Accuracy in patient-reported adverse drug reactions and their recognition: a mixed-methods study.

BACKGROUND: The causality assessment tool can be utilized to assist patients in identifying adverse drug reactions (ADRs). AIM: To evaluate the accuracy of the causality assessment tool for patients identifying ADRs compared to assessments made by pharmacists, and to explore how patients recall and recognize symptoms as ADRs. METHOD: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with patients who had experienced ADRs in the past year at a tertiary care hospital in Thailand. RESULTS: Out of 769 questionnaires, 716 were returned and 622 of these were both valid and had at least one ADR (86.8%). Classification of patient-reported symptoms using the causality assessment tool found 12 (1.9%) highly-probable ADRs, 399 (64.1%) probable ADRs, 207 (33.3%) possible ADRs, and 4 (0.6%) that were not classified as ADRs. There was fair agreement between patient-assessed and pharmacist-assessed causality classifications using the Naranjo algorithm (K = 0.268) and the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria (K = 0.373). The timing relationship between the occurrence of symptoms and administration of a suspected drug was the most frequently mentioned reason that patients gave for recalling and recognizing suspected ADRs. CONCLUSION: Promoting the causality assessment tool for use by patients in collaboration with healthcare professionals is likely to enhance patients' ability to correctly identify ADRs and ultimately contribute to increased medication safety.

Normative Reference Values of the Tibial Nerve in Healthy Individuals Using Ultrasonography: A Systematic Review and Meta-Analysis.

BACKGROUND: High-resolution ultrasound of the tibial nerve has been used for screening of several neurologic disorders, but normative reference values of tibial nerve cross-sectional areas (CSA) have not been well established. Thus, the present meta-analysis was performed to generate normative estimates of tibial nerve CSA at various sites of the lower limb based on ultrasonography. METHODS: Google Scholar, Scopus and PubMed were searched for potential studies. Studies were required to report tibial nerve CSA in healthy individuals to be included. A random-effect meta-analysis was performed to calculate tibial nerve CSA values. Subgroup and statistical analyses were performed to study covariates. RESULTS: Forty-eight eligible articles consisting of 2695 limbs were included. The average tibial nerve CSA was found to be 10.9 mm2 at the ankle (95% CI: 9.9-11.8) and should not exceed 11.8 mm2 in healthy adults. At the popliteal fossa, the overall CSA was 21.7 mm2 (95% CI: 17.5-25.8) in healthy adults. At both sites, the average tibial nerve CSA was significantly larger in adults than in children, and the differences by geographical region were not statistically significant. At the ankle, tibial nerve CSA increased with age and body mass index, while at the popliteal fossa it increased with age and weight. CONCLUSIONS: our findings indicate that the tibial nerve varied not only along its course but also among sub-variables. Establishing normal references values of tibial nerve CSA is helpful to differentiate healthy from diseased tibial nerves such as in diabetic peripheral neuropathy or tarsal tunnel syndrome.

Cross-Sectional Area of the Tibial Nerve in Diabetic Peripheral Neuropathy Patients: A Systematic Review and Meta-Analysis of Ultrasonography Studies.

Background: There is a link between diabetic peripheral neuropathy (DPN) progression and the increase in the cross-sectional area (CSA) of the tibial nerve at the ankle. Nevertheless, no prior meta-analysis has been conducted to evaluate its usefulness for the diagnosis of DPN. Methods: We searched Google Scholar, Scopus, and PubMed for potential studies. Studies had to report tibial nerve CSA at the ankle and diabetes status (DM, DPN, or healthy) to be included. A random-effect meta-analysis was applied to calculate pooled tibial nerve CSA and mean differences across the groups. Subgroup and correlational analyses were conducted to study the potential covariates. Results: The analysis of 3295 subjects revealed that tibial nerve CSA was 13.39 mm2 (CI: 10.94−15.85) in DM patients and 15.12 mm2 (CI: 11.76−18.48) in DPN patients. The CSA was 1.93 mm2 (CI: 0.92−2.95, I2 = 98.69%, p < 0.01) larger than DPN-free diabetic patients. The diagnostic criteria of DPN and age were also identified as potential moderators of tibial nerve CSA. Conclusions: Although tibial nerve CSA at the ankle was significantly larger in the DPN patients, its clinical usefulness is limited by the overlap between groups and the inconsistency in the criteria used to diagnose DPN.

