121 research outputs found

    Early insulin glargine initiation in iranian people with uncontrolled type 2 diabetes: Glycemic control, and adverse events

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    To explore glycemic control, and adverse events of Iranian people with uncontrolled type 2 diabetes after initiation of long-acting basal insulin, glargine. People with uncontrolled type 2 diabetes that was on at least two oral anti-diabetic drugs (OAD) were enrolled in this observational prospective study. Insulin glargine was prescribed by physicians in the course of routine clinical practice. Patients were followed for 24 weeks. Insulin doses were titrated to reach fasting blood sugar (FBS) target between 90 mg/dl and 130 mg/dl. HbA1c and adverse events were recorded at baseline, week 12, and week 24. Form a total of 292 participants, 243 patients completed the study. HbA1c, FBS, postprandial glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol, but not body mass index decreased during the study. The proportion of poorly controlled patients (HbA1C>9) decreased from 172 (58.9) to 39(13.4), and 21(7.2) during follow up. Controlled glycemia (HbA1C<7) was detected in 7(2.4), 48 (16.4) and 56 (19.2) of patients at baseline, week 12 and week 24. Hypoglycemia was reported in 5.1 and 3.4 of the participants in the week at 12 and 24, respectively. Patients felt more satisfied with their blood glucose control, timing and choices of meals, and hypo/hyperglycemic experiences. Insulin glargine initiation in people with uncontrolled type 2 diabetes on 2 OADs is associated with significant improvement in metabolic control. Insulin glargine has good safety profile and well tolerated by the patients. © 2018 Tehran University of Medical Sciences. All rights reserved

    Treatment with disease-modifying drugs for people with a first clinical attack suggestive of multiple sclerosis

