Painful diabetic peripheral neuropathy is difficult to treat, partially because the underlying mechanism of pain is not fully understood. Various treatment guidelines recommend first-line agents, such as α2-δ ligands, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants but combination therapy of alternative agents including opiates is often warranted. Tapentadol extended-release has a novel dual mechanism of action; it is both a mu-opioid receptor agonist and a norephinephrine reuptake inhibitor. It has been in the spotlight since it was FDA-approved specifically for the treatment of painful diabetic peripheral neuropathy in 2012. Previous reviews of tapentadol have focused on chronic pain. The purpose of this review article is to assess the efficacy and safety of tapentadol extended-release in adult populations with painful diabetic peripheral neuropathy and provide guidance for formulary decisions.
studies). Text, tables, and figures in each label's "Clinical Studies" section were independently evaluated by two authors, and disagreements were resolved through consensus with an additional author. For each indication, we extracted the primary efficacy outcome (either explicitly stated or implicitly defined) and recorded the presence or absence of the following attributes describing treatment effects for primary outcomes: point estimates, confidence intervals, and p values. Primary efficacy outcomes were categorized as either a surrogate endpoint or direct measure of patient benefit. We classified presentation of treatment effects as absolute and relative differences and whether results for new drug and control groups were presented separately. Drug therapeutic class was based o n t h e A m e r i c a n H o s p i t a l F o r m u l a r y S e r v i c e classification. 4
SUMMARY— The nutritive value of infant foods (prepared from buffalo milk) containing 10%, 12.5% and 15% protein and fortified with DL‐methionine has been studied in experiments with albino rats. The mean weekly growth rate of rats receiving milk food II (10% protein and 20% fat) and fortified with DL‐methionine was of the same order as those obtained with milk foods containing 12.5%, 15%, 22% and 26% protein. Milk food II containing 10% protein (not fortified with DL‐methionine) promoted significantly less growth than the same food fortified with DL‐methionine and other milk foods containing 12.5% to 28% protein. The protein efficiency ratio of the milk food fortified with DL‐methionine (4.0) was significantly higher than that (3.3) of the unfortified milk food at 10% level of protein in the diet. The results indicate that humanized milk food from buffalo milk containing about 12.0% protein and 20% fat and fortified with DL‐methionine will be suitable for feeding infants in place of full cream milk powder in developing countries where milk is in short supply. Adoption of the above formula for infant milk food manufactured in the country will help to double the output of infant food from the same quantity of buffalo milk without appreciable increase in cost.
Objectives: Value and health technology assessment (V/HTA) is often used in clinical, access, and reimbursement decisions. V/ HTA data-source selection may not be transparent, which is a necessary element for stakeholder understanding and trust and for fostering accountability among decision makers. Peer review is considered one mechanism for judging data trustworthiness. Our objective was (1) to use publicly available documentation of V/HTA methods to identify requirements for inclusion of peer-reviewed evidence sources, (2) to compare and contrast US and non-US approaches, and (3) to assess evidence sources used in published V/HTA reports.Methods: Publicly available methods documentation from 11 V/HTA organizations in North America and Europe were manually searched and abstracted for descriptions of requirements and recommendations regarding search strategy and evidence-source selection. The bibliographies of a subset of V/HTA reports published in 2018 were manually abstracted for evidence-source types used in each.Results: Heterogeneity in evidence-source retrieval and selection was observed across all V/HTA organizations, with more pronounced differences between US and non-US organizations. Not all documentation of organizations' methods address the evidence-source selection processes (7 of 11), and few explicitly reference peer-reviewed sources (3 of 11). Documentation of the evidence-source selection strategy was inconsistent across reports (6 of 13), and the level of detail provided varied across organizations. Some information on evidence-source selection was often included in confidential documentation and was not publicly available.Conclusions: Disparities exist among V/HTA organizations in requirements and guidance regarding evidence-source selection. Standardization of evidence-source selection strategies and documentation could help improve V/HTA transparency and has implications for decision making based on report findings.
Drugs Fund (CDF) reconsiderations in England. During the study period, we found 102 matched condition-intervention pairs; of which, nearly two-thirds (64/102) differ by assessment outcome. NICE recommended 85/102 (83%) of the drugs, whereas HAS and G-BA reported added benefit for 59/102 (58%, including 7/102 nonreimbursable drugs) and 72/102 (71%) treatments, respectively. Findings for matched cancer drug pairs show, however, substantial differences in assessment outcomes. While NICE recommended 42/58 (72%) cancer technologies (another 12 drugs were recommended for use in the CDF only), HAS and G-BA reported 37/58 (64%, including 5/58 non-reimbursable drugs) and 49/58 (85%, including 12 drugs with an orphan designation) treatments with added benefit, respectively. Notwithstanding that far more than half (33/58) of the cancer-related HTA outcomes differ, discrepancies by therapeutic area apparently exist. Our results confirm that different methodological choices are indeed associated with differences in HTA outcomes, which may be amplified by some well-defined exceptions in national HTA systems.
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