Evaluation of patient comprehension and quality of consumer medicine information

Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai- CMI is not routinely performed. Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided. Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand. Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% – 70.0% of answers found in the correct position and answered correctly. The mean values of patients’ rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size. Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers. (AU)

Evaluation of patient comprehension and quality of consumer medicine information.

Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai-CMI is not routinely performed. Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided. Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand. Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% - 70.0% of answers found in the correct position and answered correctly. The mean values of patients' rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size. Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers.

Evaluation of Patient's Knowledge of Atorvastatin Information in Patient Information Leaflets: A Pre-Post Intervention Study in Thailand.

PURPOSE: This study aimed to evaluate the effect of using atorvastatin PIL on patients' medication knowledge, perceptions of the PIL usefulness, their anxiety about the medication, and factors related to these aspects. PATIENTS AND METHODS: A pre-post intervention study was conducted in outpatients at a university hospital. Patients prescribed atorvastatin were enrolled using systematic random sampling. Participants were asked to complete Self-Administered Questionnaire to assess atorvastatin knowledge at baseline. An atorvastatin-PIL produced by the manufacturer was introduced to the participants as the intervention. One month after receiving the PIL, the participants were re-assessed. Ten questions were developed to assess atorvastatin knowledge and visual analog scale (VAS) was used to assess perceived benefits of using the PIL and patient anxiety about the medication. Multiple linear regression was used to assess the related factors. RESULTS: Of 450 questionnaires distributed, 370 were returned. Atorvastatin knowledge significantly increased with mean score of 5.06±1.92 at baseline to 8.34±1.79 at 1-month after intervention. Reading all sections of the PIL (p=0.017) and working for civil service (p=0.006) were associated with higher knowledge scores at baseline and after intervention. Low educational level was associated with lower knowledge scores at baseline (p=0.002), but experience of allergy (p=0.042) was associated with higher knowledge scores after the intervention. Patients had high level of perceived usefulness from the PIL (average scores=8.87±1.83) and low level of anxiety (average scores=3.69±3.06). Reading all sections of the PIL (p=0.007) and taking more than 5 medications (p=0.012) were related to perceived usefulness of the PIL. Females (p<0.001) and herbal supplement users (p=0.048) were related to anxiety about the medication. CONCLUSION: PILs could improve medication knowledge in patients. Patients' perceptions of benefits of PILs were high and anxiety about medication was low. Use of PILs should be encouraged to improve patients' knowledge and appropriate use of medications.

Real-world Evaluation of glycemic control and hypoglycemic Events among type 2 Diabetes mellitus study (REEDS): a multicentre, cross-sectional study in Thailand.

