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Pharmacogenetics of hypoglycemia associated with sulfonylurea therapy in usual clinical care.

ABSTRACT: Hypoglycemia is a common complication among type 2 diabetes mellitus (T2DM) patients receiving sulfonylurea therapy. The aim of this study was to determine if genetic contributions to sulfonylurea pharmacokinetics or pharmacodynamics substantially affect the risk of hypoglycemia in these patients. In a retrospective case-control study in European American patients with T2DM, we examined the potential association between CYP2C9 reduced-function variants and sulfonylurea-related hypoglycemia. We also explored the relationship between sulfonylurea-related hypoglycemia and several candidate genetic variants previously reported to alter the response to sulfonylureas. We detected no evidence of association between CYP2C9 reduced-function alleles or any of the candidate genetic variants and sulfonylurea-related hypoglycemia. In conclusion, we identified no clinically significant predictors of hypoglycemia among genes associated with sulfonylurea pharmacokinetics or pharmacodynamics.

SUBMITTER: Mitchell SL

PROVIDER: S-EPMC8174577 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Pharmacogenetics of hypoglycemia associated with sulfonylurea therapy in usual clinical care.

Mitchell Sabrina L SL Leon Daniel A Carranza DAC Chaugai Sandip S Kawai Vivian K VK Levinson Rebecca T RT Wei Wei-Qi WQ Stein C Michael CM

The pharmacogenomics journal 20200605 6

Hypoglycemia is a common complication among type 2 diabetes mellitus (T2DM) patients receiving sulfonylurea therapy. The aim of this study was to determine if genetic contributions to sulfonylurea pharmacokinetics or pharmacodynamics substantially affect the risk of hypoglycemia in these patients. In a retrospective case-control study in European American patients with T2DM, we examined the potential association between CYP2C9 reduced-function variants and sulfonylurea-related hypoglycemia. We a ...[more]

PMID: 32504053

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Project description:ImportancePostpartum depression (PPD) affects as many as 20% of mothers, yet just 1 in 10 of these women receives evidence-based treatment. The COVID-19 pandemic has increased PPD risk, reduced treatment access, and shifted preferences toward virtual care.ObjectiveTo determine whether an online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual improves PPD, anxiety, social support, mother-infant relationship quality, and infant temperament more than treatment as usual alone.Design, setting, and participantsThis randomized clinical trial included 403 women with PPD who were recruited across Ontario, Canada, during the COVID-19 pandemic (April 20 to October 4, 2020). Women with Edinburgh Postnatal Depression Scale (EPDS) scores of at least 10 who were 18 years or older and had an infant younger than 12 months were eligible.InterventionsWomen were randomly assigned to receive a live, interactive online 1-day CBT-based workshop delivered by a registered psychotherapist, psychiatrist, or clinical psychology graduate student in addition to treatment as usual (n = 202) or to receive treatment as usual and wait-listed to receive the workshop 12 weeks later (n = 201).Main outcomes and measuresThe primary outcome was change in PPD (EPDS scores) in experimental and wait list control groups 12 weeks after baseline. Secondary outcomes included maternal anxiety (7-item Generalized Anxiety Disorder Questionnaire [GAD-7]), social support (Social Provisions Scale), quality of the mother-infant relationship (Postpartum Bonding Questionnaire), and infant temperament (Infant Behavior Questionnaire-Revised Very Short Form).ResultsParticipants all identified as women with a mean (SD) age of 31.8 (4.4) years. The workshop led to significant mean (SD) reductions in EPDS scores (from 16.47 [4.41] to 11.65 [4.83]; B = -4.82; P < .001) and was associated with a higher odds of exhibiting a clinically significant decrease in EPDS scores (odds ratio, 4.15; 95% CI, 2.66-6.46). The mean (SD) GAD-7 scores decreased from 12.41 (5.12) to 7.97 (5.54) after the workshop (B = -4.44; 95% CI, -5.47 to -3.38; P < .001) and participants were more likely to experience a clinically significant change (odds ratio, 3.09; 95% CI, 1.99-4.81). Mothers also reported improvements in bonding (B = -3.22; 95% CI, -4.72 to -1.71; P < .001), infant-focused anxiety (B = -1.64; 95% CI, -2.25 to 1.00; P < .001), social support (B = 3.31; 95% CI, 1.04 to 5.57; P < .001), and positive affectivity/surgency in infants (B = 0.31; 95% CI, 0.05 to 0.56; P < .001).Conclusions and relevanceIn this randomized clinical trial, an online 1-day CBT-based workshop for PPD provides an effective, brief option for mothers, reducing PPD and anxiety as well as improving social support, the mother-infant relationship, and positive affectivity/surgency in offspring.Trial registrationClinicalTrials.gov Identifier: NCT04485000.

Project description:ImportanceThe incidence rate of neck pain is increasing worldwide, and the disease is associated with a high social burden. Manual therapy has been widely applied in the treatment of neck pain, but a high-quality, pragmatic randomized clinical trial for this treatment has not been conducted to date.ObjectiveThis study aimed to compare the effectiveness of Chuna manual therapy with that of usual care for patients with chronic neck pain.Design, setting, and participantsA multicenter, assessor-blinded, pragmatic, randomized clinical trial was conducted between October 18, 2017, and June 28, 2019. This intention-to-treat analysis included 108 patients with chronic neck pain persisting for at least 3 months; patients were recruited from 5 hospitals in Korea.InterventionsTen sessions (2 sessions per week for 5 weeks) of Chuna manual therapy or usual care (electrotherapy and oral medication) were conducted.Main outcomes and measuresThe main outcome was the difference in visual analog scale (VAS) score for chronic neck pain between baseline and 5 weeks after randomization.ResultsThis randomized clinical trial recruited 108 patients (mean [SD] age, 38.4 [9.3] years; 73 women [67.6%]). Fifty-four patients were allocated to the Chuna therapy group, and 54 received usual care. At 5 weeks after randomization, manual therapy showed statistically superior results compared with usual care in terms of pain (difference in chronic neck pain VAS, 16.8 mm; 95% CI, 10.1-23.5 mm), function (difference in Neck Disability Index, 8.6%; 95% CI, 4.2%-13.1%), and quality of life (difference in the European Quality of Life-5 Dimension 5 Levels (EQ-5D-5L) scores, -0.07 points; 95% CI, -0.11 to -0.02 points). Regarding the 1-year cumulative values measured using area under the curve analyses, superior outcomes were attained in the manual therapy group in terms of the numerical rating scale for chronic neck pain (1.3 points; 95% CI, 0.5-2.0 points), Neck Disability Index (6.7%; 95% CI, 2.5%-10.9%), Neck Pain Questionnaire (7.4%; 95% CI, 2.3%-12.6%), and EQ-5D-5L scores (-0.03 points; -0.07 to 0.00 points).Conclusions and relevanceIn this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.Trial registrationClinicalTrials.gov identifier: NCT03294785.

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Pharmacogenetics of hypoglycemia associated with sulfonylurea therapy in usual clinical care.

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Pharmacogenetics of hypoglycemia associated with sulfonylurea therapy in usual clinical care.

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