Current medical research and opinion
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Regulations for new drug approvals require stringent safety testing and efficacy trial programs. The approval process for generic drugs, however, is significantly streamlined. Bioavailability data can substitute for new rounds of efficacy trials, thereby both decreasing time to approval and reducing the costs required for new studies. ⋯ Long-acting, inert delivery vehicles for the drug have become available for the same indications. Safety and bioavailability profiles of the long-acting products are the same or improved over the parent product. A review of the long-acting drugs provides compelling evidence to recommend that generic drug-controlled release products may be eligible for alternative regulatory programs.
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Six prospective real-world studies of antihypertensive treatment with valsartan-centric regimens were pooled to: (1) examine the effectiveness of ∼90 days of second- or later-line valsartan treatment in hypertensive patients with known comorbidities; and (2) identify physician- and patient-related determinants associated with systolic (SBP) and diastolic blood pressure (DBP) outcomes in these patients. ⋯ Valsartan-centric regimens have significant BP lowering benefits in this pooled sample of patients with known comorbidities. Many observed determinants of BP outcomes are modifiable or manageable.
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Spontaneous reporting of adverse drug reactions (ADRs) to pharmacovigilance centers is a common and inexpensive method of ADR detection. Although China requires patients to report ADRs directly, the reporting rate is extremely low. We assessed public knowledge, attitudes, and practice (KAP) regarding pharmacovigilance in Shaanxi Province, China. ⋯ The public has poor awareness about, but a positive attitude toward, pharmacovigilance. Unclear feedback pathways and lack of understanding about the seriousness of ADRs were the main reasons patients did not report ADRs, and respondents had difficulty with parts of the reporting form. The government should publicize the importance of ADR monitoring and develop more suitable forms and measures for patients to report ADR.
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Few studies have investigated extrapulmonary small cell carcinoma (EPSCC) in a systematic way. This study is to analyze EPSCC in 11 tumor sites from different aspects in the United States (1975-2016). ⋯ There was an increasing trend of EPSCC incidence. The survival of EPSCC in different tumor sites was significantly different. Tumor locations, age, gender, marital status, stage, surgery, radiotherapy and chemotherapy were all important factors of survival. This study has implications for EPSCC prevention and treatment.
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To assess the burden of treatment-resistant depression (TRD) among privately insured patients with anxiety disorder and/or substance use disorders (SUD). ⋯ In patients with an anxiety disorder and/or SUD, TRD was associated with higher HRU, healthcare costs, work loss days and work loss-related costs.