OBJECTIVE: Patients with type 2 diabetes mellitus (T2DM) often experience hypoglycaemia and weight gain due to treatment side effects. Sulfonylureas (SU) and the combination of SU and metformin (SU+MET) were the most common monotherapy and combination therapies used in Thailand tertiary care hospitals. This study aimed to assess the glycaemic goal attainment rates, hypoglycaemic episodes, weight gain and treatment compliance among patients with T2DM receiving SU or SU+MET. RESEARCH DESIGN AND METHODS: A multicentre cross-sectional survey and retrospective review was conducted in five tertiary care hospitals, Thailand. Patients with T2DM aged ≥30 years were included consecutively during a 12-month period. Glycaemic control, experiences of hypoglycaemia, weight gain and compliance were evaluated. Glycaemic goal attainment was defined by HbA1c level less than 7%. RESULTS: Out of the 659 patients (mean age (±SD)), 65.5 (10.0) years and median duration of T2DM (IQR), 10 (5-15) years), 313 (47.5%) achieved the glycaemic goal. HbA1c levels in the patients with goal attainment was significantly lower compared with those without (6.3%±0.5% vs 8.1%±1.2%, p<0.001). Goal attainment was significantly lower among patients treated with SU+MET than those treated with SU alone (43.5% vs 63.0%; OR 0.45, 95% CI 0.31, 0.66, p<0.001). A third of patients reported experiencing hypoglycaemia (30.7%) and weight gain (35.4%). Weight gain in the SU+MET group was lower than those receiving SU alone (33.1% vs 44.6%, p=0.015), but there was no difference in hypoglycaemic events. Major events in the previous 12 months were experienced by 68 patients, most commonly congestive heart failure and ischaemic heart disease. Approximately half of the patients (52.2%) reported not always taking their medication as prescribed. CONCLUSIONS: Among patients with T2DM receiving SU or SU+MET, only about half of the patients achieved glycaemic goal and compliance with the treatment. Hypoglycaemia and weight gain posed a significant burden with risk of weight gain higher in the SU group.

Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus (ZEUS II study).

The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two-week run-in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add-on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between-group mean difference, -0.7% [95% CI, -0.9% to -0.4%]; P-value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.

Impact of Hypoglycemia on Health-Related Quality of Life among Type 2 Diabetes: A Cross-Sectional Study in Thailand.

Type 2 diabetes mellitus (T2DM) is one of the most common chronic diseases. Patients are generally advised lifestyle changes with antihyperglycemic agents prescribed. The major drawback of prescribing antihyperglycemic agents is the risk of hypoglycemia which subsequently impacts on health-related quality of life (HRQoL). This study is aimed at examining association between previous history of hypoglycemia and HRQoL. The study was a multicenter cross-sectional study, conducted from February 2013 to March 2015 at 5 tertiary care hospitals in Thailand (Srinagarind, Phramongkutklao, Ramathibodi, King Chulalongkorn Memorial, and Siriraj hospitals). The study population were males or females diagnosed with type 2 DM according to ADA criteria, 30 years of age or older, who had been treated with sulfonylurea (SU) monotherapy or SU and metformin combination for at least 6 months. Prespecified medical factors were extracted from medical records 12 months prior to patients' enrolment. The experience of hypoglycemia questionnaire was used to collect and measure severity of hypoglycemia experienced during the previous 6 months. HRQoL was assessed using the 3-level version of EuroQol-5-dimension (EQ-5D-3L) and visual analogue scale (EQ-VAS) questionnaires. Of 659 eligible patients surveyed, 202 patients (30.65%) had experienced symptoms of hypoglycemia. HRQoL was significantly lower among patients reporting at least one of hypoglycemic symptoms, measured by EQ-VAS scores (mean ± SD; 73.66 ± 13.18, 73.56 ± 15.10, or 68.93 ± 14.76 vs. 77.01 ± 13.02, one-way ANOVA; p = 0.006) and EQ-5D-3L index scores (0.62 ± 0.47, 0.68 ± 0.38, or 0.58 ± 0.51 vs. 0.79 ± 0.31, one-way ANOVA; p < 0.001) for mild, moderate, or severe/very severe hypoglycemic patients compared with patients without hypoglycemic symptoms. After adjusting for confounding factors in a multiple linear regression model, patients with hypoglycemic symptoms either mild, moderate, or severe/very severe demonstrated significantly higher impairment for EQ-VAS and EQ-5D indexes than those who did not experience hypoglycemic symptoms. In conclusion, our study showed decreased HRQoL determined by EQ-5D and EQ-VAS in patients reporting symptoms of hypoglycemia compared with patients not reporting hypoglycemic symptoms, relative to severity of hypoglycemia.

Survey of outpatients' use and needs of patient medicine information leaflets in Thailand.

