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Books: 0	Journals: 1	Articles: 5

Original

Difference in risk of gastrointestinal complications between users of enteric-coated and buffered low-dose aspirin

Mitsutaka Takada, Mai Fujimoto, and Kouichi Hosomi

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Volume 52 p. 181 - 191

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 3/2014 (181-191)

Difference in risk of gastrointestinal complications between users of enteric-coated and buffered low-dose aspirin

Mitsutaka Takada, Mai Fujimoto, and Kouichi Hosomi

Division of Clinical Drug Informatics, School of Pharmacy, Kinki University, Osaka, Japan
Objective: Difference in the risk of gastrointestinal (GI) complications between users of enteric-coated and buffered low-dose aspirin (LDA) is unclear. The purpose of the study is to examine the difference in risk of GI damage between enteric-coated and buffered LDA products. Methods: A large and chronologically organized receipt database constructed by a database vendor was utilized. Prescription and event sequence symmetry analysis was used to identify the risk of LDA-induced GI complications over the period from January 2005 to July 2011. LDA use in combination with H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) was examined by prescription sequence symmetry analysis. Likewise, symmetry analysis was undertaken to evaluate the association between the diagnosis of GI disease and the prescription of LDA products. Results: In July 2011, enteric-coated LDA users were more frequently co-administered PPIs than buffered LDA users (25.4% vs. 14.4%). Prescription sequence symmetry analysis of acid inhibitor use found no significant associations with enteric-coated LDA use and buffered LDA use. The event sequence symmetry analysis of ulcer, gastritis and duodenitis, and melena found significant associations with entericcoated LDA use, with adjusted sequence ratios (ASRs) of 1.58 (1.23 – 2.06), 1.30 (1.03 – 1.65), and 14.38 (2.19 – 607.95), respectively, at the 6-month interval. At the 12-month interval, analysis of ulcers and melena found significant associations for enteric-coated LDA users, with ASRs of 1.39 (1.13 – 1.73) and 20.83 (3.33 – 863.25), respectively. Conclusions: Our findings do not support that there is no difference in the risk of GI complications between enteric-coated LDA and buffered LDA, but rather may imply that the risk of GI complications associated with enteric-coated LDA is higher than that with buffered LDA.Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
School of Pharmacy, Kinki University
577-8502, 3-4-1, Kowakae,
Higashi-osaka, Osaka 577-8502, Japan
Email: [email protected]

Original

Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS

Mai Fujimoto, Kouichi Hosomi, and Mitsutaka Takada

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Volume 52 p. 259 - 266

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 4/2014 (259-266)

Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS

Mai Fujimoto, Kouichi Hosomi, and Mitsutaka Takada

Division of Clinical Drug Informatics, School of Pharmacy, Kinki University, Osaka, Japan
Objective: To examine the association between statin use and the risk of lower urinary tract symptoms (LUTS) in reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between 2004 and 2011. Methods: Relevant reports in the FAERS were identified and analyzed. The reporting odds ratio (ROR) was used to detect spontaneous report signals, calculated using the case/non-case method. Cases were identified by the presence of reports of an adverse drug reaction (ADR) in which statins were the suspected drug. Non-cases were all the reports of the same reactions induced by drugs other than statins. The reporting odds ratio (ROR) and 95% confidential interval (CI) was calculated as a measure of disproportionality. Results: A total of 44,959,104 drug-reaction pairs was found in 2,681,739 reports. Significant RORs were found for both voiding (ROR; 1.16, 95% CI; 1.10 – 1.23) and storage symptoms (ROR; 1.25, 95% CI; 1.20 – 1.30). Analysis of individual statins showed that rosuvastatin, atorvastatin, and lovastatin had significant disproportionality for voiding symptoms, while simvastatin, rosuvastatin, pravastatin, atorvastatin, pitavastatin, and lovastatin had significant disproportionality for storage symptoms. Of the four voiding symptoms, significant RORs were found for urine flow decrease and dysuria. Of the four storage symptoms, significant RORs were found for pollakiuria and nocturia. No fundamental differences in disproportionality were observed between genders. Conclusions: Analysis of the FAERS database showed small but reliable signals for LUTS in statin users. The mechanism responsible for these reactions is unknown. However, these adverse events should be monitored closely.Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
School of Pharmacy, Kinki University
3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan
Email: [email protected]

