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AIMS: Recent epidemiologic studies have examined the risk of maculopathy with pentosan polysulfate sodium (PPS), a drug indicated for the treatment of interstitial cystitis. However, results have been contradictory. Thus, we quantified the risk of maculopathy with PPS with a focus on risk with duration of use. METHODS: We used a new user, retrospective cohort study with an active comparator. We created a cohort of mutually exclusive 6221 PPS users and 89 744 amitriptyline users, a tricyclic antidepressant also used for the treatment of pain secondary to interstitial cystitis. Subjects were selected from the PharMetrics Plus database (IQVIA, Durham, NC) from 2006 to 2020. Cohort members were followed to the first event of the study outcome (maculopathy) or end of enrolment. A Cox regression model was constructed to adjust for potential confounders. RESULTS: The mean follow-up was 3.0 years for PPS users and amitriptyline users. The adjusted hazard ratio (HR) for maculopathy in PPS users was 2.64 (95% confidence interval [CI]: 1.90-3.68). The HR for the sensitivity analysis that combined maculopathy and age-related macular degeneration (AMD) was 1.38 (95% CI: 1.16-1.65). A cumulative duration-response pattern was observed, with use greater than 3 years having a 9.5-fold risk of maculopathy (HR = 9.56, 95% CI: 3.60-25.37) compared to a 2.3-fold risk of maculopathy with use for 1 year or less (HR = 2.27, 95% CI: 1.50-3.43). The number needed to harm for the first 4 years of use was 250. CONCLUSIONS: The results of this study suggest an increased risk of maculopathy with PPS use, particularly with longer duration of use.
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Cistitis Intersticial , Degeneración Macular , Amitriptilina/efectos adversos , Cistitis Intersticial/inducido químicamente , Cistitis Intersticial/tratamiento farmacológico , Cistitis Intersticial/epidemiología , Humanos , Degeneración Macular/inducido químicamente , Degeneración Macular/tratamiento farmacológico , Degeneración Macular/epidemiología , Poliéster Pentosan Sulfúrico/efectos adversos , Estudios RetrospectivosRESUMEN
AIMS: We aimed to investigate the association between hormonal contraceptive (HC) use and the incidence of glaucoma in females of reproductive age with a focus on duration and type of HCs used. METHODS: A retrospective cohort study with a case-control analysis (nested case-control) was undertaken using data from IQVIA's electronic medical record (IQVIA, USA) from 2008 to 2018. Within a cohort of 4 871 504 women, cases of glaucoma or ocular hypertension were identified. Subjects were followed to the first diagnosis of glaucoma. Each glaucoma case was matched to four controls by age, body mass index and follow up time. The main outcome measure was the first diagnosis of glaucoma defined by the first ICD-9/10 code for glaucoma or ocular hypertension. RESULTS: Among 4 871 504 women identified, there were 2366 cases of glaucoma and 9464 controls. Regular users of hormonal contraceptives had an elevated risk of glaucoma compared to non-users with an adjusted incident rate ratio (aIRR) of 1.57 (95% CI: 1.29-1.92). Current users were of greatest risk (aIRR of 2.38, 95% CI: 1.81-3.13), whereas the aIRR among past users was 1.08 (95% CI: 0.82-1.43). The aIRR for glaucoma increased from 0.82 (95% CI: 0.70-0.95) among those with one or two prescriptions in the 2 years prior to the first diagnosis of glaucoma to 1.54 (95% CI: 1.32-1.81) among those with greater than four prescriptions. CONCLUSIONS: This nested case-control study demonstrated an elevated risk, albeit low, of glaucoma in females of reproductive age who use regular hormonal contraception. Future studies are needed to confirm these findings.