Background Patient information leaflets are important sources of medicine information. Regulations of patient information leaflet provision varies among country. Little is known regarding patients' behavior and expectation on use of patient information leaflets. Objectives To explore patients' use of either package inserts or patient information leaflets and to survey patients' expectations and needs on use of patient information leaflets and their associated factors. Setting Two university hospitals in Thailand. Methods Cross-sectional study using self-administered questionnaires distributed to outpatients over a 3-month period. Participants were selected through systematic random sampling. Logistic regression was used for data analysis. Main outcome measure Patient use of medicine information. Visual Analogue Scale scores for patient needs and their expectation of knowledge gains from using patient information leaflets. Results The response rate was 77.0%. Most respondents had received package inserts (91.3%) with 59.4% reporting that they sometimes read them. While most respondents had not previously known about patient information leaflets (75.9%), 97.3% reported that patient information leaflets would be useful. Respondents scored their needs and expected knowledge gains after reading patient information leaflets as 9.68 ± 0.97 and 9.64 ± 0.99, respectively. Previous experience with package inserts was associated with increased patient need scores (p = 0.002) and higher expected knowledge gains from use of patient information leaflets (p = 0.037). In addition, patients who had not previously known about patient information leaflets had higher expectations of knowledge gains (p = 0.016). Conclusion Overall, patients showed good behavior on reading package inserts. Although many patients were not previously aware of patient information leaflets, they realized the importance. Hence, patient information leaflets should be developed and provided to Thai patients.

Confidence and accuracy in identification of adverse drug reactions reported by outpatients.

Background Patient reporting of adverse drug reactions (ADRs) could supplement the existing reporting system and contribute to early detection of ADRs. The confidence in ADR identification and their attribution of ADRs were limited to outpatients. Objective To determine the type and frequency of ADRs reported by outpatients, to evaluate confidence and accuracy in ADR identification as well as contributing factors. Setting University hospital in northeastern Thailand Method Cross-sectional study using questionnaires distributed to 500 outpatients who claimed to have experienced an ADR. Confidence in identifying ADRs was measured by visual analogue score (VAS), while accuracy of reported ADRs was determined using Naranjo algorithm and WHO criteria. Main outcome measure Number and type of ADRs, confidence rating and accuracy category. Results In total, 390 outpatients completed the questionnaire (response rate = 78.0%). Rash (19.0%), nausea/vomiting (7.4%), and dizziness (5.8%) were the top three reported ADRs. Sixty-one percent of respondents rated their level of confidence in identifying ADRs as high (VAS 9.2 ± 0.95), which was associated with having underlying diseases (OR 1.93), low number of reported symptoms (OR 0.38) and severe ADRs (OR 1.33). Causality assessment was classified as true ADRs in 90.0% and 88.9% of cases, using Naranjo algorithm and WHO criteria, respectively. Respondents with low number of reported symptoms (OR 0.27) and high level of confidence had greater accuracy in ADR identification (OR 1.11). Conclusion The outpatients reported a high proportion of potential ADRs with high confidence and accuracy. Patient reporting of ADRs has potential to support the pharmacovigilance system.

Initial development and testing of an instrument for patient self-assessment of adverse drug reactions.