Original Research

Association of statin use with storage lower urinary tract symptoms (LUTS): data mining of prescription database

Mai Fujimoto, Tomoya Higuchi, Kouichi Hosomi, and Mitsutaka Takada

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Volume 52 p. 762 - 769

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 9/2014 (762-769)

Association of statin use with storage lower urinary tract symptoms (LUTS): data mining of prescription database

Mai Fujimoto, Tomoya Higuchi, Kouichi Hosomi, and Mitsutaka Takada

Division of Clinical Drug Informatics, School of Pharmacy, Kinki University, Osaka, Japan
Objective: The efficacy and safety of statins have been studied in a number of clinical trials and epidemiological studies. In recent years, the Medicine and Healthcare Products Regulatory Agency (MHRA) has assessed the evidence available on the following adverse reactions associated with the use of statins: sleep disturbances, memory loss, micturition disorders (problems with urination), sexual disturbances, depression, and interstitial pneumopathy. However, the association between statin use and the risk of these adverse reactions remains unclear. To examine the association between statin use and the risk of lower urinary tract symptoms (LUTS) or the disorder causing LUTS, we carried out data mining using a prescription database. Methods: A large organized database of prescriptions constructed by a database vendor was used in the study. Symmetry analysis was used to identify the risk of LUTS after using statins over the period January 2006 to August 2013. Statin use in combination with drugs administered for storage LUTS was examined by prescription sequence symmetry analysis (PSSA). Results: A significant association between statins and drugs for storage LUTS was found, with adjusted sequence ratios (ASRs) of 1.21 (95% CI, 1.00 – 1.46), 1.19 (95% CI, 1.04 – 1.38), and 1.17 (95% CI, 1.05 – 1.30) for intervals of 91, 182, and 365 days, respectively. In the analyses of individual statins, significant associations were found only for pravastatin. Significant associations with individual drugs for storage LUTS were found for solifenacin succinate with ASRs of 1.36 (95% CI, 1.02 – 1.81), 1.48 (95% CI, 1.19 – 1.84), and 1.47 (95% CI, 1.25 – 1.73) for intervals of 91, 182, and 365 days, for flavoxate hydrochloride with an ASR of 1.56 (95% CI, 1.13 – 2.17) at an interval of 182 days, and for oxybutynin hydrochloride with ASRs of 2.06 (95% CI, 1.11 – 3.94) and 1.71 (95% CI, 1.09 – 2.72) at intervals of 182 and 365 days. Significant associations with gender were found only in females with ASRs of 1.25 (95% CI, 1.04 – 1.51) and 1.23 (95% CI, 1.07 – 1.41) at intervals of 182 and 365 days, respectively. Conclusions: Analysis of the prescription database showed significant association for storage LUTS in statin users.Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
School of Pharmacy, Kink University
577-8502, 3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan
Email: [email protected]

Original

Long-term impact of therapeutic drug monitoring on the risk of hypoglycemia in HOCM patients on cibenzoline therapy 

Yutaro Mukai, Kyoichi Wada, Mai Fujimoto, Kouichi Hosomi, Takeshi Kuwahara, Mitsutaka Takada

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Volume 54 p. 795 - 803

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 10/2016 (795-803)

Long-term impact of therapeutic drug monitoring on the risk of hypoglycemia in HOCM patients on cibenzoline therapy 

Yutaro Mukai¹,², Kyoichi Wada¹,², Mai Fujimoto³, Kouichi Hosomi³, Takeshi Kuwahara¹,², Mitsutaka Takada²,³

