Retrospective Studies

Hormone Therapy in Postmenopausal Persons: Primary Prevention of Chronic Conditions

Author/s: 
US Preventative Services task Force, Mangione, C. M., Barry, M. J., Nicholson, W. K., Cabana, M., Caughey, A. B., Chelmow, D., Coker, T. R., Davis, E. M., Donahue, K. E., Jaén, C. R., Kubik, M., Li, L., Ogedegbe, G., Pbert, L., Ruiz, J. M., Stevermer, J., Wong, J. B.

Importance: Menopause is defined as the cessation of a person's menstrual cycle. It is defined retrospectively, 12 months after the final menstrual period. Perimenopause, or the menopausal transition, is the few-year time period preceding a person's final menstrual period and is characterized by increasing menstrual cycle length variability and periods of amenorrhea, and often symptoms such as vasomotor dysfunction. The prevalence and incidence of most chronic diseases (eg, cardiovascular disease, cancer, osteoporosis, and fracture) increase with age, and US persons who reach menopause are expected on average to live more than another 30 years.

Objective: To update its 2017 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of systemic (ie, oral or transdermal) hormone therapy for the prevention of chronic conditions in postmenopausal persons and whether outcomes vary by age or by timing of intervention after menopause.

Population: Asymptomatic postmenopausal persons who are considering hormone therapy for the primary prevention of chronic medical conditions.

Evidence assessment: The USPSTF concludes with moderate certainty that the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons with an intact uterus has no net benefit. The USPSTF concludes with moderate certainty that the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal persons who have had a hysterectomy has no net benefit.

Recommendation: The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons. (D recommendation) The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal persons who have had a hysterectomy. (D recommendation).

Acid Suppression and Antibiotics Administered During Infancy Are Associated with Celiac Disease

Author/s: 
Boechler, M., Susi, A., Hisle-Gorman, E., Rogers, P. L., Nylund, C. M.

Objective
To investigate why certain at-risk individuals develop celiac disease, we examined the association of proton pump inhibitors (PPI), histamine-2 receptor antagonist (H2RA), and antibiotic prescriptions in the first six months of life with an early childhood diagnosis of celiac disease.
Study design
A retrospective cohort study was performed using the Military Healthcare System (MHS) database. Children with a birth record from October 1, 2001- September 30, 2013, were identified. Outpatient prescription records were queried for antibiotic, PPI, and H2RA prescriptions in the first 6 months of life. Cox proportional hazards regression was used to calculate the hazard ratio (HR) of developing CD based on medication exposure. ICD-9 codes identified children with an outpatient visit for celiac disease.
Results
968,524 children met inclusion criteria with 1,704 cases of celiac in this group. Median follow up for the cohort was about 4.5 years. PPI’s (HR, 2.23; 95% CI, 1.76-2.83), H2RA’s (HR, 1.94 95% CI, 1.67-2.26) and antibiotics (HR 1.14 95%CI 1.02-1.28) were all associated with an increased hazard of celiac disease.
Conclusion
There is an increased risk of developing celiac disease if antibiotics, PPI’s and H2RA’s are prescribed in the first 6 months of life. Our study highlights modifiable factors such as medication stewardship that may change the childhood risk of CD.

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity

Author/s: 
Ghusn, W., De la Rosa, A., Sacoto, D.

Importance No retrospective cohort study has assessed the effectiveness of semaglutide at doses used in randomized clinical trials to treat obesity (ie, 1.7 and 2.4 mg).

Objective To study weight loss outcomes associated with semaglutide treatment at doses used in randomized clinical trials for patients with overweight or obesity.

Design, Setting, and Participants This cohort study, conducted at a referral center for weight management, retrospectively collected data on the use of semaglutide for adults with overweight or obesity between January 1, 2021, and March 15, 2022, with a follow-up of up to 6 months. A total of 408 patients with a body mass index (BMI) of 27 or more were prescribed weekly semaglutide subcutaneous injections for 3 months or more. Patients with a history of bariatric procedures, taking other antiobesity medications, and with an active malignant neoplasm were excluded.

Exposures Weekly 1.7-mg or 2.4-mg semaglutide subcutaneous injections for 3 to 6 months.