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Anticonceptivos Hormonales Orales , Glaucoma , Estudios de Casos y Controles , Estudios de Cohortes , Anticonceptivos Hormonales Orales/efectos adversos , Femenino , Glaucoma/inducido químicamente , Glaucoma/diagnóstico , Glaucoma/epidemiología , Humanos , Estudios RetrospectivosRESUMEN
PURPOSE: Previous studies have indicated an increased risk of gallbladder disease with hormonal contraceptives although with discordant results. The potential increased risk of gallbladder disease with hormonal contraceptives is concerning given that women are at increased risk of this disease. Thus, the aim of this study was to examine risk of surgery-confirmed gallbladder disease (cholecystectomy) with oral contraceptives, intrauterine devices, and injectable hormonal contraceptives. METHODS: We conducted a retrospective cohort study. Females aged 15-45 who initiated hormonal contraceptive use were identified in the United States IQVIA Ambulatory electronic medical record database between 2008 and 2018. Cox proportional hazards models were used to estimate adjusted hazards ratios and 95% confidence intervals for cholecystectomy with eight formulations of contraceptives compared with levonorgestrel and ethinyl estradiol combined oral contraceptive. Sensitivity analysis was conducted by lagging exposure by 90 days and by excluding patients with history of gallbladder disease. Secondary analyses were conducted by cumulative duration of use. RESULTS: We identified 1,425,821 females who initiated the use of hormonal contraceptives and generated 4417 cholecystectomy events. Overall, the use of medroxyprogesterone acetate (HR: 1.22, 95% CI: 1.07-1.40) and at least 1 year of levonorgestrel intrauterine device use (HR: 1.74: 95% CI: 1.19-2.54) were associated with increased risk of cholecystectomy when compared with levonorgestrel and ethinyl estradiol combined oral contraceptive. However, we did not observe an increased risk with other hormonal contraceptives. Consistent results were observed across sensitivity analyses. CONCLUSION: In this large population-based study, there was an increased risk of cholecystectomy with medroxyprogesterone acetate and intrauterine device but not other hormonal contraceptives. Additional large observational studies are required to corroborate these findings.
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Colecistectomía/estadística & datos numéricos , Agentes Anticonceptivos Hormonales/efectos adversos , Adolescente , Adulto , Factores de Edad , Índice de Masa Corporal , Comorbilidad , Anticonceptivos Orales Combinados/efectos adversos , Etinilestradiol/efectos adversos , Femenino , Humanos , Dispositivos Intrauterinos Medicados/efectos adversos , Levonorgestrel/efectos adversos , Anticoncepción Reversible de Larga Duración/efectos adversos , Acetato de Medroxiprogesterona/efectos adversos , Persona de Mediana Edad , Estudios Retrospectivos , Adulto JovenRESUMEN
PURPOSE: To examine whether there is a positive association between sexual dysfunction (SD) and different types of progestin-based contraceptives. METHODS: Nested case-control study in women of child-bearing age (15-45 years) from the IQVIA® Ambulatory electronic medical record database from 2008 to 2018. Cases defined by diagnosis of sexual dysfunction identified by international classification for disease clinical modification code 9th and 10th. Each case was matched to four controls and rates of prescriptions of the following were compared: levonorgestrel intra-uterine device (IUD), progestin, and ethinyl estradiol (EE) combined oral contraceptive (COC) formulations including levonorgestrel, norgestimate, drospirenone, desogestrel, norethindrone, and norgestrel; etonogestrel vaginal ring; and medroxyprogesterone injection. RESULTS: Overall, 6689 cases of patients with SD were matched to 26,756 matched controls. Compared with matched controls, more subjects with SD used levonorgestrel IUD (OR 1.24, 95% CI 1.08-1.44), EE-levonorgestrel COC (OR 1.18, 95% CI 1.00-1.41), EE-drospirenone (OR 1.28, 95% CI 1.00-1.67), and medroxyprogesterone (OR 1.38, 95% CI 1.12-1.70). The use of norgestrel exhibited a protective effect (OR 0.83, 95% CI 0.73-0.95). When using the EE-levonorgestrel COC as a comparator, norgestrel users exhibited a protective effect (OR 0.70, 95% CI 0.57-0.87) while no other contraceptives showed a statistically significant difference in association with SD. CONCLUSION: Our study found an increase in the use of levonorgestrel (COC and IUD), drospirenone, and medroxyprogesterone in subjects with SD. The risk of contraceptives did not differ when compared with oral levonorgestrel. The small association size and lack of difference between drug formulations suggest a minimal impact of progestin-based contraceptives on sexual dysfunction.