PURPOSE: To develop and conduct preliminary testing of a causality assessment tool for patients, for potential use in encouraging both discussions with clinicians about suspected adverse drug reactions (ADRs) and reporting to authorities. METHODS: Ten causality statements, developed from qualitative studies involving patients, with a scoring system allowing categorization, were embedded in a questionnaire which also included a symptom checklist and additional details about one suspected ADR and medicine, selected for causality assessment. Patients with experiences of suspected ADRs were involved in cognitive interviews (15), piloting (20) and psychometric testing (120). Test-retest reliability, construct validity and criterion-related validity were evaluated, through repeated causality assessment, comparison with a visual analogue scale assessing certainty of causality and comparison with causality assessment using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, respectively. The study involved outpatients at a university hospital in northeast Thailand. RESULTS: Ninety-eight patients completed causality assessment twice: both causality scores (Spearman rs = 0.715; p < 0.001) and causality classification [percentage of positive agreement (PPA) = 68.4; κ = 0.419; p < 0.001] showed satisfactory reliability. Causality scores were positively correlated with certainty of causality (Spearman rs = 0.556; p < 0.01). There was moderate agreement against WHO-UMC criteria [PPA = 70.4; κ = 0.440; p < 0.001]. Of the 91 completing an evaluation, 88% agreed that the tool should be used routinely, 78% agreed that it gave them useful results and 80% agreed that it was easy to use. CONCLUSIONS: This novel instrument has satisfactory psychometric properties and was acceptable to Thai patients, but it requires further testing. It has potential for use in supporting patients with suspected ADRs to discuss these with health professionals, and perhaps to report directly.

DIFFERENCES IN MORTALITY BY EDUCATION LEVEL AMONG PATIENTS IN DIABETIC REGISTRY FOR THAILAND.

This study was conducted in order to determine the impact of education on mortality due cardiovascular, infectious and renal disease, and cancer among Thai diabetics using data from the Thailand diabetes registry cohort prospected and conducted between April 2003 and February 2006. The study population consisted of 9,370 registered diabetic patients attending ten diabetes clinics at tertiary medical centers in Bangkok and major provinces. The population was classified by education level: those who had not yet attained a bachelor's degree classified as having "lower education" (7,684: 82%) and those with a bachelor's degree or higher classified as having "higher education" (1,686:18%). The overall mortality rate among those in the higher education group was lower than those in the lower education group (8.9 vs 20.5 per 1,000 patient-years, respectively) with a hazard ratio (HR) of 0.43 (0.31-0.61). The higher education group also had lower mortality rates due to infectious disease [HR 0.10 (0.02-0.41)], renal disease [HR 0.24 (0.06-0.99)] and cardiovascular disease [HR 0.42 (0.22-0.80)]. There was no difference in cancer mortality between the two groups [HR 1.25 (0.74-2.11)].

Statin adverse effects: patients' experiences and laboratory monitoring of muscle and liver injuries.

BACKGROUND: Although statins have great benefit on the prevention of cardiovascular diseases with limited adverse effects (AEs), little is known about patients' contribution of AE reports in clinical practice. OBJECTIVES: To explore patients' experiences of statin AEs and related laboratory monitoring in clinical practice. SETTING: Outpatient clinics of two University hospitals in northeast Thailand. METHODS: Generic symptom checklist questionnaires for self-reporting AEs were distributed to patients prescribed simvastatin, atorvastatin, or rosuvastatin at outpatient clinics. Clinical information was obtained from medical records. Reported symptoms were assessed for causality considering previously known statin AEs, concomitant diseases and drugs. MAIN OUTCOME MEASURE: Potential statin AEs reported by patients and monitoring of laboratory parameters related to musculoskeletal and liver disorders. RESULTS: Of the total 718 valid responses, 76.0 % of patients reported at least one symptom, most of which (69.0 %) were probable/possible statin AEs. Musculoskeletal and liver-related symptoms were reported by 283 (39.4 %) and 134 patients (18.7 %), respectively. Probable/possible AEs were categorized in 56.7 % of their musculoskeletal and gastrointestinal symptoms. Majority of patients had at least one laboratory test on initiation of (64.8 %) and during statin treatment (61.8 %). Patients taking atorvastatin or rosuvastatin, and patients with history of chronic renal diseases were more likely to have creatine kinase (CK) monitored on initiation of and during statin treatment. Additionally, taking drugs which could potentially increase muscle injury (OR 1.929, P < 0.01) and self-reporting of musculoskeletal symptoms (OR 1.805, P < 0.01) were associated with CK monitoring during statin treatment. Reporters of musculoskeletal symptoms also had significantly higher mean CK level than those not reporting any musculoskeletal symptoms (207.35 ± 155.40 vs. 143.95 ± 83.07 U/L, respectively; P = 0.037). Patient reporting of liver AEs was not related to alanine aminotransferase (ALT) level and monitoring, however, prior history of liver disorders was significantly associated with monitoring of ALT on initiation of and during statin treatment (OR 5.745 and OR 23.063, respectively; P < 0.01). CONCLUSION: Many patients experienced at least one possible adverse effects on a statin. The findings suggest that laboratory monitoring is relatively selective in relation to risks and patient-reported adverse symptoms.