¹Department of Pharmacy, National Cerebral and Cardiovascular Center, Suita, Osaka, ²Division of Cardiovascular Drugs and Therapy, Kindai University Graduate School of Pharmacy, Higashi-osaka, and ³Division of Clinical Drug Informatics, Kindai University School of Pharmacy, Higashi-osaka, Japan
Objective: The purpose of this study was to evaluate the long-term impact of therapeutic drug monitoring (TDM) services on the risk of hypoglycemia in cibenzoline therapy. In addition, we evaluated the impact of changes in clinical setting or patient background on the risk of hypoglycemia in patients receiving cibenzoline. Methods: TDM services for cibenzoline have been performed at the Japan National Cerebral and Cardiovascular Center since March 1998. A case-control study was performed from September 2012 to February 2013, and the calculated risk of hypoglycemia associated with cibenzoline use was compared with data from our previous studies, which were performed ~ 15 years ago. Results: A significantly increased risk for hypoglycemia was observed for users of cibenzoline (adjusted OR: 2.6; 95% CI: 1.5 – 4.7). In an additional analysis, the calculated risk was slightly reduced (adjusted OR; 2.1, 95% CI; 1.1 – 3.8) and hypertrophic obstructive cardiomyopathy (HOCM) was identified as a possible risk factor for hypoglycemia (adjusted OR: 4.7, 95% CI: 1.8 – 12.3). There was a significant difference in the mean level of cibenzoline between outpatients with and without HOCM (360.5 ± 166.9 ng/mL vs. 276.4 ± 136.3 ng/mL). An inverse relationship was observed between the percentage of outpatients whose cibenzoline serum level had been measured and their risk of hypoglycemia. Conclusions: Consistent TDM services for cibenzoline have contributed to a reduced risk of hypoglycemia associated with cibenzoline therapy. Patients with HOCM have a higher risk of developing hypoglycemia. Clinicians should therefore carefully monitor serum glucose levels in patients with HOCM taking cibenzoline. Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
Kindai University School of Pharmacy
577-8502, 3-4-1, Kowakae, Higashi-osaka,
Osaka, 577-8502, Japan
Email: takada@ phar.kindai.ac.jp

Original Research

Angiotensin receptor blockers and the risk of cancer: data mining of a spontaneous reporting database and a claims database 

Mai Fujimoto, Migiwa Kanou, Kouichi Hosomi, Mitsutaka Takada 

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Volume 55 (2017) p. 295 - 303

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 4/2017 (295-303)

Angiotensin receptor blockers and the risk of cancer: data mining of a spontaneous reporting database and a claims database 

Mai Fujimoto, Migiwa Kanou, Kouichi Hosomi, Mitsutaka Takada 

Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, Osaka, Japan
Objective: The aim of this study was to examine the associations between angiotensin receptor blockers (ARBs) and the risk of 10 major cancers by employing different pharmacoepidemiological assessments. Materials & methods: Data from the first quarter of 2004 through 2012 were downloaded from the US Food and Drug Administration Adverse Event Reporting System (FAERS). The reporting odds ratio (ROR) and information component (IC) were used to detect the signals. Furthermore, symmetry analysis was applied to the claims database to identify the risk of cancer after using ARBs from January 2005 to July 2013. Results: Significant inverse associations were found for all cancer types assessed as a whole (ROR: 0.78, 95% confidence interval (CI): 0.75 – 0.80; IC: –0.36, 95% CI: –0.40 to –0.31) in the analyses of FAERS database. Likewise, significant inverse association was found for all cancer types assessed as a whole (adjusted sequence ratio: 0.89, 95% CI: 0.82 – 0.96) in claims database. In addition, a significantly decreased risk for breast cancer and increased risks for pancreatic and prostate cancer were found in patients treated with ARBs in the analyses of individual cancers. Conclusions: Significant inverse association was found between ARB use and all cancer types assessed as a whole. However, in the analyses of individual cancers, the risks of ARB-induced cancer may differ according to cancer site. It may be reasonable to assume that the risks of ARB-induced cancer may differ according to cancer site. Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
School of Pharmacy, Kindai University
577-8502, 3-4-1, Kowakae, Higashi-osaka,
Osaka, 577-8502, Japan 
Email: takada@ phar.kindai.ac.jp

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