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Progestinas/efectos adversos , Disfunciones Sexuales Fisiológicas/epidemiología , Adolescente , Adulto , Androstenos/efectos adversos , Estudios de Casos y Controles , Combinación de Medicamentos , Etinilestradiol/efectos adversos , Femenino , Humanos , Dispositivos Intrauterinos/efectos adversos , Levonorgestrel/efectos adversos , Medroxiprogesterona/efectos adversos , Persona de Mediana Edad , Adulto JovenRESUMEN
The Food and Drug Administration (FDA) has recently included a black box warning on fibromyalgia-like symptoms with fluoroquinolones (FQs) but no large epidemiologic study is to date available. We undertook a case-control study using a random sample of 9 053 240 subjects obtained from the PharMetrics Plus health claims database in the United States. Cases received at least two fibromyalgia diagnoses coded by a rheumatologist matched to ten randomly selected controls. After identifying 5148 cases of fibromyalgia and 51 480 controls, the adjusted rate ratio (RR) of fibromyalgia for use of any fluoroquinolones, amoxicillin and azithromycin were 1.63 (95% CI: 1.41-1.87), 1.64 (95% CI: 1.46-1.85) and 1.68 (95% CI, 1.49-1.89), respectively. The adjusted RR for any use of FQ compared to any use of amoxicillin or azithromycin was 0.99 (95% CI: 0.83-1.18) and azithromycin is 0.97 (95%CI: 0.82-1.16), respectively. The risk of fibromyalgia with FQs is similar to that with amoxicillin and azithromycin.
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Antibacterianos/efectos adversos , Fibromialgia/epidemiología , Fluoroquinolonas/efectos adversos , Adulto , Amoxicilina/efectos adversos , Azitromicina/efectos adversos , Estudios de Casos y Controles , Femenino , Fibromialgia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Case reports have suggested an increased risk of gynecomastia with HMG-CoA reductase inhibitors (ie, statins). A recent meta-analysis also found that statins decrease circulating testosterone levels in men. We investigated whether statin use was associated with an increased risk of gynecomastia. DESIGN: Case-control study. PATIENTS: A cohort of patients from a random sample of 9 053 240 US subjects from the PharMetrics Plus™ health claims database from 2006 to 2016 was created. MEASUREMENTS: New cases of gynecomastia requiring at least two ICD-9 codes were identified from the cohort and matched to 10 controls by follow-up time and age using density-based sampling. Rate ratios (RRs) for users of statins were computed using conditional logistic regression adjusting for alcoholic cirrhosis, hyperthyroidism, testicular cancer, Klinefelter syndrome, obesity, hypogonadism, hyperprolactinemia and use of spironolactone, ketoconazole, H2 receptor antagonists (H2 blockers), risperidone, testosterone and androgen deprivation therapy. RESULTS: Our cohort included 6147 cases of gynecomastia and 61 470 corresponding matched controls. The adjusted RR for current, recent and past statin use with respect to gynecomastia was 1.19 (1.04-1.36), 1.38 (1.15-1.65) and 1.20 (1.03-1.40), respectively. CONCLUSIONS: Statin use is associated with an increased risk of developing gynecomastia. Clinicians should be cognizant of this effect and educate patients accordingly.
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Ginecomastia/epidemiología , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Adolescente , Adulto , Estudios de Casos y Controles , Ginecomastia/etiología , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
This database study examines the association between glucagon-like peptide 1 agonists (eg, semaglutide, liraglutide) used for weight loss and reports of gastrointestinal adverse events.
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Fármacos Antiobesidad , Enfermedades Gastrointestinales , Receptor del Péptido 1 Similar al Glucagón , Sobrepeso , Pérdida de Peso , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Péptidos Similares al Glucagón , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Liraglutida/efectos adversos , Liraglutida/uso terapéutico , Pérdida de Peso/efectos de los fármacos , Fármacos Antiobesidad/efectos adversos , Fármacos Antiobesidad/farmacología , Fármacos Antiobesidad/uso terapéutico , Sobrepeso/tratamiento farmacológico , Enfermedades Gastrointestinales/inducido químicamenteRESUMEN
Fluoroquinolone-induced peripheral neuropathies and tendinopathies are well documented, but there are no epidemiologic studies on the risk of carpal tunnel syndrome (CTS). We conducted a case-control study of >6 million patients. Fluoroquinolone use is associated with increased risk of CTS (rate ratio, 1.34 [95% confidence interval, 1.31-1.37]).