A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions.

PURPOSE: To explore how Thai patients assess symptoms as adverse drug reactions (ADRs). METHODS: Out-patients at two hospitals in Thailand previously reporting suspected ADRs to statins were purposively selected to cover factors relevant to the accuracy of ADR reports. Semi-structured interviews explored the mechanisms participants used to work out whether their symptoms were related to their statin. All interviews were audio-recorded, transcribed and independently thematically analyzed by two researchers. RESULTS: One hundred interviews were suitable for analysis; 52 were male, age range was 36 to 77 years (mean ± S.D.: 59.83 ± 9.14) and most (92) were taking other medicines in addition to statins. Patient assessment of symptoms as ADRs fell into two major themes: medicine-related factors and external factors. Timing relationships were mentioned most frequently (74), followed by information received (55), seeing similar symptoms in others (7) and diagnosis through blood tests (4). Use of multiple medicines, consideration of the medicine versus diseases, symptoms occurring with more than one medicine or relieved through treatment reduced confidence in ADR attribution. Many participants proposed alternative explanations for symptoms, including old age. Lack of information and knowledge were obstacles to the assessment process. CONCLUSIONS: Patients assessed possible ADRs most often by considering timing relationships. While they also used medicine information, Thai patients received inadequate information to help them assess their symptoms. Patients expressed uncertainty and difficulties in deciding attribution when concomitant medicines and diseases were involved. The findings could support the development of a patient-friendly systematic tool for identifying and assessing possible ADRs.

Smoking and death in Thai diabetic patients: the Thailand Diabetic Registry cohort.

OBJECTIVE: To determine the impact of smoking and quit smoking on mortality rate. MATERIAL AND METHOD: This prospective cohort was a three-year follow-up of Thai Diabetes Registry project that registered 9,370 diabetic patients from 10 diabetic clinics in tertiary medical centers in Bangkok and major provinces between April 2003 and February 2006. RESULTS: The groups of 7,487 (80%), 1,315 (14%), and 568 (6%) patients were classified as non-smokers, ex-smokers, and current smokers. The crude death rate of ex-smokers (Hazard Ratio (HR) 1.52 (95% CI 1.19-1.95)) and current smokers (HR 1.55 (1.10-2.19)) were higher than death rate of non-smokers. After control for covariates, the HR comparing ex-smokers with non-smokers was not different (1.10 (0.81-1.50)), while the HR comparing current smokers with non-smokers remained statistical significant (1.74 (1.17-2.61)). CONCLUSION: Smoking increases mortality rate in diabetic patients by about 74%. Quitting smoking decreased mortality rate to the same rate as of diabetic non-smokers.

Abdominal epilepsy: an uncommon of non-convulsive status epilepticus.