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    Background: The treatment of multiple sclerosis has changed over the last 20 years. The advent of disease-modifying drugs in the mid-1990s heralded a period of rapid progress in the understanding and management of multiple sclerosis. With the support of magnetic resonance imaging early diagnosis is possible, enabling treatment initiation at the time of the first clinical attack. As most of the disease-modifying drugs are associated with adverse events, patients and clinicians need to weigh the benefit and safety of the various early treatment options before taking informed decisions. Objectives: 1. to estimate the benefit and safety of disease-modifying drugs that have been evaluated in all studies (randomised or non-randomised) for the treatment of a first clinical attack suggestive of MS compared either with placebo or no treatment; 2. to assess the relative efficacy and safety of disease-modifying drugs according to their benefit and safety; 3. to estimate the benefit and safety of disease-modifying drugs that have been evaluated in all studies (randomised or non-randomised) for treatment started after a first attack ('early treatment') compared with treatment started after a second attack or at another later time point ('delayed treatment'). Search methods: We searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group Trials Register, MEDLINE, Embase, CINAHL, LILACS, clinicaltrials.gov, the WHO trials registry, and US Food and Drug Administration (FDA) reports, and searched for unpublished studies (until December 2016). Selection criteria: We included randomised and observational studies that evaluated one or more drugs as monotherapy in adult participants with a first clinical attack suggestive of MS. We considered evidence on alemtuzumab, azathioprine, cladribine, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, immunoglobulins, interferon beta-1b, interferon beta-1a (Rebif®, Avonex®), laquinimod, mitoxantrone, natalizumab, ocrelizumab, pegylated interferon beta-1a, rituximab and teriflunomide. Data collection and analysis: Two teams of three authors each independently selected studies and extracted data. The primary outcomes were disability-worsening, relapses, occurrence of at least one serious adverse event (AE) and withdrawing from the study or discontinuing the drug because of AEs. Time to conversion to clinically definite MS (CDMS) defined by Poser diagnostic criteria, and probability to discontinue the treatment or dropout for any reason were recorded as secondary outcomes. We synthesized study data using random-effects meta-analyses and performed indirect comparisons between drugs. We calculated odds ratios (OR) and hazard ratios (HR) along with relative 95% confidence intervals (CI) for all outcomes. We estimated the absolute effects only for primary outcomes. We evaluated the credibility of the evidence using the GRADE system. Main results: We included 10 randomised trials, eight open-label extension studies (OLEs) and four cohort studies published between 2010 and 2016. The overall risk of bias was high and the reporting of AEs was scarce. The quality of the evidence associated with the results ranges from low to very low. Early treatment versus placebo during the first 24 months' follow-up There was a small, non-significant advantage of early treatment compared with placebo in disability-worsening (6.4% fewer (13.9 fewer to 3 more) participants with disability-worsening with interferon beta-1a (Rebif®) or teriflunomide) and in relapses (10% fewer (20.3 fewer to 2.8 more) participants with relapses with teriflunomide). Early treatment was associated with 1.6% fewer participants with at least one serious AE (3 fewer to 0.2 more). Participants on early treatment were on average 4.6% times (0.3 fewer to 15.4 more) more likely to withdraw from the study due to AEs. This result was mostly driven by studies on interferon beta 1-b, glatiramer acetate and cladribine that were associated with significantly more withdrawals for AEs. Early treatment decreased the hazard of conversion to CDMS (HR 0.53, 95% CI 0.47 to 0.60). Comparing active interventions during the first 24 months' follow-up Indirect comparison of interferon beta-1a (Rebif®) with teriflunomide did not show any difference on reducing disability-worsening (OR 0.84, 95% CI 0.43 to 1.66). We found no differences between the included drugs with respect to the hazard of conversion to CDMS. Interferon beta-1a (Rebif®) and teriflunomide were associated with fewer dropouts because of AEs compared with interferon beta-1b, cladribine and glatiramer acetate (ORs range between 0.03 and 0.29, with substantial uncertainty). Early versus delayed treatment We did not find evidence of differences between early and delayed treatments for disability-worsening at a maximum of five years' follow-up (3% fewer participants with early treatment (15 fewer to 11.1 more)). There was important variability across interventions; early treatment with interferon beta-1b considerably reduced the odds of participants with disability-worsening during three and five years' follow-up (OR 0.52, 95% CI 0.32 to 0.84 and OR 0.57, 95% CI 0.36 to 0.89). The early treatment group had 19.6% fewer participants with relapses (26.7 fewer to 12.7 fewer) compared to late treatment at a maximum of five years' follow-up and early treatment decreased the hazard of conversion to CDMS at any follow-up up to 10 years (i.e. over five years' follow-up HR 0.62, 95% CI 0.53 to 0.73). We did not draw any conclusions on long-term serious AEs or discontinuation due to AEs because of inadequacies in the available data both in the included OLEs and cohort studies. Authors' conclusions: Very low-quality evidence suggests a small and uncertain benefit with early treatment compared with placebo in reducing disability-worsening and relapses. The advantage of early treatment compared with delayed on disability-worsening was heterogeneous depending on the actual drug used and based on very low-quality evidence. Low-quality evidence suggests that the chances of relapse are less with early treatment compared with delayed. Early treatment reduced the hazard of conversion to CDMS compared either with placebo, no treatment or delayed treatment, both in short- and long-term follow-up. Low-quality evidence suggests that early treatment is associated with fewer participants with at least one serious AE compared with placebo. Very low-quality evidence suggests that, compared with placebo, early treatment leads to more withdrawals or treatment discontinuation due to AEs. Difference between drugs on short-term benefit and safety was uncertain because few studies and only indirect comparisons were available. Long-term safety of early treatment is uncertain because of inadequately reported or unavailable data

    Early insulin glargine initiation in iranian people with uncontrolled type 2 diabetes: Glycemic control, and adverse events

