BACKGROUND

It remains unclear whether pharmacist-led educational programs in community pharmacies could increase appropriate ophthalmic visits for patients with diabetes. We assessed efficacy of pharmacist-led education on ophthalmology visits for diabetes.

METHODS

We conducted a cluster randomized controlled trial at 32 community pharmacies in Japan, targeting individuals with diabetes with no ophthalmic visits over a year. Pharmacists in the intervention group received online training on diabetic retinopathy and educated patients, while the control group received a pamphlet. The primary outcome was ophthalmic visits during the follow-up period. Generalized estimating equations were performed with two adjusted models: age and sex (model 1), and additionally diabetic retinopathy factors (model 2). Key secondary outcomes were changes in behavior for ophthalmic visits and glycated hemoglobin (HbA1c) levels.

RESULTS

Overall, 268 patients were included (133 intervention and 135 control). Participants’ mean age was 60.1 years, and HbA1c level was 7.5%. Ophthalmic visits occurred in 18.8% (25/133) of the intervention and 20.7% (28/135) of the control group, yielding no significant difference (model 1, risk difference [RD] −0.03 [−0.14 to 0.08], risk ratio [RR] 0.88 (0.54 to 1.45); model 2, RD −0.07 [−0.21 to 0.08], RR 0.73 [0.41 to 1.30]). There was no significant difference between the two groups in the mean changes from baseline to 6 months in behavior for ophthalmic visits (0.07 [−0.23 to 0.37]) and HbA1c levels (−0.28 [−0.76 to 0.20]).

CONCLUSIONS

Pharmacist-led education on diabetic retinopathy did not increase ophthalmology visits or improve diabetes-related outcomes. Effective strategies to encourage ophthalmology visits are required.

BACKGROUND

This study aimed to evaluate the association between metformin use and the risk of cervical cancer in women with diabetes compared to dipeptidyl peptidase-4 inhibitors (DPP-4is), using a new-user active-comparator design.

METHODS

We analyzed data from the JMDC claims database for new users of metformin or DPP-4i between 2010–2022 who were women. Propensity score overlap-weighting was applied to adjust for differences in age, complications, comorbidities, and other anti-diabetic medications. Kaplan–Meier curves and Cox proportional hazards models were used to compare cervical cancer incidence between the metformin and DPP-4i groups.

RESULTS

A total of 31,269 eligible individuals were identified, comprising 11,466 metformin users and 19,803 DPP-4i users. Cervical cancer occurred in 11 women (34.0/100,000 person-years) from the metformin group and 34 (59.0/100,000 person-years) in the DPP-4i group. Metformin use was associated with a lower risk of cervical cancer in our unadjusted Kaplan–Meier analysis (P = 0.058), and multivariable-adjusted Cox model (hazard ratio, 0.49; 95% CI, 0.22–1.09; P = 0.082), although neither difference was statistically significant.

CONCLUSIONS

Our findings did not show a statistically significant association between metformin use and cervical cancer incidence. However, this study’s limited sample size precluded definitive conclusions.

BACKGROUND

In Japan, biosimilars have the potential to reduce drug expenditure because their official price is lower than the price of the original products. To promote biosimilars, the Japanese government introduced a new financial incentive scheme for medical institutions to prescribe biosimilars to outpatients in April 2020. However, the impact of the incentive remains unevaluated. Hence, in this study, we conducted an interrupted time-series analysis to evaluate the impact of the incentive scheme on biosimilar prescription.

METHODS

We used the DeSC database in Japan. From this database, we included 3,348 patients who required self-injection and were prescribed insulin, human growth hormone, or etanercept. Interrupted time-series analyses were conducted by fitting Prais–Winsten linear regression models to assess the association of the financial incentive with the outcomes, namely, monthly proportions of biosimilar prescriptions between April 2019 and March 2021.

RESULTS

No significant changes were observed in the monthly proportion of biosimilar prescriptions immediately after the introduction of the incentive. The sustained effect, representing the effect of the intervention over time, was also not significant.

CONCLUSIONS

Our study suggests that the financial incentive introduced in April 2020 in Japan was not associated with an increase in biosimilar prescriptions.

This article introduces the basic concept of a novel 6-parameter model case-crossover study with active comparator design. While case-crossover study design eliminates time-invariant confounding, the 6-parameter model as a modified version also allows studying the effect of drug initiation patterns between two interacting drugs. The implementation of the case-crossover study is illustrated, including the generation of the dataset for data analysis and performing the 6-parameter model using conditional logistic regression. Potential interpretation framework is proposed using eight combinations based on three scenarios shown in the results of the 6-parameter case-crossover study design.