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Síndrome del Túnel Carpiano/inducido químicamente , Síndrome del Túnel Carpiano/epidemiología , Fluoroquinolonas/efectos adversos , Adolescente , Adulto , Estudios de Casos y Controles , Comorbilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Farmacoepidemiología , Adulto JovenRESUMEN
BACKGROUND: Recently, the US Food and Drug Administration issued a warning regarding the potential risk of gambling disorder, but large epidemiologic studies are lacking. METHODS: We used a large health claims database from the United States and conducted a nested case-control study. Cases were defined as subjects newly diagnosed with gambling disorder or impulse control disorder. For each case, 10 controls were selected and matched to cases by age and follow-up time and calendar time. Adjusted rate ratios were computed with conditional logistic regression. RESULTS: There are 355 cases of gambling disorder and 3550 controls along with 4341 cases of impulse control disorder and 43,410 corresponding controls. After adjusting for confounders, users of aripiprazole demonstrated an increased risk of pathologic gambling (rate ratio [RR], 5.23; 95% confidence interval [CI], 1.78-15.38) and impulse control disorder (RR, 7.71; 95% CI, 5.81-10.34). The risk was also elevated for pramipexole or ropinirole for both gambling disorder and impulse control disorder (RR, 7.61; 95% CI, 2.75-21.07; RR, 3.28; 95% CI, 2.31-4.66, respectively). CONCLUSIONS: Our study confirms an association between aripiprazole, pramipexole, or ropinirole and impulse control disorder and gambling disorder.
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Antipsicóticos/efectos adversos , Aripiprazol/efectos adversos , Benzotiazoles/efectos adversos , Trastornos Disruptivos, del Control de Impulso y de la Conducta/inducido químicamente , Agonistas de Dopamina/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Indoles/efectos adversos , Adulto , Canadá/epidemiología , Estudios de Casos y Controles , Estudios de Cohortes , Trastornos Disruptivos, del Control de Impulso y de la Conducta/epidemiología , Femenino , Juego de Azar/inducido químicamente , Juego de Azar/epidemiología , Humanos , Masculino , Persona de Mediana Edad , PramipexolRESUMEN
OBJECTIVE: Recently, there has been great interest in the use, abuse and over-prescribing of opioid analgesics for children. However, there is a paucity of evidence on patterns of prescribing of both narcotic and non-narcotic analgesics for children by dentists. METHODS: We used a population-wide prescription drug database (PharmaNet) in British Columbia, Canada, to examine prescribing and dispensing of analgesics surrounding dental procedures. We examined all drugs prescribed for children by dentists between 1997 and 2013, as we had access to data on drug doses and days of medication supply. We also examined trends in the use of various narcotic and non-narcotic analgesics and benzodiazepines. RESULTS: In total, 268 691 children were prescribed at least 1 study drug by a dentist. Codeine was the most frequently prescribed: 50% of children received codeine for more than 3 days. Duration of use of codeine was greatest among children ≥12 years, the longest duration of use being 5 days. CONCLUSIONS: Our study reveals that codeine prescription by dentists increased over the 16-year study period. Codeine is prescribed by dentists for 50% of children; prescriptions are for too long a duration to avoid potential morphine accumulation and are not in line with current treatment guidelines.
