaucoma: results of a multi-center open-label observational studyACTA OPHTHALMOLOGICA, Issue 2010I LANZL Purpose Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated. Methods Data were collected in a non-interventional prospective multi-center observational open label study. IOP readings were recorded for each eye at baseline (prior therapy or untreated) and 12 weeks after changing or initiating treatment with preservative-free tafluprost. Change in IOP was evaluated over the study period for all patients and for specific pre-treatment subgroups. Local comfort was measured using a 5 step scale. All adverse events were recorded. Results Data from 2123 patients with glaucoma or ocular hypertension were eligible for the final evaluation. In all patients preservative-free tafluprost lowered IOP from 19.5+4.4 mmHg at baseline to 16.4+2.9 mmHg after 12 weeks. Preservative-free tafluprost also lowered IOP significantly in all monotherapy-subgroups: Na,ve patients (N=440): 22.6+3.9 mmHg to 16.7+2.7mmHg; betablockers (N=307): 20.3+3.5 mmHg (baseline) to 16.7+2.6 mmHg (week 12); CAI's (N=158): 19.0+3.6 mmHg to 16.0+2.6 mmHg; PG's (N=447): 16.8+2.9 mmHg to 15.8+2.6 mmHg. Local comfort was rated as 'very good' or 'good' by 85.6% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion Preservative-free tafluprost was effective, well tolerated and safe in a broad patient population. Local comfort and patient satisfaction improved after change of medical treatment in the vast majority of patients. Commercial interest [source] Serum IgG reactivity to subgingival bacteria in initial periodontitis, gingivitis and healthy subjectsJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 7 2000A. C. R. Tanner Abstract Background/aims: Established periodontal diseases may be associated with antibody responses to periodontal pathogens, but it is not known at which stage of disease this antibody response is initiated. This study aimed to characterize the host systemic response in initial periodontitis, gingivitis, and periodontal health, to evaluate whether elevated serum antibodies to subgingival species could be detected in initial periodontitis. Method: Human systemic immune response were evaluated to 40 subgingival bacterial species in 16 healthy, 21 gingivitis, 11 initial periodontitis and 5 progressing recession adults. Subjects had minimal periodontal attachment level (AL) loss at baseline. Disease categories were determined after 12 months monitoring at three-month intervals. Increased AL loss 1.5 mm (disease activity) at interproximal sites defined initial periodontitis, recession was characterized by AL loss at buccal sites. Serum IgG antibodies were evaluated semi-quantitatively by immunoblot from blood taken at baseline, active and final visits. Results: No antibody was detected from 55% of reactions. When detected, levels were below those reported for advanced periodontitis subjects. There were no major differences in serum antibody levels between healthy, gingivitis and initial periodontitis subjects, despite differences in the subgingival microbiota. Serum antibodies for more species were detected in recession subjects, compared with the other study subjects. No changes in antibody levels were detected between baseline, active, and final visits. No systematic association between species colonization and presence of systemic antibody was observed. Conclusions: This study did not detect differential elevation of mean serum antibody levels in initial periodontitis subjects, suggesting that serum antibody levels are not sensitive risk markers for initial periodontitis. [source] Accommodative esotropia following surgical treatment of infantile esotropia: frequency and risk factorsACTA OPHTHALMOLOGICA, Issue 3 2008Onder Uretmen Abstract. Purpose:, We aimed to examine the frequency of and risk factors for the development of accommodative esotropia following surgical treatment for infantile esotropia. Methods:, A total of 29 children were recruited. Potential risk factors for the development of accommodative esotropia included: sex; angle of deviation at initial and final visits; cycloplegic refractive error at initial and final visits; increase in hyperopia; amblyopia; amblyopia treatment; age at surgical treatment; pre- and postoperative latent nystagmus; dissociated vertical deviation or inferior oblique muscle overaction; additional surgical procedures; unstable alignment, and binocular sensory status. Results:, Overall, 14 (48.2%) of 29 children developed accommodative esotropia during the 36- to 132-month postoperative follow-up period. Twelve (85.7%) of the 14 patients developed refractive accommodative esotropia and two developed non-refractive accommodative esotropia. The onset of accommodative esotropia occurred at a mean of 8.8 months (range 6,24 months) after the initial surgical alignment. This corresponded to a mean age of onset for accommodative esotropia of 43.2 months. We determined that, among children with infantile esotropia, those who had hyperopia of , 3.0 D and increasing hyperopia after surgery and those who did not develop dissociated vertical deviation during the follow-up period were more likely to develop accommodative esotropia. Conclusions:, Children who have the established risk factors should be followed closely for the development of accommodative esotropia. The treatment of these children with appropriate glasses may prevent the development of adverse effects of accommodative esotropia on sensory and motor functions. [source] | ||||||||||||||||||||||