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29 Jul 2020
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Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.

Selexipag most effective when initiated early after PAH diagnosis

Roshini Claire Anthony
11 Jun 2019

The reduced mortality/morbidity benefit previously demonstrated with selexipag in patients with pulmonary arterial hypertension (PAH) may be more pronounced when treatment is initiated soon after diagnosis, according to results of a post hoc analysis of the GRIPHON* study presented as a poster at ATS 2019.

The multinational, double-blind, phase III GRIPHON trial involved 1,156 adults with PAH who were randomized to receive the oral prostacyclin receptor agonist selexipag (n=574) or placebo (n=582). This present post hoc analysis categorized patients according to time of treatment from baseline (early: 6 months from diagnosis [n=404] and late: >6 months from diagnosis [n=752]). Of these, 207 and 367 patients received selexipag early and late, respectively.

The main causes of morbidity/mortality among patients regardless of treatment were hospitalization and disease progression which occurred at a similar rate among patients who received treatment early or late (80.8 and 82.6 percent, respectively). [ATS 2019, abstract A2502/101]

Among placebo recipients, more patients who received early treatment experienced morbidity/mortality events than those treated later (50.3 percent vs 37.1 percent).

The reduction in morbidity/mortality events among selexipag compared with placebo recipients was evident in patients who received early and late treatment, though the benefit was more pronounced among those who received selexipag earlier rather than later (hazard ratio [HR], 0.45, 95 percent confidence interval [CI], 0.33–0.63 vs HR, 0.70, 95 percent CI, 0.54–0.91; pinteraction=0.0391).

The results were similar after adjusting for background PAH therapy, WHO** functional class, age (< or 65 years), sex, race, geographical region, aetiology, 6-minute walk test, and NT-proBNP** levels at baseline (HR, 0.47, 95 percent CI, 0.33–0.65 [early] and HR, 0.74, 95 percent CI, 0.57–0.96 [late]; pinteraction=0.0301).

The results were also consistent in a subgroup analysis of selexipag recipients who were categorized according to baseline receipt of background treatment for PAH (HR, 0.45 and HR, 1.02 for early and late treatment, respectively, among patients not receiving background treatment and HR, 0.47 and HR, 0.73, respectively, for patients receiving background treatment).

Mean time of exposure to selexipag was comparable between patients who received treatment early and late (76.7 vs 76.3 weeks).

The most common adverse events (AEs) experienced by selexipag recipients were headache, diarrhoea, and nausea. The proportion of selexipag recipients experiencing AEs and serious AEs was comparable between those who were treated early and late (98.1 percent vs 98.4 percent [AEs] and 43.0 percent vs 44.3 percent [serious AEs]). 

“Selexipag … reduced the risk of morbidity/mortality in patients who were treated earlier and later … with a more pronounced treatment effect in patients who were treated earlier. This pattern was observed regardless of background PAH therapy. [Furthermore], selexipag was generally well tolerated, irrespective of time from PAH diagnosis at baseline,” said the researchers.

“These data highlight the importance of initiating therapy early in PAH patients,” they said.

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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.