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Analgésicos/uso terapéutico , Pautas de la Práctica en Odontología/estadística & datos numéricos , Analgésicos Opioides/uso terapéutico , Colombia Británica , Niño , Codeína/uso terapéutico , Femenino , Humanos , Ibuprofeno/uso terapéutico , MasculinoAsunto(s)
Aripiprazol/efectos adversos , Trastornos Disruptivos, del Control de Impulso y de la Conducta/inducido químicamente , Agonistas de Dopamina/efectos adversos , Olanzapina/efectos adversos , Fumarato de Quetiapina/efectos adversos , Adulto , Femenino , Juego de Azar/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Riesgo , Adulto JovenRESUMEN
PURPOSE: Fluoroquinolones are popular antibiotics used for a myriad of conditions including ocular procedures. Despite numerous case reports of acute pigmentary degeneration of the iris with fluoroquinolone use, a pharmacoepidemiological study has not been performed to examine and quantify this risk. DESIGN: Retrospective cohort study with a case-control analysis. PARTICIPANTS: A cohort of 1,231,881 new users of oral or topical moxifloxacin, levofloxacin, and azithromycin were followed to first diagnosis of pigmentary degeneration of the iris or pigmentary glaucoma. Four controls were selected for each case using density sampling, matching on age and calendar time. METHODS: Users of oral or topical moxifloxacin were compared to levofloxacin and azithromycin, a negative control drug from a separate class. MAIN OUTCOMES AND MEASURES: First incidence of pigmentary degeneration of the iris or pigmentary glaucoma. RESULTS: The cohort was comprised of 1,231,881 new users of topical or oral levofloxacin, moxifloxacin, or azithromycin. 542 cases of pigmentary degeneration of the iris and 460 cases of pigmentary glaucoma were identified. The incidence of iris pigmentary degeneration or pigmentary glaucoma for topical moxifloxacin was 10.2/1000 person years compared to 2.6/1000 person years for topical azithromycin. Current topical moxifloxacin users had the highest adjusted IRR for pigmentary degeneration of the iris (IRR = 6.81, [95%CI:2.00-23.18]) and pigmentary glaucoma (IRR = 4.07 [95%CI:1.42-11.62]) respectively. CONCLUSIONS: The study findings suggest that patients using topical moxifloxacin may have increased risk of developing pigmentary degeneration of the iris and pigmentary glaucoma although the absolute increase was low. Future studies are needed to confirm this association.
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Importance: Recent case reports suggest use of topical prostaglandin analogues (PGAs) might increase the risk of spontaneous abortions in pregnant people who take these drugs for intraocular pressure control. However, because these reports are derived mainly from voluntary adverse drug reaction databases, they might be prone to reporting bias. Objective: To examine the risk of spontaneous abortions among pregnant people who take topical PGAs. Design, Setting, and Participants: The PharMetrics Plus database (IQVIA) for health claims in the United States from 2006 to 2020 was used as the data source. The percentage of spontaneous abortions was quantified among patients aged 15 to 45 years who were pregnant and took a topical PGA medication during this period compared with a random sample of people in the database not taking a PGA agent. Main Outcomes and Measures: Diagnosis of a spontaneous abortion was ascertained through procedure codes or codes from the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision. Results: A total of 3881 people of reproductive age who were prescribed PGAs and 3881 control participants not taking PGAs were identified. Among the 3881 patients in the PGA cohort, 261 were pregnant and 26 had a spontaneous abortion code. Among the 26 individuals, 12 (4.6%) had a spontaneous abortion code within 90 days of the pregnancy code and had an overlapping prescription for a PGA. Among the 12 individuals, 5 (41.7%) were in the age category 40 to 45 years. In the control group, there were 801 pregnancies, 56 of which led to spontaneous abortions (7%), resulting in an increased risk of 2.4% (95% CI, -0.7% to 5.4%; P = .17). Conclusion and Relevance: The results of this case-series study suggest no association between use of PGAs and risk of spontaneous abortions. Given the nature of this study design and potential for unmeasured confounding factors, these results could be explored further in future epidemiologic studies that can better control for potential confounding variables and more accurately ascertain spontaneous abortions through perinatal databases.