    Get PDF
    To explore glycemic control, and adverse events of Iranian people with uncontrolled type 2 diabetes after initiation of long-acting basal insulin, glargine. People with uncontrolled type 2 diabetes that was on at least two oral anti-diabetic drugs (OAD) were enrolled in this observational prospective study. Insulin glargine was prescribed by physicians in the course of routine clinical practice. Patients were followed for 24 weeks. Insulin doses were titrated to reach fasting blood sugar (FBS) target between 90 mg/dl and 130 mg/dl. HbA1c and adverse events were recorded at baseline, week 12, and week 24. Form a total of 292 participants, 243 patients completed the study. HbA1c, FBS, postprandial glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol, but not body mass index decreased during the study. The proportion of poorly controlled patients (HbA1C>9) decreased from 172 (58.9) to 39(13.4), and 21(7.2) during follow up. Controlled glycemia (HbA1C<7) was detected in 7(2.4), 48 (16.4) and 56 (19.2) of patients at baseline, week 12 and week 24. Hypoglycemia was reported in 5.1 and 3.4 of the participants in the week at 12 and 24, respectively. Patients felt more satisfied with their blood glucose control, timing and choices of meals, and hypo/hyperglycemic experiences. Insulin glargine initiation in people with uncontrolled type 2 diabetes on 2 OADs is associated with significant improvement in metabolic control. Insulin glargine has good safety profile and well tolerated by the patients. © 2018 Tehran University of Medical Sciences. All rights reserved

    Treatment with disease modifying drugs for people with a first clinical attack suggestive of multiple sclerosis

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    This is the protocol for a review and there is no abstract. The objectives are as follows: To estimate the benefit and safety of all DMDs that have been evaluated in all studies (randomised and non-randomised) for early treatment. We will employ novel, high-quality methods for systematic reviews and network meta-analysis in collaboration with the Cochrane Multiple Interventions Group. To evaluate the quality of the evidence provided by existing studies. We will consider the credibility of included studies and other characteristics of the evidence base as we characterise conclusions pertaining to high, low or very low quality of evidence. We will undertake this review in accordance with the methods described by the template protocol published online and will use this template as we prepare the review

    Challenges to promoting population-based cancer registration in Iran: A workshop report

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    In December 2011, the Cancer Research Centre of the Cancer Institute of Iran sponsored a 3-day workshop on "Cancer Registration Principle and Challenges in Iran", which convened cancer registry experts. The objectives of the workshop were: to introduce standard cancer registration, to review the policy and procedure of cancer registration in Iran, and to review the best practices in the cancer registries in Iran. Challenges to cancer registration were discussed and recommendations were developed. The workshop was evaluated by participants for better organization of subsequent workshops. The objective of publication of this report is that based on Cancer in 5 Continents, many low- or middle-income countries do not meet the criteria for a standard population-based cancer registry (PBCR); on the other hand cancer is the most important cause of mortality and the essential part of any cancer control program is the cancer registry. Therefore this report focuses on problems and challenges of PBCR and provides recommendations which might help other developing countries to decrease their PBCR defects

    Using data linkage to electronic patient records to assess the validity of selected mental health diagnoses in English Hospital Episode Statistics (HES)

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    <div><p>Background</p><p>Administrative data can be used to support research, such as in the UK Biobank. Hospital Episode Statistics (HES) are national data for England that include contain ICD-10 diagnoses for inpatient mental healthcare episodes, but the validity of these diagnoses for research purposes has not been assessed.</p><p>Methods</p><p>250 peoples' HES records were selected based on a HES recorded inpatient stay at the South London and Maudsley NHS Foundation Trust with a diagnosis of schizophrenia, a wider schizophrenia spectrum disorder, bipolar affective disorder or unipolar depression. A gold-standard research diagnosis was made using Clinical Records Interactive Search pseudonymised electronic patient records using, and the OPCRIT+ algorithm.</p><p>Results</p><p>Positive predictive value at the level of lifetime psychiatric disorder was 100%, and at the level of lifetime diagnosis in the four categories of schizophrenia, wider schizophrenia spectrum, bipolar or unipolar depression was 73% (68–79). Agreement varied by diagnosis, with schizophrenia having the highest PPV at 90% (80–96). Each person had an average of five psychiatric HES records. An algorithm that looked at the last recorded psychiatric diagnosis led to greatest overall agreement with the research diagnosis.</p><p>Discussion</p><p>For people who have a HES record from a psychiatric admission with a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or unipolar depression, HES records appear to be a good indicator of a mental disorder, and can provide a diagnostic category with reasonable certainty. For these diagnoses, HES records can be an effective way of ascertaining psychiatric diagnosis.</p></div
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