Main Outcomes and Measures The primary end point was the percentage of weight loss. Secondary end points were the proportion of patients achieving weight loss of 5% or more, 10% or more, 15% or more, and 20% or more after 3 and 6 months and the percentage of weight loss for patients with or without type 2 diabetes after 3 and 6 months.

Results The study included 175 patients (132 women [75.4%]; mean [SD] age, 49.3 [12.5] years; mean [SD] BMI, 41.3 [9.1]) in the analysis at 3 months and 102 patients at 6 months. The mean (SD) weight loss after 3 months was 6.7 (4.4) kg, equivalent to a mean (SD) weight loss of 5.9% (3.7%) (P < .001), and the mean (SD) weight loss after 6 months was 12.3 (6.6) kg, equivalent to a mean (SD) weight loss of 10.9% (5.8%) (P < .001 from baseline). Of the 102 patients who were followed up at 6 months, 89 (87.3%) achieved weight loss of 5% or more, 56 (54.9%) achieved weight loss of 10% or more, 24 (23.5%) achieved weight loss of 15% or more, and 8 (7.8%) achieved weight loss of 20% or more. Patients with type 2 diabetes had a lower mean (SD) percentage weight loss at 3 and 6 months compared with those without type 2 diabetes: 3.9% (3.1%) vs 6.3% (3.7%) at 3 months (P = .001) and 7.2% (6.3%) vs 11.8% (5.3%) at 6 months (P = .005).

Conclusions and Relevance The results of this cohort study suggest that weekly 1.7-mg and 2.4-mg doses of semaglutide were associated with weight loss similar to that seen in randomized clinical trials. Studies with longer periods of follow-up are needed to evaluate prolonged weight loss outcomes.

Syncope and the Risk of Subsequent Motor Vehicle Crash A Population-Based Retrospective Cohort Study

Author/s: 
Staples, J. A., Erdelyi, S., Merchant, K., Yip, C., Khan, M., Redelmeier, D. A., Chan, H., Brubacher, J. R.

Importance Medical driving restrictions are burdensome, yet syncope recurrence while driving can cause a motor vehicle crash (MVC). Few empirical data inform current driving restrictions after syncope.

Objective To examine MVC risk among patients visiting the emergency department (ED) after first-episode syncope.

Design, Setting, and Participants A population-based, retrospective observational cohort study of MVC risk after first-episode syncope was performed in British Columbia, Canada. Patients visiting any of 6 urban EDs for syncope and collapse were age- and sex-matched to 4 control patients visiting the same ED in the same month for a condition other than syncope. Patients’ ED medical records were linked to administrative health records, driving history, and detailed crash reports. Crash-free survival among individuals with syncope was then compared with that among matched control patients. Data analyses were performed from May 2020 to March 2022.

Exposures Initial ED visit for syncope.

Main Outcomes and Measures Involvement as a driver in an MVC in the year following the index ED visit. Crashes were identified using insurance claim data and police crash reports.

Results The study cohort included 43 589 patients (9223 patients with syncope and 34 366 controls; median [IQR] age, 54 [35-72] years; 22 360 [51.3%] women; 5033 [11.5%] rural residents). At baseline, crude MVC incidence rates among both the syncope and control groups were higher than among the general population (12.2, 13.2, and 8.2 crashes per 100 driver-years, respectively). In the year following index ED visit, 846 first crashes occurred in the syncope group and 3457 first crashes occurred in the control group, indicating no significant difference in subsequent MVC risk (9.2% vs 10.1%; adjusted hazard ratio [aHR], 0.93; 95% CI, 0.87-1.01; P = .07). Subsequent crash risk among patients with syncope was not significantly increased in the first 30 days after index ED visit (aHR, 1.07; 95% CI, 0.84-1.36; P = .56) or among subgroups at higher risk of adverse events after syncope (eg, age >65 years; cardiogenic syncope; Canadian Syncope Risk Score ≥1).

Conclusions and Relevance The findings of this population-based retrospective cohort study suggest that patients visiting the ED with first-episode syncope exhibit a subsequent crash risk no different than the average ED patient. More stringent driving restrictions after syncope may not be warranted.

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