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Aborto Espontáneo , Aborto Espontáneo/inducido químicamente , Aborto Espontáneo/epidemiología , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Humanos , Embarazo , Prostaglandinas A , Prostaglandinas Sintéticas , Estados Unidos/epidemiologíaRESUMEN
Importance: A number of case reports and small epidemiologic studies have quantified the risk of ocular adverse events associated with the use of phosphodiesterase type 5 inhibitors (PDE5Is). However, results have been conflicting, and epidemiologic data on the risk of serous retinal detachment (SRD) and retinal vascular occlusion (RVO) are not available. Objective: To quantify the risk of SRD, RVO, and ischemic optic neuropathy (ION) associated with the use of PDE5Is. Design, Setting, and Participants: This cohort study with a nested case-control analysis was performed using data obtained from the PharMetrics Plus database (IQVIA) from January 1, 2006, to December 31, 2020. Cohort members were followed up until the first diagnosis of SRD, RVO, or ION or termination of insurance coverage. For each case, 4 controls were matched by age and time of study entry using density-based sampling. Risk for regular users of PDE5Is was compared with that for nonusers, adjusting for potential confounding variables. Cases with diagnoses of SRD, RVO, and ION in the year before the cohort were excluded. Main Outcomes and Measures: First diagnosis of SRD, RVO, or ION identified by International Classification of Diseases, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Adjusted incidence rate ratios (IRRs) with 95% CIs were calculated using conditional logistic regression, controlling for hypertension, coronary artery disease, smoking, and diabetes (for all 3 outcomes) as well as sleep apnea for the ION outcome. Results: The cohort consisted of 213â¯033 men receiving PDE5Is, including sildenafil, tadalafil, vardenafil, and avanafil. The case-control analysis included a total of 1146 cases of SRD (278), RVO (628), and ION (240) and 4584 controls, and the mean (SD) age in both groups was 64.6 (13.3) years. Patients with SRD, RVO, and ION were more likely to have hypertension, diabetes, coronary artery disease, and sleep apnea. The adjusted IRR for the composite end points of any of the 3 outcomes was 1.85 (95% CI, 1.41-2.42; incidence, 15.5 cases per 10â¯000 person-years). The adjusted IRR for SRD, RVO, and ION as individual outcomes was 2.58 (95% CI, 1.55-4.30; incidence, 3.8 cases per 10â¯000 person-years), 1.44 (95% CI, 0.98-2.12; incidence, 8.5 cases per 10â¯000 person-years), and 2.02 (95% CI, 1.14-3.58; incidence, 3.2 cases per 10â¯000 person-years), respectively. Conclusions and Relevance: Findings of this cohort study suggest that regular users of PDE5Is might have an increased risk for SRD, RVO, and ION. Regular users of PDE5Is need to be cognizant of ocular adverse events associated with these drugs and alert their physicians if they experience any visual deficits.
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Enfermedad de la Arteria Coronaria , Hipertensión , Desprendimiento de Retina , Oclusión de la Vena Retiniana , Síndromes de la Apnea del Sueño , Estudios de Cohortes , Enfermedad de la Arteria Coronaria/complicaciones , Humanos , Hipertensión/complicaciones , Incidencia , Masculino , Persona de Mediana Edad , Inhibidores de Fosfodiesterasa 5/efectos adversos , Oclusión de la Vena Retiniana/diagnóstico , Estudios Retrospectivos , Factores de Riesgo , Síndromes de la Apnea del Sueño/complicacionesRESUMEN
Importance: Taxane-based chemotherapy agents, such as docetaxel and paclitaxel, are used for treating a wide range of cancers. Although much has been published on adverse events related to taxanes, data on ocular outcomes with these very important drugs are scant. Objective: To quantify the risk of 3 mutually exclusive ocular adverse events of epiphora, cystoid macular edema (CME), and optic neuropathy with taxane-based chemotherapy agents by undertaking a large pharmacoepidemiologic study. Design, Setting, and Participants: This retrospective cohort study design used a private health-claims database from the US that captures health information of more than 150 million enrollees. The study team created a cohort of new users of women with cancer who were taking taxane-based chemotherapy (docetaxel or paclitaxel) and new users of tamoxifen as controls. Study members were observed to the first incidence of each of the 3 mutually exclusive outcomes. An analysis of taxane-only users was also undertaken. Exposure: Tamoxifen (unexposed) and taxanes (ie, paclitaxel and docetaxel) as the exposed. Main Outcomes and Measures: First diagnosis of (1) epiphora, (2) cystoid macular edema (CME), or (3) optic neuropathy ascertained using International Statistical Classification of Diseases and Related Health Problems, Ninth Revision or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision. Results: Among the 18â¯219 users in the epiphora analysis and optic neuropathy analysis, there were 1824 taxane users (paclitaxel and docetaxel) (age, mean [SD], 62.1 [12.7] years) and 16â¯395 tamoxifen users (age, mean [SD], 54.6 [12.8] years), respectively. The crude hazard ratio (HR) for epiphora was 5.55 (95% CI, 2.99-10.29) and adjusted HR was 5.15 (95% CI, 2.79-9.54). For optic neuropathy, the crude HR was 4.43 (95% CI, 1.10-17.82) and the adjusted HR was 4.44 (95% CI, 1.04-18.87). Among the 18â¯433 users in the CME analysis, there were 1909 taxane users (paclitaxel and docetaxel) (age, mean [SD], 62.5 years) and 16â¯524 tamoxifen users (age, mean [SD], 54.6 years). The crude HR for CME comparing taxane users with tamoxifen users was 1.37 (95% CI, 0.72-2.60) and adjusted HR was 1.33 (95% CI, 0.70-2.53). The HRs for epiphora and CME in the taxane cohort during the time of exposure compared with the period prior to use of the drugs were 2.86 (95% CI, 1.11-7.39) and 2.27 (95% CI, 0.68-7.54), respectively. Conclusions and Relevance: In a cohort of women who were using taxane chemotherapy agents, there was an association with elevated risk for epiphora, CME, and optic neuropathy. Ophthalmologists and oncologists should be aware of these adverse events in women with breast cancer who receive these drugs.
