Musculoskeletal Adverse Events Associated with PCSK9 Inhibitors: Disproportionality Analysis of the FDA Adverse Event Reporting System

Table 2

Disproportionality analyses for the various PCSK9 inhibitor regimen and statin treatment.

DDI	Exposure	Cases	Noncases	ROR (95% CI)
PCSK9 inhibitors +statins	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Statins, no PCSK9 inhibitors	7817	37516	20.17 (19.64-20.70)
	PCSK9 inhibitors+statins	97	292	32.15 (25.55-40.46)
Evolocumab+statins	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	Evolocumab, no statins	2699	46761	5.59 (5.37-5.81)
	Statins, no evolocumab	7817	37516	20.17 (19.64-20.70)
	Evolocumab+statins	72	192	36.29 (27.68-47.59)
Alirocumab+statins	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	Alirocumab, no statins	402	3976	9.79 (8.83-10.85)
	Statins, no alirocumab	7817	37516	20.17 (19.64-20.70)
	Alirocumab+statins	25	107	22.61 (14.63-34.95)
PCSK9 inhibitors +atorvastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Atorvastatin, no PCSK9 inhibitors	4217	19931	20.48 (19.78-21.20)
	PCSK9 inhibitors+atorvastatin	51	166	29.73 (21.72-40.70)
PCSK9 inhibitors +lovastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Lovastatin, no PCSK9 inhibitors	107	372	27.84 (22.45-34.52)
	PCSK9 inhibitors+lovastatin	0	29	NA
PCSK9 inhibitors +pravastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Pravastatin, no PCSK9 inhibitors	606	2801	20.93 (19.17-22.87)
	PCSK9 inhibitors+pravastatin	22	29	73.42 (42.18-127.80)
PCSK9 inhibitors +rosuvastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Rosuvastatin, no PCSK9 inhibitors	2079	8090	24.87 (23.68-26.13)
	PCSK9 inhibitors+rosuvastatin	48	136	34.16 (24.58-47.48)
PCSK9 inhibitors +simvastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Simvastatin, no PCSK9 inhibitors	2022	7485	26.14 (24.87-27.49)
	PCSK9 inhibitors+simvastatin	24	66	35.19 (22.06-56.16)
PCSK9 inhibitors +pitavastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Pitavastatin, no PCSK9 inhibitors	122	422	26.14 (24.87-27.49)
	PCSK9 inhibitors+pitavastatin	7	9	75.27 (28.03-202.13)
PCSK9 inhibitors +fluvastatin	No PCSK9 inhibitors, no statins	39034	3777742	Reference
	PCSK9 inhibitors, no statins	3088	50502	5.92 (5.70-6.15)
	Fluvastatin, no PCSK9 inhibitors	59	346	16.50 (12.52-21.75)
	PCSK9 inhibitors+fluvastatin	0	1	NA

Drug-drug interaction: DDI. NA: not applicable because of incapability to calculate the ROR (the absence of cases).