OBJECTIVE: To recognize abdominal epilepsy in adults. MATERIAL AND METHOD: Case report. RESULTS: Case 1: A 21-year-old woman with DM type I presented with a 2-month history involving four episodes of severe abdominal pain and vomiting, each of which lasted four to five days. She had a recurrence every two weeks. The EEG revealed 'spike and wave ' and she was started an intravenous phenytoin that resolved the symptoms. Case 2: A 20-year-old woman with DM type I was admitted with a 2-month history of recurring severe left upper quadrant pain associated with occasional nausea but no vomiting. She experienced two more episodes of generalized tonic-clonic seizures and was treated with 300 mg phenytoin given orally The abdominal pains gradually subsided and she was symptom-free within two days. An EEG showed frequent sharp waves. She was treated with 10 mg intravenous diazepam and her symptoms and sharp waves disappeared within two minutes. Case 3: A 46-year-old man with DM type I was admitted with a four-month history of recurring severe epigastric pain and vomiting. His physical examination, laboratory tests, and extensive investigation for a primary GI disorder revealed nothing unusual. The EEG revealed spike and wave and he was treated with intravenous AED (phenytoin) loading after which the symptoms disappeared. CONCLUSION: Physicians should consider abdominal epilepsy in diabetics with recurrent, intractable abdominal pain in whom extensive investigations for primary gastrointestinal (GI) disorders are unremarkable.

Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: a multicenter, a double-blinded, randomized-controlled study.

OBJECTIVE: To compare the efficacy and safety of generic (Utmos) and original (Actos) 30 mg Pioglitazone tablets. STUDY DESIGN: A multicenter, parallel randomized, double-blinded, controlled study. MATERIAL AND METHOD: Type 2 diabetic patients, with glycosylated hemoglobin (HbA,) > or = 7.0%, who received Metformin not less than 1000 mg/day over three months were recruited. Patients were randomized to receive either generic or original Pioglitazone 30 mg/day for 24 weeks. RESULTS: Eighty-five patients were enrolled, forty-four patients received generic Pioglitazone andforty-one received original Pioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazone group. There were significantly reduced HbA(1c), fasting plasma glucose (FPG) and significantly increased HDL-cholesterol from baseline (p < 0.0001) without statistically differences between the two groups. Headache and edema were found in both groups at comparable rates (p > 0.05). CONCLUSION: Generic Pioglitazone (Utmos) is effective in controlling blood glucose and has similar effects on lipid profile as the original one. Both generic (Utmos) and original (Actos) 30 mg Pioglitazone tablets were not different in the efficacy and safety profiles.

Thailand Diabetic Registry cohort: predicting death in Thai diabetic patients and causes of death.

INTRODUCTION: The prevalence of type 2 diabetes in Thailand is 9.8 percent which is double the number forecast by World Health Organization. There is inadequate information to statistically represent all Thai diabetic patients for their causes of death. OBJECTIVE: To determine the clinical characteristics that predicted death and causes of death in Thai diabetic patients. MATERIAL AND METHOD: This prospective cohort was a 3-year follow-up study of the Thai Diabetes Registry project done between April, 2003, and February, 2006, which registered 9,419 diabetic patients attending 11 diabetic clinics in tertiary medical centers in Bangkok and major provinces of Thailand. The dead or alive status (99.5%) was determined. The causes of death were defined by reviewing the medical records. RESULTS: Of the 9,370 diabetic patients registered, 425 patients died, 1.84 percent per year. There was an increased risk of death associated with age, type of healthcare plan, lower education, insulin use, smoking, history of coronary artery disease and cerebrovascular disease, serum creatinine and high HbA1c. Lipid-lowering medication and metformin decreased the risk of death. Cardiovascular disease, infection and cancer were the prevalent causes of death. CONCLUSION: The present study showed risk factors that influenced death and causes of death in Thai diabetics.

Prediction of seizure control in non-ketotic hyperglycemic induced seizures.

BACKGROUND: To study the factors predictive for seizure control in non-ketotic hyperglycemic induced seizures (NKHS). METHODS: We studied 21 patients who were clinically diagnosed as NKHS at Khon Kaen University hospital, Thailand. Multiple linear regression analysis was used to identify the factors predictive for seizure control. RESULTS: Most patients had no previous history of diabetes and presented with repetitive partial seizures. The mean number of seizure attacks was 45 times prior to admission. The average duration to terminate seizure was 36 hours and significantly predicted by frequency of seizures (estimate 0.9, p value 0.013). CONCLUSION: Frequency of seizures is the only predictive factor for the success of seizure control in NKHS.