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Antineoplásicos Fitogénicos , Neoplasias de la Mama , Enfermedades del Aparato Lagrimal , Edema Macular , Enfermedades del Nervio Óptico , Antineoplásicos Fitogénicos/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Hidrocarburos Aromáticos con Puentes , Niño , Docetaxel/efectos adversos , Femenino , Humanos , Edema Macular/inducido químicamente , Edema Macular/tratamiento farmacológico , Persona de Mediana Edad , Enfermedades del Nervio Óptico/tratamiento farmacológico , Paclitaxel/efectos adversos , Estudios Retrospectivos , Tamoxifeno/efectos adversos , Taxoides/efectos adversosRESUMEN
Ophthalmic surgery requires a highly dexterous and precise surgical approach to work within the small confines of the eye, and the use of robotics offers numerous potential advantages to current surgical techniques. However, there is a lag in the development of a comprehensive training and credentialing system for robotic eye surgery, and certification of robotic skills proficiency relies heavily on industry leadership. We conducted a literature review on the curricular elements of established robotics training programs as well as privileging guidelines from various institutions to outline key components in training and credentialing robotic surgeons for ophthalmic surgeries. Based on our literature review and informal discussions between the authors and other robotic ophthalmic experts, we recommend that the overall training framework for robotic ophthalmic trainees proceeds in a stepwise, competency-based manner from didactic learning, to simulation exercises, to finally operative experiences. Nontechnical skills such as device troubleshooting and interprofessional teamwork should also be formally taught and evaluated. In addition, we have developed an assessment tool based on validated global rating scales for surgical skills that may be used to monitor the progress of trainees. Finally, we propose a graduating model for granting privileges to robotic surgeons. Further work will need to be undertaken to assess the feasibility, efficacy and integrity of the training curriculum and credentialing practices for robotic ophthalmic surgery.
Asunto(s)
Oftalmología , Procedimientos Quirúrgicos Robotizados , Competencia Clínica , Habilitación Profesional , Curriculum , Humanos , Oftalmología/educación , Procedimientos Quirúrgicos Robotizados/educaciónRESUMEN
There have been concerns regarding the safety of nonsteroidal antiinflammatory drugs (NSAIDs) in patients with respiratory infections. However, to date, the quality of the evidence has not been systematically assessed. The purpose of this systematic review was to evaluate the role of NSAIDs on pneumonia complications. OVID MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Google Scholar were searched. Studies that examined pneumonia complications in patients who had taken NSAIDs before onset of symptoms were identified. Quality assessment was conducted using the Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) assessment tool, which was adapted to include biases that were pertinent to this question. The search strategy identified 1721 potential studies through the 5 primary databases and searching reference lists. Of these, 10 studies met the inclusion criteria, including 5 nested case-control studies, 2 population-based case-control studies, and 3 cohort studies. In total, 59,724 adults were included from 4 of the studies (range = 57-59,250) and 1217 children from 5 studies (range = 148-540). All studies demonstrated a positive association; in adults (odds ratio/risk ratio range = 1.8-8.1) and children (odds ratio/risk ratio range = 1.9-6.8). Studies were limited by moderate or serious risk of confounding bias, exposure misclassification, and protopathic biases and sparse data bias. The results of this review demonstrate that published studies on the effect of NSAIDs use and risk of pneumonia complications are subject to a number of biases. These results should not be extrapolated as evidence of harm for NSAIDs, including ibuprofen, in respiratory ailments but highlight the need for more methodologically robust studies to evaluate this potential relationship.