Trends of phosphodiesterase 5 inhibitors, glibenclamide & sibutramine adverse drug reaction reporting in Malaysia, Australia and Canada / Hasnida Mohd Ali
Bibliographic record
Abstract
Background: Phosphodiesterase 5 inhibitors such as sildenafil was originally developed for angina treatment, then discovered to have significant effect on erectile dysfunction. Sildenafil claimed to have high safety profile, but there are reports of serious adverse drug reactions (ADRs). Glibenclamide is an antidiabetic drug under sulphonylurea class. Sulphonylureas are the most prescribed oral hypoglycemic agents in Malaysia. Sibutramine is a serotonin, norepinephrine and dopamine reuptake inhibitor. It was used in obesity treatment and was withdrawn from the market in 2010. In Malaysia, PDE 5 inhibitors, glibenclamide & sibutramine are the most common poison found in the cancelled traditional complementary products within 2008-2013. There are limited knowledge whether this products are associated withADRs. Objective: This study aims to determine and compare the trends of ADR reporting of PDE 5 inhibitors, glibenclamide, and sibutramine in Malaysia, Australia and Canada. Method: Data of ADR reports of PDE 5 inhibitors, glibenclamide and sibutramine ADR reporting were collected from the Malaysia National Pharmaceutical Control Bureau (NPCB), Australia Therapeutic Goods Administrations website and Health Canada website. All data were collected from 2008-2014 for PDE 5 inhibitors and glibenclamide, and 2008-2012 for sibutramine. Then, the data were transferred onto data collection forms and ADR terms were classified according to Medical Dictionary for Regulatory (MedDRA). All ADRs were identified whether known or unknown ADR based on product information. Descriptive analyses were carried out by using Microsoft Excel software version 2013. Result: Generally, there is a decreasing trends of PDE 5 inhibitors ADR reports in Malaysia, Australia and Canada from 2008 to 2014. Nervous system diorders, eye disorders and cardiovascular disorders are the common ADRs reported associated with PDE 5 inhibitors. Blindness is the similar ADRs reported in all three countries.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".